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

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



Case Details

This is page 116 out of 172

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VAERS ID: 1322665 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021531986

Write-up: Hypophagia; Pneumonia aspiration; Pyrexia; This is a spontaneous report from a contactable other health professional via the Regulatory authority. Regulatory Authority report number is 549431. An 83-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced hypophagia (Dypophagia), pneumonia aspiration and pyrexia all on 01May2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of events reported as fatal. Medicine (Onset Time in Days): COMIRNATY COVID-19 vaccine (BNT162b2 (mRNA)) - Suspect (16 days). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Hypophagia; Pneumonia aspiration; Pyrexia


VAERS ID: 1322666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
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: AUPFIZER INC2021531987

Write-up: Adverse event following immunisation/Outcome: Fatal; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. The regulatory authority report number is 549639. An 86-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unspecified age) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse event following immunisation on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. 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: Adverse event following immunisation


VAERS ID: 1322764 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021527609

Write-up: Unknown cause of death; This is as spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100058005. A 71-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Apr2021 as unknown, 0.3 mL, single for covid-19 immunisation. No medical history or concomitant medications were reported. On 27Apr2021, the patient died with unknown cause. An autopsy was performed and results were not provided. The outcome was fatal. This report is serious - death. Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory Authority. Result of Assessment: D. Unclassifiable. Autopsy pending. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1322765 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-05-02
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021527612

Write-up: Unknown cause of death; This is as spontaneous report downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100058012. A contactable physician reported that a 90 years old female patient received the second dose of BNT162B2 (COMIRNATY, Lot No. unknown) at 0.3 ml single dose for COVID-19 immunisation on 15Apr2021. Relevant medical history and concomitant drugs were not reported. The patient received the first dose of COMIRNATY for COVID-19 immunization on 19Mar2021. On 02May2021 the patient experienced Unknown cause of death. It was unknown if Autopsy was performed or not. Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory Authority. Result of Assessment: D. Unclassifiable. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1322767 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: Cardiomyopathy; COPD; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021527603

Write-up: Death sudden; Abdominal pain upper; Vomiting; This is as spontaneous report received from a non contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100058970. This report was received from Regulatory Authority. A 72 years old male patient received BNT162B2 (COMIRNATY (mRNA TOZINAMERAN, lot ET3045), on 14Apr2021 at age of 72 years old at 0.3ml single for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: ongoing COPD (Chronic obstructive pulmonary disease), Diabetes and Cardiomyopathy. No concomitant medications were reported. On 30Apr2021 the patient experienced abdominal pain upper, vomiting. On 01May2021 the patient experienced death sudden. This report is serious - death. The patient''s outcome was fatal for abdominal pain upper, vomiting and death sudden. An autopsy was unknow. Relatedness of drug to reactions/events was all events. Result of Assessment: D. Unclassifiable. It is unknown f autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vomiting; abdominal pain upper


VAERS ID: 1322779 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypertension, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 28
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 INC2021527618

Write-up: death/unknown cause of death; Hypertension; Syncope; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021059728. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100052026. An 85 years old female patient received BNT162B2 (COMIRNATY, mRNA TOZINAMERAN, Batch/Lot Number: EX3599), via Intramuscular on 28Apr2021 at 0.3 single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions were not reported. No concomitant medications were reported. On 29Apr2021 the patient experienced unknown cause of death. This report is serious - death. The patient''s outcome was fatal for unknown cause of death. An autopsy was unknow and the reported cause of death was unknown as well as other events. Sender Comment: Known allergies? If yes, which? Unknown. Information on risk factors or previous illnesses, Hypertension. Syncope / death closely related to vaccination, Relatedness of drug to reactions/events. Comirnaty/ death/ PEI/ D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1322780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 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: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac arrhythmia; Cardiac insufficiency; Coronary heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021527627

Write-up: sudden cardiac death; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021062062. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100054300. An 84 Years old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: EW8904), at 0.3 ml single dose for COVID-19 immunisation on 08Apr2021. The patient''s medical history included: Cardiac insufficiency, Coronary heart disease, Cardiac arrhythmia, all were ongoing. Relevant concomitant drug was not reported. On 15Apr2021 the patient experienced Infarct myocardial with fatal outcome. Relatedness of drug to reactions/events: Comirnaty/Infarct myocardial/ Regulatory Authority/ D. Unclassifiable. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses heart failure, coronary heart disease, cardiac arrhythmias. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1322781 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LOSAZID; CONGESCOR; SLOWMET; ASPIRINETTA; TORVAST
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infarct myocardial (2 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021527615

Write-up: Death due to massive thromboembolism in the lungs; This is as spontaneous report from a non-contactable consumer downloaded from the Regulatory Authoirty-WEB. The regulatory authority report number is DE-PEI-CADR2021065081. Safety report unique identifier DE-PEI-202100058687. A 67 years old male patient received BNT162B2 (COMIRNATY, Batch/lot number: Unknown) Intramuscular on 23Apr2021 at single dose for covid-19 immunization. The patient''s medical history and concurrent conditions included Infarct myocardial. Concomitant medications included hydrochlorothiazide/losartan potassium (LOSAZID), bisoprolol fumarate (CONGESCOR), metformin hydrochloride (SLOWMET), acetylsalicylic acid (ASPIRINETTA), atorvastatin calcium (TORVAST). On 29Apr2021 the patient experienced Thrombosis pulmonary. Patient death date was 29Apr2021. It was unknown whether autopsy was done. The patient''s outcome was fatal for Thrombosis pulmonary. Sender Comment: Details of risk factors or pre-existing conditions Taking Losazid, Congescor, Slowmed, Aspirinetta and Torvast. Had an unconscious heart attack 2 years ago. Relatedness of drug to reaction(s)/event(s): Source of assessment: Regulatory Authority, Result of Assessment: D. Unclassifiable. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Thrombosis pulmonary


VAERS ID: 1324339 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
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 INC2021534383

Write-up: probably lung embolism; This is a spontaneous report based on information received by Pfizer from Biontech (manufacturer control number: 54457), license party for BNT162B2. A contactable consumer or other non-healthcare professional reported that a 58-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced probably lung embolism on an unspecified date in 2021. Event reported as follows: as per report of the emergency physician, the cause of death was most probably lung embolism. The patient died on 01May2021. An autopsy was not performed. The outcome of event was fatal. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: lung embolism


VAERS ID: 1324354 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Cardiac arrest, Circulatory collapse, Dyspnoea, Echocardiogram, Electrocardiogram, Fall, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FINASTERIDE; TAMSULOSIN TEVA; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]; LYSODREN
Current Illness: Adrenocortical carcinoma; Enlarged prostate; Urination difficulty; Vitamin B12 deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal gland operation (Uncomplicated surgery performed for a single-sided adrenal gland tumor); Flank pain (Pain in the left flank); Hemithyroidectomy (Uncomplicated rightsided hemithyroidectomy performed, patient was feeling well after this); Thyroid gland cancer (Spreading to the right thyroid lobe)
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Large dilated right sided cavities; Test Date: 20210407; Test Name: EKG; Result Unstructured Data: Test Result:right sided block with sinus tachycardia
CDC Split Type: DKPFIZER INC2021521971

Write-up: Lung embolism; bradycardia; Clinical heart arrest with bradycardia and circulatory stop; Circulatory stop; The patient collapsed with dyspnea in the morning; The patient collapsed; This is as spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is DK-DKMA-WBS-0063637. A 77-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 06Apr2021 (Batch/Lot Number: ET3674; Expiration Date: 31Jul2021) as 1st dose, single for covid-19 immunisation. Medical history included Thyroid gland cancer (Spreading to the right thyroid lobe, stopped), adrenal gland operation from 08Feb2021 and stopped (Uncomplicated surgery performed for a single-sided adrenal gland tumor), flank pain from Dec2020 and stopped (Pain in the left flank), Hemithyroidectomy from 25Mar2021 and stopped (Uncomplicated right sided hemithyroidectomy performed, patient was feeling well after this), ongoing Vitamin B12 deficiency, ongoing Enlarged prostate, ongoing Adrenocortical carcinoma, ongoing Urination difficulty. The patient had no chronic diseases, and the patient has not had embolisms previously. Concomitant medications included finasteride 5mg taken for enlarged prostate from 24Apr2020; tamsulosin hydrochloride (TAMSULOSIN TEVA, 0.4mg) taken for Urination difficulty from 13Jun2017; cyanocobalamin-tannin complex (BETOLVEX, 1mg) taken for vitamin B12 deficiency from 16Jan2012; mitotane (LYSODREN, 500 mg) taken for adrenocortical carcinoma from 08Mar2021. There was no information regarding past medication. On 07Apr2021, one day after the vaccination, the patient developed Lung embolism. On 07Apr2021 in the morning the patient developed Dyspnea and Fall/collapsed, and an ambulance arrived. The patient developed clinical Heart arrest with Bradycardia and Circulatory failure/ circulatory stop. The patient received cardiac massage, and a Chest Compression System was placed on the patient. The patient was intubated and driven to the Emergency Clinic. Resuscitation was not possible. The patient underwent lab tests and procedures which included Transthoracic echocardiography: Large dilated right sided cavities on 07Apr2021, EKG: right sided block with sinus tachycardia on 07Apr2021. The patient died on 07Apr2021. Reported causes of death included Lung embolism, Bradycardia, Heart arrest and Circulatory failure. The ADRs were by the reporter reported as being Fatal. Date of death was on 07Apr2021. No autopsy performed. The outcome of Fall and Dyspnea were not recovered/not resolved. The outcome of Lung embolism, Heart arrest, Bradycardia and Circulatory failure was fatal. Causality assessment: The physician indicates that a pulmonary embolism is suspected to be the cause of death. The physician maintains his report, as the physician cannot rule out that the vaccine has caused the death. The physician suspects the vaccine as the cause, as the death occurs the day after the vaccination. Patient medical history provided in patient notes: The patient had no chronic diseases, and the patient has not had embolisms previously. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Circulatory failure; Heart arrest; Lung embolism; Bradycardia


VAERS ID: 1324358 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Computerised tomogram, Magnetic resonance imaging, Platelet count, Pulmonary embolism
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), Embolic and thrombotic events, venous (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CICLOSPORIN; AZITHROMYCIN; MEDROL [METHYLPREDNISOLONE]
Current Illness: Chronic osteomyelitis (recurrent chronic osteomyelitis, multiple focal non-bacterial osteomyelitis); Immunodeficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis recurrent; Juvenile arthritis; Multiple fractures
Allergies:
Diagnostic Lab Data: Test Date: 20210429; Test Name: CT scan; Result Unstructured Data: Test Result:extensive bilateral pulmonary embolism; Test Date: 20200204; Test Name: MRI; Result Unstructured Data: Test Result:persistent bone destructions; Test Name: platelet count; Result Unstructured Data: Test Result:Unknown
CDC Split Type: EEPFIZER INC2021521345

Write-up: Pulmonary embolism; Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number EE-SAM-361221042911. A 16-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 23Apr2021 (Lot Number: EW4811) as 1st dose, 0.3 mL single for covid-19 immunization. Medical history included juvenile idiopathic arthritis from an unknown date and unknown if ongoing , ongoing immunodeficiency , ongoing osteomyelitis chronic recurrent chronic osteomyelitis, multiple focal non-bacterial osteomyelitis , multiple fractures from an unknown date and unknown if ongoing and deep vein thrombosis from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin taken for an unspecified indication, start and stop date were not reported; azithromycin taken for an unspecified indication, start and stop date were not reported; methylprednisolone (MEDROL) taken for an unspecified indication, start and stop date were not reported. On 29Apr2021 at 14.00, the patient had pulmonary embolism and cardiac arrest. The side effect was fatal. The patient has concomitant immunodeficiency, recurrent chronic osteomyelitis. He has history of recurrent deep vein thrombosis, fractures. Concomitant treatment includes methylprednisolone, azithromycin, cyclosporine. It is not known whether the patient had any side effects for 6 days after vaccination. The patient arrived at the hospital in the post-resuscitation state on 29Apr2021 at 15:00 and died at 15:47. No analyzes could be taken. CT scan was performed on suspicion of pulmonary embolism. The platelet count is unknown. On 29Apr2021 at 16:35 CT: On both sides, there are thrombi in the pulmonary arteries that extend from left to right. The right cavities of the heart are dilated. Summary: Extensive bilateral pulmonary embolism, indications of right heart overload. Liver contrast is uneven - swelling? There is a thickening of adipose tissue in the hepatic portal, anterior and aortocaval, indicating swelling; also periportally there is swelling. The persistent bone destructions in the right hip joint are similar to the MRI examination on 04Feb2020, the fluid collections with contrasting walls are approximately the same. It is possible that the patient also had sepsis as an adjunct, but given the CT scan, sepsis was unlikely to be the cause of death. No definite cause of immunodeficiency was found in the documents of the hospital, investigated. The patient died on 29Apr2021. It was not reported if an autopsy was performed. Sender Comment: Serious, fatal pulmonary embolism 6 days after vaccination, but other risk factors were present and the available data do not allow a further assessment of the association with the vaccine. There is a temporal relationship. Reporter Comment: Certainly, the patient had many risk factors for thrombosis, but a 100% association with the vaccine cannot be ruled out. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Certainly, the patient had many risk factors for thrombosis, but a 100% association with the vaccine cannot be ruled out.; Reported Cause(s) of Death: Pulmonary embolism; Cardiac arrest


VAERS ID: 1324415 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 2 - / 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: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder (Cardiovascular disease (excluding hypertension)); Hypertension; Comments: Enfermedad cardiovascular (excluida la HTA) HTA
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021527611

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-854211. A 78-years-old male patient received second dose bnt162b2 (COMIRNATY,Formulation: Solution for injection,Lot Number: EY3014) via intramuscular on 04May2021 (the day of vaccination) (at the age of 78 years) at 2nd dose, single for covid-19 immunisation. Medical history included hypertension, cardiovascular disorder. The patient''s concomitant medications were not reported. Historical vaccine included the first dose of BNT162b2 (COMIRNATY, Lot# EW2243 and Expiration date were unknown) via intramuscular on 12Apr2021. On 05May2021, the patient experienced acute myocardial infarction. It was not reported if an autopsy was performed. The outcome of event was fatal. Reporter comment: Reasons for patient vaccination: Over 65 years, Cardiovascular disease (excluding HT), HT. Has had COVID-19: Unknown. Two doses administered. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1324416 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMINA [METFORMIN]; RESINCALCIO; TELMISARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancrum oris; Cardiovascular disease, unspecified; Hypertension arterial; Squamous cell carcinoma of the oral cavity stage IV; Transient ischaemic attack; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021533561

Write-up: Dyspnea; Cardiac death; presenting cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-854480. A 79-year-old male patient received second dose of bnt162b2 (COMIRNATY) via intramuscular on 04May2021 morning (Lot Number: EX8679, expiration date was unknown) as 2nd dose, single for covid-19 immunisation. Medical history included Hypertension arterial (HTA), transient ischaemic attack (TIA) in 2019, type II diabetes, stage IV squamous cell carcinoma of the mouth progressing to 2 lines of chemotherapy treatment, Cancrum oris and cardiovascular disease (excluding hypertension). Concomitant medications included metformina (METFORMIN) from 17Jan2020; calcium polystyrene sulfonate (RESINCALCIO); telmisartan taken for hypertension from 17Jan2020. Patient previously received first dose of bnt162b2 (COMIRNATY) via intramuscular on 12Apr2021 (Lot Number: EW2243, expiration date was unknown) as 1st dose, single for covid-19 immunisation. In the afternoon on 04May2021, he came to emergency department with acute dyspnea, presenting cardio-respiratory arrest upon arrival at the emergency room. Cardiopulmonary resuscitation was started without success. The patient died due to dyspnea, cardio-respiratory arrest and cardiac death on May2021. It was not reported if an autopsy was performed. It was not clear whether or not the problem was related to the vaccine, due to age, multiple comorbidities, oncological disease, a history of TIA in 2019; but given the temporal coincidence, reporter report it as a possible adverse reaction. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: dyspnea; Cardiac death; presenting cardio-respiratory arrest


VAERS ID: 1324417 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Endoscopy gastrointestinal, Mesenteric vein thrombosis, Microbiology test, Oesophageal manometry
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific dysfunction (broad), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis atrophic
Allergies:
Diagnostic Lab Data: Test Date: 201911; Test Name: abdominal CT; Result Unstructured Data: Test Result:without findings of acute pathology; Test Date: 202002; Test Name: Endoscopy gastrointestinal; Result Unstructured Data: Test Result:chronic atrophic gastritis; Test Date: 202003; Test Name: Helicobacter Pylori; Test Result: Negative ; Test Date: 202003; Test Name: esophageal manometry; Result Unstructured Data: Test Result:without altered motility
CDC Split Type: ESPFIZER INC2021527614

Write-up: Mesenteric vein thrombosis; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-855215. An 87-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in deltoid left on 08Apr2021 (Batch/Lot Number: Unknown) as 1st dose, 0.3 mL single for covid-19 immunisation. The patient medical history included chronic atrophic gastritis. The patient''s concomitant medications were not reported. The patient experienced mesenteric vein thrombosis on 16Apr2021. Outpatient study with abdominal CT in Nov2019, without findings of acute pathology. Endoscopy gastrointestinal in Feb2020, with a diagnosis of chronic atrophic gastritis, negative Helicobacter Pylori and esophageal manometry in Mar2020 without altered motility. She stayed at home with autonomy, until about 15 days before her admission on 16Apr2021, that she needed help for the basic activities of daily life and on 16Apr2021 She was admitted to attempt mobility rehabilitation in socio-sanitary center, hemodynamically stable and afebrile. Bedridden hypothetical. On 20Apr2021 in the afternoon / night she crashed, requiring volume and transfer to the hospital emergency room, where she died on 21Apr2021 around 4:00 a.m. with superior mesenteric vein thrombosis. The patient died on 21Apr2021. 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: Mesenteric vein thrombosis


VAERS ID: 1324418 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Dyspnoea, Heart rate abnormal, Hyperhidrosis, Rhonchi, Tachypnoea
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction (with medicated stent); Obesity; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021533530

Write-up: Bradycardia; Dyspnea; tachypneic; sweaty; generalized rhonchi; heartbeat not audible; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-855893. A 82-year-old male patient received second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 22Apr2021 (Lot Number: EW6326) as single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, obesity, acute myocardial infarction with medicated stent from 2005. The patient previously took ezetimiba, vildagliptin/metformin hydrocloride (ICANDRA), insulin glargine (ABASAGLAR), olmesartan medoxomil / amlodipine besilate / hydrochlorothiazide (CAPENON), pitavastatina, acetylsalicylic acid (ADIRO), pentoxifilina. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Mar2021 for COVID-19 immunisation. The patient experienced bradycardia and dyspnea on 22Apr2021. The patient was vaccinated in the morning on 22Apr2021, in the afternoon began with sudden dyspnea, tachypneic, sweaty, generalized rhonchi, heartbeat not audible by interposition of breath sounds. While the patient was transferred to exchange with the medicalized mobile unit, the patient began to desaturate, bradycardia. At 9:30 pm the patient died. ACTORTIN 200 mg iv was administered, Furosemide one ampoule, nebulization with albuterol (VENTOLIN) and Budesonide. It was not reported if an autopsy was performed. The outcome of events bradycardia and dyspnea was fatal, outcome of other events was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : ES-AEMPS-855893 AEMPS; Reported Cause(s) of Death: Bradycardia; Dyspnoea


VAERS ID: 1324420 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-30
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sensory mixed axonal and demyelinating neuropathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021533523

Write-up: Guillain Barre syndrome; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number ES-AEMPS-856662. A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 16Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included sensory mixed axonal and demyelinating neuropathy from 2014 to an unknown date. The patient''s concomitant medications were not reported. The patient experienced Guillain Barre syndrome on 30Apr2021. Additional information: 79-year-old male who 15 days after receiving bnt162b2 presented Guillain Barre syndrome with rapid progression and fatal outcome. Time Interval between Beginning/Last dose of Drug Administration and Start of Reaction / Event : 15 days (as reported). The outcome of event was fatal. The patient died on 06May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Guillain Barre syndrome


VAERS ID: 1324421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Glomerular filtration rate
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: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PERMIXON; OMEPRAZOL CINFA; AZILECT; DEPRAX [FLUOXETINE HYDROCHLORIDE]; NOLOTIL [METAMIZOLE MAGNESIUM]; SINEMET PLUS; QUETIAPINA CINFA; VESICARE; ATORVASTATINA CINFA; ACETYLSALICYLIC ACID
Current Illness: General physical health deterioration
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicectomy; Aspiration pneumonia; Benign prostatic hyperplasia; Chronic kidney disease; Cognitive impairment; Esophagitis; Essential hypertension; Gastroesophageal reflux disease; Hypertension arterial; Pneumonia; Transient cerebral ischaemia (in the left carotid territory)
Allergies:
Diagnostic Lab Data: Test Name: GFR; Result Unstructured Data: Test Result:59; Comments: mL / min / 1.73 m2.
CDC Split Type: ESPFIZER INC2021533504

Write-up: Cardiac arrest; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-856750. An 88-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 10Mar2021 (Batch/Lot Number: ET1831) as 0.3 mL single for covid-19 immunisation. Medical history included essential HT, benign prostatic hyperplasia, esophagitis due to gastroesophageal reflux (Grade I / IV), chronic kidney disease, last GFR 59 mL / min / 1.73 m2, transient cerebral ischemia in the left carotid territory from 2016, cognitive impairment of a subcortical nature and rigid-akinetic component from 2018, hypertension arterial, left basal pneumonia from unknown date to Jul2020, aspirational pneumonia in the upper and lower right lobe from unknown date to Nov2020, surgical history appendectomy, ongoing poor general condition. Concomitant medications included serenoa repens extract (PERMIXON) taken for an unspecified indication from 12Sep2012 to 12Mar2021; omeprazole (OMEPRAZOL CINFA) taken for an unspecified indication from 09Apr2019 to 12Mar2021; rasagiline mesylate (AZILECT) taken for an unspecified indication from 19Jul2012 to 12Mar2021; fluoxetine hydrochloride (DEPRAX) taken for an unspecified indication from 25Jun2020 to 12Mar2021; metamizole magnesium (NOLOTIL) taken for an unspecified indication from 12Sep2012 to 12Mar2021; carbidopa monohydrate, levodopa (SINEMET PLUS) taken for an unspecified indication from 09Apr2019 to 12Mar2021; quetiapine fumarate (QUETIAPINA CINFA) taken for an unspecified indication from 01Apr2020 to 12Mar2021; solifenacin succinate (VESICARE) taken for an unspecified indication from 18Feb2013 to 12Mar2021; atorvastatin calcium (ATORVASTATINA CINFA) taken for an unspecified indication from 19Nov2019 to 12Mar2021; acetylsalicylic acid. The patient experienced cardiac arrest on 12Mar2021 with fatal outcome. No autopsy was performed. Current illness: on 12Mar2021, family alert for the patient''s death. The Emergency service ambulance has been there, was performed 12-leads ECG: flat. Cardiopulmonary auscultation: auscultatory silence. Certified death. No signs of violence. Death occurs 36 hours after the 1st dose of the PFIZER / COMIRNATY (ET1831) vaccine (11Mar2021, as reported), in a patient with low cardiac output, although it was sudden and unexpected. Due to her poor general condition, it could have happened without any relation to the vaccine. Causation assessment: (SEFV-method of assessment): Chronology compatible with the vaccine. The notifier considers that due to the poor general condition the patient it could have happened without relation to the vaccine. Therefore, the role of the vaccine in death cannot be ruled out or confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1324439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, General physical health deterioration, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VISCOTEARS; THYROXIN; ELIQUIS; MIRTAZAPINE; ZYPREXA; LAXOBERON; PARA-TABS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Appetite disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021527617

Write-up: Death; Unresponsive to verbal stimuli; General physical health deterioration; This is a spontaneous report from a contactable physician, downloaded from the Agency Regulatory Authority-WEB regulatory authority number FI-FIMEA-20212429. An 81-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: EW4815), via an unspecified route of administration on 27Apr2021 at single dose for COVID-19 immunisation. Medical history included Alzheimer''s disease, and poor appetite. Concomitant medications included carbomer (VISCOTEARS), levothyroxine sodium (THYROXIN), apixaban (ELIQUIS) for atrial fibrillation, mirtazapine, olanzapine (ZYPREXA), sodium picosulfate (LAXOBERON), and paracetamol (PARA-TABS). Patient previously received influenza vaccine on an unspecified date in 2019 for immunization, and the first dose of BNT162B2 (COMIRNATY) on 23Feb2021 for COVID-19 immunization (no adverse events). The patient experienced unresponsive to verbal stimuli on 28Apr2021, death on 28Apr2021 16:10, and general physical health deterioration on 28Apr2021. Patient moved with help. Last night and morning feeling worsened. BP had been on good level. No fever. Did not react to speech. Had not been able to communicate with speech. Received the second of corona vaccine. Patient''s feeling had worsened for quite some time but a change for the worse had happened. Ran out of strength. Peaceful exitus at 16:10 on 28Apr2021. The patient died on 28Apr2021. 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: Unresponsive to verbal stimuli; Death; General physical health deterioration


VAERS ID: 1324442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-30
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Coma, Diarrhoea, Dyspnoea, Hyperthermia, Oxygen saturation, SARS-CoV-2 test, Serology test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic cirrhosis of liver; Anaemia (Severe anemia with repeated transfusions every 15 days); Angiodysplasia (Angiodysplasia of the colon); Anticoagulation drug level normal (Effective anticoagulation); Aortic stenosis (Tight aortic stenosis); Ascites (Refractory ascites requiring ascites punctures every 3 weeks); Ascites drainage; Atrial fibrillation; Atrial flutter; Auricular fibrillation; Blood transfusion; Cirrhosis liver; COVID-19; End stage renal failure (End-stage chronic renal failure); Essential hypertension (Essential hypertension (primary)); Fibrogastroscopy (VO grade 1 on FOGD (esopropic-duodenal fibroscopy) in February 2020); Heart valve replacement; Hemodialysis (Beginning of hemodialysis in April 2020); Hypertension arterial; Nephropathy; Non-insulin-dependent diabetes mellitus; Peptic ulcer (Peptic ulcers 2012); Peritoneal dialysis (Beginning of peritoneal dialysis in June 2020); Sleep apnoea syndromes (Paired sleep apnea syndrome); Transcatheter aortic valve implantation (TAVI in December 2019); Valvular heart disease NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: oxygen saturation; Test Result: 77 %; Comments: in AA; Test Date: 20210503; Test Name: oxygen saturation; Test Result: 87 %; Comments: under O2 5 L / min; Test Date: 20210503; Test Name: oxygen saturation; Test Result: 100 %; Comments: under O2 15L; Test Date: 20210430; Test Name: SARS-CoV-2 test PCR; Test Result: Positive ; Test Name: Serology test; Test Result: Negative ; Comments: had a control serology (date unknown): negative return
CDC Split Type: FRPFIZER INC2021521581

Write-up: calm coma; acute respiratory distress; dyspnea; diarrhea; hyperthermia; Vaccination failure; SARS-CoV-2 test positive; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB regulatory authority FR-AFSSAPS-2021048283. A 65-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), on 24Feb2021 (lot number and expiry date not reported) as first dose, single; and on 17Mar2021 (lot number and expiry date not reported) as second dose, single; both via intramuscular for covid-19 immunisation. Medical history included cirrhosis liver; severe anemia with repeated transfusions every 15 days, auricular fibrillation, hypertension arterial, COVID-19, end stage renal failure (end-stage chronic renal failure), sleep apnoea syndromes (paired sleep apnea syndrome), heart valve replacement, beginning of hemodialysis from Apr2020, beginning of peritoneal dialysis from Jun2020, non-insulin-dependent diabetes mellitus, refractory ascites requiring ascites punctures every 3 weeks, esopropic-duodenal fibroscopy (VO grade 1 on FOGD (esopropic-duodenal fibroscopy)) in Feb2020, peptic ulcers from 2012, angiodysplasia of the colon, essential hypertension (primary), effective anticoagulation, tight aortic stenosis, transcatheter implantation of an aortic valve (TAVI) in Dec2019, child C10 ethyl cirrhosis, IgA nephropathy secondary to cirrhosis, atrial fibrillation and flutter, and heart disease valve. The patient''s concomitant medications were not reported. Patient who received 2 doses of Pfizer vaccine (24Feb2021 and 17Mar2021), had a serology test (control serology) on an unknown date with negative return. Patient had SARS-CoV-2 test PCR positive on 30Apr2021 (contact of his wife and son). Patient experienced appearance of progressive dyspnea and diarrhea on 03Mar2021. On 03May2021, patient was reported to have vaccination failure. Upon arrival on 03Mar2021, patient was in peritoneal dialysis for consultation plus transfusion and patient was hyperthermia and with acute respiratory distress with O2 saturation 77% in AA (03Mar2021), 87% under O2 5 L / min (03Mar2021), and 100% under O2 15L (03Mar2021), and patient was transferred to COVID unit for treatment of severe infection. The patient was admitted in the hospital on 03May2021. On 04May2021, patient was non-reactive and in calm coma, and experienced death 05May2021. Treatments were received by the patient in response to the events reported. The outcome of the events dyspnea, diarrhea, hyperthermia, acute respiratory distress was unknown. The patient died on 05May2021. The causes of death were reported as vaccination failure, SARS-CoV-2 test positive and coma. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 test positive; Coma; vaccination failure


VAERS ID: 1324576 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-12
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX9789 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PAROXETINE; SERESTA; LANSOPRAZOLE; FOLIC ACID; DOLIPRANE; SERETIDE; PULMICORD; PREDNISONE; INNOHEP; ZYMA; TRANSIPEG [MACROGOL]; LACRYVISC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Depression; Osteoporosis; Senile macular degeneration; Stroke; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: blood pressure; Result Unstructured Data: Test Result:159/75 mmHg; Test Date: 20210414; Test Name: pulse; Result Unstructured Data: Test Result:95 beats per minute; Test Date: 20210413; Test Name: sat; Test Result: 86 %; Comments: under 5 liters of O2; Test Date: 20210414; Test Name: sat; Test Result: 81 %; Comments: desaturation under 4l of O2 through 81% glasses, rise to 5l on an extractor with saturation at 85 %,; Test Date: 20210415; Test Name: sat; Test Result: 56 %; Test Date: 20210412; Test Name: Sars-Cov-2 PCR test; Test Result: Positive ; Comments: (variant)
CDC Split Type: FRPFIZER INC2021521569

Write-up: COVID-19 pneumonitis; Vaccination failure; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-AN20211579, Safety report unique identifier FR-AFSSAPS-2021047588. A 94-year-old female patient received bnt162b2 (COMIRNATY), intramuscular (left arm) on 18Feb2021 (Batch/Lot Number: EX9789) as 2nd dose, single; and intramuscular (left arm) on 27Jan2021 (Batch/Lot Number: EJ6795) as 1st dose, single for Covid-19 immunization. Medical history included COPD (chronic obstructive pulmonary disease), senile macular degeneration, depression, osteoporosis, vascular dementia, and stroke from 02Feb2020 to an unknown date. Concomitant medications included paroxetine (PAROXETINE); oxazepam (SERESTA); lansoprazole (LANSOPRAZOLE); folic acid (FOLIC ACID); paracetamol (DOLIPRANE); fluticasone propionate, salmeterol xinafoate (SERETIDE); budesonide (PULMICORD); prednisone (PREDNISONE); tinzaparin sodium (INNOHEP); enzymes nos (ZYMA); macrogol (TRANSIPEG); and carbomer (LACRYVISC); all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient was vaccinated with a first and a second dose of Comirnaty vaccine on 27Jan2021 and 18Feb2021 respectively. It was reported that 54 days after the last dose, on 12Apr2021 the patient had COVID PCR positive (variant). On 13Apr2021, oxygen saturation was 86% under 5 liters of O2, patient asleep. On 14Apr2021, blood pressure at 159/75 and pulse at 95 beats per minute, spontaneous complaint of respiratory discomfort, desaturation under 4l of O2 through 81% glasses, rise to 5l on an extractor with saturation at 85 %, cyanosis of the extremities, all productive, expiratory brake, diffuse sibilants on auscultation, crackles up to 2/3 bilateral fields. The abdomen is tense but appearing painless and being depressible. On 15Apr2021, onset of polypnea, cyanosis with 56% saturation. It was reported that the patient had Covid-19 pneumonitis (13Apr2021). Treatment and Evolution: patient was put on Innohep and Cortancyl on 13Apr2021; introduction of morphine in palliative care on 15Apr2021; death the next day (16Apr2021). Conclusion: Patient who presented 54 days after a second dose of COMIRNATY vaccine with vaccine failure; death of the patient. Summary: Woman who has a failure vaccination 54 days after second administration of Comirnaty. Death of patient. The patient died on 16Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19 pneumonitis


VAERS ID: 1324601 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood test, Cardio-respiratory arrest, Ejection fraction, Fatigue, 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), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   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: NIFEDIPINE; BISOPROLOL; TELMISARTAN; PRADAXA; PANTOPRAZOLE; OXAZEPAM; VITAMIN D [VITAMIN D NOS]; PARACETAMOL; SYMBICORT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic obstructive lung disease; Hypertension arterial; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 202007; Test Name: blood test; Result Unstructured Data: Test Result:Nothing to report; Comments: Nothing to report (no anemia, good renal function, prediabetic condition, no malnutrition, vitamin D overload).; Test Date: 202007; Test Name: LVEF; Test Result: 52 %
CDC Split Type: FRPFIZER INC2021527610

Write-up: cardiopulmonary arrest following asthenia; cardiopulmonary arrest following asthenia; certain fatigue; Sudden death; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-LL20212519, Safety report unique identifier FR-AFSSAPS-2021048574. A 91-year-old female patient received 1st dose of BNT162B2 (COMIRNATY, lot number ET3620) at single dose intramuscular on 14Mar2021 for COVID-19 vaccination. Medical history included atrial fibrillation, Chronic obstructive lung disease, Hypertension arterial, grade 1 obesity. Concomitant drugs (usual treatment) included nifedipine, bisoprolol, telmisartan, dabigatran etexilate mesilatep (RADAXA), pantoprazole, oxazepam, vitamin D, paracetamol, budesonide, formoterol fumarate (SYMBICORT). Patient experienced sudden death on 16Mar2021 with cause of death cardiopulmonary arrest following asthenia. Patient who lived at home, well surrounded by her daughter in particular, who had seen her on 15Mar2021 when the patient had told her of a certain fatigue. Patient found dead in her bed on 16Mar2021 (lateral position, "peaceful" face). No autopsy or further explorations. Death certificate sent by the Regulatory Authority where the doctor who certified the death mentioned as the cause of death were cardiopulmonary arrest following asthenia, following the COMIRNATY vaccination. Last cardiologist consultation in Jul2020: Nothing to report (LVEF 52%). Last blood test on 02Feb2021: Nothing to report (no anemia, good renal function, prediabetic condition, no malnutrition, vitamin D overload). Outcome of certain fatigue was unknown. Outcome of other events was fatal. Note: Accountability 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.; Reported Cause(s) of Death: cardiopulmonary arrest following asthenia; Sudden death; cardiopulmonary arrest following asthenia


VAERS ID: 1324603 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Adult failure to thrive, Aphasia, Blood pressure measurement, Body temperature, Cachexia, Coma, Coma scale, Computerised tomogram head, Fall, Haematoma, Heart rate, Imaging procedure, Nervous system disorder, Pyrexia, Radius fracture, Somnolence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Osteoporosis/osteopenia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; COVID-19; Hypertension arterial; Ischemic stroke; Major depressive disorder NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: BP; Result Unstructured Data: Test Result:123/69; Test Date: 20210326; Test Name: BP; Result Unstructured Data: Test Result:141/87; Test Date: 20210325; Test Name: Temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Test Date: 20210326; Test Name: Temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210326; Test Name: Temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210329; Test Name: glasgow scale; Result Unstructured Data: Test Result:10; Comments: : there is a sliding situation with neurological disorders, aphasia, Glasgow at 10, deviation of the head and extension of the left side which will lead to a suspicion of a stroke.; Test Date: 20210326; Test Name: brain scan; Result Unstructured Data: Test Result:unremarkable: no intra or pericerebral hemorrhage; Comments: Ischemic scar of the deep territory of the right MCA (middle cerebral artery); Test Date: 20210326; Test Name: heart rate; Result Unstructured Data: Test Result:93; Test Date: 20210326; Test Name: imagining; Result Unstructured Data: Test Result:shows a fracture of the radius
CDC Split Type: FRPFIZER INC2021496650

Write-up: Falling down; Pyrexia, Temperature: 38.3 C; drowsiness; cachectic and mutic; hematoma of the left parietal scalp; Imaging shows a fracture of the radius; Adult failure to thrive; Aphasia; sliding situation with neurological disorders/deviation of the head and extension of the left side which will lead to a suspicion of a stroke; coma with worsening/Glasgow at 10; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-LM20211041. An 89-year-old patient of an unspecified gender received bnt162b2 (COMIRNATY), dose 1 intramuscular on 25Mar2021 (Lot Number: ER9470) as 1st dose, single for COVID-19 immunisation. Medical history included atrial fibrillation (AFib), major depressive disorder NOS, ischemic stroke from 2004 to an unknown date, hypertension arterial, and COVID-19 from Mar2020 to an unknown date. The patient''s concomitant medications were not reported. On the day of vaccination body temperature (T) was 35.9 C, BP 123/69. On 26Mar2021, the patient had falling down in the bathroom and pyrexia with T: 38.3 C. In the face of drowsiness, the patient was referred to the Emergency Department. On arrival at the emergency room, cachectic and mutic; hematoma of the left parietal scalp; T 37.7 C, BP 141/87, heart rate 93, and imaging shows a fracture of the radius on 26Mar2021. The brain scan (26Mar2021) was unremarkable: no intra or pericerebral hemorrhage. Ischemic scar of the deep territory of the right MCA (middle cerebral artery). The XARELTO stopped at the entrance to the emergency room. It was possible that it was resumed on 27Mar2021 (no certainty). On 29Mar2021, there was a sliding situation with neurological disorders, aphasia, Glasgow at 10, deviation of the head and extension of the left side which will lead to a suspicion of a stroke. Faced with the situation of coma with worsening on an unspecified date in 2021, imaging was not performed. The patient died on 03Apr2021. Cause of death was reported as adult failure to thrive. It was not reported if an autopsy was performed. The events falling down, pyrexia, drowsiness, cachexia, hematoma, and radius fracture led to admission of the patient in the hospital. The outcome of the event pyrexia was recovered; coma, aphasia, and neurological disorder NOS was unknown; adult failure to thrive was fatal, and not recovered for the rest of the events. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Adult failure to thrive


VAERS ID: 1324637 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-04-17
   Days after vaccination:43
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Beta 2 microglobulin, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood calcium, Blood creatinine, Blood folate, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood thyroid stimulating hormone, C-reactive protein, Cardiovascular examination, Computerised tomogram, Cytomegalovirus test negative, Echocardiogram, Electrocardiogram, Epstein-Barr virus test, Gamma-glutamyltransferase, Glomerular filtration rate, HIV test, Haemoglobin, Heart rate, Hepatic cytolysis, Hepatitis B virus test, Hepatitis C virus test, Hepatitis E virus test, Neurological examination, Neutrophil count, Oxygen saturation, Platelet count, Prealbumin, Prothrombin time, Reticulocyte count, SARS-CoV-2 test, Serum ferritin, Transferrin saturation, Vitamin B12, Vitamin D, White blood cell count
SMQs:, Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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: BRILIQUE; KARDEGIC; ATORVASTATINE ACCORD; BIPRETERAX N; BISOPROLOL; LEVOTHYROXINE SODIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract bilateral NOS; Cerebellar atrophy; COVID-19; Degeneration macular; Dyslipidaemia; Epstein-Barr virus infection; Hypertension; Microscopic haematuria (Evaluated in 2020 (normal cystoscopy) .); Penicillin allergy; Spinocerebellar ataxia (Genetically undetermined.); Stent insertion NOS (Left anterior descending artery stent in Jun2020); Stripping of rectal mucosa; Thyroid nodule
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:x10N; Test Date: 20210417; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:401 IU/L; Test Date: 20210421; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:380 IU/L; Test Date: 20210424; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:15N; Test Date: 20210413; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:$g x10N; Test Date: 20210417; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:618 IU/L; Test Date: 20210424; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:21N; Test Date: 20210421; Test Name: B2 microglobulin; Result Unstructured Data: Test Result:4.2; Comments: increase; Test Date: 20210417; Test Name: Albumin; Result Unstructured Data: Test Result:32 g/l; Test Date: 20210421; Test Name: Albumin; Result Unstructured Data: Test Result:27.5 g/l; Test Date: 20210417; Test Name: alkaline phosphatase; Result Unstructured Data: Test Result:88 IU/l; Test Date: 20210421; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:666; Test Date: 20210413; Test Name: Bilirubin; Result Unstructured Data: Test Result:slightly increased; Test Date: 20210417; Test Name: Bilirubin; Result Unstructured Data: Test Result:Subnormal; Test Date: 20210417; Test Name: Calcium serum; Result Unstructured Data: Test Result:2.78 mmol/L; Test Date: 20210417; Test Name: Creatinine; Result Unstructured Data: Test Result:74 ug/L; Test Date: 20210417; Test Name: Folate level; Result Unstructured Data: Test Result:4.2 ng/ml; Test Date: 20210421; Test Name: lactate dehydrogenase; Result Unstructured Data: Test Result:1026; Test Date: 20210417; Test Name: Potassium level; Result Unstructured Data: Test Result:3.5 mmol/L; Test Date: 20210417; Test Name: Blood pressure; Result Unstructured Data: Test Result:126/68 mmHg; Test Date: 20210429; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/75 mmHg; Test Date: 20210429; Test Name: Blood pressure; Result Unstructured Data: Test Result:80/50 mmHg; Comments: At 2:30 pm, in both arms, no tachycardia, pallor. start of vascular filling 1,000 ml of sodium chloride over 20 minutes. Blood pressure increases to 100/70 mmHg. Stable afterward.; Test Date: 20210429; Test Name: Blood pressure; Result Unstructured Data: Test Result:100 mmHg; Comments: After transfusion 2 free flow O- packed red cells, then 3-4 packed red cells + 3 fresh frozen platelets + 1 platelets and continued filling. Blood pressure around 100 mmHg afterward, stable; Test Date: 20210417; Test Name: thyroid stimulating hormone; Result Unstructured Data: Test Result:0.7 MiU/L; Test Date: 20210417; Test Name: Cardiopulmonary examination; Result Unstructured Data: Test Result:regular heart sounds, no murmur; Comments: pulse +/+ no heart failure, soft calves without pain, some sub-crackling at the bases; Test Date: 20210429; Test Name: Cardiopulmonary examination; Result Unstructured Data: Test Result:regular heart sounds; Comments: without murmur or additional noise; Test Date: 20210419; Test Name: CT scan; Result Unstructured Data: Test Result:8.5 mm nodule of the left lower lobe; Comments: Thorax: 8.5 mm nodule of the left lower lobe without suspicious criterion, with regular contours, trifoliate appearance. In addition, no intra-parenchymal lesion. Pleural void. No mediastinal adenomegaly. Normal infusion of the large vessels. No pericardial effusion. Abdomen-pelvis: the liver and pancreas are of normal morphology, there is no adenomegaly. The spleen is homogenous and of normal size.; Test Date: 20210413; Test Name: C-reactive protein; Result Unstructured Data: Test Result:41 mg/l; Test Date: 20210417; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210421; Test Name: C-reactive protein; Result Unstructured Data: Test Result:30 mg/l; Test Date: 20210421; Test Name: CMV test; Test Result: Negative ; Test Date: 20210421; Test Name: Echocardiogram; Result Unstructured Data: Test Result:no visible tumour; Comments: no visible dilation of the bile ducts; Test Date: 20210429; Test Name: Echocardiogram; Result Unstructured Data: Test Result:Normal; Comments: satisfactory echocardiography with preserved left ventricular ejection fraction, flow rate maintained, left and right filling pressures normal; Test Date: 20210429; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Normal; Test Date: 20210429; Test Name: Epstein-Barr virus test; Test Result: Negative ; Test Date: 20210417; Test Name: gamma-glutamyltranspeptidase; Result Unstructured Data: Test Result:63 IU/l; Test Date: 20210417; Test Name: GFR; Result Unstructured Data: Test Result:43 ml/min; Test Date: 20210417; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.8 g/dl; Test Date: 20210421; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.1 g/dl; Test Date: 20210429; Test Name: Hemoglobin; Result Unstructured Data: Test Result:4.5 g/dl; Test Date: 20210429; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.8 g/dl; Comments: After transfusion 2 free flow O- packed red cells, then 3-4 packed red cells + 3 fresh frozen platelets + 1 platelets and continued filling. Blood pressure around 100 mmHg afterward, stable.; Test Date: 20210417; Test Name: Heart rate; Result Unstructured Data: Test Result:76bpm; Test Date: 20210421; Test Name: Hepatitis B; Test Result: Negative ; Test Date: 20210421; Test Name: Hepatitis C; Test Result: Negative ; Test Date: 20210429; Test Name: Hepatitis E test; Test Result: Negative ; Test Date: 20210421; Test Name: Human immunodeficiency virus; Test Result: Negative ; Test Date: 20210417; Test Name: Neurological examination; Result Unstructured Data: Test Result:oriented in time and space; Comments: intact cranial pairs, no motor deficit, no pyramidal or extrapyramidal syndrome; Test Date: 20210417; Test Name: PNN; Result Unstructured Data: Test Result:8.6 g/l; Test Date: 20210417; Test Name: Saturation; Test Result: 96 %; Test Date: 20210417; Test Name: Platelet count; Result Unstructured Data: Test Result:321 g/l; Test Date: 20210417; Test Name: Prealbumin; Result Unstructured Data: Test Result:0.13 g/l; Test Date: 20210417; Test Name: Prothrombin time; Test Result: 90 %; Test Date: 20210421; Test Name: Prothrombin time; Result Unstructured Data: Test Result:Normal %; Test Date: 20210424; Test Name: Prothrombin time; Test Result: 86 %; Test Date: 20210417; Test Name: Reticulocytes; Result Unstructured Data: Test Result:72 g/l; Test Date: 20210417; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20210417; Test Name: serum ferritin; Result Unstructured Data: Test Result:1438 ng/ml; Test Date: 20210421; Test Name: serum ferritin; Result Unstructured Data: Test Result:1438 ng/ml; Test Date: 20210417; Test Name: transferrin saturation coefficient; Test Result: 23 %; Test Date: 20210421; Test Name: transferrin saturation coefficient; Test Result: 23 %; Test Date: 20210417; Test Name: Vitamin B12; Result Unstructured Data: Test Result:599 pg/mL; Test Date: 20210417; Test Name: Vitamin D; Result Unstructured Data: Test Result:32.3 ng/ml; Test Date: 20210417; Test Name: Leucocytes; Result Unstructured Data: Test Result:10.8 g/l
CDC Split Type: FRPFIZER INC2021527600

Write-up: Hepatic cytolysis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA). Regulatory Authority Report Number: FR-AFSSAPS-NT20211378. Safety Report Unique Identifier: FR-AFSSAPS-2021048291. An 84-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: ER2659), intramuscularly in left arm on 05Mar2021 at single dose for COVID-19 immunisation. Medical history included dyslipidaemia, stripping of rectal mucosa, hypertension (essential high blood pressure), stent insertion nos (left anterior descending artery stent in Jun2020), cataract bilateral NOS, degeneration macular, thyroid nodules, penicillin allergy, genetically undetermined spinocerebellar ataxia with cerebellar atrophy, microscopic haematuria evaluated in 2020 (normal cystoscopy), epstein-barr virus infection, and COVID-19. Concomitant medications included ticagrelor (BRILIQUE), acetylsalicylate lysine (KARDEGIC), atorvastatin calcium (ATORVASTATINE ACCORD), indapamide/perindopril arginine (BIPRETERAX N), bisoprolol, and levothyroxine sodium. Patient previously received the first dose of BNT162B2 (COMIRNATY) on 02Feb2021 in left arm for COVID-19 immunisation. The patient experienced hepatic cytolysis on 17Apr2021. Appearance of diarrhoea in mid-February, negative stool culture, abdominal ultrasound performed. Then sudden deterioration of his general condition for 3 weeks (end of Mar2021) with disturbance in the liver assessment with loss of 3 kg, was no longer able to get out of bed, aversion to food, stoppage of diarrhoea, no fever. No new treatments introduced (last treatment introduced in Jun2020 and normal liver assessment in Dec2020). City biological assessment 13Apr2021: Aspartate aminotransferase higher than x10N, alanine aminotransferase x10N, no cholestasis, slightly increased bilirubin, no hyperleukocytosis, C-reactive protein at 41 mg/L. For 1 week (07Apr2021), was no longer eating, could no longer get up because he was too impaired. The patient was hospitalised on 17Apr2021. Clinical examination on admission: Constants: no fever, blood pressure 126/68, 76 beats per minute, 96% in ambient air. Neurological examination: oriented in time and space, intact cranial pairs, no motor deficit, no pyramidal or extrapyramidal syndrome. Cardiopulmonary examination: regular heart sounds, no murmur, pulse +/+ no heart failure, soft calves without pain, some sub-crackling at the bases. Abdominal examination: supple, depressible abdomen without pain, no full bladder, no contracture or defence. Breast examination: breast palpation nothing to report. Locomotor examination: joints ok, right ischial haematoma, hip mobility ok. Free lymph nodes areas. Atrophy + dehydrated. Biology assessment on admission: Haemoglobin at 10.8 g/dl, platelets at 321 G/L, leukocytes at 10.8 G/L, including 8.6 G/L of polynuclear neutrophils, reticulocytes 72 G/L, prothrombin time 90%, creatinine at 74 ug/L, cockroft at 43 ml/min, natraemia at 139 mmol/L, serum potassium at 3.5 mmol/L, serum calcium corrected at 2.78 mmol/L, transferrin saturation coefficient at 23%, serum ferritin at 1438 ng/ml, subnormal bilirubin, aspartate aminotransferase at 618 IU/L, alanine aminotransferase at 401 IU/L, gamma-glutamyltranspeptidase at 63 IU/L, alkaline phosphatase at 88 IU/L, albumin 32 g/L, prealbumin at 0.13 g/L, C-reactive protein at 30 mg/L, B9 at 4.2 ng/ml, B12 at 599 pg/ml, thyroid stimulating hormone at 0.70 mIU/L, vitamin D at 32.3 ng/ml. Thoraco-abdomino-pelvic scan, 19Apr2021: Thorax: 8.5 mm nodule of the left lower lobe without suspicious criterion, with regular contours, trifoliate appearance. In addition, no intra-parenchymal lesion. Pleural void. No mediastinal adenomegaly. Normal infusion of the large vessels. No pericardial effusion. Abdomen-pelvis: the liver and pancreas were of normal morphology, there was no adenomegaly. The spleen was homogenous and of normal size. Covid-19 history: Covid-19: yes. Patient was tested yes on 17Apr2021. On 21Apr2021: albumin 27.5, normo-aregenarative haemoglobin 9.1, serum ferritin 1438, transferrin saturation coefficient 23%, C-reactive protein 30, cytolysis: Alkaline phosphatase 666, alanine aminotransferase 380, prothrombin time normal, renal function normal, lactate dehydrogenase 1026, B2 microglobulin increase 4.2. Human immunodeficiency viruses, Hepatitis B and C virus serologies, cytomegalovirus negative, previous Epstein-Barr virus infection. Deterioration of the general status highlighted, neuro disorder and hepatic cytolysis. Echo: no visible tumour, no visible dilation of the bile ducts. Introduction of corticosteroid therapy 60 mg 1 week then 40 mg and liver assessment 2/week. Progression of hepatic cytolysis during the stay. Hypothesis of an autoimmune hepatitis: sampling of the antibodies performed in that respect, and establishment of a test corticosteroid therapy. Lack of clinical improvement and progression of cytolysis. On 24Apr2021: aspartate aminotransferase cytolysis 21N, alanine aminotransferase 15N. No cholestasis, no jaundice. Prothrombin rate 86%. On 27Apr2021 suspension of the corticosteroid therapy. Introduction of N-acetyl cysteine: slow intravenous infusion of 150 mg/kg (in 250 ml of G5%) in 60 minutes then 50 mg/kg (in 500 ml of G5%) in 4 hours then 100 mg/kg (in 1,000 ml of G5%) in 16 hours. Add anti-soluble liver antigen, anti-liver kidney microsomal 1, anti-cytosol, anti-immunoglobulin 4 antibodies. Suspension of unnecessary treatment. In the absence of a favourable clinical outcome, decision to proceed with a liver biopsy on 29Apr2021: Liver biopsy puncture: small amount of liver tissue obtained. On 29Apr2021: Clinical examination: Blood pressure 130/75 mmHg, regular heart sounds without murmur or additional noise. Reassuring cardiovascular assessment, normal electrocardiogram, satisfactory echocardiography with preserved left ventricular ejection fraction, flow rate maintained, left and right filling pressures normal. Lack of argument to describe a disturbance in the liver assessment of cardiac origin, lack of argument for coronary destabilisation, the increase in troponin in this seriously ill coronary patient could be explained by the picture of deterioration of the general condition, inflammatory syndrome. On 29Apr2021, around 2:30 pm today, call because he felt worse. Low blood pressure identified in both arms at around 80/50 mmHg. No tachycardia. Pallor observed. No obvious pain described. Biological assessment performed on an urgent basis. In view of blood pressure which remains low, start of vascular filling 1,000 ml of sodium chloride over 20 minutes. Blood pressure increases to 100/70 mmHg. Stable afterward. Suspicion of haemorrhage following the liver biopsy puncture. Haemorrhagic shock situation in response to the filling. Probable haemorrhagic shock. Haemoglobin at 4.5 g/dl. Continued sodium chloride vascular filling 1,000 ml. Beginning of transfusion 2 free flow O- packed red cells, then 3-4 packed red cells + 3 fresh frozen platelets + 1 platelets and continued filling. Blood pressure around 100 mmHg afterward, stable. Biology laboratory assessment on an urgent basis: 7.8 g/dl. After decline to shock treatment, rapid deterioration, during placement of the second venous route. Blood pressure cannot be taken. Sudden haemodynamic failure. Summary: Major liver impairment with significant hepatic cytolysis, no cholestasis or associated jaundice. Prothrombin time which is maintained. No toxic or medication cause found. No recent introduction of medication. No cardiac cause found. Imaging: thoraco-abdomino-pelvic scan without abnormality on the sub-diaphragmatic floor to explain the symptoms. Viral serologies Hepatitis A (cured), hepatitis B negative, hepatitis C negative, hepatitis E negative. Negative cytomegalovirus, Epstein-Barr virus, human immunodeficiency viruses. Evolution: Sudden onset of haemorrhagic shock on 29Apr2021 following a liver biopsy puncture. Death occurred on 29Apr2021. Note: Accountability without prejudice to the elements of investigation that could be carried out within the framework of legal procedures. The patient died on 29Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, no further information obtained.; Reported Cause(s) of Death: Haemorrhagic shock


VAERS ID: 1324638 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-04-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood gases, Blood lactic acid, COVID-19, Coma scale, Computerised tomogram, Electrocardiogram, Multiple organ dysfunction syndrome, Nutritional assessment, PCO2, PO2, SARS-CoV-2 test, Urine analysis, Vaccination failure, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ASPIRIN [ACETYLSALICYLIC ACID]; PRAVASTATIN; ABASAGLAR; HUMALOG; FOLIC ACID; MACROGOL; PERMIXON; VITAMIN D NOS; LOVENOX HP; FUROSEMIDE; DEXAMETHASONE; CEFTRIAXONE; GLUCIDION
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hyperplasia; Blood pressure high; Cancer in remission; Cognitive disturbance; Cognitive impairment; Crystal arthropathy; Disease coronary artery; Hernia inguinal; Hypercholesterolaemia; Sleep apnea syndrome; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Bicarbonates; Result Unstructured Data: Test Result:18 mmol/L; Test Date: 20210421; Test Name: Gasometry; Result Unstructured Data: Test Result:alkalosis; Comments: under 6 L: Respiratory alkalosis associated with hypoxaemia; Test Date: 20210421; Test Name: Lactates; Result Unstructured Data: Test Result:2.6 mmol/L; Test Date: 20210421; Test Name: Glasgow score; Result Unstructured Data: Test Result:10/15; Comments: At the COVID unit: The patient presents with a comatose state with Cheyne-Stokes dyspnoea and loss of alertness with a Glasgow score of 6/15 (Y1, V1, M4), also presence of signs of Babinski in the lower left limb.; Test Name: Cerebral CT scan; Result Unstructured Data: Test Result:sequelae of left temporal stroke; Test Date: 20210421; Test Name: Cerebral CT scan; Result Unstructured Data: Test Result:recent superficial sylvian left ischemic stroke; Comments: Somewhat recent superficial sylvian left ischemic stroke, also right and left occipital, without haemorrhagic change. Permeable Willis polygon. Probable embolic aetiology.; Test Name: Thoraco-abdomino-pelvic CT scan; Result Unstructured Data: Test Result:bilateral pleural effusions, an enlarged prostate; Test Date: 20210421; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:discovery of atrial fibrillation; Test Name: Biological assessment; Result Unstructured Data: Test Result:deficiencies in vitamin D and folate; Comments: also sub-clinical hypothyroidism; Test Date: 20210421; Test Name: Biological assessment; Result Unstructured Data: Test Result:moderate hypernatraemia, acute renal failure; Comments: Moderate hypernatraemia at 147 mmol/L, acute renal failure at 236 ?mol/L; Test Date: 20210421; Test Name: pCO2; Result Unstructured Data: Test Result:20 mmHg; Test Date: 20210421; Test Name: pH; Result Unstructured Data: Test Result:7.57; Test Date: 20210421; Test Name: pO2; Result Unstructured Data: Test Result:70 mmHg; Test Date: 20210417; Test Name: COVID-19 virus test; Test Result: Positive ; Test Name: Cytobacteriogical urine test; Result Unstructured Data: Test Result:sterile
CDC Split Type: FRPFIZER INC2021527605

Write-up: Multiorgan failure/heart failure/renal failure and respiratory failure; Vaccination failure/positive for COVID-19; Vaccination failure/positive for COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-NT20211393. Safety Report Unique Identifier: FR-AFSSAPS-2021048736. An 80-year-old male patient received BNT162B2 (COMIRNATY), dose 2 intramuscular, administered in arm left on 28Mar2021 (Batch/Lot Number: ET3620) as 2nd dose, single, dose 1 intramuscular, administered in arm left on 02Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history included Coronary artery disease: last cardiological consultation in Feb2021; type 2 diabetes being treated; high blood pressure; hypercholesterolaemia; sleep apnoea syndrome not treated with a device; left frontotemporal stroke of probable atheromatous origin; cognitive difficulties evolving since 2019. Last assessment finding a mini-mental state at 19/30, with reported frontal behavioural disorders (irritability); otorhinolaryngology cancer: Right tonsil treated with surgery + radio-chemotherapy in 2019 considered to be in remission since then; gout-like microcrystalline arthropathy; right inguinal hernia operated on; benign prostate hypertrophy. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) at 75 mg daily in the morning; pravastatin at 20 mg daily in the evening; insulin glargine (ABASAGLAR) at 15 units in the mornings; insulin lispro (HUMALOG) 4 units morning 4 units noon 4 units evening; folic acid 5 mg; macrogol; serenoa repens extract (PERMIXON) 160 mg; vitamin D NOS; enoxaparin sodium (LOVENOX HP) 6000 DF once a day; furosemide at 80 mg 4 times a day; dexamethasone at 6 mg; ceftriaxone at 1 g; glucose, potassium chloride, sodium chloride (GLUCIDION) at 1 L daily, all taken for an unspecified indication, start and stop date were not reported. The patient experienced multiorgan failure on 21Apr2021 and vaccination failure/positive for covid-19 on 17Apr2021 with clinical course was reported as patient referred by his attending physician to the Hospital on 14Apr2021 for cognitive impairment with urinary disorders (sterile cytobacteriogical urine test performed in the city). The assessment performed in the city was the following: a cerebral CT scan finding sequelae of left temporal stroke, a thoraco-abdomino-pelvic CT scan finding bilateral pleural effusions, an enlarged prostate, a biological assessment performed finding deficiencies in vitamin D and folate as well as sub-clinical hypothyroidism. Upon his admission, the patient was diagnosed positive for COVID-19 on 17Apr2021 (the patient was vaccinated with 2 doses, the last of which was performed on 28Mar2021). Respiratory deterioration with appearance of a right base focus leading to the introduction of antibiotic therapy with Augmentin on 19Apr2021. The next day, 20Apr2021, the patient became oxygen-dependent (93% under 2 L/min) and also presented with a deterioration of alertness with oral intake not being possible. Antibiotic therapy with intravenous ceftriaxone associated with methylprednisolone 20 mg is then introduced with regard to the COVID-19 infection. At the same time, the results of 20Apr2021 found ascending brain natriuretic peptide, as well as acute renal failure. In the event of associated cardiac decompensation, intravenous furosemide 80 mg was introduced. On 21Apr2021, in view of a clear deterioration in alertness with a Glasgow score of 10/15, the patient was referred to a Covid unit. The patient presented with a comatose state with Cheyne-Stokes dyspnoea and loss of alertness with a Glasgow score of 6/15 (Y1, V1, M4), also presence of signs of Babinski in the lower left limb. Cerebral computerised tomography: Somewhat recent superficial sylvian left ischemic stroke, also right and left occipital, without haemorrhagic change. Permeable Willis polygon. Probable embolic aetiology. Biological assessment: Moderate hypernatraemia at 147 mmol/L, acute renal failure at 236 ?mol/L. Gasometry under 6 L: Respiratory alkalosis associated with hypoxaemia: pH 7.57, pCO2 at 20 mmHg, bicarbonates at 18 mmol/l, pO2 at 70 mmHg, lactates at 2.6 mmol/l. Electrocardiogram: discovery of atrial fibrillation. Medical care: Bolus of acetylsalicylic acid 300 mg administered on 21Apr2021. Introduction of a curative anticoagulant on 22Apr2021. Summary: 80-year-old patient admitted to the department with a COVID 19 infection. Picture of multi-visceral failure upon arrival in the department with major alertness problems secondary to recent multiple strokes probably of emboligenic origin, heart failure on probable non-ST + acute coronary syndrome with left ventricular ejection fraction plummeting to 25%, renal failure and respiratory failure on SARS CoV 2 infection with probable bacterial superinfection. No improvement after 48 hours of active therapy combining: Oxygen therapy with high-concentration mask. Corticosteroid therapy with dexamethasone 20 mg. Bolus of ASPIRIN alternating with curative heparin calcium (CALCIPARIN). Antibiotic therapy with tazocillin. Evolution: collective decision to limit treatment with suspension of active therapy: comfort care with midazolam and morphine. Suspension of oxygen therapy with high-concentration mask. Temperature and respiratory rate monitoring only. The patient died on 27Apr2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Multiple organ failure; Vaccination failure/positive for COVID-19; Vaccination failure/positive for COVID-19


VAERS ID: 1324648 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Malaise, Overdose, Speech disorder, Transplant rejection
SMQs:, Dementia (broad), Drug abuse and dependence (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive airways disease; Cirrhosis of liver without mention of alcohol; Liver transplant; Lung transplant
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021527630

Write-up: suspected acute rejection; Death NOS; spoke a little inconsistently; not feeling well; Overdose; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-PB20212677, Safety report unique identifier FR-AFSSAPS-2021049184. A 57-year-old male patient received BNT162b2 (COMIRNATY) intramuscular on 03May2021 (Batch/Lot Number: EX6537) as 3RD DOSE, SINGLE, on 06Apr2021 (Batch/Lot Number: EW2239) as 2ND DOSE, SINGLE, and on 05Mar2021 (Batch/Lot Number: EP2166) as 1ST DOSE, SINGLE for Covid-19 immunisation. Medical history included bipulmonary and hepatic transplant on 14Sep2019 with chronic obstructive pulmonary disease (COPD), and non-alcoholic liver cirrhosis. The patient''s concomitant medications were not reported. The patient experienced death nos on 05May2021, overdose (non-serious) on 03May2021 with outcome of unknown (as reported). The patient died on 05May2021. On 03May2021, the patient received the third dose of Pfizer anti-SARS CoV2 vaccination (batch EX6537) as an outpatient basis. No effect or specific complaint immediately after. He allegedly spoke a little inconsistently on Tuesday (04May2021) and told his daughter he was not feeling well. He was found deceased at his home on 05May2021. It was not an expected death, despite the severity of his pathology. No cardiovascular antecedent, no hypertension, normal coronary angiography and ultrasound. No kidney damage. He had been hospitalized for a corticosteroid bolus a few days before, for suspected acute rejection, with a normal ionogram (as reported). It is unknow if autopsy was done. The outcome of other events were unknown.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1324706 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, COVID-19, Diabetes mellitus, Diabetic hyperosmolar coma, Drug ineffective, Heart rate, Hypoxia, Inappropriate schedule of product administration, Off label use, Oxygen saturation, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Medication errors (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 14
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: GARDENALE [PHENOBARBITAL]; SERESTA; MIRTAZAPINE; L THYROX; ERYTROMYCIN; TIORFAN; SCOPODERM [HYOSCINE]; OXYNORMORO; HUMALOG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia absoluta (AFib); Arterial hypertension; Cognitive disorders; Deglutition disorder; Fluid replacement; Gastrointestinal tube insertion; Hyperkalemia; Hyperuricaemia; Hyponatraemia; Hypothyroidism; Insulin-dependent diabetes mellitus; Ketosis-prone diabetes mellitus; Kidney failure; Obesity; Sleep apnea; Stroke; Swallowing disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: dextro; Result Unstructured Data: Test Result:5.8 g/l; Test Date: 20210406; Test Name: blood pressure; Result Unstructured Data: Test Result:100/60; Test Date: 20210406; Test Name: heart rate; Result Unstructured Data: Test Result:65; Test Date: 20210406; Test Name: oxygen saturation; Test Result: 85 %; Test Date: 20210402; Test Name: covid-19 test; Test Result: Positive ; Comments: British variant; Test Date: 20210406; Test Name: covid-19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021527624

Write-up: comatose state / a state of hyper osmolarity linked to a decompensation of her diabetes/hyperosmolar coma; decompensation of her diabetes; respiratory decompensation; hypoxia/oxygen saturation 85%; Vaccination failure/Vaccination date: 19Jan2021, Injection 1/Date of vaccination: 25Mar2021, Injection 2; COVID-19 confirmed by positive COVID-19 test; Vaccination date: 19Jan2021, Injection 1/Date of vaccination: 25Mar2021, Injection 2; Vaccination date: 19Jan2021, Injection 1/Date of vaccination: 25Mar2021, Injection 2; This is as spontaneous report received from a contactable pharmacist downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-TO20213292, Safety report unique identifier FR-AFSSAPS-2021049377. A 69-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly on 25Mar2021 as 2nd dose, single (Batch/Lot Number: ER9470), intramuscularly on 19Jan2021 as 1st dose, single (Batch/Lot Number: ES6788) for covid-19 immunisation. Medical history included ketosis-prone diabetes mellitus, insulin-dependent diabetes, arterial hypertension, complete arrhythmia due to atrial fibrillation (AFib), kidney failure, sequelae cognitive disorders, stroke, sleep apnea, hypothyroidism, obesity, hyperuricaemia, deglutition disorder, hyponatraemia, hyperkalemia, swallowing disorders with currently rehydration by exclusive gastric tube. Concomitant medications included phenobarbital (GARDENALE); oxazepam (SERESTA 10 mg tablet); mirtazapine 15 mg tablet; levothyroxine sodium (L THYROX); erythromycin; racecadotril (TIORFAN); hyoscine (SCOPODERM patch); oxycodone hydrochloride (OXYNORMORO 5mg); insulin lispro (HUMALOG). On 25Mar2021, vaccination against COVID 19 Dose 2. On 02Apr2021, covid-19 tested positive, British variant. On 06Apr2021, tested positive for COVID 19 with on 06Apr2021 respiratory decompensation, dextro 5.8g/l, oxygen saturation 85%, heart beat 65, blood pressure 100/60. Patient was hospitalized on an unspecified date. Hospital care put under oxygen (O2) 6L/min. the patient presented on arrival a comatose state with concomitant hypoxia linked to COVID and especially a state of hyper osmolarity linked to a decompensation of her diabetes. Treatment was performed with rehydration for hyperosmolar coma insulin therapy antibiotic therapy. Palliative comfort management given the patient''s condition and the seriousness of the situation with the appearance of signs of respiratory discomfort justifying the prescription of a low dose of MIDAZOLAM. The patient eventually died on 08Apr2021 despite the treatment. An autopsy was not performed. The reported cause of death was drug ineffective, COVID-19, hyperosmolar (non-ketotic) coma and decompensation of diabetes. Outcome of drug ineffective, COVID-19, hyperosmolar (non-ketotic) coma and decompensation of diabetes was fatal, outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure/Vaccination date: 19Jan2021, Injection 1/Date of vaccination: 25Mar2021, Injection 2; COVID-19 confirmed by positive COVID-19 test; decompensation of her diabetes; Hyperosmolar (non-ketotic) coma


VAERS ID: 1324815 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 004M20A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 65
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20211

Write-up: Haemorrhage brain; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Haemorrhage brain) in an 80-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, after starting mRNA-1273 (Moderna CoviD-19 Vaccine), the patient experienced CEREBRAL HAEMORRHAGE (Haemorrhage brain) (seriousness criteria death and medically significant). The patient was treated with Surgery (Brain surgery) for Cerebral haemorrhage. The patient died on 11-Apr-2021. The reported cause of death was Haemorrhage brain. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The reporter mentioned the patient underwent brain surgery for treatment of the event, stating "Brain surgery - successful for the first bleed, not the second." Very limited information regarding this event has been provided at this time for a causal assessment.; Sender''s Comments: Very limited information regarding this event has been provided at this time for a causal assessment.; Reported Cause(s) of Death: Haemorrhage brain


VAERS ID: 1325108 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
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.MOD20211

Write-up: rabies; Based on the current case data, this case has been classified as invalid. This regulatory authority case was reported by a consumer and describes the occurrence of RABIES (rabies) in a patient of an unknown age and gender who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RABIES (rabies) (seriousness criteria death and medically significant). The patient died on 08-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided Concomitant medications were not reported. Treatment information was not reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown) dosage form. On an unknown date, the patient experienced RABIES (rabies) (seriousness criterion death). For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to event was not applicable. Very limited information regarding this event has been provided at this time. This case lacks information regarding the exact time to onset of the event, time to death, patient information, and clinical context.; Sender''s Comments: Very limited information regarding this event has been provided at this time. This case lacks information regarding the exact time to onset of the event, time to death, patient information, and clinical context.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1325129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
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 INC2021536194

Write-up: father has fallen ill and dying after taking the Pfizer vaccine; This is a spontaneous report from a non contactable consumer (patients son). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown dose, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported his father had fallen ill and dying after taking the pfizer vaccine on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. He knew many that has fallen ill after taking the vaccine. He wanted to know why Pfizer was using hydroxybutyl in the vaccine, which was usually used to cause tumour in lab mice. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: father has fallen ill and dying after taking the Pfizer vaccine


VAERS ID: 1325158 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021545293

Write-up: AORTIC DISSECTION; This is a spontaneous report from a non-contactable healthcare professional via a regulatory authority (regulatory authority number: not provided) based on information received by Pfizer from BioNtech SE (manufacturer control number HK-Fosun-2021FOS001089), license party for bnt162b2 (COMIRNATY). This healthcare professional reported two patients. This is the first of two reports. This is a spontaneous report received from a non-contactable HCP received via a regulatory authority. The regulatory authority report number is not applicable. A 58-year-old female patient started to receive a dose of TOZINAMERAN (COMIRNATY) (lot number: unknown) on 01-May-2021 via unknown route at unspecified dosing frequency for COVID-19 immunization. There was no record that the woman complained of feeling unwell during observation at the vaccination centre. Medical history, concomitant medication(s) and past product were not reported. The patient complained of chest pain and shortness of breath on 07-May-2021 and attended the Accident and Emergency Department (ADE) of hospital. Hospital examination revealed she had aortic dissection and she passed away on 08-May-2021 morning. Aortic dissection met the seriousness criterion of death. Patient died on 08-May-2021. It was unknown if the autopsy was done. Provisional cause of death was aortic dissection and there was no clinical evidence to indicate association with COVID-19 vaccination. The action taken for TOZINAMERAN (COMIRNATY) was not applicable. At the time of the report, the outcome of event was unknown. This is one of two reports received from the same reporter and this case has been linked with others. Link AER numbers are as follows: 2021FOS001089 (master case) and 2021FOS001090. Initial report was received on 08-May-2021. Follow-up closed, no further information is possible. Causality Assessment:: Aortic dissection Per Reporter = Possible Per Company (BioNTech SE) = Possible; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-2021545143 Same reporter/drug, different patient/event; Reported Cause(s) of Death: AORTIC DISSECTION


VAERS ID: 1325159 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: COVID-19 immunization
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: examination; Result Unstructured Data: Test Result:Hospital examination revealed the patient had vent
CDC Split Type: HKPFIZER INC2021545143

Write-up: ACUTE MYOCARDIAL INFARCTION; This is a spontaneous report from a non-contactable healthcare professional via a regulatory authority(regulatory authority number: not applicable), based on information received by Pfizer from BioNTech SE (manufacturer control number: HK-Fosun-2021FOS001090), license party for bnt162b2 (COMIRNATY). Two reports were received from the same reporter. This is the second of two reports. A 61-year-old male patient received BNT162B2 (COMIRNATY) (lot number: unknown) on 05May2021 at single dose for COVID-19 immunization. There was no record that the patient complained of feeling unwell during observation at the vaccination centre. Medical history, concomitant medications and past product were not reported. The patient was found collapsed at workplace at night on 07May2021 and was admitted to the Accident and Emergency Department (AED) of hospital. Hospital examination revealed the patient had ventricular fibrillation and he passed away on the same night. Acute myocardial infarction met the seriousness criterion of death. The patient died on 07May2021. It was unknown if an autopsy was performed. Provisional cause of death was acute myocardial infarction and there was no clinical evidence to indicate association with COVID-19 vaccination. The outcome of Acute myocardial infarction was fatal. Follow-up closed, no further information is possible. Causality Assessment: The reporter considered that the event Acute myocardial infarction was Unlikely related to BNT162B2. The Company (BioNTech SE) considered that the event Acute myocardial infarction was Unlikely related to BNT162B2.; Sender''s Comments: Linked Report(s) : HK-PFIZER INC-2021545293 Same reporter/drug, different patient/event; Reported Cause(s) of Death: ACUTE MYOCARDIAL INFARCTION


VAERS ID: 1325163 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-08
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA UNK / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness: Diabetes mellitus (Diabetes mellitus)
Preexisting Conditions: Comments: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRMODERNATX, INC.MOD20211

Write-up: Nemam podataka da li je bilo kakve neposredne reakcije; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Nemam podataka da li je bilo kakve neposredne reakcije) in a 59-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. UNK) for COVID-19 vaccination. Diabetes mellitus. Concurrent medical conditions included Diabetes mellitus (Diabetes mellitus). Concomitant products included INSULIN for Diabetes mellitus. On 31-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter once a day. Death occurred on 08-Apr-2021 The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not reported by the reporter. Company Comment : This is a case of death in a 59-year-old male subject with a medical history of DM, who died 8 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 59-year-old male subject with a medical history of DM, who died 8 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1325173 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-04-20
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VENTOLIN [SALBUTAMOL]; BERODUAL; THEOPHYLLINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021546158

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-256921. This spontaneous, serious case was reported on 20Apr2021 by a physician and concerns the occurrence of death after COMIRNATY injection for active immunization to prevent COVID-19. On 23Mar2021 the 77-year-old female patient received COMIRNATY concentrate for dispersion for injection (one dose 0.3 ml, contains tozinameran (COVID-19 mRNA Vaccine embedded in lipid nanoparticles), lot number: ET3620, expiry date: unknown, MAH: BioNTech Manufacturing GmbH/Pfizer) intramuscularly in the left arm to prevent COVID-19. On 20Apr2021 the patient was found dead in the stairway of her flat by a stranger. Police was notified. Autopsy was performed. Further information is expected about the cause of death. According to the doctor''s opinion the patient possibly suffered pulmonary embolism. Concomitant drugs are Berodual (fenoterol, ipratropium bromide), Ventolin (salbutamol) and theophylline. Medical history includes asthma. Sender Comment: The patient died 27 days after the vaccination. Further information is expected about the cause of death. The causal relationship between the reported death and the vaccine is unassessable. The case is considered serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1325174 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, Paraplegia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Obesity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021546156

Write-up: COVID-19/COVID-19 pneumonia; COVID-19; COVID-19 pneumonia; respiratory failure; paraplegia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB HU-OGYI-259821. A 68-year-old male patient received BNT162B2 (COMIRNATY) Lot number ET7205, Intramuscular in left arm on 26Mar2021 at 0.3 ml single for COVID-19 immunisation. Medical history included ongoing Obesity. Concomitant medication was not reported. The patient experienced COVID-19, COVID-19 pneumonia, paraplegia and respiratory failure after the use of BNT162B2. On 16Apr2021, the patient died. The outcome of all events was fatal. Sender Comment: COVID-19, COVID-19 pneumonia, paraplegia and respiratory failure is not expected after the use of Comirnaty concentrate for injection. TTO is 21 days. Dechallenge and rechallenge were not applicable. According to the SmPC, individuals may not be fully protected until 7 days after their second dose. The causal relationship between the suspected drug and the events is considered unlikely. The case is considered serious due to fatal outcome. ; Reported Cause(s) of Death: COVID-19; COVID-19/COVID-19 pneumonia; COVID-19 pneumonia; respiratory failure; paraplegia


VAERS ID: 1325175 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrioventricular block complete, Bradycardia, Cardiac failure congestive, Cardiogenic shock, Circulatory collapse, Dizziness, Head injury, Ischaemic cardiomyopathy, Loss of consciousness, Respiratory arrest, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Conduction defects (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: STIPATIN; SYNCUMAR; APO-FAMOTIDIN; RENITEC COMP; MILURIT; METOPROLOL HEXAL Z; ASPIRIN PROTECT; CITROKALCIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency; Heart valve replacement; Hypertension; Secondary parkinsonism
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021535705

Write-up: full atrial chamber block; head trauma; momentary loss of consciousness 4-5 times; cardiogenic shock; syncope; congestive heart failure; bradycardia; ischemic cardiomyopathy; dizziness; cardiovascular collapse; respiratory arrest; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number HU-OGYI-280621. An 84-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 17Mar2021 (Batch/Lot Number: ET1831) as 1st dose, 0.3 mL, single for Covid-19 immunization. Medical history included hypertension, secondary parkinsonism, prosthetic heart valve replacement and chronic renal insufficiency; all from an unknown date and unknown if ongoing. Concomitant medications included fluvastatin sodium (STIPATIN); acenocoumarol (SYNCUMAR); famotidine (APO-FAMOTIDIN); enalapril maleate, hydrochlorothiazide (RENITEC COMP); allopurinol (MILURIT); metoprolol succinate (METOPROLOL HEXAL Z); acetylsalicylic acid (ASPIRIN PROTECT); calcium citrate (CITROKALCIUM); all taken for an unspecified indication, start and stop date were not reported. On 30Mar2021, the patient was transported to the hospital with a head trauma which caused momentary loss of consciousness 4-5 times, due to serious bradycardia. In consequence of cardiovascular instability, the patient experienced cardiovascular collapse and respiratory arrest. It was reported by a physician that the patient had the occurrence of head loss of consciousness, bradycardia, cardiogenic shock, ischemic cardiomyopathy and congestive heart failure resulting in death after COMIRNATY injection for active immunization to prevent COVID-19. The patient also had full atrial chamber block, syncope, and dizziness. Temporary pacemaker implantation, and resuscitation was unsuccessful. The outcome of events was fatal. The patient died on 30Mar2021. It was unknown if an autopsy was performed. Senders comments: Loss of consciousness, bradycardia, cardiogenic shock, ischemic cardiomyopathy and congestive heart failure are neither listed nor expected as an adverse event in the SmPC of COMIRNATY. The causality between the vaccine and the events considered unlikely. The case is considered serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on available information the reported events assessed as unrelated to BNT162B2. The events likely represent intercurrent medical conditions in this elderly patient with underlying chronic renal insufficiency, hypertension, prosthetic heart valve replacement, concurrent head trauma and polypharmacy. 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: syncope; congestive heart failure; bradycardia; ischemic cardiomyopathy; dizziness; cardiovascular collapse; respiratory arrest; full atrial chamber block; head trauma; momentary loss of consciousness 4-5 times; cardiogenic shock


VAERS ID: 1325202 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, Fall, Pulseless electrical activity, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EPILIM CHRONO; ELTROXIN; RISPERDAL CONSTA; SINEMET PLUS; MIDON; RISPERIDONE; ULTIBRO BREEZHALER; AVODART; ASPIRIN [ACETYLSALICYLIC ACID]; KEMADRIN; NEXIUM [ESOMEPRAZOLE SODIUM]; ADENURIC; FUROSEMIDE; BISOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: BPH; Delirium (Admission in January.); Gout; Heart disease pulmonary; LRTI (Admission in January.); Oxygen therapy (baseline sats 80-82%); Parkinsonism (drug induced); Psychosis; Pulmonary embolism; Pulmonary fibrosis; Urinary tract infection (Admission in January.)
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: ECG; Result Unstructured Data: Test Result:Pulseless electrical activity (PEA)
CDC Split Type: IEPFIZER INC2021527633

Write-up: UNRESPONSIVE; PEA ON ECG; CARERS HEARD A ROAR AND A THUMP AS PATIENT FELL TO GROUND; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance WEB, regulatory authority report number IE-HPRA-2021-071649. An 81-year-old male patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: EW2243) at 0.3ml single for covid-19 immunisation. Medical history included benign prostatic hyperplasia, pulmonary fibrosis, previous pulmonary embolism, undifferentiated psychosis, urinary tract infection (Admission in January), delirium (Admission in January), lower respiratory tract infection (Admission in January), home oxygen therapy baseline saturation 80-82%, gout, and drug induced parkinsonism and Heart disease pulmonary, all from an unknown date and unknown if ongoing. On 09Mar2021, the patient was vaccinated with his first dose of bnt162b2 (COMIRNATY, batch number unknown), at a dose of 0.3 ml. Concomitant medication(s) included valproate sodium/ valproic acid (EPILIM CHRONO); levothyroxine sodium (ELTROXIN); risperidone (RISPERDAL CONSTA); carbidopa monohydrate, levodopa (SINEMET PLUS); midodrine hydrochloride (MIDON); risperidone; glycopyrronium bromide/ indacaterol maleate (ULTIBRO BREEZHALER); dutasteride (AVODART); acetylsalicylic acid (ASPIRIN); procyclidine hydrochloride (KEMADRIN); esomeprazole sodium (NEXIUM); febuxostat (ADENURIC); furosemide; and bisoprolol for cardiac disorder from an unspecified start date to 06Apr2021. The patient had a fall, became unresponsive to stimuli and pulseless following vaccination with bnt162b2 for COVID-19 immunisation. On 06Apr2021, the patient was vaccinated with his second dose. On 07Apr2021, in the morning at 6 am, the patient fell to the ground while walking and became unresponsive. CPR was performed immediately and ambulance arrived 15 20 minutes later. Pulseless electrical activity was shown on electrocardiogram and the patient was pronounced dead at the scene. The reporter stated they were unclear as to whether this was a result of the vaccine or coincidental given the patient''s vast comorbidities and polypharmacy. The patient was referred to the coroner and a post mortem was performed and the post mortem results were pending. No follow up attempts possible. No further information expected.; Reported Cause(s) of Death: unresponsive; PEA ON ECG; CARERS HEARD A ROAR AND A THUMP AS PATIENT FELL TO GROUND


VAERS ID: 1325203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-12
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Cyanosis, Pulmonary embolism, Respiratory arrest, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVODOPA/CARBIDOPA; ASPIRIN [ACETYLSALICYLIC ACID]; ROSUVASTATIN; TAMSULOSIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: BPH; Hypercholesterolaemia; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:large bilateral Pulmonary embolim''s; Comments: the CT pulmonary angiogram showed large bilateral pulmonary embolism.
CDC Split Type: IEPFIZER INC2021527629

Write-up: RESPIRATORY ARREST; COLLAPSE; CYANOSIS; ACUTE BILATERAL PULMONARY EMBOLUS; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is [IE-HPRA-2021-071732]. An 86-year-old male patient received the second dose of bnt162b2 (COMIRNATY), on 01Apr2021 (Lot Number: ER9480) as single dose for covid-19 immunisation. The patient medical history included Parkinson''s disease, benign prostatic hyperplasia (BPH), and hypercholesterolaemia. The patient''s concomitant medication included tamsulosin for BPH, levodopa/cardidopa for Parkinson''s disease, rosuvastatin for cholesterol and acetylsalicylic acid (ASPIRIN). The patient previously received the first dose of bnt162b2 (COMIRNATY), on 04Mar2021 (Lot Number: ER2659) as single for covid-19 immunisation. The patient experienced collapse on 12Apr2021, cyanosis on 12Apr2021, acute bilateral pulmonary embolus on 12Apr2021, and respiratory arrest on 14Apr2021. On 12Apr2021, the patient collapse at home and was cyanotic. It was reported that when ambulance arrived the patient''s cyanosis had improved. Subsequently, the patient was admitted to hospital and experienced one further episode of cyanosis. The patient was treated with Clexane. On 14Apr2021, the CT pulmonary angiogram showed large bilateral pulmonary embolism. The patient experienced respiratory arrest and passed away on 14Apr2021. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: respiratory arrest; COLLAPSE; CYANOSIS; ACUTE BILATERAL PULMONARY EMBOLUS


VAERS ID: 1325204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OPSUMIT; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]; ASPIRIN [ACETYLSALICYLIC ACID]; NIFEDIPINE; PROLIA; NEUPRO; ROSUVASTATIN; TADALAFIL; COLECALCIFEROL; ESOMEPRAZOLE; TRELEGY; FRUMIL; VENLAFAXINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Interstitial lung disease; Mixed connective tissue disease; Pulmonary fibrosis; Restless legs
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021527625

Write-up: ACUTE RESPIRATORY ARREST; acute chronic respiratory distress; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-071765. A 77 years old female patient received 2nd dose of BNT162B2 (COMIRNATY, lot number EW8904) at 0.3 ml single dose on 13Apr2021 via an unknown route for COVID-19 immunisation. Medical history included pulmonary fibrosis , mixed connective tissue disease, depression, restless legs syndrome, interstitial lung disease. Concomitant drugs included macitentan (OPSUMIT), hydroxychloroquine sulfate (PLAQUENIL), acetylsalicylic acid (ASPIRIN), nifedipine, denosumab (PROLIA), rotigotine (NEUPRO) for restless leg, rosuvastatin, tadalafil, colecalciferol, esomeprazole, fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), amiloride hydrochloride, furosemide (FRUMIL, low strength), and venlafaxine for depression. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY, lot number ER7812) at 0.3 ml single dose on 116Mar2021 for COVID-19 immunisation. Following vaccination with Comirnaty on 15Apr2021, the patient experienced acute chronic respiratory distress and fatal respiratory arrest on 15Apr2021. Time interval between beginning of drug administration and start of reaction / event was 2 days. It was unknown if autopsy was done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: acute chronic respiratory distress; Acute respiratory arrest


VAERS ID: 1325205 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bedridden, Dyspnoea exertional, Hyperhidrosis, Pyrexia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 4
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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021527622

Write-up: TACHYCARDIA; BREATHLESS ON EXERTION; WEAKNESS ON EXERTION / TOO WEAK TO GET UP; TOO WEAK TO GET UP; SWEATING ++; FEVER; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [IE-HPRA-2021-071813]. A 73-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW2243) as 1ST DOSE, 0.3 ML SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient experienced hyperhidrosis, pyrexia, asthenia, dyspnoea exertional, tachycardia, and bedridden following vaccination with Comirnaty for COVID-19 immunisation. Clinical details was reported as below: On 10Apr2021, approximately 12-24 hours post-vaccination, the patient was reported to be experiencing sweating, fever, weakness on exertion, and too weak to get up. The patient took paracetamol. On 12Apr2021, the patient contacted her general practitioner and was reported to be feeling a little better. On 13Apr2021, in the afternoon, the patient was feeling breathless with tachycardia and too weak to get up. Subsequently, she was transferred to hospital by ambulance. On 14Apr2021, the patient died. It was not reported if an autopsy was performed. The reporter stated the patient was infrequent attender and it was unknown if the patient had any medical history or any undiagnosed underlying conditions. The reporter noted on 13Apr2021, the patient had a large abdomen despite being thin, which the patient claimed it was normal for her. The reporter also stated they were not sure if the reaction was a result of the vaccine as they did not receive information from the hospital on the possible cause of death. Outcome of the events was fatal. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Tachycardia; Too weak to get up; Sweating ++; Fever; BREATHLESS ON EXERTION; WEAKNESS ON EXERTION / TOO WEAK TO GET UP


VAERS ID: 1325213 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021521642

Write-up: Sudden death; This is a spontaneous report from a contactable other health professional downloaded from the a regulatory authority-WEB IS-IMA-2269. An 85-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Batch/Lot Number: Unknown), via an unspecified route of administration on 30Mar2021 as 2nd dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY; Batch/Lot Number: Unknown) on 09Mar2021 for COVID-19 immunisation. The patient had a sudden death on 14Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible, information on the batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1325297 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of DYSPNOEA in a 99-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cardiomyopathy NOS. On 16-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On 17-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced DYSPNOEA (seriousness criterion death). The patient died on 20-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not reported. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Follow up (translation) report received on 06MAY2021 included no new information.; Sender''s Comments: This is a case of death in a 99-year-old female subject with a medical history of Cardiomyopathy NOS, who died 4 days after receiving the first dose of vaccine. Based on information received, patient''s age and cardiomyopathy with recurrent respiratory crisis, the event is assessed as unlikely related to mRNA-1273..; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1325300 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Erythema, Hyperhidrosis, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: AFib; Cardiac failure (HA class IV); Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: cardio-circulatory conditions worsened; This regulatory authority case was reported by a physician and describes the occurrence of CARDIOVASCULAR DISORDER (cardio-circulatory conditions worsened) in an 88-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cardiac failure (HA class IV), AFib and Parkinson''s disease. On 20-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 20-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIOVASCULAR DISORDER (cardio-circulatory conditions worsened) (seriousness criterion death). On 21-Apr-2021, the patient experienced ERYTHEMA, HYPERHIDROSIS , VOMITING and PYREXIA. The patient died on 21-Apr-2021. The reported cause of death was Cardiovascular disorder. An autopsy was not performed. At the time of death, ERYTHEMA , HYPERHIDROSIS , VOMITING and PYREXIA outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Immediately after the vaccination, the patient''s cardio-circulatory conditions worsened, which led to death. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was not applicable as the patient died. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Cause of death added and narrative updated. On 07-May-2021: No new information. On 10-May-2021: Autopsy done was updated to no On 11-May-2021: No new information.; Sender''s Comments: This is a case of death in a 88-year-old female subject with a medical history of Cardiac failure (HA class IV), A Fib and Parkinson''s disease, who died one day after receiving the first dose of vaccine. Although a temporal association exists, based on reporter''s causality, patient''s age and Cardiac failure (HA class IV), the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Cardiovascular disorder


VAERS ID: 1325433 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-03
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6327 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Anaemia, Chest pain, Death, Haematuria, Thrombocytopenia
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: anemia; Result Unstructured Data: Test Result:7 g/dl; Test Name: PLATELETOPENIA; Result Unstructured Data: Test Result:86000
CDC Split Type: ITPFIZER INC2021527635

Write-up: died; Chest pain, likely acute coronary syndrome. On 04/28/2021 he received second dose of anticovid pfizer vaccine. Plateletopenia (86000), anemia (7 g / dl), hematuria; Chest pain, likely acute coronary syndrome. On 04/28/2021 he received second dose of anticovid pfizer vaccine. Plateletopenia (86000), anemia (7 g / dl), hematuria; Chest pain, likely acute coronary syndrome. On 04/28/2021 he received second dose of anticovid pfizer vaccine. Plateletopenia (86000), anemia (7 g / dl), hematuria; Chest pain, likely acute coronary syndrome. On 04/28/2021 he received second dose of anticovid pfizer vaccine. Plateletopenia (86000), anemia (7 g / dl), hematuria; Chest pain, likely acute coronary syndrome. On 04/28/2021 he received second dose of anticovid pfizer vaccine. Plateletopenia (86000), anemia (7 g / dl), hematuria; This is a spontaneous report from a contactable physician downloaded from the regulatory authority IT-MINISAL02-724156. An 81-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 28Apr2021 (Batch/Lot Number: EW6327) as 0.3 mg, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) for covid-19 immunization. The patient experienced chest pain, likely acute coronary syndrome. on 28Apr2021 he received second dose of anticovid pfizer vaccine. plateletopenia (86000), anemia (7 g / dl), hematuria (death) on 03May2021. The patient underwent lab tests and procedures which included anaemia: 7 g/dl, thrombocytopenia: 86000. The patient died on 03May2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: The reporter contacted on 03May2021: the patient''s autopsy has been ordered, all data will be updated as soon as available. - Ethnic origin (PRIVACY)) - COVID 19 COMIRNATY VACCINE (PFIZER): Booster dose number (2). Batch number: EW6327 No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: died


VAERS ID: 1325439 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-28
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: Hypertension arterial (treated with ace-inhibitors); Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: ECG; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021533412

Write-up: Chest pain; heart attack; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-724859. A 68-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular at 19:29 on 16Apr2021 (Batch/Lot Number: EX0893; Expiration Date: 31Jul2021) as 1st dose, single for COVID-19 immunisation. Medical history included hypertension arterial (treated with ace-inhibitors) and obesity, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced chest pain and heart attack on 28Apr2021. The patient underwent lab tests and procedures which included ECG with unknown results on 28Apr2021. Therapeutic measures were taken as a result of the events. The patient died of chest pain and heart attack on 03May2021. It was not reported if an autopsy was performed. Sender Comment: Local Responsibles for Pharmacist: The reporter was contacted on 05May2021 to ask for information regarding the reason for the death, whether it was a first or second dose, the date of administration and time of administration of the suspected vaccine and a clinical report.Once the above information is received the form will be updated. The clinical report received from the reporter is attached on 07May2021. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Chest pain; heart attack


VAERS ID: 1325442 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Atrial fibrillation, Pneumonia, Pulmonary embolism, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SANDOSTATINA [OCTREOTIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperglycemia (sporadic episodes); Hypertension (sporadic episodes); Thymoma malignant (prevention of cancer recurrence operated in 2002 for malignant thymoma and treated with Sandostatin)
Allergies:
Diagnostic Lab Data: Test Name: Angio CT; Result Unstructured Data: Test Result:numerous embolism emanate
CDC Split Type: ITPFIZER INC2021527634

Write-up: Four days after the second dose of Comirnaty, there was a consistent onset of respiratory distress, atrial fibrillation and pneumonia which required emergency hospitalization.; pulmonary embolism, numerous embolism emanate; Four days after the second dose of Comirnaty, there was a consistent onset of respiratory distress, atrial fibrillation and pneumonia which required emergency hospitalization.; Four days after the second dose of Comirnaty, there was a consistent onset of respiratory distress, atrial fibrillation and pneumonia which required emergency hospitalization.; This is a spontaneous report received from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-725362. This is first of two reports. An 84-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 08Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included hyperglycaemia from an unknown date and unknown if ongoing (sporadic episodes), hypertension from an unknown date and unknown if ongoing (sporadic episodes), thymoma malignant from an unknown date and unknown if ongoing (prevention of cancer recurrence operated in 2002 for malignant thymoma and treated with Sandostatin). Concomitant medication included octreotide (SANDOSTATINA [OCTREOTIDE]) taken for neoplasm of thymus, start and stop date were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) on 18Mar2021 for covid-19 immunization and experienced fatigue due to slight respiratory problems which then resolved spontaneously in a few days. The patient experienced four days after the second dose of comirnaty, there was a consistent onset of respiratory distress, atrial fibrillation and pneumonia which required emergency hospitalization (death) on 12Apr2021. The patient underwent lab tests and procedures which included angiogram: numerous embolism emanate. Therapeutic measures were taken as a result of four days after the second dose of comirnaty, there was a consistent onset of respiratory distress, atrial fibrillation and pneumonia which required emergency hospitalization. The patient died on 05May2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Gestation Period at Time of Exposure (number) (unit) for Comirnaty 50days. After the 1st dose of 18Mar onset of fatigue due to slight respiratory problems which then resolved spontaneously in a few days; 4 days after the second dose of the 08Apr onset of AF and an important exacerbation of respiratory difficulty that on 26Apr made hospitalization necessary. Pneumonia and pulmonary embolism are diagnosed. Death occurs on 5May - Actions taken (Hospitalization, pulmonary Angio CT from which numerous embolism emanate; cortisone and antibiotic therapy undertaken.) - Pregnancy (yes) - Impact on quality of life (10/10) - COVID 19 COMIRNATY VACCINE (PFIZER): Side of administration (left shoulder) Booster dose number (2). Reporter''s comments: Patient in prevention of cancer recurrence operated in 2002 for malignant thymoma and treated with Sandostatin; in clinical history sporadic episodes of hyperglycemia and hypertension. Sender''s comments: On 06May the reporter reports the patient''s death on 05May at the Clinic due to probable pulmonary complications; the clinical documentation provided by the Clinic and of which the reporter does not have for now, will be attached. Information on the lot/batch number has been requested.; Reporter''s Comments: Patient in prevention of cancer recurrence operated in 2002 for malignant thymoma and treated with Sandostatin; in clinical history sporadic episodes of hyperglycemia and hypertension.; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-2021533406 the same patient/reporter, different event/dose; Reported Cause(s) of Death: probable pulmonary complications


VAERS ID: 1325444 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 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: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN; TIMOGEL; POLYVITAMIN [VITAMINS NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ocular hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021533613

Write-up: Death; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-725645. A 65-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot number: EX7389; expiration date: 31Aug2021), intramuscularly, administered in left arm (left shoulder) on 04May2021 13:14 (at 65-year-old) at 300 uL, single for COVID-19 immunisation. Medical history included type 2 diabetes mellitus, ocular hypertension. Concomitant medications included metformin taken for type 2 diabetes mellitus; timolol maleate (TIMOGEL) taken for ocular hypertension from 12Jun2013 to 03May2021; vitamins nos (POLYVITAMIN [VITAMINS NOS]). The patient experienced death on 04May2021 14:13. It was unknown if an autopsy was performed. Reporter comments: reporter provided the following report for the temporal proximity between the administration of the vaccine, about 13:14 of 04May2021 and the time of death 14:13 on 04May2021 - VACCINE COVID 19 COMIRNATY (PFIZER): Site of administration (left shoulder) Booster dose number (1) Time of administration (13:14) Lot expiry date (31Aug2021) - polyvitamin: Substance name (food supplement) Type of administration (concomitant). Reporter did not believe that the death was due to the drug reporter was making this report because of the proximity in time between the administration of the vaccine at 13:14 on 04May2021 and the time of death at 14:13 on 04May2021 Vaccination took place at the Hospital. Sender Comment: On 06May2021 requested and received from the information on lot, time of deltoid No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporter did not believe that the death was due to the drug reporter was making this report because of the proximity in time between the administration of the vaccine at 13:14 on 04May2021 and the time of death at 14:13 on 04May2021 Vaccination took place at the PRIVACY Hospital; Sender''s Comments: The event sudden death considered unlikely related to suspect product BNT162B2 (COMIRNATY, lot number: EX7389; expiration date: 31Aug2021) in this 65-year old elderly patient with comorbidities type 2 diabetes mellitus, ocular hypertension.; Reported Cause(s) of Death: Death


VAERS ID: 1325445 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Dyspnoea, Electrocardiogram, Fibrin D dimer, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:S1Q3T3, Echocardium right sections increased; Test Name: Fragment D dimer; Result Unstructured Data: Test Result:enormously elevated; Test Date: 20210501; Test Name: Fragment D dimer; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021533518

Write-up: Chest pain and dyspnea; Chest pain and dyspnea; suspected pulmonary embolism; cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-725795. A 71-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EX7389), intramuscularly, administered in Right arm (also reported as right shoulder) on 28Apr2021 at 11:54 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: et7205), on 07Apr2021 at single dose for COVID-19 immunisation. The patient experienced chest pain and dyspnea, suspected pulmonary embolism and cardiac arrest on 30Apr2021. It was reported that patient arrived in the emergency room for chest pain from the afternoon and dyspnoic on 30Apr2021, immediate subsequent cardiac arrest resumed with CPR and IOT on 30Apr2021, very likely very suspected pulmonary embolism on 30Apr2021 (enormously elevated dimer, ECG: S1Q3T3, Echocardium right sections increased on unspecified dates). Patient being treated with insulin, furosemide, nebivolol, perindopril, ASA, amlodipine, allopurinol, sinvastatin, lansoprazole (Actions taken included IOT, administration of heparin sodium, adrenals, bicarbonates, Potassium, insulin). The patient underwent lab tests and procedures which included ECG: S1Q3T3, Echocardium right sections increased, enormously elevated dimer, both on unspecified dates; fragment D dimer with unknown results on 01May2021. Therapeutic measures were taken as a result of all events. The outcome of the events chest pain, dyspnea and suspected pulmonary embolism was fatal; outcome of event cardiac arrest was recovered on 30Apr2021. The patient died on 01May2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Chest pain and dyspnea; Chest pain and dyspnea; suspected pulmonary embolism


VAERS ID: 1325446 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: Pulmonary fibrosis (on long-term home oxygen therapy for pulmonary fibrosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021533597

Write-up: worsening dyspnea in a patient on long-term home oxygen therapy for pulmonary fibrosis. probable underlying heart disease (poor clinical documentation available); worsening dyspnea in a patient on long-term home oxygen therapy for pulmonary fibrosis. probable underlying heart disease (poor clinical documentation available); This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-725959. A 75-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular, administered in left arm (left shoulder) on 31Mar2021 (Batch/Lot Number: ET7205; Expiration Date: 31Jul2021) as 1st dose, single dose for covid-19 immunisation. Patient was on long-term home oxygen therapy for pulmonary fibrosis. The patient''s concomitant medications were not reported. On 12Apr2021, the patient experienced worsening dyspnea in a patient on long-term home oxygen therapy for pulmonary fibrosis. probable underlying heart disease. The patient died on 13Apr2021. It was not reported if an autopsy was performed. The outcome of event was reported as fatal. Reporter Comment: the lot was not available at the time of evaluation. Vaccination performed at PRIVACY. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: worsening dyspnea in a patient on long-term home oxygen therapy for pulmonary fibrosis. probable underlying heart disease (poor clinical documentation available); worsening dyspnea in a patient on long-term home oxygen therapy for pulmonary fibrosis.


VAERS ID: 1325541 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram head, Computerised tomogram thorax, Echocardiogram, Fibrin D dimer, Genital haemorrhage, Physical deconditioning, Pulmonary embolism, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 31
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: Adenomyosis uteri
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210502; Test Name: head CT; Result Unstructured Data: Test Result:no finding which was the cause of death within the; Comments: skull, and no findings such as aortic dissection; Test Date: 20210502; Test Name: chest CT; Result Unstructured Data: Test Result:no finding which was the cause of death within the; Comments: skull, and no findings such as aortic dissection; Test Date: 20210502; Test Name: echocardiography; Result Unstructured Data: Test Result:findings of right heart strain; Test Date: 20210502; Test Name: D-dimer; Result Unstructured Data: Test Result:41.9 ug/ml; Comments: high
CDC Split Type: JPPFIZER INC2021538193

Write-up: Sudden death; cardio-respiratory arrest; pulmonary embolism; genital haemorrhage; physical deconditioning; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21105963. A 47-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ER7449; Expiration Date: 30Jun2021), via an unspecified route of administration, on 27Apr2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included adenomyosis uteri. The patient had no particular family history. The patient''s concomitant medications were not reported. The patient previously took leuprorelin (MANUFACTURER UNKNOWN) from 28May2020 to 30Oct2020 (a total of 6 times, once per month). The patient experienced sudden death on 02May2021 at 06:00, reported as 5 days after the vaccination. The patient also experienced genital haemorrhage and physical deconditioning in Apr2021 (reported as 2 to 3 days before death) and cardio-respiratory arrest and pulmonary embolism on 02May2021. The clinical course was reported as follows: The body temperature before vaccination was 36.3 degrees Centigrade on 27Apr2021. On 02May2021, in the early morning, the patient began to suffer, and she had cardio-respiratory arrest in the restroom, and she was emergently transferred to the hospital. The heart rate was restored with administration of adrenaline (MANUFACTURER UNKNOWN). The patient repeatedly had cardiac arrest, and she was confirmed to be dead at 09:18 (as reported) on the same day. It was reported that 2 to 3 days before the death, the patient had genital haemorrhage and physical deconditioning. A head and chest computerised tomogram (CT) showed no finding which was the cause of death within the skull, and no findings such as aortic dissection were observed on 02May2021. The echocardiography showed findings of right heart strain on 02May2021, and the patient was suspected to have pulmonary embolism based on the clinical course. The D-dimer was high at 41.9 mcg/mL on 02May2021. Therapeutic measures were taken as a result of sudden death and cardio-respiratory arrest as aforementioned. The clinical outcome of genital haemorrhage and physical deconditioning was unknown and of cardio-respiratory arrest and pulmonary embolism was fatal. The patient died on 02May2021. The cause of death was reported as sudden death and assessed as due to cardio-respiratory arrest and pulmonary embolism. It was not reported if an autopsy was performed. The reporting physician assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases reported. The reporting physician reported that: a 47-year-old healthy female without serious underlying diseases died 5 days after receiving the vaccination. Thus, the side reaction was considered highly likely, and this case was reported.; Reported Cause(s) of Death: sudden death; cardio-respiratory arrest; pulmonary embolism


VAERS ID: 1325542 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-06
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Brain stem infarction, Magnetic resonance imaging
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: 2021-05-11
   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: Cerebral vasoconstriction
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: blood pressure; Result Unstructured Data: Test Result:170s mmHg; Comments: at 19:15; Test Date: 20210420; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination; Test Date: 20210506; Test Name: MRI; Result Unstructured Data: Test Result:no abnormal findings were observed
CDC Split Type: JPPFIZER INC2021538239

Write-up: Brain stem infarction; This is a spontaneous report from a contactable physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number is v21106044. A 41-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: ER7449; Expiration Date: 30Jun2021), via an unspecified route of administration on 20Apr2021 at 13:00 at a single dose for covid-19 immunisation. Medical history included cerebral vasoconstriction syndrome. The patient had no particular family history. The patient''s concomitant medications were not reported. The body temperature was 36.7 degrees Centigrade on 20Apr2021 before vaccination. On 06May2021 at 19:15, the patient experienced brain stem infarction, which was serious for death. The clinical course was as follows: on 20Apr2021 (the day of vaccination), the patient received the first dose of BNT162b2. No significant side reaction was noted immediately after the vaccination. On 06May2021, at 19:15 (16 days, 6 hours, and 15 minutes after vaccination), the patient experienced dizziness and headache. The patient crouched down and was unable to move at the entrance of the outpatient department of the hospital. At that time, the blood pressure was 170s mmHg. The patient was examined by the doctor on duty, and she was transferred to the Hospital by an ambulance. While the patient was being transferred, she was able to have conversation. At around 21:00 (16 days and 8 hours after vaccination), the patient arrived at the Hospital. MRI was performed, but no abnormal findings were observed, and a intravenous drip infusion was performed. The patient went home on this day. From 07May2021 (17 days after vaccination) to 11May2021 (21 days after vaccination), the patient recuperated at home. On 11May2021 (21 days after vaccination), at 04:00, the patient was transferred to the Hospital by an ambulance for physical deconditioning. At 06:30, the patient lost her consciousness. At 18:00 on this day, the patient passed away. She was diagnosed with brain stem infarction. Therapeutic measures were taken as a result of brain stem infarction. The clinical outcome of the event, brain stem infarction, was fatal. The patient died on 11May2021 at 18:00 due to brain stem infarction. It was not reported if an autopsy was performed. The reporting physician classified the event, brain stem infarction, as serious (death) and assessed that the causality between the event and bnt162b2 was unassessable. Other possible cause of the event such as any other diseases included cerebral vasoconstriction syndrome. REPORTER COMMENT: The infarction caused by cerebral vasoconstriction was most suspected; however, relationship with thrombosis could not be ruled out.; Reported Cause(s) of Death: brain stem infarction


VAERS ID: 1325545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-12
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021538726

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable healthcare professional via a Pfizer sales representative. A 69-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced subarachnoid haemorrhage on 12May2021, which was reported as fatal. The clinical course was reported as follows: On 12May2021, the patient was transported to a hospital on emergency because of subarachnoid haemorrhage and the patient died. The patient was scheduled to receive the second dose on that day as well. The patient died on 12May2021. The cause of death was reported as subarachnoid haemorrhage. It was not reported if an autopsy was performed. The causality assessment between the event and BNT162B2 was not provided. The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of subarachnoid haemorrhage . The reported event likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1325546 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

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: 2021-05-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiectasis; Heart disease, unspecified; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021538915

Write-up: Cerebral infarction; This is a spontaneous report from a contactable pharmacist. This report was received via a Pfizer sales representative. An 80-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: ER9480; Expiration Date: 31Jul2021), via an unspecified route of administration on 20Apr2021 at a single dose for covid-19 immunisation. Medical history included atrial disease, rheumatoid arthritis, and bronchiectasis. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced cerebral infarction, which was serious for death. The clinical course was as follows: on 20Apr2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ER9480, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 27Apr2021 (7 days after the vaccination), the patient was hospitalized. On 01May2021 (11 days after the vaccination), the patient died. The clinical outcome of the event, cerebral infarction, was fatal. The patient died on 01May2021 due to cerebral infarction. It was not reported if an autopsy was performed. The reporting pharmacist classified the event as serious (fatal outcome) and assessed that causal relationship between bnt162b2 and the event was unknown at present. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event cerebral infarction. The reported event likely represent intercurrent medical condition in this elderly 80 year old patient. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1325555 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Hypoxic-ischaemic encephalopathy
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Acute central respiratory depression (broad), Noninfectious encephalopathy/delirium (narrow), Hostility/aggression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021544880

Write-up: Asphyxia; Hypoxic encephalopathy; This is a spontaneous report from a contactable physician received from the a regulatory authority. Regulatory authority report number is v21106229. An 83-year and 6-month-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ET3674; Expiration Date: 31Jul2021), via an unspecified route of administration on 10May2021 at 13:30 (at the age of 83-years-old) as a single dose for COVID-19 immunisation. There was no medical history. The patient had no relevant family history. No concomitant medications were reported. Body temperature before vaccination was not reported. On 10May2021 at 16:30 (3 hours after the vaccination), the patient experienced asphyxia and hypoxic encephalopathy, both fatal events. On 11May2021 at 17:47 (1 day after the vaccination), the patient died. The cause of death was asphyxia. It was not reported whether an autopsy was performed. The course of the event was as follows: On 10May2021 at around 16:30, the patient was found sitting at the dinner table in a state of unconsciousness. She was transferred to the outpatient department and a trancheal tube was intubated. Resuscitation by cardiac massage was performed. Spontaneous circulation returned once, but her heart arrested again. Spontaneous breathing was not noted, and on 11May2021 at 17:47, the patient''s death was confirmed. During the trancheal intubation, a large amount of food residue was found in the pharynx, therefore, asphyxia was considered to be the cause of death. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Hypoxic encephalopathy and asphyxia were reported as possible causes of the event. The reporting physician commented as follows: This was a fatal case due to an unexpected accident (asphyxia), and the event was considered not to be related to BNT162b2. ; Reported Cause(s) of Death: asphyxia


VAERS ID: 1325557 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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: Medical History/Concurrent Conditions: Oesophageal carcinoma (her progress was being regularly followed)
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021549693

Write-up: suicide (hanging death); This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21106329. The patient was a 53-year and 3-month-old female. Body temperature before vaccination was 36.1 degrees centigrade. The patient had a medical history of upper oesophageal carcinoma, and her progress was being regularly followed (details not reported). It was uncertain whether the patient had a family history. No information on concomitant medications was provided. On 24Mar2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported). On 14Apr2021 at 10:10 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# ER2659, Expiration date 30Jun2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16Apr2021 (2 days after the vaccination), the patient died because of suicide (hanging death). It was not reported whether an autopsy was performed. The course of the event was as follows: After the patient received the first dose of BNT162b2 on 24Mar2021, no symptoms occurred. On 14Apr2021, she received the second dose. The patient was rested and observed for 30 minutes after the vaccination, afterwards she did her regular work. While she was working, she did not complain of poor physical conditions. The next day (15Apr2021) was a public holiday. On 16Apr2021, in early morning, the patient was found dead at home (she killed herself by hanging). The reporting physician classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. Her underlying condition, upper oesophageal carcinoma was other possible cause of the event. The reporting physician commented as follows: It was uncertain if there was a causal relationship between the event and BNT162b2, but it was considered that BNT162b2 might affect brain or psychiatric system like infant abnormal behaviour caused by oseltamivir (TAMIFLU). Therefore, this case has been reported as paying attention should be necessary. There were no scientific grounds (the reporter stated that he had no idea).; Reported Cause(s) of Death: suicide (hanging death)


VAERS ID: 1325663 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-05-02
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Cardiac arrest, Computerised tomogram, Pulmonary embolism, Syncope
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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210502; Test Name: Computerised tomogram; Result Unstructured Data: Test Result:global cerebral edema; Comments: CT caput. Result: pronounced global cerebral edema.
CDC Split Type: NOPFIZER INC2021527641

Write-up: Acute pulmonary embolism with subsequent cardiac arrest and more; CEREBRAL EDEMA; SYNCOPE; Acute pulmonary embolism with subsequent cardiac arrest and more; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB [NO-NOMAADVRE-FHI-2021-Uap3zq], Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00028225]. A 59 years old female patient received first dose of bnt162b2 (COMIRNATY) via Intramuscular at single dose on 07Apr2021 for covid-19 immunisation. The batch number for Comirnaty has been requested, but could not be retrieved due to lack of registration. No concomitant medication or further medical history was included in this report. On 02May2021, the patient developed syncope. This was soon perceived by the patients husband as cardiac arrest. CPR was immediately started and then taken over by ambulance personnel. ROSC after about 30 minutes. Admitted to hospital, where large, bilateral pulmonary embolism was found. CT caput showed pronounced global cerebral edema. The patient received intravenous anticoagulant treatment for the pulmonary embolism and was placed in intensive care, intubated and sedated. The patient died 03May2021 at 14:19. Relevant laboratory findings and investigations included in the report (computerized tomogram, 02May2021, CT caput. Result: pronounced global cerebral edema. ). The patients outcome was Fatal. The case was considered to be Serious. Sender Comment: Thank you for reporting a suspected side effect after vaccination. The information is registered in the national adverse reaction register (a regulatory authority), and then forwarded to international adverse reaction databases. In this way, your message becomes part of an important international collaboration that is continuously ongoing to monitor and maintain safe vaccination worldwide. Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. Your message is therefore important to expand knowledge about adverse reactions that were not discovered in the studies, and it is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports of the coronavirus vaccination in the Register of Adverse Reactions are processed by a regulatory authority in collaboration with a regulatory authority. The publication publishes weekly summaries of reports of suspected adverse reactions after vaccination. Causality is assessed according to international criteria (1). We do not currently have the capacity to send individual adverse reaction reports. For updated information and advice on the use of the vaccines and precautions, refer to the Vaccination Guide via website. It appears in the message that the vaccine has been administered subcutaneously. Coronavirus vaccine should be given intramuscularly (i.m.) into the deltoid muscle. Vaccines intended for intramuscular use may have a lower effect and cause more severe local side effects such as pain, swelling and tenderness at the injection site if administered subcutaneously. If it is not true that the vaccine is given subcutaneously, we want information about this. If you have further information about the course of events, such as to do with outcomes, a copy of the medical record / discharge summary / laboratory response, and/or other reports, you can send them as a response to this message. The information is processed in a secure manner and is automatically deleted after 4 months. Processing and storage of personal data takes place in accordance with the Health Register Act. A regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Stop Date/Time for events Pulmonary embolism, Brain oedema, Syncope, Cardiac arrest with Outcome of Event: Recovered/Resolved: 03May2021 00:00. Batch/lot number: Unknown. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: PULMONARY EMBOLISM


VAERS ID: 1325667 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021491734

Write-up: patient died/cause of death was not known; CONVULSIONS GENERALIZED; CONVULSIONS GENERALIZED; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NO-NOMAADVRE-FHI-2021-Umwzmq with safety report unique identifier NO-NOMAADVRE-E2B_00027128. An 80-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 08Jan2021 (lot number EJ6795) as 1st dose, single and; intramuscular on 29Jan2021 (lot number EM0477) as 2nd dose, single for covid-19 immunisation. Medical history included advanced dementia. The patient''s concomitant medications were not reported. On 11Jan2021 the patient developed convulsions generalized with outcome of recovered on 11Jan2021. On Feb2021, a few days after vaccination with the second dose of Comirnaty, the patient developed convulsions generalized with outcome of unknown. On 12Feb2021 the patient died peacefully. The cause of death was not known, but the primary reporter stated that the generalized convulsions were not suspected as a cause of death. No relevant laboratory findings and investigations were included in the report. It was unknown if an autopsy was performed. Convulsions generalized was considered serious as medically significant. Relatedness of drug to reactions/events convulsions generalized: Source of Assessment: Regulatory Authority/Result of Assessment: Possible. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Reporters qualifications: Physician. 27-Apr-2021 Regulatory Authority: Additional information was received by phone, from the primary reporter. This is a final report.; Reported Cause(s) of Death: patient died/cause of death was not known


VAERS ID: 1325690 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Lividity, Malaise, Vaccination site discolouration, Vaccination site reaction
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021527658

Write-up: Vaccination site lividity; Lividity of the right leg from mid-thigh to the torso; Vaccination site reaction with diameter of 3-5 cm; Malaise; Weakness; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB PL-URPL-3-596-2021. A 65-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 11Apr2021 13:45 (Lot Number: EW2243) as 1st dose, single for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced vaccination site lividity, lividity of the right leg from mid-thigh to the torso, vaccination site reaction with diameter of 3-5 cm, malaise, weakness on 12Apr2021 11:44. The patient died on 12Apr2021. It was not reported if an autopsy was performed. The outcome of events was fatal. The reporting person classified them as severe. The Regulatory Authority also classified the application as severe. Source of assessment: Agency Method of assessment WHO Relatedness of drug Comirnaty to event "Vaccination site lividity" Result of Assessment: Possible Relatedness of drug Comirnaty to event "Lividity": Result of Assessment: Unclassifiable Relatedness of drug Comirnaty to event "Vaccination site reaction": Result of Assessment: Probable Relatedness of drug Comirnaty to event "Malaise": Result of Assessment: Possible Relatedness of drug Comirnaty to event "Weakness": Result of Assessment: Possible No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: Vaccination site lividity; Lividity; Vaccination site reaction; Malaise; Weakness


VAERS ID: 1325718 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: RT-PCR; Result Unstructured Data: Test Result:Negative
CDC Split Type: ROPFIZER INC2021528868

Write-up: dead; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB RO-NMA-2021-SPCOV8857. An 84-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Apr2021 at single dose for COVID-19 immunization. Medical history incluided arterial hypertension and type 2 diabetes mellitus, both ongoing. Concomitant medications were not reported. On 09Apr2021, the woman was found dead by neighbors. Neighbors hypothesized that she felt unwell after the vaccine and that the death was due to the vaccine. The family doctor of the woman was contacted who mentioned that on 08Apr2021 she went to the office to prescribe the medication necessary for her preexisting chronic diseases and that the patient did not present clinical manifestations suggesting post-vaccine adverse reactions. The family doctor mentioned that the patient had not taken her antidiabetic medication for several days. The Regulatory Authority mentioned that on 09Apr2021 the forensic service was notified, which performed the sampling for RT-PCR simultaneously with the autopsy and other investigations. The RT-PCT test result was negative on 09Apr2021. The Regulatory Authority comments were: So far we have no autopsy result. With the data we have, no direct association can be made between the administration of the vaccine and the death of the person concerned. The outcome of the event 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: dead


VAERS ID: 1325754 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-03-01
   Days after vaccination:52
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Fatigue, General physical health deterioration, Neuropsychiatric symptoms
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), Dementia (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESCITALOPRAM SANDOZ; HEMINEVRIN [CLOMETHIAZOLE EDISILATE]; METOPROLOL SANDOZ [METOPROLOL SUCCINATE]; FINASTERID AUROBINDO; ALVEDON; DUROFERON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic ischemic heart disease, unspecified; Cognitive impairment; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021528098

Write-up: BPSD; Deterioration at, lying in bed; Tiredness; cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is [SE-MPA-2021-032676]. A 99-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 08Jan2021 (Lot Number: EL1484) as 1ST DOSE, SINGLE for covid-19 immunisation . Medical history included hypertension, Chronic ischemic heart disease, unspecified, Cognitive impairment. Concomitant medications included escitalopram oxalate (ESCITALOPRAM SANDOZ); clomethiazole edisilate; metoprolol succinate (METOPROLOL SANDOZ); finasteride (FINASTERID AUROBINDO); paracetamol (ALVEDON); ferrous sulfate (DUROFERON). In the beginning of March. Patient had BPSD symptoms, aggressiveness, became more and more tired, after about a week he lay in bed and was not contactable, a few days later he died due to cardiac arrest. 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 possible. No further information expected.; Reported Cause(s) of Death: Tiredness; BPSD; Deterioration at, lying in bed; Cardiac arrest


VAERS ID: 1326092 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-18
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001655-01 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19 pneumonia, Pleural effusion, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: positive
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PLEURAL EFFUSION and COVID-19 PNEUMONIA in a 95-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001655-01) for COVID-19 vaccination. No Medical History information was reported. On 08-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 18-Apr-2021, the patient experienced PLEURAL EFFUSION (seriousness criterion death) and COVID-19 PNEUMONIA (seriousness criterion death). The patient died on 29-Apr-2021. The reported cause of death was Effusion pleural and COVID-19 pneumonia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not provided by the reporter. Covid infection between the first and second dose: positive covid-19 molecular test. Onset of bronchopneumonia with pleural effusion due to covid-19 in a patient who was vaccinated at home on 08 April 2021. The patient was hospitalized due to effusion pleural and COVID-19 pneumonia. Treatment of the events was not reported. ADRs transferred to the a regulatory authorities on 22 Apri 2021. The reporter was asked to edit the profile. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Translation uploaded. On 14-May-2021: Updated outcome of events from not resolved to fatal. Added serious criteria of events to death, added death details.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Effusion pleural; COVID-19 pneumonia


VAERS ID: 1326331 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-28
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   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: ELECTROLIT; ELIQUIS; LASIX [FUROSEMIDE]; CEREBOKAN; QUETIALAN; SERTRALIN [SERTRALINE]; TRITTICO; FURO-SPIROBENE; MOLAXOLE; PANTOPRAZOLUM; CANDESARTAN
Current Illness: Bradycardia (persistent symptomatic bradycardia (pacemaker since 17Apr2018)); Cardiac pacemaker insertion; Decompensation cardiac (cardiac decompensation); Dementia; General physical condition decreased (poor AZ (old age))
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: PCR-Test; Test Result: Positive ; Test Date: 20210328; Test Name: Rapid test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021539331

Write-up: Covid disease after 2 vaccinations; Covid disease after 2 vaccinations; fever; general weakness/ General debility; This is a spontaneous report from a contactable physician and consumer downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier AT-BASGAGES-2021-24747. A 96 years old female patient received 1st dose of BNT162B2 (COMIRNATY, lot# EJ6796) on 12Jan2021 at single dose, 2nd dose (lot#EJ6134) at single dose on 02Feb2021 for COVID-19 immunization. Medical history was Dementia (continuing), Bradycardia (persistent symptomatic bradycardia, pacemaker since 17Apr2018), Cardiac pacemaker insertion (continuing), Decompensation cardiac (continuing), General physical condition decreased (continuing). Concomitant medications included glucose/potassium chloride/sodium citrate acid (ELECTROLIT), Candesartan 8 mg, ginkgo biloba extract (CEREBOKAN, 80 mg), apixaban (ELIQUIS, 2.5 mg), furosemide/spironolactone (FURO-SPIROBENE), furosemide (LASIX, 40 mg), macrogol 3350/potassium chloride/sodium bicarbonate/sodium chloride (MOLAXOLE), Pantoprazolum 20 mg, quetiapine fumarate (QUETIALAN, 25 mg), Sertraline 50 mg, trazodone hydrochloride (TRITTICO,150 mg). On 28Mar2021 the patient experienced Vaccination failure, SARS-CoV-2 infection, COVID-19 PCR test positive. COVID illness after 2 vaccinations. Other diseases/basic diseases not known, except poor AZ (old age). At the end of Mar2021 she developed a fever, then general weakness/ General debility, otherwise she had no symptoms. At the time of the vaccination she was so far healthy, had no infection. It was tested once a week and the quick test on 28Mar2021. if it was positive, a PCR test was then carried out by the Agency, also on 28Mar2021, which was also positive. We are not aware of any sequencing. The antibody titers were never determined. Patient was passed away on 09Apr2021, not in the hospital. No autopsy was made. Cause of death reported as covid-19 infection. The patient''s outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID illness after 2 vaccinations; Covid disease after 2 vaccinations


VAERS ID: 1326382 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Coronary artery occlusion
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: GLUCOPHAGE; MOXONIDINE; COAPROVEL; ROSUVASTATIN; ASAFLOW; EZETROL; AMLOR; KREDEX; NOVOMIX; PANTOMED [PANTOPRAZOLE SODIUM SESQUIHYDRATE]
Current Illness: Coronary heart disease; Diabetes (requiring insulin); Esophagitis; Hypertension; Hypothyroidism; Renal disease
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery (Double bypass); Infarction; Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Coronary artery occlusion; Cardiovascular disorder; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CORONARY ARTERY OCCLUSION and CARDIOVASCULAR DISORDER in an 85-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. The patient''s past medical history included Infarction, Bypass surgery (Double bypass) and Pacemaker insertion (cardiac). Concurrent medical conditions included Coronary heart disease, Diabetes (requiring insulin), Hypertension, Hypothyroidism, Renal disease and Esophagitis. Concomitant products included METFORMIN HYDROCHLORIDE (GLUCOPHAGE), MOXONIDINE, HYDROCHLOROTHIAZIDE, IRBESARTAN (COAPROVEL), ROSUVASTATIN, ACETYLSALICYLIC ACID (ASAFLOW), EZETIMIBE (EZETROL), AMLODIPINE BESILATE (AMLOR), CARVEDILOL (KREDEX), INSULIN ASPART, INSULIN ASPART PROTAMINE (CRYSTALLINE) (NOVOMIX) and PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOMED [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) for an unknown indication. On 14-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced CORONARY ARTERY OCCLUSION (seriousness criterion death) and CARDIOVASCULAR DISORDER (seriousness criterion death). The patient died on 20-Apr-2021. The reported cause of death was Coronary occlusion. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: This is a case of death in a 85-year-old male subject with a medical history of Coronary heart disease with CABG and Pacemaker insertion, Diabetes (requiring insulin), Hypertension, Hypothyroidism, Renal disease and Esophagitis, who died 6 days after receiving the second dose of vaccine. Based on the reports causality that coronary occlusion led to the death of the patient, the death is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow-up report received on 10MAY2021 included medical history and cause of death information. On 10-May-2021: Additional information added included no new information; Sender''s Comments: This is a case of death in a 85-year-old male subject with a medical history of Coronary heart disease with CABG and Pacemaker insertion, Diabetes (requiring insulin), Hypertension, Hypothyroidism, Renal disease and Esophagitis, who died 6 days after receiving the second dose of vaccine. Based on the reports causality that coronary occlusion led to the death of the patient, the death is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Coronary occlusion


VAERS ID: 1326386 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Tumour thrombosis
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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related conditions (narrow), Acute central respiratory depression (broad), Respiratory failure (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: PANTOMED [DEXPANTHENOL]; PENTASA; ATORVASTATINE TEVA; BETOPTIC S; FERRICURE [FERRIC HYDROXIDE POLYMALTOSE COMPLEX]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolemia; Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021539361

Write-up: PATIENT DEATH from cardiopulmonary arrest; embolic in her advanced prostate cancer; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB regulatory authority [BE-FAMHP-DHH-N2021-90957]. An 86-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 29Apr2021 (Batch/Lot Number: Unknown) at second dose, single for covid-19 immunisation. The patient medical history included Prostate cancer, Hypercholesterolemia - normal build - lived independently at home. Concomitant medications included dexpanthenol (PANTOMED [DEXPANTHENOL]); mesalazine (PENTASA); atorvastatin calcium; betaxolol hydrochloride (BETOPTIC S); ferric hydroxide polymaltose complex (FERRICURE [FERRIC HYDROXIDE POLYMALTOSE COMPLEX]). The patient experienced patient death from cardiopulmonary arrest on 06May2021, embolic in her advanced prostate cancer on 06May2021. No treatment. The patient died on 06May2021. An autopsy was not performed. Reporter comment: Treatment was No. Evolution of the ADR was Death. The patient did not report any complaints following his vaccine. The patient fell suddenly unconscious in his garden despite being in good shape according to his son the previous days. The embolic hypothesis of her advanced prostate cancer seems the most likely hypothesis to me. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Treatment - No Evolution of the ADR - Death The patient did not report any complaints following his vaccine. The patient fell suddenly unconscious in his garden despite being in good shape according to his son the previous days. The embolic hypothesis of her advanced prostate cancer seems the most likely hypothesis to me.; Reported Cause(s) of Death: embolic in her advanced prostate cancer; PATIENT DEATH from cardiopulmonary arrest


VAERS ID: 1326391 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: SIMVASTATIN; SERTRALINE HYDROCHLORIDE; DOMPERIDONE; RISPERIDONE; ZOLPIDEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depressive disorder; Down''s syndrome; Insomnia
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2021541584

Write-up: Cardiorespiratory arrest; This is a spontaneous report received by a contactable consumer and a contactable nurse. A 50-year-old Non-pregnant female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EX2405), intramuscular, administered in Deltoid Left on 05May2021 (at age of 50 years old) as single dose for COVID-19 immunisation. Medical history included depressive condition, Down''s syndrome, insomnia. Concomitant medications included simvastatin ongoing; sertraline hydrochloride; domperidone; risperidone; zolpidem for insomnia. The patient had Cardiorespiratory arrest on 06May2021. Seriousness classification: Serious. Seriousness: Cause of death. Interval between administration and start of reaction/Day was 1 day. Death occurred 1 day after vaccination (on 06May2021 at 08:30 am). The case is under investigation. The patient did not have any health problems. At around 7 am on 06May2021, the patient was unconscious and immediately called the emergency service, when they arrived at the place they stated death due to cardiorespiratory arrest. She states that the patient did not show any symptoms after the vaccine administration. Emergency room visit. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Cardiorespiratory arrest


VAERS ID: 1326422 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000 4273 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood creatinine, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   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: TEMESTA EXPIDET; PARACETAMOL SANDOZ; NOVALGIN [METAMIZOLE SODIUM]; MEFENAMIC ACID; VITARUBIN [HYDROXOCOBALAMIN ACETATE]; TRANSIPEG [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE;SODIUM SULFATE ANHYDR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral insufficiency (Unknown date of diagnosis)
Allergies:
Diagnostic Lab Data: Test Date: 20191210; Test Name: Blood creatinine; Result Unstructured Data: 86 micromole per litre
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in a 96-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000 4273) for COVID-19 immunisation. The patient''s past medical history included Mitral insufficiency (Unknown date of diagnosis). Concomitant products included LORAZEPAM (TEMESTA EXPIDET), PARACETAMOL (PARACETAMOL SANDOZ), METAMIZOLE SODIUM (NOVALGIN [METAMIZOLE SODIUM]), MEFENAMIC ACID, HYDROXOCOBALAMIN ACETATE (VITARUBIN [HYDROXOCOBALAMIN ACETATE]) and MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE, SODIUM SULFATE ANHYDROUS (TRANSIPEG [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE;SODIUM SULFATE ANHYDROUS]) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 15-Feb-2021 The patient died on 15-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2019, Blood creatinine: 86 micromole per litre (normal) 86 micromole per litre. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH to be unlikely related. No treatment information was provided. As patient died, action taken with respect to mRNA-1273 was not applicable. This is a case of death in a 96-year-old male subject with a medical history of Mitral insufficiency, who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-MAY-2021 contains no new information.; Sender''s Comments: This is a case of death in a 96-year-old male subject with a medical history of Mitral insufficiency, who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1326792 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pyrexia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021539482

Write-up: Death sudden; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100062004. A 90-year-old male patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 21Apr2021 as UNKNOWN SINGLE dose for Covid-19 immunisation. Medical history included ongoing dementia. The patient''s concomitant medications were not reported. The patient experienced pyrexia on 23Apr2021 and death sudden on 27Apr2021. The patient died on 27Apr2021. It was unknown if an autopsy was performed. The Regulatory Authority assessed the causal relationship between BNT162b2 (COMIRNATY) and Death sudden as "Unclassifiable", between BNT162b2 (COMIRNATY) and pyrexia as "Consistent" No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1326831 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021539552

Write-up: Pulmonary embolism was suspected but not confirmed as the cause of death.; Pulmonary embolism was suspected but not confirmed as the cause of death.; This is a spontaneous report received from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021060240, Safety report unique identifier DE-PEI-202100052134. An 81-years-old male patient received bnt162b2 (COMIRNATY), on 22Mar2021 (Lot Number: ER7812) as UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. On 25Mar2021 the patient experienced Lung embolism (hospitalization), Unknown cause of death. The patient''s outcome was not recovered/not resolved for Lung embolism, fatal for Unknown cause of death. Relatedness of drug to reaction(s)/event Lung embolism, Unknown cause of death was D. Unclassifiable. The patient died on 25Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1326839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-04
Onset:2021-04-09
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021539238

Write-up: Cerebral haemorrhage; Cerebral haemorrhage; This is a spontaneous report downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021060390, from a non-contactable consumer or other non hcp. An elderly male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Apr2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 09Apr2021 the patient experienced cerebral haemorrhage(serious as fatal), accident cerebrovascular(serious as hospitalization). The patient''s outcome was fatal for cerebral haemorrhage, not recovered/not resolved for accident cerebrovascular. The patient died on 18Apr2021. It was not reported if an autopsy was performed. Sender Comment: Stroke with paralysis symptoms. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1326848 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-22
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hepatitis
SMQs:, Hepatitis, non-infectious (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021539537

Write-up: Hepatitis; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority (RA)-WEB DE-PEI-202100052925. Additional identifier: DE-PEI-CADR2021060403. An elderly female patient received the second dose of bnt162b2 (COMIRNATY), intramuscular on 12Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced hepatitis on 22Apr2021 with fatal outcome. The patient died on 29Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: Hepatitis


VAERS ID: 1326861 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Decreased appetite, Dehydration, Diarrhoea, Disturbance in attention, Fatigue, Feeling cold, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder incontinence; Gait disturbance
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021527623

Write-up: then loss of appetite, weakness and reduced vigilance; Then loss of appetite, weakness and reduced vigilance; Then loss of appetite, weakness and reduced vigilance; died unknown; tiredness; sensation of cold; massive diarrhea; nausea; Initially tiredness and sensation of cold, then slight to later massive diarrhea, as well as nausea and severe recurrent vomiting with desiccosis. Died on the 24th day after the vaccination.; desiccosis; This is a spontaneous report from a non-contactable consumer or other non-health professional (non-HCP) downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021066273. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100059051. A 91-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 (Batch/Lot Number: ER9480) as single dose for COVID-19 immunisation. Medical history included urinary incontinence and gait disturbance, from an unknown date and unknown if ongoing. The patient was allergic to cefotaxime sodium (CLAFORAN). The patient''s concomitant medications were not reported. On the day after the vaccination, 09Apr2021, the patient experienced tiredness and sensation of cold, then increasing diarrhea. Sensation of cold intensified after 1 week, and after 1 week she had worsening of the diarrhea and in addition massive nausea and recurrent vomiting with desiccosis. Event term was provided as "Initially tiredness and sensation of cold, then slight to later massive diarrhea, as well as nausea and severe recurrent vomiting with desiccosis. Died on the 24th day after the vaccination.", with onset date 09Apr2021. Then she had loss of appetite, weakness and reduced vigilance, onset date unknown. Infusion therapy with electrolytes and glucose showed only short-term slight improvements, Lopedium was ineffective, Ondansetron Bluefish was effective. Nausea subsided after about 5 days of treatment and vomiting ceased for several days. In the last 4-5 days of life, repeated frequent vomiting of "coffee grounds". The outcome of events tiredness, sensation of cold, diarrhea, nausea and vomiting with desiccosis was not resolved. The outcome of loss of appetite, weakness and reduced vigilance was unknown. The patient died on 02May2021, cause unknown. An autopsy was not performed. Relatedness of drug to reactions/events: Comirnaty/ Unknown cause of death, Diarrhea, Vomiting, Fatigue/ regulatory authority/ D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1327910 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-20
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aspiration, Computerised tomogram head, Electroencephalogram, Generalised tonic-clonic seizure, SARS-CoV-2 test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SINTROM; METFORMIN; FUROSEMIDE; CRESTOR; TOVIAZ; DUTASTERIDE/TAMSULOSIN; RISPERIDONE; TRAZODONE; ARICEPT; HIDROFEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (due to atrial fibrillation); Dementia Alzheimer''s type (with daily life dependency); Diabetes mellitus; Fibrillation atrial; Hypertension arterial; Prostatic hyperplasia
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: EEG; Result Unstructured Data: Test Result:with diffuse slowing; Comments: with diffuse slowing; Test Date: 202104; Test Name: SARS-cov-2 test; Test Result: Negative ; Test Date: 20210408; Test Name: Brain CT; Result Unstructured Data: Test Result:cerebral atrophy; Comments: Computed axial tomography- cerebral atrophy. No acute hemorrhagic or ischemic lesions visible
CDC Split Type: ESPFIZER INC2021527607

Write-up: Tonic-clonic seizures; bronchial aspiration/probable aspiration; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is ES-AEMPS-855431. A 90-years-old male patient received BNT162b2 (COMIRNATY), dose 2 intramuscularly on 08Apr2021 (Batch/Lot Number: EW2246) at 0.3 ml single dose for COVID-19 immunisation. Medical history included Hypertension (HT); Complete arrhythmia due to atrial fibrillation anticoagulated with acenocoumarol (SINTROM); Mellitus diabetes; Alzheimer''s with daily life dependency; Prostatic hyperplasia. Concomitant medications included acenocoumarol (SINTROM) taken for atrial fibrillation, start and stop date were not reported; metformin (METFORMIN), furosemide (FUROSEMIDE), rosuvastatin calcium (CRESTOR), fesoterodine fumarate (TOVIAZ), dutasteride/tamsulosin hydrochloride (DUTASTERIDE/TAMSULOSIN), risperidone (RISPERIDONE), trazodone (TRAZODONE), donepezil hydrochloride (ARICEPT), calcifediol (HIDROFEROL), indication, start and stop date were not reported. The patient had received the first dose of BNT162b2 at 0.3 ml intramuscularly (bacth unknown) for COVID-19 immunization on 18Mar2021. On 08Apr2021 the patient received the 2nd dose of COMIRNATY vaccine (batch EW2246). On 20Apr2021 he was admitted due to deterioration of the general state of a patient with advanced Alzheimer''s. Suspicion of Tonic-Clonic seizures plus bronchial aspiration. PCR Covid-19 (unknown date in Apr2021): negative. Brain CT (computed axial tomography) 08Apr2021: Atrophy. No acute hemorrhagic or ischemic lesions visible. Electroencephalogram (EEG) (unknown date in Apr2021) with diffuse slowing. Clonus were observed clinically in the right arm. Evolution as of 30Apr2021: Poor general condition, clinical worsening compared to previous days, more frequent crises, more noise of secretions. Diagnoses: Seizure crisis / Intense brain suffering. Advanced degenerative dementia type Alzheimer. Probable aspiration. Low dose sedation was started. On 01May2021 he passed away. Physician''s comment: Suspicion of unconfirmed epileptic etiology. No autopsy performed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: 90-year-old man. Medical history: HT, Complete arrhythmia due to atrial fibrillation anticoagulated with SINTROM. Mellitus diabetes. Alzheimer''s with daily life dependency. Prostatic hyperplasia. Usual treatment: Metformin, Furosemide, CRESTOR, TOVIAZ, Dutasteride / Tamsulosin, Risperidone, TRAZODONE, ARICEPT, HIDROFEROL. On 08Apr2021 he receives the 2nd dose of COMIRNATY vaccine (batch EW2246). On 20Apr2021 he was admitted due to deterioration of the general state of a patient with advanced Alzheimer''s. Suspicion of Tonic-Clonic seizures plus bronchial aspiration.PCR Covid-19: negative. Brain CT: Atrophy. No acute hemorrhagic or ischemic lesions are visible EEG with diffuse slowing. Clonus were observed clinically in the right arm. Evolution (30Apr2021): Poor general condition, clinical worsening compared to previous days, more frequent crises, more noise of secretions. Diagnoses: Seizure crisis / Intense brain suffering. Advanced degenerative dementia type Alzheimer. Probable aspiration.Low dose sedation is started. On 01May2021 he passed away.Notifying physician s comment: Suspicion of unconfirmed epileptic etiology.; Reported Cause(s) of Death: Tonic-Clonic seizures; Probable aspiration


VAERS ID: 1327919 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atelectasis, Atrial fibrillation, Breath sounds abnormal, Cerebral infarction, Chest X-ray, Dyspnoea, Inappropriate schedule of product administration, Increased upper airway secretion, Off label use, Pleural effusion, Pneumonia
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; CEFUROXIM; DESLORATADIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden (can sit in a G-chair for short periods of time.); Dementia aggravated; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Name: thorax image; Result Unstructured Data: Test Result:abundant pleural fluid on the left; Comments: atelectasis and inflammation.
CDC Split Type: FIPFIZER INC2021539280

Write-up: dose 1 on 11Feb2021, dose 2 on 27Apr2021; dose 1 on 11Feb2021, dose 2 on 27Apr2021; Pleural effusion; Coarse breath sounds; Difficulty breathing; Lung infection; Cerebral infarction; Atelectasis; Atrial fibrillation; Increased upper airway secretion; This is a spontaneous report from a contactable physician downloaded from the a regulatory authority-WEB FI-FIMEA-20212431. A 91-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 27Apr2021 (Lot Number: EW4815) as 2nd dose, single for covid-19 immunization. Medical history included living in a nursing home, advanced dementia, mainly a bedridden patient (can sit in a G-chair for short periods of time). Concomitant medication included bisoprolol taken for an unspecified indication, start and stop date were not reported; cefuroxime sodium (CEFUROXIM) taken for an unspecified indication, start and stop date were not reported; desloratadine taken for an unspecified indication, start and stop date were not reported. The patient previously took comirnaty for covid-19 immunisation on 11Feb2021 and there have been no side effects, trimethoprim (TRIMOPAN) and amorion, experienced skin symptoms, prevenar from 2018 for immunization, annually influenza vaccine for immunization. The patient experienced pleural effusion, coarse breath sounds, difficulty breathing, lung infection, cerebral infarction, atelectasis, atrial fibrillation, increased upper airway secretion, all on 28Apr2021 with fatal outcome. Event description: After coronary vaccination, difficulty breathing, was slimy and rancid. Transported to the central hospital emergency department. There received Robinul and morphine, with a good response to mucus and difficulty breathing. Atrial fibrillation was diagnosed, thorax image showed abundant pleural fluid on the left, atelectasis and inflammation. In addition, upon entering the department the deviation of the pupils to the left side, hand and foot powerless. Unspecified cerebral infarction, clinically clear. Discussed with relatives and transferred to hospice care. Peaceful death in the presence of relatives on 03May2021 at 11:30. 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: pleural effusion; coarse breath sounds; difficulty breathing; lung infection; cerebral infarction; atelectasis; atrial fibrillation; increased upper airway secretion


VAERS ID: 1327921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-04-14
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia NOS; Cardiac failure (RHYTHM DISORDERS); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021539279

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-2021048847. A 89-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23Jan2021 (Batch/Lot Number: EM0477) as 1st dose, single, dose 2 intramuscular on 13Feb2021 (Batch/Lot Number: EK9788) as 2nd dose, single for covid-19 immunisation. Medical history included arrhythmia NOS, cardiac failure (rhythm disorders), type 2 diabetes mellitus. No COVID-19 disease history. The patient''s concomitant medications were not reported. On 14Apr2021, the patient experienced vaccination failure and COVID-19 confirmed by positive COVID-19 test with fatal outcome. Event description: 2 months after complete vaccination, the patient experienced severe COVID SARS infection with respiratory distress. After a call from the establishment, vaccine failure confirmed by a positive test a few days before death. No information on variant search. Treatment in place / correction included: urgent medical intervention, maintenance in the accommodation establishment for dependent elderly people and comfort care. Relevant test included SARS-CoV-2 test: positive on Apr2021. The patient died on Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1327938 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Cerebral haematoma, Fibrin D dimer, Haemorrhagic stroke, Magnetic resonance imaging head, NIH stroke scale, Neutrophil count, Oxygen saturation, Platelet count, Prothrombin time, Respiratory rate, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; APROVEL; ATARAX [HYDROXYZINE HYDROCHLORIDE]; LOXEN [NICARDIPINE HYDROCHLORIDE]; CORDARONE; ZYMAD; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; DAFALGAN; XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Rivaroxaban for at least 2 years.); Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:152/86 mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:176/86 mmHg; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Name: D dimers; Result Unstructured Data: Test Result:less than 215 ng/ml; Test Name: Cerebral MRI; Result Unstructured Data: Test Result:right thalamic hematoma; Comments: Large recent right thalamic hematoma, associated with diffuse ventricular contamination, and at the level of the basal cisterns. Mass effect and surrounding structures with a deviation of the median line lateralized to the left measured at 10 mm. Perilesional hypersignal nose, probably related to reactive edema. Dilation of the ventricular system, in connection with an incipient hydrocephalus. Multiple hypersignals flair of deep white matter and periventricular, in connection with a vasculo-degenerative microangiopathy (FAZEKAS grade 3). Presence of two microbleeds in the left post-central cortex as well as in the right deep sylvian level. Absence of suspicious underlying enhancement. No sign of arteriovenous malformation. No cerebral venous thrombosis.; Test Name: Neutrophil count; Result Unstructured Data: Test Result:11540 /mm3; Test Name: NIHSS; Result Unstructured Data: Test Result:20; Test Name: Oxygen saturation; Test Result: 95 %; Test Name: platelet count; Result Unstructured Data: Test Result:210 g/l; Test Name: Prothrombin time; Test Result: 22.3 s; Test Name: Prothrombin time; Test Result: 41 %; Test Name: Respiratory rate; Result Unstructured Data: Test Result:24 rpm; Test Name: Leucocyte count; Result Unstructured Data: Test Result:15870 /mm3
CDC Split Type: FRPFIZER INC2021539459

Write-up: magnetic resonance imaging head: right thalamic hematoma, Large recent right thalamic hematoma, associated with diffuse ventricular contamination, and at the level of the basal cisterns.; blood pressure measurement: 176/86 mmhg; Haemorrhagic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20214027. Sender''s (Case) Safety Report Unique Identifier : FR-AFSSAPS-2021047902. A 92-year-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 14Apr2021 (Batch/Lot Number: EW2246) as single dose for covid-19 immunisation; rivaroxaban (XARELTO), oral from 2019 (Batch/Lot Number: Unknown) to an unspecified date, at 20 mg, daily for atrial fibrillation. Medical history included hypertension from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing Rivaroxaban for at least 2 years. Concomitant medication(s) included levothyroxine sodium (LEVOTHYROX) taken for an unspecified indication, start and stop date were not reported; irbesartan (APROVEL) taken for an unspecified indication, start and stop date were not reported; hydroxyzine hydrochloride (ATARAX [HYDROXYZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; nicardipine hydrochloride (LOXEN [NICARDIPINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported; amiodarone hydrochloride (CORDARONE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (ZYMAD) taken for an unspecified indication, start and stop date were not reported; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) taken for an unspecified indication, start and stop date were not reported; paracetamol (DAFALGAN) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) for covid-19 immunization. The patient experienced haemorrhagic stroke (death) on 26Apr2021. The patient underwent lab tests and procedures which included blood pressure measurement: 152/86 mmhg on unknown date, blood pressure measurement: 176/86 mmhg on unknown date, body temperature: 36.2 centigrade on unknown date, fibrin d dimer: less than 215 ng/ml on unknown date, magnetic resonance imaging head: right thalamic hematoma, Large recent right thalamic hematoma, associated with diffuse ventricular contamination, and at the level of the basal cisterns. Mass effect and surrounding structures with a deviation of the median line lateralized to the left measured at 10 mm. Perilesional hypersignal nose, probably related to reactive edema. Dilation of the ventricular system, in connection with an incipient hydrocephalus. Multiple hypersignals flair of deep white matter and periventricular, in connection with a vasculo-degenerative microangiopathy (FAZEKAS grade 3). Presence of two microbleeds in the left post-central cortex as well as in the right deep sylvian level. Absence of suspicious underlying enhancement. No sign of arteriovenous malformation. No cerebral venous thrombosis , neutrophil count: 11540 /mm3 on unknown date, nih stroke scale: 20 on unknown date, oxygen saturation: 95 % on unknown date, platelet count: 210 g/l on unknown date, prothrombin time: 22.3 seconds on unknown date, prothrombin time: 41 % on unknown date, respiratory rate: 24 rpm on unknown date, white blood cell count: 15870 /mm3 on unknown date. Therapeutic measures were taken as a result of haemorrhagic stroke. The patient died on 26Apr2021. It was not reported if an autopsy was performed. The action taken with rivaroxaban was not applicable. The outcome of the other events was unknown. The clinical course was reported as follows: Haemorrhagic stroke under Rivaroxaban for Atrial fibrillation for at least 2 years, on 12th day after the 2nd dose of Comirnaty, batch EW2246, on 14Apr2021. Undesirable effect: Patient found by her daughter around 12 a.m. with left hemiplegia and neglect, blood pressure at 152/86 mmHg during home care, respiratory rate at 24 rpm, saturation 95%, temperature 36.2 C and dysarthria. Transfer to the emergency room, on admission NIHSS at 20, left hemiplegia, left facial paralysis, neglect, POM (oculomotor nerve paralysis), dysarthria, anesthesia with signs of intracranial hypertension (nausea / vomiting) and headache. Blood pressure at 176/86 mHg. Cerebral MRI: Large recent right thalamic hematoma, associated with diffuse ventricular contamination, and at the level of the basal cisterns. Mass effect and surrounding structures with a deviation of the median line lateralized to the left measured at 10 mm. Perilesional hypersignal nose, probably related to reactive edema. Dilation of the ventricular system, in connection with an incipient hydrocephalus. Multiple hypersignals flair of deep white matter and periventricular, in connection with a vasculo-degenerative microangiopathy (FAZEKAS grade 3). Presence of two microbleeds in the left post-central cortex as well as in the right deep sylvian level. Absence of suspicious underlying enhancement. No sign of arteriovenous malformation. No cerebral venous thrombosis. Biology: Complete Blood Count with hyperleukocytosis (15,870 / mm3) predominantly neutrophils (11540 / mm3), platelets 210 G / L, D-dimers <215 ng / ml, Prothrombin time 41%, Prothrombin time 22.3 s (VR: 10-15 s), FII 51%, FV 72%. Evolution: Start of anti-hypertensive treatment (nicardipine) IVSE (intravenous syringe pump), comfort care with morphine, midazolam, unfavorable outcome with respiratory arrest then death at 10:05 p.m. Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1327946 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-04-26
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DIFFU K; STRESAM; FUROSEMIDE; NOVORAPID; LANTUS; PLAVIX; ZYLORIC; ESOMEPRAZOLE; IKOREL; BISOPROLOL
Current Illness: Diabetes; Hypertension arterial; Insufficiency renal; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary arteritis
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021539325

Write-up: Respiratory distress; Vaccination failure; COVID-19 positivity; This is a spontaneous report from a consumer or other non HCP downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-DJ20211054. Safety Report Unique Identifier: FR-AFSSAPS-2021048085. Declaration from an EHPAD director via the reporting portal of the Agency and registered under the number 2021.0503124559648. This consumer reported similar events for two patients. This is the first of two reports. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via intramuscular on 11Feb2021 (Lot Number: EJ6789) as single dose, dose 2 via intramuscular on 04Mar2021 (Lot Number: EP2166) as single dose for COVID-19 immunisation. Patient age at vaccination was reported as 69 years old. The patient medical history included ongoing diabetes, ongoing hypertension arterial, ongoing obesity, ongoing insufficiency renal, coronary arteritis. The patient had no history of COVID-19 disease. The patient''s concomitant medication included potassium chloride (DIFFU K), etifoxine hydrochloride (STRESAM), furosemide, insulin aspart (NOVORAPID), insulin glargine (LANTUS), clopidogrel bisulfate (PLAVIX), allopurinol (ZYLORIC), esomeprazole, nicorandil (IKOREL), bisoprolol. The patient experienced vaccine failure with a fatal outcome. The registrant reported on 26Apr2021, or 53 days after the injection of the second dose of vaccine, the occurrence of COVID-19 positivity. Before 26Apr2021 no variant has been identified. On 02May2021 the patient presented with respiratory distress requiring hospitalization. The patient died on 06May2021. The cause of death was reported as COVID infection following vaccination failure. Autopsy was not done. Hospitalization report pending. Several cases in the same AFDEP (Accommodation facility for dependent elderly people), in particular another death (DJ20211042). No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021546915 Different patient/ same AE and suspect product.; Reported Cause(s) of Death: COVID infection following vaccination failure; respiratory distress; COVID infection following vaccination failure


VAERS ID: 1328466 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-29
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Computerised tomogram, Platelet count, Pneumonia, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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: 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: Alzheimer''s disease; Dementia (Severe alzheimers dementia); Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Name: CT scan and clinical examination; Result Unstructured Data: Test Result:suffered a cerebral infarction; Test Name: platelet count; Result Unstructured Data: Test Result:182; Test Name: platelet count; Result Unstructured Data: Test Result:284; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021540899

Write-up: bronchopneumonia; Cerebral infarction; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (RA). Regulatory authority report number (GB-MHRA-WEBCOVID-202105121218265400-BOAIC), Safety Report Unique Identifier (GB-MHRA-ADR 25284984). A 90-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 at single dose for COVID-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing (severe alzheimers dementia), non-tobacco user from an unknown date and unknown if ongoing. Unsure if patient had had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient previously took heparin. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced bronchopneumonia on 29Mar2021, cerebral infarction on 29Mar2021. It was reported that patient suffered cerebral infarction 4 days after 2nd dose of Pfizer vaccine. Suffered further infarct and developed bronchopneumonia leading to death, ultimately triggered by initial infarction. This report related to possible thromboembolic event / thombocytopenia additional questions. No previous venous or arterial thromboses. No history of, or current, malignancy. No currently smoke. No haemorrhage identified. No concurrent or recent intracranial infections. Patient did not have recent surgical or medical interventions to the central nervous system (including lumbar puncture). Patient did not have a recent trauma/head injury. Unknown if the patient had any previous reactions to medications, especially heparin or anticoagulants. Unknown if the patient had confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient underwent lab tests and procedures which included COVID-19 virus test on unspecified date: no - negative COVID-19 test; CT scan and clinical examination on 29Mar2021: suffered a cerebral infarction; platelet count (usual normal range 150-450) on unspecified dates: 182 and 284 (the last platelet count before vaccine, patient did not review by a haematologist). The patient died on an unspecified date. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: bronchopneumonia; Cerebral infarction


VAERS ID: 1328496 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Maternal exposure timing unspecified, Ultrasound scan
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: Sonograph; Result Unstructured Data: Test Result:Gestational sac, yolk sac and a thickening &; Comments: foetal pole & measuring just under 2mm & said 5 weeks 5 days.; Test Date: 20210425; Test Name: Sonograph; Result Unstructured Data: Test Result:pole now just under 3mm, so just under 1mm growth; Comments: so just under 1mm growth in a week. Heart beat present and gestation 6 weeks (only a change in 2 days over 7 day period). On dates should be 7 plus 3 days.; Test Date: 20210502; Test Name: Sonograph; Result Unstructured Data: Test Result:measuring 5mm. Sonographer said heartbeat was very; Comments: Sonographer said heartbeat was very slow/faint.; Test Date: 20210504; Test Name: Sonograph; Result Unstructured Data: Test Result:Two sonographers confirmed no heartbeat present; Comments: The CRL measured at 4.1 mm (should have been 8 weeks 5 days) measurement was around 5 weeks 5 days. So there was very minimal growth in early pregnancy.
CDC Split Type: GBPFIZER INC2021550806

Write-up: sonographers confirmed no heartbeat present; maternal exposure during pregnancy; This is a spontaneous report from a contactable nurse (parent). This nurse reported information for both mother and fetus. This is a fetus report. The mother received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in Arm Left on 28Mar2021 10:00 (Lot Number: ER1741) as single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included omeprazole 20MG. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The mother received first dose of BNT162B2 on 16Jan2021 10:00 as single dose for COVID-19 immunisation. COVID vaccine on cycle day 25, 3 days before mother expected period. Positive test the same day of vaccination. On 18Apr2021 early scan at what would have been 6 weeks 3 days. Gestational sac, yolk sac and a thickening & foetal pole & measuring just under 2mm & said 5 weeks 5 days. 25Apr2021 repeat scan. foetal pole now just under 3mm, so just under 1mm growth in a week. Heart beat present and gestation 6 weeks (only a change in 2 days over 7 day period). On dates should be 7 plus 3 days. On 02May2021 repeat scan at what should be 8 weeks 3 days, measuring 5mm. Sonographer said heartbeat was very slow/faint. The mpther needed seeing by EPU. On 04May2021 seen EPU. Two sonographers confirmed no heartbeat present. The CRL measured at 4.1 mm (should have been 8 weeks 5 days) measurement was around 5 weeks 5 days. So there was very minimal growth in early pregnancy. For surgical/medical management of removal. The adverse event result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included Next week due Medical/surgical removal pregnancy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of maternal exposure during pregnancy was unknown. It was unknown if Autopsy Done. No follow up required. No further information is expected.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of foetal death due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-2021503593 mother case; Reported Cause(s) of Death: sonographers confirmed no heartbeat present


VAERS ID: 1328519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8958 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021544626

Write-up: Cerebral hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is GR-GREOF-20213078. A 49-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 26Apr2021 (Batch/Lot Number: ET8958; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cerebral hemorrhage on 03May2021. The patient died on 03May2021. An autopsy was performed that revealed cerebral haemorrhage of pathological aetiology (cerebral haemorrhage). The death certificate was sent to Regulatory Authority. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral hemorrhage; Autopsy-determined Cause(s) of Death: CEREBRAL HAEMORRHAGE OF PATHOLOGICAL AETIOLOGY


VAERS ID: 1328525 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (UNDER MEDICATION); Pancreatitis (1.5 YEARS AGO); Thrombophlebitis leg (Thrombophlebitis legs)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021544618

Write-up: ACUTE DYSPNEA; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number GR-GREOF-20213153. An 85-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included thrombophlebitis leg from an unknown date and unknown if ongoing, pancreatitis 1.5 years ago, hypertension from an unknown date and unknown if ongoing under medication. The patient''s concomitant medications were not reported. The patient experienced acute dyspnea (death, hospitalization, medically significant) on 01Feb2021. The patient died on 01Feb2021: cause of death was massive pulmonary embolism, cataplexy, dyspnea. An autopsy was not performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: massive pulmonary embolism; CARDIAC CATAPLEXY; dyspnea


VAERS ID: 1328661 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 1 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: 2021-04-30
   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: DEPAKIN; LAMICTAL; CARDIOASPIRIN; TACHIPIRINA; PEPTAZOL [LANSOPRAZOLE]; PLAUNAZIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Cholelithiasis; Epilepsy; Hypertension arterial; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021544632

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (regulatory authority number IT-MINISAL02-726005). A 78 years old female patient received the first dose of BNT162B2 (COMIRNATY; lot EW6326, expiry date 07Jul2021) intramuscular, in left shoulder, on 28Apr2021 at 19:00, at 0.3 ml single, for COVID-19 immunisation. Medical history included epilepsy, obesity, cholelithiasis, hypertension arterial and arthrosis, all from an unknown date and unknown if ongoing. Concomitant medications included valproate sodium (DEPAKIN), lamotrigine (LAMICTAL), acetylsalicylic acid (CARDIOASPIRIN), paracetamol (TACHIPIRINA), lansoprazole (PEPTAZOL), hydrochlorothiazide, olmesartan medoxomil (PLAUNAZIDE). The patient experienced acute myocardial infarction on 30Apr2021 with fatal outcome. Actions taken: emergency service intervention. The patient died on 30Apr2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1328765 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-05-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood sodium, Body temperature, Chest X-ray, Coma scale, Computerised tomogram, Dehydration, Hypernatraemia, Oxygen saturation, Pneumonia aspiration, X-ray
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration; Debility; Dysphagia; Late effects of cerebral infarction (anticoagulant agent was not used); Left hemiplegia; Unable to eat (received replenisher solution)
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: BS; Result Unstructured Data: Test Result:124; Test Date: 20210511; Test Name: Na; Result Unstructured Data: Test Result:168; Comments: high; Test Date: 20210510; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210511; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210511; Test Name: chest x-ray; Result Unstructured Data: Test Result:diffuse infiltrative shadow in the right lung; Test Date: 20210511; Test Name: JCS; Result Unstructured Data: Test Result:300; Test Date: 20210511; Test Name: CT; Result Unstructured Data: Test Result:consciousness disturbed; Comments: due to pneumonia aspiration, dehydration, and hypernatraemia, not cerebrovascular disorder; Test Date: 20210511; Test Name: SpO2; Result Unstructured Data: Test Result:83 to 89 %; Comments: under oxygen mask at 10 L; Test Date: 20210511; Test Name: x-ray; Result Unstructured Data: Test Result:consciousness disturbed; Comments: due to pneumonia aspiration, dehydration, and hypernatraemia, not cerebrovascular disorder
CDC Split Type: JPPFIZER INC2021538159

Write-up: Pneumonia aspiration; Dehydration; Hypernatraemia; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21105962. An 88-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration, on 10May2021 at 10:15 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included late effects of cerebral infarction (anticoagulant agent was not used) from 2010, left sided paralysis due to cerebral infarction, dysphagia, tendency to debility, not able to eat (received replenisher solution) from 28Mar2021 to 30Mar2021, and aspiration. The patient had no family history. The patient''s concomitant medications were not reported. The patient experienced pneumonia aspiration, dehydration, and hypernatraemia on 11May2021 at 14:20 (1 day and 4 hours and 5 minutes after the vaccination), which required hospitalization from 11May2021 to 11May2021 and were reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 36.3 degrees Centigrade on 10May2021. On 11May2021, the Japan Coma Scale (JCS) was 300, but the patient sometimes complained of pain, and the body temperature was 36.7 degrees Centigrade and blood sugar (BS) was 124. The chest x-ray showed diffuse infiltrative shadow in the right lung and the oxygen saturation (SpO2) was in the range of 83 to 89% under oxygen mask at 10 liters (L) on 11May2021. The treatment included antibiotics such as ampicillin sodium, sulbactam sodium (UNASYN-S) 3.0 grams, levofloxacin (CRAVIT) 500 mg bag, and magnesium carbonate, potassium chloride, sodium chloride, sodium citrate dihydrate, sodium phosphate monobasic (anhydrous) (SOLITA-T NO. 3), and unspecified replenisher solution. On 11May2021, the patient developed dyspnoea and consciousness disturbed. The possibility of cerebrovascular disorder was considered, and the patient visited another hospital. As a result of a computerised tomogram (CT) and x-ray on 11May2021, the patient was diagnosed with consciousness disturbed due to pneumonia aspiration, dehydration, and hypernatraemia, not cerebrovascular disorder. The reporting physician commented as follows: Although the events occurred on the following day of the vaccination, it was considered coincidence because the patient already had debility and aspiration, typical manifestations of pneumonia aspiration were observed, and blood sodium (Na) was high at 168 on 11May2021. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 11May2021. The causes of death were reported as pneumonia aspiration, dehydration, and hypernatraemia. It was not reported if an autopsy was performed. The reporting physician assessed that the events were unrelated to BNT162B2. Other possible causes of the events, such as any other diseases, were reported as aforementioned in the reporting physician''s comment.; Sender''s Comments: The reported events are considered intercurrent and unrelated to suspect drug BNT162B2.; Reported Cause(s) of Death: Pneumonia aspiration; Dehydration; Hypernatraemia


VAERS ID: 1328766 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

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: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; TULOBUTEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021538548

Write-up: Cerebral infarction; This is a spontaneous report from a contactable pharmacist received via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of the two reports. A 95-year-old female patient received BNT162B2 (COMIRNATY; Number: ER9480; Expiration Date: 31Jul2021), via an unspecified route of administration on 20Apr2021 as 1st dose, single for covid-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing. No information on family history was provided. Concomitant medications included furosemide (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; tulobuterol (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebral infarction on 25Apr2021, which is serious as it lead to death. Details were as follows: On 25Apr2021 (5 days after vaccination), the patient died. The cause of death was noted as cerebral infarction. It was not reported if an autopsy was performed. The reporting pharmacist classified the event as serious sue to fatal outcome, and causality assessment between BNT162B2 and the event was reported as uncertain at present. The patient died on 25Apr2021. It was not reported if an autopsy was performed.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported event cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : JP-PFIZER INC-2021538915 same drug, reporter and event; different patient; Reported Cause(s) of Death: cerebral infarction


VAERS ID: 1328774 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Haematemesis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:not provided; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021541943

Write-up: Haematemesis; Vomiting; This is a spontaneous report from a contactable pharmacist and from a contactable physician. This report was received via a Pfizer sales representative. An 87-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in 2021 at a single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced haematemesis and vomiting, which were serious for death. The course of the event was as follows: on unknown date in 2021 at (the day of vaccination), the patient received a dose of BNT162b2. On unknown date in 2021 (the day of vaccination), the patient experienced vomiting and haematemesis. On unknown date in 2021 (unknown days after vaccination), the patient died. Body temperature before vaccination was not provided. The clinical outcome of the events was fatal. The patient died on an unspecified date in 2021 due to haematemesis and vomiting. An autopsy was being performed at the other hospital with unknown results. The causality between the event and BNT162b2 was unknown. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: haematemesis; vomiting


VAERS ID: 1328778 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Coronary artery stenosis, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Other ischaemic heart disease (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: 2021-05-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021542418

Write-up: Loss of consciousness; Cardiac arrest; Marked coronary artery stenosis; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is v21106100. A 95-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: ER9480, Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 11May2021, at 13:45 as 1ST DOSE, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced loss of consciousness and cardiac arrest on 11May2021, at 18:40; the patient also experienced marked coronary artery stenosis on 11May2021. The patient underwent lab tests and procedures which included body temperature: 36.2 Centigrade on 11May2021 before vaccination. Details were as follows: On 11May2021 (the day of vaccination), the patient had a light dinner. After the meal, she experienced loss of consciousness while brushing her teeth. Cardiac arrest occurred. Around 19:00, resuscitation was started. The patient underwent tracheal intubation and received drip infusion (LACTEC 500) and BOSMIN 1A intravenously (IV). She was urgently transported to Hospital B and was confirmed dead. On 13May2021 at 09:30, legal autopsy was performed at the hospital. Marked coronary artery stenosis was noted. A diagnosis of death with unknown cause was made. The reporting physician classified the events as serious (per death) and assessed the causality between the events and BNT162b2 as unassessable. Other possible causes of the events such as any other diseases was noted as advanced age. The reporting physician commented as follows: The department of legal medicine would perform further investigation for several months. If no vaccination had been given, heart disorder could be the plausible cause. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 11May2021.; Reported Cause(s) of Death: Loss of consciousness; Cardiac arrest; Marked coronary artery stenosis


VAERS ID: 1328783 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Body temperature, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, Pneumonia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210508; Test Name: SpO2; Test Result: 94 %; Comments: 16:30 room air; Test Date: 20210508; Test Name: SpO2; Result Unstructured Data: Test Result:89- 91 %; Comments: After IV drip decreasing tendency; Test Date: 20210508; Test Name: SpO2; Result Unstructured Data: Test Result:89-92 %; Comments: on admission room air Oxygen 3L/min; Test Date: 20210509; Test Name: SpO2; Result Unstructured Data: Test Result:89-90 %; Comments: 03:30 Oxygen 5L/min; Test Date: 20210509; Test Name: SpO2; Result Unstructured Data: Test Result:89 - 94 %; Comments: 06:52 Oxygen 5L/min; Test Date: 20210509; Test Name: SpO2; Result Unstructured Data: Test Result:88-89 %; Comments: 09:50 Oxygen 10L/min; Test Date: 20210509; Test Name: SpO2; Test Result: 89 %; Comments: 11:20
CDC Split Type: JPPFIZER INC2021549715

Write-up: Acute pneumonia; bronchial asthma; breathing difficulty/inspiratory dyspnoea; wheezing; SpO2 Oxygen saturation 89- 91, SpO2 Oxygen saturation 88-89; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21106433. A 81-years-old male ( also reported as 81-year and 10-month-old) patient received the first dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 08May2021 13:30 (also reported as ''from 13:30 to 14:30 (the day of vaccination),'' at the age of 81 years old (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) 0.3 ml, single for covid-19 immunization. The patient medical history was not reported. Body temperature before vaccination was 36.3 degrees Centigrade. The patient was receiving blood-thinner medicine and medicines for blood pressure. No information on family history was provided. On 08May2021 16:30, The patient experienced acute pneumonia (death, hospitalization) on 08May2021 16:30 , bronchial asthma (death, hospitalization), breathing difficulty/inspiratory, wheezing and spo2 oxygen saturation 89- 91, spo2 oxygen saturation 88-89. The adverse event involved emergency room visit and hospitalization. The patient was hospitalized from 08May2021 to 09May2021. The patient underwent lab tests and procedures which included body temperature: 36.3 centigrade on 08May2021 Before vaccination , oxygen saturation: 94 % on 08May2021 16:30 room air , oxygen saturation: 89- 91 % on 08May2021 After IV drip decreasing tendency , oxygen saturation: 89-92 % on 08May2021 on admission room air Oxygen 3L/min , oxygen saturation: 89-90 % on 09May2021 03:30 Oxygen 5L/min , oxygen saturation: 89 - 94 % on 09May2021 06:52 Oxygen 5L/min , oxygen saturation: 88-89 % on 09May2021 09:50 Oxygen 10L/min , oxygen saturation: 89 % on 09May2021 11:20. Treatment was given for the events. The clinical outcome of the events pneumonia and bronchial asthma was fatal while the remaining events was unknown. The patient died on 09May2021. It was not reported if an autopsy was performed. The course of the event was as follows: On 08May2021 from around 16:30, the symptoms (such as breathing difficulty, wheezing, and inspiratory dyspnoea) started to appear. SpO2 (oxygen saturation percutaneous) was 94% (room air). On 08May2021 at 19:49, the patient visited the emergency department of the reporter''s hospital as an outpatient where IV drip (SOLDEM 1 200 mL, 1 bottle and SOLU-CORTEF 250 mg, 1 bottle), and inhalation (inhalator, VENETLIN 0.3 mL and normal saline solution 2.0 mL) were administered. After IV drip was completed, SpO2 of 89% - 91% (decreasing tendency) and worsening of wheezing were noted. As the possibility of adverse reactions was suspected, the patient was hospitalized for the purpose of observation of his progress (at 22:00 on 08May2021). At the time of admission (from 22:00), oxygen administration (3L/min, SpO2 of 89% - 92%, room air) was started. Wheezing on exertion was worsened. On 09May2021 at 03:30, oxygen flow rate was changed to 5L/min (SpO2 of 89% - 90%) because of worsening of wheezing and decreased SpO2. On 09May2021 at 06:52, oxygen flow rate was set at 5L/min (SpO2 of 89% - 94%). On 09May2021 at 08:31, DECADRON injection, 3.3 mg, 1 ampule was intravenously administered. On 09May2021 at 09:50, as SpO2 was decreased, oxygen flow rate was changed to 10L/min (SpO2 of 88% - 89%), PCR test was performed (the result was negative), consciousness disturbed (JCS [coma scale]-2) was noted. On 09May2021 at 11:00, indwelling bladder catheter was inserted. On 09May2021 at 11:20, TAZOPIPE for combination injection, 4.5 mg was administered (2 kits in total) (SpO2 89%). On 09May2021 at 14:40, disimpaction was performed (glycerin enema 50%, 60 mL). On 09May2021 at 14:50, furosemide injection 20 mg, 1 ampule was administered. On 09May2021 at 16:00, his breathing was stopped (JCS-300), cardiac massage was started. Adrenaline injection 0.1% syringe was administered. Prevaccination Screening Questionnaire for COVID-19 vaccine as follow: Have you read the Instructions for the COVID-19 vaccine and do you understand the effects and adverse side effects?:Yes Are you currently suffering from any kind of illness and receiving treatment or medication? ?:Yes Name of disease:(Blank), Nature of treatment: blood-thinning medicine and medicine for blood pressure Has a doctor who is treating you for the disease told you that you can have the vaccine today?:No Have you had a fever or gotten sick in the last month?:No Are there any parts of your body that are not feeling well today?:No Have you ever had a convulsion (seizure)?:No Have you ever experienced severe allergic symptoms (such as anaphylaxis) from medications or foods?:No Have you had any vaccines within the last two weeks?:No In light of the results of the questions above and examination, today''s vaccine is :possible ''(by doctor) The reporting physician classified the event as serious (death and hospitalization). There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: acute pneumonia; bronchial asthma


VAERS ID: 1328793 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-03
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Altered state of consciousness, Arrhythmia, Atrial fibrillation, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood pH, Body temperature, C-reactive protein, COVID-19, Cardiac failure congestive, Fibrin D dimer, Glomerular filtration rate, Haemoglobin, Heart rate, Imaging procedure, International normalised ratio, Lethargy, Lymphocyte count, Microscopy, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Procalcitonin, Prothrombin time, Respiratory rate, SARS-CoV-2 test, Sulphur dioxide test, Thrombocytopenia, Vaccination failure, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATENOLOL; BURINEX; AMIROL; OMEPRAZOLE; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cataract; Chronic kidney disease; Hypertension; Osteoarthritis spinal
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: Alk phosphatase; Result Unstructured Data: Test Result:143 IU/l; Comments: (40-104 units/L) RAISED; Test Name: HCO3; Result Unstructured Data: Test Result:22; Test Date: 20210407; Test Name: bilirubin; Result Unstructured Data: Test Result:29.6 umol/l; Comments: (0-21micromol/L) RAISED; Test Date: 20210407; Test Name: Creatinine; Result Unstructured Data: Test Result:118 umol/l; Comments: (45-84micromol/L) RAISED; Test Name: blood pH; Result Unstructured Data: Test Result:7.498; Test Date: 20210403; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4; Comments: rectal; Test Date: 20210407; Test Name: C-reactive protein; Result Unstructured Data: Test Result:50.3 mg/l; Comments: RAISED; Test Date: 20210407; Test Name: D dimer; Result Unstructured Data: Test Result:563 ng/ml; Comments: (0-500ng/ml) ABNORMALLY HIGH; Test Name: GRF; Result Unstructured Data: Test Result:about 38; Test Date: 20210407; Test Name: GRF; Result Unstructured Data: Test Result:39; Comments: ml/min/1.73m2; Test Date: 20210404; Test Name: Hb; Result Unstructured Data: Test Result:10.5 g/dl; Comments: LOW; Test Date: 20210403; Test Name: heart rate; Result Unstructured Data: Test Result:54; Comments: slow AF; Test Date: 20210403; Test Name: Pulse rate; Result Unstructured Data: Test Result:54; Test Date: 20210404; Test Name: Imaging for COVID-Pneumonia; Result Unstructured Data: Test Result:No significant abnormality; Test Date: 20210404; Test Name: INR; Result Unstructured Data: Test Result:1.13; Comments: (0.94-1.06 ratio) RAISED; Test Date: 20210404; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.82 g/l; Comments: (1.3-3.6 X 109 g/L) LOW; Test Date: 20210404; Test Name: Urine microscopy; Result Unstructured Data: Test Result:E.coli ESBL positive cultivated; Test Date: 20210404; Test Name: neutrophils; Result Unstructured Data: Test Result:normal; Test Name: SPO2; Test Result: 96 %; Comments: on 15L/min Oxygen. ABGs on 15L/min NMR; Test Date: 20210403; Test Name: SPO2; Test Result: 73 %; Comments: on room air; Test Name: pCO2; Result Unstructured Data: Test Result:28.1; Test Date: 20210404; Test Name: Platelet count; Result Unstructured Data: Test Result:77; Comments: 132-349 X109/L low; Test Name: pO2; Result Unstructured Data: Test Result:79.4; Test Date: 20210407; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.137 ng/ml; Comments: (0.02-0.046 ng/mL) RAISED; Test Date: 20210404; Test Name: PT; Test Result: 11.7 s; Comments: (9.96-11.24s) RAISED; Test Date: 20210403; Test Name: Respiratory Rate; Result Unstructured Data: Test Result:28; Test Date: 20210405; Test Name: Nasal swab (RT-PCR); Test Result: Positive ; Comments: Nasal swab (RT-PCR) Detected: CT=36 Abnormal; Test Name: SO2; Result Unstructured Data: Test Result:97.2; Test Date: 20210404; Test Name: WBC; Result Unstructured Data: Test Result:normal
CDC Split Type: MTPFIZER INC2021541717

Write-up: covid-19 infection; covid-19 infection; Congestive Heart Failure; Atrial Fibrillation; Arrhythmia; Acute kidney injury; Altered consciousness; Thrombocytopenia; Increased lethargy; This is a spontaneous report from a contactable physician. A 96-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection), dose 2 intramuscular, administered in Arm Left on 11Feb2021 (Lot Number: EL8723) as 2nd dose, single; dose 1 intramuscular, administered in Arm Left on 21Jan2021 (Lot Number: EM0477) as 1st dose, single for covid-19 immunisation. Medical history included hypertension, atrial fibrillation, chronic kidney disease since 2016, right eye cataract, spinal osteoarthritis. Non-smoker. Concomitant medications included atenolol at 100 mg daily; bumetanide (BURINEX) at 1 mg daily; amitriptyline hydrochloride (AMIROL) at 10 mg nocte; omeprazole at 20 mg twice daily; paracetamol at 1 g, as needed (tds) and Diarolyte sachet as needed (twice daily). The patient experienced covid-19 infection 03Apr2021. The patient was hospitalized for covid-19 infection on 03Apr2021. The patient experienced Dyspnea (Hypoxia), Tachypnea (RR more than 25bpm), Respiratory failure (Type 1 Respiratory Failure), Arrhythmia (atrial fibrillation known case), Hypoxemia (SPO2 73% RA rising to 95% on 15L/min NRM), Acute kidney injury (CKD - GFR about 38), Altered consciousness, Increased lethargy, Thrombocytopenia (Platelets - 77). On 05Apr2021 she was administered treatment with Remdesivir 200mg iv stat, then 100mg iv daily, Dexamethasone 6mg iv daily and Augmentin 1.2g 8hrly IV. The patient underwent lab tests and procedures which included: Nasal swab (RT-PCR) - positive on 05Apr2021 (new infection, Detected: CT=36 Abnormal). On admission (03Apr2021: Rectal Temp 36.4; RR=28; Pulse=54; Heart 54 - Slow AF; SpO2 on room air - 73%. Oxygen saturations rose to 96% on 15L/min Oxygen. ABGs on 15L/min NRM: pH 7.498; pCO2 28.1; pO2 79.4; SO2 97.2; HCO3 22. Imaging for COVID-Pneumonia (04Apr2021) No significant abnormality. On 04Apr2021 WBC, Neutrophils - normal, Lymphocytes 0.82 (1.3-3.6 X 109 g/L) LOW, Hb - 10.5 (12-15.5g/dL) LOW, Platelets - 77 (132-349 X109/L) LOW, PT 11.7 (9.96-11.24s) RAISED, INR 1.13 (0.94-1.06 ratio) RAISED, Imaging for COVID-Pneumonia: No significant abnormality, Urine microscopy E.coli ESBL positive cultivated. On 07Apr2021 D-DIMER 563 (0-500ng/ml) ABNORMALLY HIGH, Creatinine 118 (45-84micromol/L) RAISED, Bilirubin 29.6 (0-21micromol/L) RAISED, Alk phosphatase 143 (40-104 units/L) RAISED, GFR 39 ml/min/1.73m2, CRP 50.3 (0-5mg/L) RAISED, Procalcitonin 0.137 (0.02-0.046 ng/mL) RAISED. The patient died on 09Apr2021. It was unknown if an autopsy was performed. Cause of death: Hypoxia due to COVID-19 infection. Significant contributory causes: Congestive Heart Failure; Atrial Fibrillation. Outcome of the events covid-19 infection, Congestive Heart Failure, Atrial Fibrillation was fatal; of the other events was unknown. Follow-up attempts completed. No more information are expected.; Sender''s Comments: This patient experienced Fatal vaccination failure since a COVID-19 Infection developed 1 month 23 days days after the administration of the 2nd dose. The doses were properly spaced (42 days between the 1st and second dose).The vaccine preventable illness, COVID-19 infection, showed unfavorable course with Respiratory failure, Hypoxemia and Congestive Heart Failure, Atrial Fibrillation as significant contributory factors to the fatal outcome. Other serious events, like Arrhythmia, Acute kidney injury, Altered state of consciousness, Thrombocytopenia further worsened the clinical course of current infection. 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: Hypoxia due to COVID-19 infection; Congestive Heart Failure; Atrial Fibrillation; Hypoxia due to COVID-19 infection


VAERS ID: 1328850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac death, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), COVID-19 (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:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (already vulnerable with a declining of his health due to dementia and a possible respiratory infection (COVID-19 negative).); Respiratory infection (Patient was already vulnerable with a declining of his health due to dementia and a possible respiratory infection (COVID-19 negative).)
Allergies:
Diagnostic Lab Data: Test Name: covid negative; Test Result: Negative
CDC Split Type: NLPFIZER INC2021539546

Write-up: Vulnerable patient, deterioration in dementia in DD respiratory infection, covid negative/Cause of death was either acute cardiac death or lung embolism; Vulnerable patient, deterioration in dementia in DD respiratory infection, covid negative/Cause of death was either acute cardiac death or lung embolism; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00533140. A 75-year-old male patient received second dose of bnt162b2 (COMIRNATY), on 06May2021 (Lot Number: ET6956) at 2nd dose , single for covid-19 immunisation. Medical history included the patient was already vulnerable with a declining of his health due to dementia and a possible respiratory infection (COVID-19 negative). The patient previously received first dose of bnt162b2 (COMIRNATY) on 06Apr2021 for covid-19 immunisation. Had no complaints after 1st vaccination. The patient''s concomitant medications were not reported. Vulnerable patient, deterioration in dementia in DD (differential diagnosis) respiratory infection, covid negative. The patient experienced sudden death (death) following administration of covid-19 vaccine pfizer injectable solution for covid 19 immunisation. The outcome of sudden death is fatal. Patient had no complaints or side effects on the day of vaccination: no fever, patient was eating and drinking. Patient died suddenly 7 hours after vaccination. Cause of death was either acute cardiac death or lung embolism. Day of vaccination free of complaints, no temp, just sat up at the table, ate and drank well. No contraindication to vaccination. After representative consultation, vaccinated. Patient was vulnerable, the physician doubt whether vaccination contributed to the worsening condition. No Previous COVID-19 infection. The lab data included covid negative. The patient died on 06May2021. It was not reported if an autopsy was performed. Reporter Comment: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: no Date: 06Apr2021 Vulnerable patient, deterioration in dementia in DD respiratory infection, covid negative. Additional information ADR: Day of vaccination free of complaints, no temp, just sat up at the table, ate and drank well. No contraindication to vaccination. After representative consultation, vaccinated. Had no complaints after 1st vaccination. Patient was vulnerable, I doubt whether vaccination contributed to the worsening condition. Iom family decided to report anyway. COVID-19 Previous COVID-19 infection: No. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Patient was vulnerable, I doubt whether vaccination contributed to the worsening condition. Family decided to report anyway.; Reported Cause(s) of Death: DD (differential diagnosis) acute cardiac death DD pulmonary embolism; DD (differential diagnosis) acute cardiac death DD pulmonary embolism


VAERS ID: 1328852 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-11
Onset:2021-05-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: NLPFIZER INC2021539480

Write-up: Cardiac arrest; Myocardial infarction; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00534918, received from Regulatory Authority. A 74-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 11Apr2021 (Batch/Lot Number: ET9096) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient didn''t have COVID-19 infection previous. The patient experienced cardiac arrest on 03May2021, Myocardial infarction (Heart attack) followed by cardiac arrest. Cardiac ultrasound in emergency room hospital. Both events treated with Reanimatie. The outcome of cardiac arrest and heart attack was fatal. Patient died on 03May2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Myocardial infarction; Cardiac arrest


VAERS ID: 1328853 (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: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 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: 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: INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac fibrillation; Diabetes mellitus; Heart failure; Obesity (BMI=31)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021539531

Write-up: Died within 4 hours; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority -WEB [NL-LRB-00535361]. A 69-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: ET6956) as 1st dose, single for covid-19 immunisation; Acenocoumarol via an unspecified route of administration from 2020 to 28Apr2021, according to scheme for an unspecified indication. Medical history included diabetes mellitus, obesity (BMI=31), heart failure, cardiac fibrillation from 2020. No Previous COVID-19 infection. Concomitant medication included Insulin. The patient experienced died within 4 hours (Heart attack) on 28Apr2021. Action taken for Acenocoumarol was unknown. The outcome of heart attack is fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no confounding factors confounding factors: Diabetes and heart failure COVID-19 Previous COVID-19 infection: No.; Reported Cause(s) of Death: Died within 4 hours


VAERS ID: 1328871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-05-03
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 LA / -

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: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021539287

Write-up: SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uwzpr3. A 71-year-old female patient received first dose of BNT162B2 (COMIRNATY, Lot Number: EX2405) via an unspecified route of administration, administered in left arm on 14Apr2021 at 12:00 as single dose for covid-19 immunisation. Medical history included breast cancer from 2019 and lung cancer from 2016, both not ongoing (as reported). The patient did currently not have any active cancerous disease or other known diseases. The patient''s concomitant medications were not reported. The patient experienced sudden death on 03May2021. The patient had not had any symptoms following vaccination. The patient died on 03May2021. An autopsy was not performed. The reporter stressed the uncertainty as to whether or not the death could be associated with vaccination, due to the death occurring more than two weeks after vaccination. Thus, Causality by reporter was also registered and set to Uncertain. The clinical investigation did not establish any clear cause of a sudden death. Due to the vaccine being administered some weeks before the sudden death, death as a possible adverse reaction to vaccination could not be ruled out, although the physician was uncertain whether to report it or not. The Regulatory Authority assessed the causal relationship between BNT162B2 and sudden death as possible. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SUDDEN DEATH


VAERS ID: 1328884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-30
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypercholesterolemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021534752

Write-up: Hemorrhagic stroke; This is a spontaneous report from a contactable pharmacist. An 83-year-old female patient (not pregnant) received the second dose of BNT162B2 (COMIRNATY), via intramuscular in Apr2021 (at an unknown age) at 0.3 mL, single for COVID-19 immunisation. Medical history included diabetes, hypercholesterolemia, and hypertension arterial. Concomitant medications included unspecified medications for treatment of diabetes, hypercholesterolemia, and hypertension arterial. The patient previously received the first dose of BNT162B2 (COMIRNATY) (lot number: unknown) in Mar2021 at the age of 82-year-old via intramuscular for COVID-19 immunisation. The patient didn''t receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. It is unknown if since the vaccination, the patient was tested for COVID-19. On 30Apr2021 at 06:00, the patient was found lying on the floor. She had experienced hemorrhagic stroke and was taken to the hospital on 30Apr2021 at 06:00. She remained hospitalized and died on 06May2021. Autopsy was performed. The outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available and currently known drug safety profile, it is unlikely that event hemorrhagic stroke was related to BNT162B2. The patient''s underlying risk factors/predisposing conditions diabetes, hypercholesterolemia, and hypertension arterial and the advanced age have been assessed to have played a contributory role toward the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Hemorrhagic stroke


VAERS ID: 1328923 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Dyspnoea, Investigation, Nausea, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Dementia (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure; Cardiac fibrillation; Gout
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Investigation; Result Unstructured Data: Test Result:search for infection; Comments: in urine, lungs, unclear where it was.
CDC Split Type: SEPFIZER INC2021545053

Write-up: severe nausea the same evening as the vaccination; apathetic; Breathing difficulties; she gurgled as if the lungs were full of water; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-034142. An 86-year-old female patient received first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration in Feb2021 (Batch/Lot Number were not reported) as single dose for COVID-19 immunisation. Medical history included ongoing cardiac fibrillation, ongoing cardiac failure and ongoing gout. The patient''s concomitant medications were not reported. The reporter stated that in Feb2021 the patient experienced severe nausea the same evening as the vaccination. The woman was very ill about 7-8 days after the vaccination. Suddenly apathetic. Hospitalized for a week. At home for a day, sudden severe breathing difficulties. Hospitalized for two weeks, search for infection in urine, lungs, unclear where it was. The patient was sent home. Breathing difficulties for eleven days. The last day she gurgled as if the lungs were full of water. The events were serious life-threatening, caused hospitalization and the outcome was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: nausea; illness; apathetic; Breathing difficulties; she gurgled as if the lungs were full of water


VAERS ID: 1328940 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Blood glucose, C-reactive protein, Cerebral haemorrhage, Computerised tomogram, International normalised ratio, Intraventricular haemorrhage, PCO2, PO2, Platelet count, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: WARAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker user; Atrioventricular block third degree; Chronic obstructive pulmonary disease; Chronic pulmonary embolism; Lobar pneumonia (Previous lobar pneumonia with septic image, chronic pulmonary embolism.); Oxygen therapy; Smoker
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:63; Test Date: 202105; Test Name: Blood Glucose; Result Unstructured Data: Test Result:18.6; Test Date: 202105; Test Name: computerized tomography; Result Unstructured Data: Test Result:intraparenchymal hemorrhage; Comments: CT (computerized tomography) brain showed Large intraparenchymal hemorrhage about 50x45x 35 cm large frontal left involving basal, medial parts and operculum frontale with moderate ambient edema, ventricular rupture of the hemorrhage (blood in lateral ventricles, third ventricle, aqueduct and fourth ventricle). In the left frontal lobe can be sensed about 11 mm large round area with a little calcification, unclear genesis. The bleeding causes mass effect against the adjacent parenchyma and compresses and deviates the left lateral ventricle frontal horn and 3rd ventricle to the right side. Transfalcint pinching, narrow conditions in the left mesencephalic cistern hippocampal area. Right-sided lateral ventricle and left lateral ventricular temporal horn dilation - hydrocephalus development.; Test Date: 202105; Test Name: C-Reactive Protein; Result Unstructured Data: Test Result:44; Test Date: 202105; Test Name: PK/INR (International Normalized Ratio); Result Unstructured Data: Test Result:3,2; Test Date: 202105; Test Name: pCO2; Result Unstructured Data: Test Result:18.6; Test Date: 202105; Test Name: thrombocytes; Result Unstructured Data: Test Result:480; Test Date: 202105; Test Name: pO2; Result Unstructured Data: Test Result:6.0; Test Date: 202105; Test Name: leukocytes; Result Unstructured Data: Test Result:20.6
CDC Split Type: SEPFIZER INC2021539445

Write-up: superficial intracerebral hemorrhage in the cerebrum; intraventricular hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB SE-MPA-2021-037328. A 58-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included pneumonia from an unknown date and unknown if ongoing Previous lobar pneumonia with septic image, chronic pulmonary embolism , atrioventricular block complete from an unknown date and unknown if ongoing , pulmonary embolism from 2014 to an unknown date , tobacco user from an unknown date and unknown if ongoing, cardiac assistance device user from an unknown date and unknown if ongoing, oxygen therapy from an unknown date and unknown if ongoing, chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medications included warfarin sodium (WARAN) taken for an unspecified indication, start and stop date were not reported. The patient experienced superficial intracerebral hemorrhage in the cerebrum (death) on May2021, intraventricular hemorrhage (death) on May2021. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 63 on May2021, blood glucose: 18.6 on May2021, computerised tomogram: intraparenchymal hemorrhage on May2021 CT (computerized tomography) brain showed Large intraparenchymal hemorrhage about 50x45x 35 cm large frontal left involving basal, medial parts and operculum frontale with moderate ambient edema, ventricular rupture of the hemorrhage (blood in lateral ventricles, third ventricle, aqueduct and fourth ventricle). In the left frontal lobe can be sensed about 11 mm large round area with a little calcification, unclear genesis. The bleeding causes mass effect against the adjacent parenchyma and compresses and deviates the left lateral ventricle frontal horn and 3rd ventricle to the right side. Transfalcint pinching, narrow conditions in the left mesencephalic cistern hippocampal area. Right-sided lateral ventricle and left lateral ventricular temporal horn dilation - hydrocephalus development , c-reactive protein: 44 on May2021, international normalised ratio: 3,2 on May2021, pco2: 18.6 on May2021, platelet count: 480 on May2021, po2: 6.0 on May2021, white blood cell count: 20.6 on May2021. Therapeutic measures were taken as a result of superficial intracerebral hemorrhage in the cerebrum, intraventricular hemorrhage. The patient died on May2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: Report from a physician regarding a 58-year-old female. Medical history included chronic obstructive pulmonary disease and oxygen therapy, atrioventricular block third degree. She has been a smoker and she was a cardiac assistance device user. Previous lobar pneumonia with septic image, chronic pulmonary embolism. Reported suspect vaccine was Comirnaty (covid-19 vaccines), 1:st dose. Reported suspect adverse events were superficial intracerebral hemorrhage in the cerebrum and intraventricular hemorrhage. The woman arrived at the hospital 6 days after receiving dose 1 of Comirnaty, during the day she had been alert and had talked to a relative, but suddenly she had strange breathing, was not contactable, an ambulance was called on. At arrival PK/INR (International Normalized Ratio) 3,2; APTT (activated partial thromboplastin time) 63. Routine tests without remark except leukocytes 20,6; TPK (thrombocytes 480; C-Reactive Protein 44; Blood Glucose 18,6. pO2 6,0; pCO2 18,6. CT (computerized tomography) brain showed Large intraparenchymal hemorrhage about 50x45x 35 cm large frontal left involving basal, medial parts and operculum frontale with moderate ambient edema, ventricular rupture of the hemorrhage (blood in lateral ventricles, third ventricle, aqueduct and fourth ventricle). In the left frontal lobe can be sensed about 11 mm large round area with a little calcification, unclear genesis. The bleeding causes mass effect against the adjacent parenchyma and compresses and deviates the left lateral ventricle frontal horn and 3rd ventricle to the right side. Transfalcint pinching, narrow conditions in the left mesencephalic cistern hippocampal area. Right-sided lateral ventricle and left lateral ventricular temporal horn dilation - hydrocephalus development. The woman received treatment with Konaktion, but it was assessed that there was nothing more to do, the woman was admitted to the stroke ward, for palliative care but died the same day. Assessment was massive intracerebral haemorrhage with ventricular breakthrough based on CT image and clinical course, one can possibly speculate in the underlying aneurysm. Waran (warfarin) may have contributed to a serious process. Probably not related to the given Comirnaty dose 1 week earlier. Outcome: Fatal. Report assessed as serious, death. Concomitant medications were Waran. Comirnaty LOT number: UNKNOWN. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: intraventricular hemorrhage; Intracerebral haemorrhage


VAERS ID: 1329626 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT in an 81-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Atrial fibrillation. On 07-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (seriousness criteria death, hospitalization and medically significant). The patient died on 15-Apr-2021. The reported cause of death was Stroke. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This is a case of death in a 81-year-old female subject with a medical history of Atrial fibrillation, who died 8 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 81-year-old female subject with a medical history of Atrial fibrillation, who died 8 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Stroke


VAERS ID: 1329702 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-16
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: Cardiac insufficiency (Chronic cardiac insufficiency)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: PCR; Test Result: Positive ; Comments: (CT value 6.9)
CDC Split Type: ATPFIZER INC2021544622

Write-up: COVID-19 PCR test positive; Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-26177. An 82 years old male patient received BNT162B2 (COMIRNATY), 1st dose (Lot#EP2163) Intramuscular on 11Mar2021 at single dose, 2nd dose (Lot#EW2239) intramuscular on 08Apr2021 at single dose for COVID-19 immunization. The patient''s medical history and concurrent conditions included was Cardiac insufficiency (continuing). No concomitant medication reported. Date of death was 21Apr2021 due to COVID-19 Pneumonia. On 16Apr2021 the patient experienced vaccination failure, COVID-19 pneumonia. On 18Apr2021, COVID-19 PCR test positive (CT value 6.9). The patient''s outcome was fatal. It was unknown whether autopsy was done. No follow-up attempts needed. No further information is expected.; Reported Cause(s) of Death: COVID-19 Pneumonia; vaccination failure


VAERS ID: 1329705 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, General physical health deterioration, Hyperkalaemia, Low density lipoprotein, Low density lipoprotein increased, Renal failure, Transaminases, Transaminases increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Dyslipidaemia (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Peripheral arterial disease
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: LDH; Result Unstructured Data: Test Result:significantly increased; Test Date: 20210418; Test Name: Low density lipoprotein cholesterol; Result Unstructured Data: Test Result:high; Test Date: 20210418; Test Name: Transaminases; Result Unstructured Data: Test Result:significantly increased
CDC Split Type: ATPFIZER INC2021544616

Write-up: Kidney failure; Transaminases / LDH significantly increased (shock organs?); Transaminases / LDH significantly increased (shock organs?); Hyperkalaemia; General condition worsening; Low density lipoprotein cholesterol high; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB AT-BASGAGES-2021-26820. An 89-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 15Apr2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension and peripheral arterial disease. The patient''s concomitant medications were not reported. On 18Apr2021 the patient experienced general condition worsening (general physical condition decreased), kidney failure, hyperkalaemia, transaminase value increased, Low density lipoprotein cholesterol high. Transaminases / LDH significantly increased (shock organs?). The outcome of events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Transaminases / LDH significantly increased (shock organs?); Hyperkalaemia; General condition worsening; Low density lipoprotein cholesterol high; Kidney failure; Transaminases / LDH significantly increased (shock organs?)


VAERS ID: 1329706 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactic acid, Blood lactic acid increased, C-reactive protein, C-reactive protein increased, Diarrhoea, General physical health deterioration, SARS-CoV-2 test, Somnolence, Vomiting
SMQs:, Acute pancreatitis (broad), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac pacemaker insertion; Cardiomyopathy; Transcatheter aortic valve implantation
Allergies:
Diagnostic Lab Data: Test Date: 20210421; Test Name: Lactate; Result Unstructured Data: Test Result:increased; Test Date: 20210421; Test Name: CRP; Result Unstructured Data: Test Result:increased; Test Date: 20210421; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: ATPFIZER INC2021544627

Write-up: Diarrhea; CRP, lactate elevated; CRP, lactate elevated; Vomiting; Somnolence; Deterioration of general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-26825]. An 89 years old female patient received 2nd dose of BNT162B2 (COMIRNATY) on 20Apr2021 for COVID-19 immunisation. The patient''s medical history included: Transcatheter aortic valve implantation, Atrial fibrillation, Cardiac pacemaker insertion, Cardiomyopathy. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY) on 30Mar2021 for COVID-19 immunisation. Concomitant drugs were not provided. On 21Apr2021 the patient experienced Deterioration of general condition, Diarrhea, Vomiting, Somnolence, CRP increased, Lactate increased. The outcome of all the events was fatal. SARS-CoV-2 PCR test was negative on 21Apr2021. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained. ; Reported Cause(s) of Death: CRP increased; Diarrhea; Lactate increased; Vomiting; Somnolence; Deterioration of general condition


VAERS ID: 1329787 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANOPYRIN; SPIOLTO RESPIMAT; FORMOVENT; VASOCARDIN; ATORVASTATIN; VEROSPIRON; AMLORATIO; SEDACORON; BERODUAL; EUPHYLLIN [THEOPHYLLINE]; FOSINOPRIL SODIUM; FURON [FUROSEMIDE]; NOLPAZA
Current Illness: Arterial hypertension; Chronic venous insufficiency; COPD; Double vessel disease; Ex-smoker (Stopped smoking 2 years ago); Insufficiency cardiac (NYHA (New York Heart Association) scale: 3); Ischemic heart disease; Malleolus edema; Obesity (Grade: 3); Oxygen therapy (Long-term oxygentherapy at home); Paroxysmal atrial flutter; Peripheral arterial disease; Polyposis intestinal; Renal insufficiency; Sleep apnea syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic bi-femoral bypass; Aortocoronary bypass; Coronary revascularization (coronarography - Severe damage of the coronary arteries); DVT of calf (Right lower limb); Dyspnea; Inferior myocardial infarction (Inapparent); Septic shock (Caused by intestine perforation); Thrombectomy (Of the aorto-bifemoral bypass)
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: Echocardiography; Result Unstructured Data: Test Result:dysfunction, aneurysm, dilatation; Comments: Mild systolic dysfunction of the left ventricule, aneurysm of the inferior wall, mild dilatation of the left atrium; Test Date: 20210503; Test Name: Ejection fraction; Test Result: 45 %; Test Date: 20210503; Test Name: Holter monitoring; Result Unstructured Data: Test Result:Sinus rhythm; Comments: Sinus rhythm, infrequent isolated ventricule extrasystoles; Test Date: 20210503; Test Name: Holter monitoring; Result Unstructured Data: Test Result:severe bradycardia with frequency of 15 beats per; Comments: severe bradycardia with frequency of 15 beats per minute was seen at first, then it passed into ventricular fibrillation, then after defibrillation it passed into an isoelectric line
CDC Split Type: CZPFIZER INC2021544637

Write-up: death; Loss of consciousness; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [CZ-CZSUKL-21005177]. A 70-year-old male patient received first dose of bnt162b2 (COMIRNATY, Batch/lot number EY3014), via intramuscular on 03May2021 at single dose for covid-19 immunization. Medical history included ongoing ischemic heart disease, ongoing chronic cardial insufficiency NYHA III, in Feb2014 coronary revascularization, coronarography - severe damage of the coronary arteries, in 2012 aortocoronary bypass, in 2012 inapparent myocardial infarction of the inferior wall, ongoing double vessel disease, ongoing chronic obstructive pulmonary disease, long-term oxygen therapy at home since Oct2019 and ongoing, ongoing sleep apnea syndrome, ongoing paroxysmal atrial flutter, ongoing arterial hypertension, ongoing renal insufficiency, ongoing peripheral arterial disease, in 2004 aorto-bifemoral bypass, in 2004 septic shock caused by intestine perforation, in Jan2019 bypass thrombectomy (Of the aorto-bifemoral bypass), ongoing chronic venous insufficiency, ongoing chronic perimalleolar oedemas, in Jun2018 deep venous thrombosis of the right calf (Right lower limb), ongoing large intestine polyposis, grade III obesity, ongoing ex-smoker for 2 years, and long lasting mild dyspnea. Concomitant medications included acetylsalicylic acid (ANOPYRIN); olodaterol hydrochloride, tiotropium bromide monohydrate (SPIOLTO RESPIMAT); formoterol fumarate (FORMOVENT); metoprolol tartrate (VASOCARDIN); atorvastatin; spironolactone (VEROSPIRON); amlodipine besilate (AMLORATIO); amiodarone hydrochloride (SEDACORON); fenoterol hydrobromide, ipratropium bromide (BERODUAL); theophylline (EUPHYLLIN); fosinopril sodium; furosemide (FURON); pantoprazole sodium sesquihydrate (NOLPAZA). The patient lost consciousness 2 minutes after being vaccinated (life-threatening). Cardiopulmonary resuscitation was started, including intubation and artifical ventilation. On electrocardiogram severe bradycardia with frequency of 15 beats per minute was seen at first, then it passed into ventricular fibrillation, then after defibrillation it passed into an isoelectric line. During resuscitation the patient was administered 2 mg of Atropin, 3 mg of Adrenalin, two electrical discharges and 75 mg of Amiodaron. Cardiopulmonal resuscitation was started at 13:02, at 13:50 it was stopped and the patient was proclaimed dead. Cause of death was unknown. Outcome of event loss of consciousness was not recovered. Autopsy was performed and no result available. The patient underwent lab tests and procedures on 03May2021 which included echocardiography: Mild systolic dysfunction of the left ventricule, aneurysm of the inferior wall, mild dilatation of the left atrium, ejection fraction: 45 %, holter monitoring: Sinus rhythm, infrequent isolated ventricule extrasystoles. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1329796 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary disease; End stage COPD (COPD IV); Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021544661

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100062331. A 75-year-old female patient received BNT162B2 (COMIRNATY, strength: 0.3ml), via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: EX3599, at the age of 75-year-old) as single dose for covid-19 immunisation. Medical history included end stage chronic obstructive pulmonary disease (COPD) (COPD IV), coronary disease, renal insufficiency. The patient''s concomitant medications were not reported. On 30Apr2021, the patient experienced unknown cause of death. The patient died on 30Apr2021. An autopsy was not performed. The reporter''s assessment on the causal relationship between the suspect vaccine and the event was indeterminate. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1329798 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis leg
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021544649

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100062953. An 80-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration at the age of 80-year-old on 10Apr2021 (batch/Lot Number: EW8904) as single dose for covid-19 immunisation. Medical history included deep vein thrombosis leg. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 14Apr2021. The patient died on 14Apr2021. An autopsy was not performed. The reporter''s assessment on the causal relationship between the suspect product Comirnaty and the event death was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


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