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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine is COVID19 and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1592209 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Cardiogenic shock, Echocardiogram, Fibrin D dimer, Hyperkalaemia, Interchange of vaccine products, Off label use, Pneumonia, Pulmonary embolism, Right ventricular failure, Septic shock, Troponin T
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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: Test Date: 20210810; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:Right heart failure; Test Date: 20210809; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:7.59 ug/ml; Test Date: 20210810; Test Name: Troponin T; Result Unstructured Data: Test Result:0.073
CDC Split Type: DEPFIZER INC202101054540

Write-up: This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100163909. A male patient of an unspecified age received bnt162b2 (COMIRNATY) (strength: 0.3 ml), dose 2 via an unspecified route of administration on 28Jul2021 (Batch/Lot number was not reported) as dose 2, 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. First vaccination was administered with covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA) on 04Mar2021 (batch unknown). On 10Aug2021 the patient experienced lung embolism. Fibrin D Dimer 7.59 ?g/ml 09Aug2021; Troponin T 0.073 10Aug2021. Transthoracic echocardiography: Right heart failure 10Aug2021. Respiratory failure - pneumonia; Sepsis - septic shock; Cardiogenic shock; Hyperkalemia; Acute kidney failure; Lung embolism. Therapeutic measures included anticoagulation, high dose catecholamines, alteplase (ACTILYSE). Differential diagnosis excluded: pneumothorax, hypoxia, myocardial infarction. The outcome was fatal for lung embolism. The outcome of other event was unknown. This event lung embolism is serious due to death, hospitalization, life threatening. The patient died on 10Aug2021. It was not reported if an autopsy was performed. The PEI assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1592220 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Off label use, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101056168

Write-up: Lung embolism; First vaccination was administered with Vaxzevria/ second dose of Comirnaty; First vaccination was administered with Vaxzevria/ second dose of Comirnaty; This is a spontaneous report from an other healthcare professional downloaded from the Regulatory Authority-WEB DE-PEI-202100164946. A 83-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 83-years-old on 28Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA) at the age of 82-years-old on 04Mar2021(Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 10Aug2021, the patient experienced lung embolism. This report was serious - death, hospitalization, life threatening. The outcome of the event lung embolism was fatal. The patient died on 10Aug2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1592223 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol abuse; Nicotine abuse; Obesity
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (10 years ago); Infarct myocardial (10 years ago)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101061861

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, Safety Report Unique Identifier DE-PEI-202100165267. A 56-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Aug2021 (Lot Number: FE9174) as dose 1, single for COVID-19 immunization. Medical history included ongoing nicotine abuse from an unknown date, apoplexy from 2011 (reported as 10 years ago) to an unknown date (not ongoing), ongoing obesity from an unknown date, ongoing alcohol abuse from an unknown date, infarct myocardial on an unknown date in 2011 (reported as 10 years ago) to an unknown date (not ongoing). The patient''s concomitant medications were not reported. On 07Aug2021, 2 days after vaccination, the patient had an unknown cause of death. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1592409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-08
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F030A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   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:
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101056006

Write-up: This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021159793, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100163364. An 89-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 29Jul2021 (Lot Number: 1F030A) as dose 2, single for covid-19 immunisation. Medical history included ongoing dementia. There was no allergies. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on 08Aug2021. The patient died on 08Aug2021. An autopsy was not performed. Sender''s comments: Are you or the person affected aware of any allergies? If yes, which ones? no Information on risk factors or previous illnesses Dementia, but otherwise fit in case of vaccination / death. Result of Assessment: Comirnaty/ event(s): Unknown cause of death/ PEI: D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death.


VAERS ID: 1592410 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Blood pressure high
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101056011

Write-up: pneumonia; Pyrexia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021159893, Safety Report Unique Identifier DE-PEI-202100163459. This is first of two reports. A 78-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing Alzheimer''s disease; ongoing high blood pressure. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization and 3 days after the first dose development of high fever, generalised muscle cramps as well as severe pneumonia with strong drop in oxygen saturation - after 14 days slow improvement of health condition. The patient experienced relapse/new pneumonia, hospitalisation with medication plus oxygen administration; pyrexia. The outcome of the event pneumonia was fatal, of the event pyrexia was not recovered. The patient died on 20Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-202101067461 same patient, different dose; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1592431 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-11
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-11
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101048486

Write-up: This is a spontaneous report from a contactable physician via COVAES. A 39-year-old female patient received BNT162B2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (COMIRNATY) dose 1, single for COVID-19 immunization. The patient had no medical history. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction 5 days after second dose (death, hospitalization) on 11Aug2021 01:30. The patient was hospitalized for 1 day due to myocardial infarction, 5 days after second dose. The patient received treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine or used any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient died on 11Aug2021 due to myocardial infarction and cardiogenic shock. An autopsy was performed, and results were not provided. Information on the lot/batch number has been requested.; Sender''s Comments: based on the available information the fatal events and the suspected vaccine cannot be completely ruled out; Reported Cause(s) of Death: Myocardial infarction; Cardiogenic Shock.


VAERS ID: 1592437 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1DO14A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
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: Cardiac arrhythmia; Pacemaker insertion (cardiac); Pulmonary embolism
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: DEPFIZER INC202101067542

Write-up: This is a spontaneous report from a contactable consumer received via COVAES portal. An 87-year-old female patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: 1DO14A, expiration date unknown) via an unspecified route of administration on 02Jun2021 at age of 87-year-old for COVID-19 immunisation. Medical history (previous illnesses that were treated at the clinic in Mar2021) included pulmonary embolism, inserting a pacemaker because of abnormal cardiac arrhythmias, adjustment of blood pressure and heart rate by means of medication. Patient previously received 1st dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunisation. On 01Jul2021, patient died of the consequences of a pneumonia. On 02Jun2021, she got her second Biontech vaccination. At the time of admission to the hospital, the corona test was negative. The reporter was afraid the second Biontech vaccination weaken patient''s immune system and so she had catch pneumonia in the summer. Until patient''s death, she was treated to the complete satisfaction. However, they refused an autopsy. Patient died on 01Jul2021. Autopsy was not performed.; Reported Cause(s) of Death: consequence of a pneumonia


VAERS ID: 1592438 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101067665

Write-up: This is a spontaneous report from a contactable physician based on the information received by Pfizer from Biontech [manufacturer control number: 80239], license party for COMIRNATY. A 16-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration in Mar2021 (lot number and expiry date: unknown) as dose 2, single; via an unspecified route of administration in Jan2021 (lot number and expiry date: unknown) as dose 1, single for COVID-19 immunisation. The patient''s medical history and patient''s concomitant medications were not reported. On unspecified date, the patient was found dead in bed at the age of 16. The autopsy did not reveal any cause. Presumably had a rhythmogenic event that led to death.; Sender''s Comments: The causal relationship between bnt162b2 and the event Arrhythmia (Fatal) cannot be assessed as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: rythmogenic event led to death


VAERS ID: 1592507 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1435 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram cerebral, Blood bicarbonate, Blood glucose, Blood lactic acid, Blood potassium, Blood pressure measurement, Blood sodium, Electrocardiogram, Fraction of inspired oxygen, Haemoglobin, Heart rate, Investigation, Laboratory test, Lumbar puncture, Meningoencephalitis viral, Meningoradiculitis, Neurological examination, PCO2, PO2, Pharyngitis, Physical examination, Platelet count, Procalcitonin, Protein total, SARS-CoV-2 test, Scan brain, White blood cell count, pH body fluid
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210810; Test Name: Angiogram cerebral; Result Unstructured Data: Test Result:Absence of opacification of the M3-M4 segment of b; Comments: Absence of opacification of the M3-M4 segment of both MCAs (left MCA does not completely opacify / right MCA only segment M1-M2, in a filiform manner) and internal cerebral veins (FRAMPES scale, 4 vessels) nor pericalous arteries or vein of Galen (DUPAS, 7 glasses). Criteria for Brain Death are met.; Test Name: HCO3; Result Unstructured Data: Test Result:26; Comments: no units reported; Test Date: 20210810; Test Name: blood glucose; Result Unstructured Data: Test Result:good; Test Name: lactic; Result Unstructured Data: Test Result:0.9; Comments: no units reported; Test Name: K; Result Unstructured Data: Test Result:4.19; Comments: no units reported; Test Date: 20210810; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Name: Na; Result Unstructured Data: Test Result:124; Comments: no units reported; Test Name: ECG; Result Unstructured Data: Test Result:VIRAL ENCEPHALITIS. CHEYNE-STOKES. ATELCTASIA RIGH; Test Date: 20210810; Test Name: FiO2; Result Unstructured Data: Test Result:0.35; Comments: no units reported; Test Name: Hg; Result Unstructured Data: Test Result:14; Comments: no units reported; Test Date: 20210810; Test Name: heart rate; Result Unstructured Data: Test Result:85; Comments: bpm, no murmurs; Test Name: Radiology Image; Result Unstructured Data: Test Result:Infiltrate with laminar atelectasis in the right b; Comments: Infiltrate with laminar atelectasis in the right base; Test Name: tests; Result Unstructured Data: Test Result:without significant alterations except for lymphop; Test Date: 202108; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:COMPATIBLE WITH VIRAL MENINGOENEPHALITIS; Comments: COMPATIBLE WITH VIRAL MENINGOENEPHALITIS; Test Date: 20210730; Test Name: magnetoencephalography; Result Unstructured Data: Test Result:Unknown Results; Test Name: pCO; Result Unstructured Data: Test Result:48; Comments: no units reported; Test Name: pH; Result Unstructured Data: Test Result:7.35; Test Date: 20210810; Test Name: physical examination; Result Unstructured Data: Test Result:Abdomen: globular, soft. without masses or megalie; Comments: Abdomen: globular, soft. without masses or megalies Hyperreflexic Osteotendinous reflexes except right patellar. Left plantar cutaneous response in retreat, Right indifferent. Extremities: no edema or signs of VTT; Test Name: platelets; Result Unstructured Data: Test Result:149000; Comments: no units reported; Test Name: pO2; Result Unstructured Data: Test Result:40; Comments: no units reported; Test Name: procalcitonin; Result Unstructured Data: Test Result:normal; Test Name: TP ratio; Result Unstructured Data: Test Result:1.16; Comments: no units reported; Test Date: 20210730; Test Name: COVID-19 virus test/antigen test; Test Result: Negative ; Test Date: 20210808; Test Name: CT with no contrast; Result Unstructured Data: Test Result:no pathologies; Test Name: leucocytes; Result Unstructured Data: Test Result:4820; Comments: no units reported
CDC Split Type: ESPFIZER INC202101055775

Write-up: This is a spontaneous report from a contactable Pharmacist downloaded from the Regulatory Authority-WEB ES-AEMPS-970838. A 28-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Jul2021 (Lot Number: FC1435) as DOSE 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced viral meningoencephalitis (death, hospitalization) on 30Jul2021, meningoradiculitis (death, hospitalization) on 31Jul2021, acute pharyngitis (non-serious) on 31Jul2021 with outcome of unknown. The patient underwent lab tests and procedures which included angiogram cerebral: absence of opacification of the M3-M4 segment of both MCAs (left MCA does not completely opacify / right MCA only segment M1-M2, in a filiform manner) and internal cerebral veins (FRAMPES scale, 4 vessels) nor pericalous arteries or vein of Galen (DUPAS, 7 glasses). Criteria for Brain Death are met on 10Aug2021, blood bicarbonate: 26 on an unknown date, blood glucose: good on 10Aug2021, blood lactic acid: 0.9 on an unknown date, blood potassium: 4.19 on an unknown date, blood pressure measurement: normal on 10Aug2021, blood sodium: 124 on an unknown date, electrocardiogram: viral encephalitis. cheyne-stokes. atelctasia righ on an unknown date, fraction of inspired oxygen: 0.35 on 10Aug2021, haemoglobin: 14 on an unknown date, heart rate: 85 bpm on 10Aug2021; Radiology - Image: Infiltrate with laminar atelectasis in the right base on an unknown date, a battery of tests: without significant alterations except for lymphop on an unknow date, lumbar puncture: compatible with viral meningoenephalitis in Aug2021, pco2: 48 on an unknown date, CT with no contrast: no pathologies on 08Aug2021. The clinical course reported as following: on 30Jul2021, patient started with headache, magnetoencephalography and fever and an antigen test was done at the pharmacy being negative. On 31Jul2021, it was assessed in health center where they advised sueroral and paracetamol. On 31Jul2021, patient experienced sore throat, non-thermometered fever, vomiting. On 02Aug21, it was reviewed in the health center with acute pharyngitis and they advised azithromycin. On 04Aug20021, telephone contact reported headache. On 06Aug2021 06:56 home assistance reported that the headache for a week of evolution accompanied by fever and vegetative symptoms, upon they arrival, patient sitting disoriented with disturbance of attention, agitated that didn''t cooperate. Family members reported that this condition has started abruptly and has recently been in the hospital less than an hour ago. On 06Jun2021 they observed a battery of tests performed recently without significant alterations except for lymphopenia without absolute leukocytosis with hypoxemia. It was decided to transfer to the hospital with a diagnosis of probable herpetic encephalitis hospital income. Lumbar puncture. Clear liquid with fast exit rate. CSF: compatible with viral meningitis. Psychomotor agitation persists that requires sedation cursing admission in intensive care unit. Intensive Care Unit evolution as of 10Aug2021 Exploration: Overall Impression: Severe Attitude: calm, Awareness: CGS Glasgow Coma Scale M4 O3 V2 Respiratory: Spontaneous with BIPAP IPAP 16 EPAP 10 FiO2 0.35. Presents Cheyne-Stone BMV pattern Circulatory: Rhythmic at 85 bpm no murmurs Hemodynamics: Blood pressure maintained without amines. Abdomen: globular, soft. without masses or megalies. Nervous System: CGS 9 (M4 O3 V2) with preserved trunk reflexes. Hyperreflexic Osteotendinous reflexes except right patellar. Left plantar cutaneous response in retreat, Right indifferent. Extremities: no edema or signs of VTT Kidney and Internal ennvironment: D 1535 BH +2573 blood glucose levels good. Supplementary tests: Analytical - Microbiology: pH 7.35 pCO48 pO2 40 HCO3 26 lact 0.9 Leuc 4820 sec 88% Hg 14 platelets 149000 TP 1.16 ratio 1.23 Frenal normal Na 124 K 4.19 procalcitonin normal. Radiology - Image: Infiltrate with laminar atelectasis in the right base. ECG: Other Explorations. Clinical Judgment: viral encephalitis. cheyne-stokes. atelctasia right. Clinical picture compatible with symptoms of meningoencephalitis after vaccination in the AESI window period but with clinical judgement of viral meningoencephalitis. Death on 10Aug2021 with clinical judgement of viral meningoencephalitis. Patient died on 10Aug2021, it''s known if the autopsy was conducted.; Reported Cause(s) of Death: viral meningoencephalitis; Meningoradiculitis


VAERS ID: 1592598 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-03-20
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dysphagia, Motor dysfunction, Muscular weakness, Musculoskeletal disorder, Musculoskeletal stiffness, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Memory impaired
Preexisting Conditions: Medical History/Concurrent Conditions: Cirrhosis of liver; Hypertension; Mental disorder NOS; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202101056109

Write-up: This is a spontaneous report from a contactable consumer (patient''s father) downloaded from the Regulatory Authority-WEB FI-FIMEA-20213931. A 74-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration in Jan2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included cirrhosis of liver, mentally ill, hypertension, type 2 diabetes and ongoing memory disorder from 2017. Weak but stable condition and did well at home, but in January received the 1st coronary vaccination from which the downturn began. Concomitant medication was not reported. At first, the patient swallowing became more difficult. Before, even the big drugs had been swallowed well, now they got stuck in the palate, then the legs became weak and he was sometimes "petrified", no proper contact with him could be established. In 2021, the patient experienced musculoskeletal disorder. Condition fluctuated drastically in Feb2021. Sometimes he was at home until the legs became powerless again. Went back and forth 4-5 times between home and health station. In Mar2021, the feet ceased to function completely, thus went to the department. The right hand also stopped working and there was a fever all the time against which the wide-spectrum antibiotic did not help. Eventually, the ability to swallow was lost and no hydration was given anymore when the doctor said it would be prolonging the inevitable. On 20Mar2021, the patient died. Personally, the reporter would consider that the organism of a poor-condition elderly person failed as a result of the vaccine. Until then, though, the patient was just fine and suddenly this happened after the vaccination. The cause of death was unknown. Autopsy was unknown. The outcome of limbs stiffness and motor dysfunction was unknown. The outcome of other events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unknown.


VAERS ID: 1592628 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-30
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Hypertension arterial; Ischemic heart disease
Allergies:
Diagnostic Lab Data: Test Date: 20201223; Test Name: SARS-CoV-2 test; Test Result: Negative.
CDC Split Type: FRPFIZER INC202101056097

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BR20213096. A 91-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 10Feb2021 (Lot Number: EJ 6789) as single dose for covid-19 immunisation. Medical history included cardiac failure, atrial fibrillation, hypertension, myocardial ischaemia. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 30Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 23Dec2020. 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: unexplained death.


VAERS ID: 1592634 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-07-25
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6984 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time ratio, Activated partial thromboplastin time ratio decreased, Alanine aminotransferase, Bacterial test positive, Blood creatine phosphokinase, Blood culture, Blood electrolytes, Blood fibrinogen, C-reactive protein, COVID-19 pneumonia, Computerised tomogram thorax, Creatinine renal clearance, Culture urine, Fall, Lactobacillus test positive, Legionella infection, Legionella test, Platelet count, Prothrombin time, Red blood cells urine, SARS-CoV-2 test, Sputum culture, Troponin, Troponin I, Urine analysis, Vaccination failure, White blood cell count, White blood cells urine
SMQs:, Lack of efficacy/effect (narrow), Accidents and injuries (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC; SIMVASTATIN; GLICAZIDA; AMLODIPINE; FUROSEMIDE; LEVEMIR; METFORMIN; INEXIUM [ESOMEPRAZOLE MAGNESIUM]
Current Illness: Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Acromioplasty; Algodystrophy; Rotator cuff syndrome (left)
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: activated partial thromboplastin time ratio; Result Unstructured Data: Test Result:1.02; Test Date: 20210726; Test Name: Alanine transaminase; Result Unstructured Data: Test Result:normal; Test Date: 20210726; Test Name: CPK; Result Unstructured Data: Test Result:1645 IU/l; Test Date: 20210726; Test Name: blood culture; Result Unstructured Data: Test Result:negative; Test Date: 20210726; Test Name: Ionogram; Result Unstructured Data: Test Result:normal; Test Name: fibrinogen; Result Unstructured Data: Test Result:$g9.0 g/l; Test Date: 20210727; Test Name: thoracic CT with contrast; Result Unstructured Data: Test Result:Covid 19 pneumonia with moderate involvement, no s; Comments: Covid 19 pneumonia with moderate involvement, no systematic condensation, no pulmonary embolism. CT reassessment was not performed during hospitalization and after worsening hypoxia; Test Name: CRP; Result Unstructured Data: Test Result:253 mg/l; Test Date: 20210726; Test Name: CRP; Result Unstructured Data: Test Result:206 mg/l; Test Date: 20210726; Test Name: Clearance; Result Unstructured Data: Test Result:71 ml/min; Test Date: 20210726; Test Name: Urine culture; Result Unstructured Data: Test Result:positive for lactobacillus sp 10 7 CFU / ml and Es; Comments: positive for lactobacillus sp 10 7 CFU / ml and Escherichia coli$g 10 7 CFU / ml; Test Date: 20210728; Test Name: Urine culture; Result Unstructured Data: Test Result:negative initially; Test Date: 20210728; Test Name: lagionella pneumophils PCR; Test Result: Positive ; Comments: results available on 10Aug2021, twice positive; Test Date: 20210726; Test Name: legionella urinary antigen; Test Result: Negative ; Test Date: 20210726; Test Name: Platelets; Result Unstructured Data: Test Result:180 x10 9/l; Test Date: 20210726; Test Name: Prothrombin time; Test Result: 74 %; Test Date: 20210726; Test Name: Red blood cells urine; Result Unstructured Data: Test Result:less or equl to 5; Comments: /mm3; Test Date: 20210726; Test Name: Covid-19 virus test; Test Result: Positive ; Comments: on nasopharyngeal swab: positive with the presence of the L452 R mutation; Test Name: long culture of the input sputum; Result Unstructured Data: Test Result:positive to Legionella whose final result; Comments: positive to Legionella whose final result and phenotype are pending; Test Name: Troponin; Result Unstructured Data: Test Result:decreasing; Test Date: 20210726; Test Name: Troponin I HS; Result Unstructured Data: Test Result:4959 ng/L; Comments: normal range: <47; Test Date: 20210726; Test Name: pneumococcal urinary Antigen; Test Result: Negative ; Test Date: 20210726; Test Name: Leukocyte count; Result Unstructured Data: Test Result:6.87 x10 9/l; Test Date: 20210726; Test Name: White blood cells urine; Result Unstructured Data: Test Result:79; Comments: /mm3
CDC Split Type: FRPFIZER INC202101056092

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BS20211531. An 83-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular in left arm on 26Apr2021 (Lot Number: ET6956), dose 2 intramuscular in left arm on 07Jun2021 (Lot Number: FC6984), all at single dose for COVID-19 immunisation. Medical history included algodystrophy, ongoing type 2 diabetes mellitus and ongoing hypertension arterial; Surgical history included rotator cuff syndrome left and acromioplasty. The patient had no history of COVID-19. No drug addiction. Lifestyle: lives alone at home with helpers, drives and does his shopping. Concomitant medications included acetylsalicylate lysine (KARDEGIC), simvastatin, gliclazide (GLICAZIDA), amlodipine, furosemide, insulin detemir (LEVEMIR), metformin, esomeprazole magnesium (INEXIUM), all taken for unspecified indication(s) from unspecified date(s). On Day 45, 25Jul2021 Hospitalization for mechanical fall with prolonged state of being on the ground. The assessment carried out on 26Jul2021 highlights: A dissociated inflammatory syndrome: leukocytes = 6.87 x10 9/ l [3.8 -10.0], CRP = 206 mg / l [0-5], PCT not specified; Coagulation: Prothrombin time = 74%, activated partial thromboplastin time ratio = 1.02, platelets = 180 10 9/l, fibrinogen not reported; Ionogram: normal; CPK = 1645 U / l [46-171], troponin I HS 4959 ng / L [<47]; Renal function: clearance = 71 ml / min; Normal ALAT (Alanine transaminase); A PCR test (26Jul2021) looking for coronavirus on nasopharyngeal swab: positive with the presence of the L452 R mutation; A bacteriological assessment: negative blood cultures, negative Legionella and pneumococcal urinary Ag, Urine examination: White blood cells (leucocytes) = 79 / mm3, red blood cells = <5 / mm3, Urine culture positive for lactobacillus sp 10 7 CFU / ml and Escherichia coli$g 10 7 CFU / ml, urine culture 28Jul2021 negative initially. The injected thoracic CT with contrast of 27Jul2021 shows Covid 19 pneumonia with moderate involvement, no systematic condensation, no pulmonary embolism. CT reassessment was not performed during hospitalization and after worsening hypoxia. From a therapeutic point of view, the patient benefited from: Antibiotic therapy with cefotaxime from 26Jul2021 to 01Aug for multi-sensitive urine test E Coli positive; preventive anticoagulation 26Jul2021 then curative from 27Jul2021; Oxygen therapy by nasal oxygen from 28Jul2021: 5 l/min on 28Jul, 10 l/min on 30Jul then 17 l/min with a high concentration mask; Treatment with dexamethasone (6 mg per day) started on 27Jul2021 and TOCILIZUMAB (2 doses of 600 mg given) from 28Jul2021. CRP was at this time at 253 mg/ml and fibrinogen$g9.0 g/l. The respiratory evolution is unfavorable with persistence and increase in hypoxia requiring an intensive care unit advice which does not retain any indication for high flow oxygen therapy or intensive care. The patient was found dead in his room on 01Aug2021. The department doctor contacted did not rule out a worsening of the COVID pneumonia. A pulmonary edema and / or a coronary syndrome seems excluded because the troponin was decreasing. However, he reported that a long culture of the input sputum returns positive to Legionella whose final result and phenotype are pending. On 10Aug2021, the National Research Center of Legionella biologist confirms that the Cytobacteriological examination of sputum of 28Jul2021 is twice positive for legionella pneumophila PCR, the long culture is in progress but will not be available for 8 days. In conclusion: vaccine failure at Day45 of a complete vaccination schedule complicated by a fatal SARS covid 19 pneumonia. The possibility of legionellosis is being considered due to the double positivity of legionella pneumophila PCR. Long pending culture result. The outcome of events vaccination failure, sars covid 19 pneumonia, and legionella pneumophila infection considered as fatal, the outcome of other events was unknown. The patient died on 01Aug2021. An autopsy was not performed.; Reported Cause(s) of Death: SARS covid 19 pneumonia; SARS covid 19 pneumonia; legionella pneumophila infection


VAERS ID: 1592640 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Chills, Condition aggravated, Headache, Hepatic vein thrombosis, Lung cancer metastatic, Myocardial infarction, Pulmonary embolism, Pyrexia, Tendonitis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 80
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: Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101055172

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-BX20217293. A 54-year-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number EK9788) at single dose on 01Feb2021 via an unknown route for COVID-19 immunisation. Medical history included Metastatic lung cancer. Concomitant drug was not provided. Historical vaccine included 1st dose of BNT162B2 (COMIRNATY, lot number EM0477) on 11Jan2021 for COVID-19 immunisation. Serious adverse event was reported as Hepatic vein thrombosis, Embolism pulmonary/embolie pulmonaire massive, and Thrombocytopenia with onset date of 23Apr2021. It was reported as death from massive pulmonary embolism with hepatic vein thrombosis and thrombocytopenia in the context of recent discovery of metastatic lung cancer two and a half months on 23Apr2021. The clinical course was reported as follows: On Day 2 of D2, asthenia, headache, fever, chills, back arthralgia and MI, left elbow tendonitis (injected side), dyspnea, dry cough similar to that of whooping cough. dry cough similar to that of whooping cough. Antibiotic therapy was initiated. Patient had persistent cough at Day 71 appearance of blood expectoration when coughing, always with dyspnea and arthralgia. After exploration, diagnosis of metastatic lung cancer was made. 2 and a half months after D2, on 23Apr2021, death in a context of hepatic vein thrombosis, pulmonary embolism and thrombocytopenia. Outcome of hepatic vein thrombosis, pulmonary embolism and thrombocytopenia was death. Outcome of the other events was medically significant. The case was not medically confirmed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Parenteral; Reported Cause(s) of Death: Embolism pulmonary/embolie pulmonaire massive; Hepatic vein thrombosis; Thrombocytopenia


VAERS ID: 1592684 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure increased, Body temperature decreased, Brain death, Brain hypoxia, C-reactive protein, Cardiac arrest, Coma, Computerised tomogram, Computerised tomogram head, Echocardiogram, Electrocardiogram, Electroencephalogram, Full blood count, Headache, Magnetic resonance imaging, Pain in extremity, SARS-CoV-2 antibody test positive, Ultrasound Doppler
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 27
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: Asthma; Barlow''s syndrome; Marfan''s syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: arterial pressure; Result Unstructured Data: Test Result:90/60 mmHg; Test Date: 20210713; Test Name: temperature control; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210713; Test Name: CT scan; Result Unstructured Data: Test Result:The ascending aorta is moderately dilated; Comments: No aortic dissection or large vsx, no intracranial bleeding, the super sigmoid aortography does not show any aortic insufficiency; Test Date: 20210715; Test Name: CT scan; Result Unstructured Data: Test Result:appearance of parenchymal parenchymal hemispherica; Comments: appearance of parenchymal parenchymal hemispherical hemispherical right upper cerebellar areas of ischemic appearance; Test Date: 20210713; Test Name: brain CT scan; Result Unstructured Data: Test Result:no bleeding; Comments: no traumatic injury; Test Date: 20210723; Test Name: brain CT scan; Result Unstructured Data: Test Result:stability of ischemic; Comments: lesions appearance of cerebral edema compatible with anoxo-ischemic lesions, put under Mannitol; Test Date: 20210727; Test Name: brain CT scan; Result Unstructured Data: Test Result:increase in cerebral edema; Comments: reaching almost the entire sustentorial stage, sudden episodes of desaturation.; Test Date: 20210713; Test Name: C-reactive protein; Result Unstructured Data: Test Result:1.4; Test Name: Trans-thoracic echocardiography; Result Unstructured Data: Test Result:finding a 30%; Comments: altered left ventricular ejection fraction with kinetic disorders suggestive of Takotsubo; Test Date: 20210713; Test Name: Electrocardiography; Result Unstructured Data: Test Result:Not very evocative; Comments: Respiratory rate; Test Date: 20210723; Test Name: electroencephalogram; Result Unstructured Data: Test Result:flat; Comments: with a few waves of intermittent activity; Test Date: 20210727; Test Name: electroencephalogram; Result Unstructured Data: Test Result:Pathological; Comments: Keppra introduction; Test Date: 20210713; Test Name: complete blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210713; Test Name: cardiac magnetic resonance imaging; Result Unstructured Data: Test Result:cardio; Comments: in favor of a takotsubo; Test Date: 20210713; Test Name: covid; Test Result: Positive ; Comments: (Ig G antiS and antiN and IgM), re-reading of the entry serology concluded with a Covid infection starting at the same time as the anti-covid vaccination; Test Date: 20210713; Test Name: Left transcranial doppler; Result Unstructured Data: Test Result:left more disturbed; Comments: than the right (Vdiastolic 20 vs 40 on the right)
CDC Split Type: FRPFIZER INC202101056242

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-MP20215396]. A 15-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 11Jul2021 07:30 (Lot Number: Unknown) (at the age of 15-year-old) as dose 1, single for COVID-19 immunization. Medical history included ongoing asthma, ongoing Barlow''s syndrome, ongoing Marfan''s syndrome. The patient''s concomitant medications were not reported. In good health overall, apart from a loss of 10kg over one year (since entering high school). During the day (11Jul2021), asthenia and isolated arm pain. The next day (12Jul2021), headaches yielding under Doliprane. On 13Jul2021, around 16:30 (last moment conscious view), her mother drops her off to her father. Father watered the garden and she cleaned the garage to prepare for her birthday party. On 13Jul2021 17:20, her father found her in cardio respiratory arrest, back to the ground, next to a ladder. No flow was unknown. At 17:30 arrival of firefighters: 2 external electric shocks were given and 1 mg of adrenaline injected. Moderately reactive pupils. At 17:50 arrival of Specialist mobile emergency unit: asystole (Life-threatening). Two injections of 1 mg of adrenaline, transition to ventricular fibrillation. 2 external electric shock, 2 ampule of Cordarone and one ampule of Calcium Gluconate. Return to regular sinus rythme without disturbance of repolarization and resumption of a pulse. Orotracheal intubation (probe no 6). New: 1 external electric shock, one ampule of Cordarone and 1 mg of adrenaline. Return of a sinus rhythm but presence of a sub ST in infero lateral. 90/60 mmHg arterial pressure excluding sedation. Tight areactive bilateral miosis pupils. Ventilated in Ventilator-Associated Conditions but presence of spontaneous ventilation requiring sedation by Hypnovel and Sufentanyl and 10 mg of Nimbex. Parallel introduction of Noradrenaline 0.8 mg/h. No filling. In total: low flow of 30 minutes. Recovered and transfer to intensive care. Examinations: biology: complete blood count normal, C-reactive protein 1.4. Coroner considered as normal no coronary dissection. Computed tomography scan Computed tomography arterial portography: No aortic dissection or large vsx, no intracranial bleeding, the super sigmoid aortography does not show any aortic insufficiency. The ascending aorta is moderately dilated. Computerised tomogram head: no bleeding, no traumatic injury. Electrocardiogram: Not very evocative. Respiratory rate. Maintenance of sedation, temperature control at 36 degrees. Complicated cardiac arrest of a Takotsubo. Trans-thoracic echocardiography finding a 30% altered left ventricular ejection fraction with kinetic disorders suggestive of Takotsubo (post stress?). More doubt about intra-left ventricular thrombus. Low left ventricular filling pressures. Integral time speed= 8. Inferior vena cava= 15. 15Jul2021 Appearance in the morning of continual clonies of the multiple sulfatase deficiency, put under Keppra increased to 750x2. Electroencephalography results pending + Left transcranial doppler more disturbed than the right (Vdiastolic 20 vs 40 on the right), Control contrast enhanced computed tomography scan superimposable at the level of large vsx, but appearance of parenchymal parenchymal hemispherical hemispherical right upper cerebellar areas of ischemic appearance. 20Jul2021 pathological awakening, inhalation lung disease, myocarditis assessment in progress (negative). 23Jul2021 no sign of wakign up flat electroencephalogram alternating with a few waves of intermittent activity. Computered tomography scan stability of ischemic lesions appearance of cerebral edema compatible with anoxo-ischemic lesions, put under Mannitol. Cardio: cardiac magnetic resonance imaging in favor of a takotsubo, myocarditis unlikely, infective and immunological workup negative. 27Jul2021 Pathological electroencephalogram, Keppra introduction. Computered tomography scan increase in cerebral edema reaching almost the entire sustentorial stage, sudden episodes of desaturation. The COVID serology returns positive (Ig G antiS and antiN and IgM), re-reading of the entry serology concluded with a Covid infection starting at the same time as the anti-covid vaccination. 30Jul2021 retro-rolandic aspect of brain death, vegetative coma. Decision to limit therapy. Complete file no further information. The patient died on 07Aug2021. An autopsy was not performed. Cause of Death: Anoxia cerebral and Cardiac arrest while outcome of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Anoxia cerebral


VAERS ID: 1592685 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-08-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: MP20215979) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH in a 28-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on August 2021 The patient died in August 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug information provided. No concomitant drug information provided. Company comment: This is a case of Death Not Otherwise Specified in a 28-year-old male patient, that occurred at an unspecified number of days after receiving first dose of vaccine (Lot number unknown). Very limited information regarding the date of death and the clinical details pertaining to death, medical history, and concomitant medication was provided at this time. No further information is expected.; Sender''s Comments: This is a case of Death Not Otherwise Specified in a 28-year-old male patient, that occurred at an unspecified number of days after receiving first dose of vaccine (Lot number unknown). Very limited information regarding the date of death and the clinical details pertaining to death, medical history, and concomitant medication was provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of Death


VAERS ID: 1592686 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Angiogram, Anosmia, Arthralgia, Bence Jones proteinuria, Benign prostatic hyperplasia, Biopsy oesophagus, Biopsy stomach, Blood albumin, Blood culture, Blood iron, Blood pressure diastolic, Blood pressure systolic, Blood sodium, C-reactive protein, Colitis, Computerised tomogram head, Cough, Crepitations, Decreased appetite, Diverticulitis, Endoscopy, Fungal infection, Granulocyte count, Heart rate, Heart rate increased, Hypoacusis, Immunohistochemistry, Investigation, Liver function test, Microbiology test, Multiple organ dysfunction syndrome, Musculoskeletal pain, Oedema peripheral, Productive cough, Protein albumin ratio, Proteinuria, Prothrombin level, Pulmonary mass, Pyrexia, Serology test, Sputum test, Systemic lupus erythematosus, Ultrasound scan, Urine analysis, Weight, Weight decreased, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Ischaemic colitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hearing impairment (narrow), Chronic kidney disease (broad), Arthritis (broad), Noninfectious diarrhoea (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 84
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Thoracic angioscan; Result Unstructured Data: Test Result:aspecific right laterobasal pulmonary micronodule; Comments: no pulmonary embolism, aspecific right laterobasal pulmonary micronodule; no evidence of recent or old tuberculosis.; Test Date: 20210531; Test Name: bence jones proteinuria; Test Result: Negative ; Test Date: 20210608; Test Name: Esophageal biopsies; Result Unstructured Data: Test Result:confirmed esophageal mycosis; Test Date: 20210608; Test Name: Gastric biopsy; Result Unstructured Data: Test Result:absence of glandular atrophy; Comments: absence of glandular atrophy, intestinal metaplasia, signs of activity or dysplasia; Test Date: 20210528; Test Name: Albumin; Result Unstructured Data: Test Result:29 g/l; Comments: Hypoalbuminemia; Test Date: 20210531; Test Name: Albumin; Result Unstructured Data: Test Result:25 g/l; Comments: Hypoalbuminemia; Test Date: 20210528; Test Name: blood cultures; Result Unstructured Data: Test Result:Sterile; Test Date: 20210531; Test Name: hyperferritinemia; Result Unstructured Data: Test Result:604.57 ng/L; Comments: hyperferritinemia; Test Date: 20210621; Test Name: diastolic blood pressure; Result Unstructured Data: Test Result:65; Test Date: 20210621; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:106; Test Date: 20210528; Test Name: Hyponatremia; Result Unstructured Data: Test Result:131 mmol/L; Comments: hyponatremia; Test Date: 20210531; Test Name: Hyponatremia; Result Unstructured Data: Test Result:131 mmol/L; Comments: hyponatremia, no other blood ionogram abnormality; Test Date: 20210609; Test Name: brain CT scan; Result Unstructured Data: Test Result:without abnormality; Test Date: 20210528; Test Name: CRP; Result Unstructured Data: Test Result:47 mg/l; Test Date: 20210531; Test Name: CRP; Result Unstructured Data: Test Result:37 mg/l; Test Date: 20210608; Test Name: Endoscopy oeso-gastro-duodenal; Result Unstructured Data: Test Result:peptic oesophagitis; Comments: peptic oesophagitis and probable oesophageal candidosis, gastritis, bulbitis. Ulcer of the tip of the bulb.; Test Date: 20210525; Test Name: Polynuclear neutrofile; Result Unstructured Data: Test Result:10878 /mm3; Test Date: 20210528; Test Name: Polynuclear neutrofile; Result Unstructured Data: Test Result:9540 /mm3; Test Date: 20210621; Test Name: Heart rate; Result Unstructured Data: Test Result:109; Comments: bpm; Test Date: 20210608; Test Name: Immunohistochemical; Result Unstructured Data: Test Result:negative anti-HP antibodies.; Comments: Immunohistochemical study performed with negative anti-HP antibodies.; Test Date: 20210602; Test Name: pulmonary artery scan; Result Unstructured Data: Test Result:no deep tumor syndrome; Test Date: 20210528; Test Name: liver function; Result Unstructured Data: Test Result:No abnormalities in the liver function; Test Date: 20210531; Test Name: acid-fast bacillus; Test Result: Negative ; Test Date: 20210531; Test Name: hypoproteinemia; Result Unstructured Data: Test Result:58 g/l; Test Date: 20210531; Test Name: Proteinuria; Result Unstructured Data: Test Result:0.20 g/l; Test Date: 20210528; Test Name: prothrombin; Result Unstructured Data: Test Result:58% %; Test Date: 20210525; Test Name: serology; Result Unstructured Data: Test Result:HBV serology in favour of a vaccination; Comments: HBV serology in favour of a vaccination, HCV and HEV serologies negative.; Test Date: 20210603; Test Name: serology; Result Unstructured Data: Test Result:Auto antibody anti nuclear positive; Comments: Auto antibody anti nuclear positive, anti native DNA negative, SSA/Ro +, SSB/La -,Sm -,U1RNP -,Scl70 -,Jo-1 -. ANCA + Serologies Q fever, brucellosis, HIV negative. Toxoplasmosis, EBV and CMV serology in favor of old infections. Covid-19 serology: IgG positive.; Test Date: 20210528; Test Name: cytobacteriological examination of sputum; Result Unstructured Data: Test Result:unknown results; Comments: contamination by saliva; Test Date: 20210527; Test Name: Ultrasound; Result Unstructured Data: Test Result:Hypertrophic prostate (210 cc).; Comments: no hepatic, pancreatic, renal or splenic abnormalities. Inflammation of the descending colon and numerous diverticula. Hypertrophic prostate (210 cc).; Test Date: 20210525; Test Name: cytobacterioligical urine exam; Result Unstructured Data: Test Result:without anomaly; Test Date: 20210528; Test Name: Body weight; Result Unstructured Data: Test Result:loss of 8kg in two months kg; Test Date: 20210621; Test Name: Body weight; Test Result: 58.4 kg; Test Date: 20210525; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:13700 /mm3; Comments: hyperleukocytosis; Test Date: 20210528; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:11840 /mm3; Comments: hyperleukocytosis
CDC Split Type: FRPFIZER INC202101056237

Write-up: edema of the lower limbs to mid-calf; multiple organ failure; 109 beats per minute; bilateral crackles; knee and ankle pain on mobilization; confirmed esophageal mycosis; Disseminated lupus erythematosus; Weight loss of 8kg in two months; aspecific right laterobasal pulmonary micronodule; Hypertrophic prostate (210 cc); Inflammation of the descending colon; Inflammation of the descending colon and numerous diverticula; arthromyalgia syndrome; Severe fever; anorexia; agueusia; anosmia; partial hearing loss; Cough; sputum; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-MP20216051. This is first of two reports, for the second dose. An elderly male patient received BNT162B2 (COMIRNATY), intramuscularly on 23Apr2021 (Lot Number: EX2405) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of COVID-19. The patient previously received first dose of COMIRNATY on 02Apr2021 (lot number: ER9480) and experienced severe diarrhea for 2 or 3 days accompanied by joint pains on 04Apr2021.The patient experienced disseminated lupus erythematosus on 03Jun2021 and multiple organ failure on 16Jul2021 which were considered serious due to death. The patient experienced edema of the lower limbs to mid-calf on 28May2021 which was considered serious due to hospitalization from 28May2021 to 16Jun2021. The patient also experienced inflammation of the descending colon and numerous diverticula on 27May2021, severe fever, anorexia, agueusia, anosmia, partial hearing loss, cough, sputum on 23Apr2021, arthromyalgia syndrome on 18May2021, confirmed esophageal mycosis on 08Jun2021, hypertrophic prostate (210 cc) on 27May2021, weight loss of 8kg in two months and aspecific right laterobasal pulmonary micronodule on 28May2021, 109 beats per minute, bilateral crackles and knee and ankle pain on mobilization on 21Jun2021. Description of the events was as follows: 23Apr2021: following the Dose 2, appearance of an important fever (temperature not known), with anorexia, agueusia, anosmia, partial hearing loss, dry cough then sputum treated with SYMBICORT and AUGMENTIN 1gx3 and SOLUPRED 20 mg during 3 days. 10May2021: Appearance of a fever, the cough becomes oily. 18May2021: Cough cured but arthromyalgia syndrome appeared: prescription of BIPROFENID. 25May2021: hyperleukocytosis (13700/mm3) with Polynuclear neutrofile (10878/mm3), HBV serology in favour of a vaccination, HCV and HEV serologies negative. cytobacterioligical urine exam without anomaly. 27May2021: Ultrasound: no hepatic, pancreatic, renal or splenic abnormalities. Inflammation of the descending colon and numerous diverticula. Hypertrophic prostate (210 cc). 28May2021: Hospitalization. On clinical examination: edema of the lower limbs to mid-calf, agueusia, anosmia. Weight loss of 8kg in two months. Bio: hyperleukocytosis (11840/mm3) with polynuclear neutrofile (9540/mm3), prothrombin at 58%, C-reactive protein at 47 mg/l. No abnormalities in the liver function. Hypoalbuminemia (29 g/l). Hyponatremia at 131 mmol/l. Sterile blood cultures. Cytobacteriological examination of sputum : contamination by saliva. Thoracic angioscan: no pulmonary embolism, aspecific right laterobasal pulmonary micronodule; no evidence of recent or old tuberculosis. 31May2021: Search for BAAR in the explorations: negative. CRP 37 mg/l, hyponatremia 131 mmol/l, no other blood ionogram abnormality. Hypoalbuminemia at 25 g/l, hypoprotidemia at 58 g/l, hyperferritinemia at 604.57 ng/l. Proteinuria at 0,20 g/l, negative bence jones proteinuria. 02Jun2021: AP scan: no deep tumor syndrome. 03Jun2021 : Auto Ac anti nuclear positive, anti native DNA negative, SSA/Ro +, SSB/La -,Sm -,U1RNP -,Scl70 -,Jo-1 -. ANCA + Serologies Q fever, brucellosis, HIV negative. Toxoplasmosis, EBV and CMV serology in favor of old infections. Covid-19 serology: IgG positive. 08Jun2021: Endoscopy oeso-gastro-duodenal: peptic oesophagitis and probable oesophageal candidosis, gastritis, bulbitis. Ulcer of the tip of the bulb. Esophageal biopsies: confirmed esophageal mycosis. Gastric biopsies: absence of glandular atrophy, intestinal metaplasia, signs of activity or dysplasia. Immunohistochemical study performed with negative anti-HP antibodies. 09Jun2021: brain CT scan without abnormality. 16Jun2021: discharge from hospital. 21Jun2021: Hospitalization. On admission: apyretic, weight 58.4 kg, 109 beats per minute, systolic blood pressure 106 and Blood pressure diastolic 65, Dry cough, bilateral crackles, edema of the lower limbs , knee and ankle pain on mobilization; EVOLUTION: 16Jul2021: death at 6 a.m. The outcome of the events except disseminated lupus erythematosus and multiple organ failure was unknown. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202101067929 same patient/product, different dose, similar event; Reported Cause(s) of Death: Disseminated lupus erythematosus; multiple organ failure


VAERS ID: 1592703 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood count, Blood creatine phosphokinase, Blood creatinine, Blood potassium, Computerised tomogram head, Electrocardiogram, Encephalopathy, Fibrin D dimer, Glomerular filtration rate, PCO2, PO2, Prothrombin time ratio, Respiratory arrest, Troponin, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Chronic kidney disease (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: DIAMICRON; LEVOTHYROX; TAREG; ALDACTONE [SPIRONOLACTONE]; ELISOR; MOPRAL [OMEPRAZOLE]; PREVISCAN [FLUINDIONE]; DAFALGAN; XELEVIA
Current Illness: Gross obesity (overweight = 180 kg); Hypothyroidism
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Diabetes mellitus non-insulin-dependent; Fall (ECG(Echocardiogram): T wave negative in D3, CPK = 1531, troponin = 62.2 , normal brain scan); Hyperkalemia; Leg amputation; Pulmonary embolism; Rhabdomyolysis; Vertebral fracture (indication to wear a corset; no surgery)
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: bicarbonates; Result Unstructured Data: Test Result:39.9 mmol/L; Test Date: 20210708; Test Name: blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210628; Test Name: CPK; Result Unstructured Data: Test Result:1531; Test Date: 20210708; Test Name: creatinine; Result Unstructured Data: Test Result:84 umol/l; Test Date: 20210628; Test Name: blood potassium; Result Unstructured Data: Test Result:5.3 mol/L; Test Date: 20210628; Test Name: head scan; Result Unstructured Data: Test Result:rhabdomyolysis; Test Date: 20210628; Test Name: ECG; Result Unstructured Data: Test Result:negative T wave in D3; Test Date: 20210708; Test Name: D-dimers; Result Unstructured Data: Test Result:3500 ng/ml; Test Date: 20210708; Test Name: GFR; Result Unstructured Data: Test Result:82 ml/min; Comments: ml/min/1.73 m(squared); Test Date: 20210708; Test Name: pco2; Result Unstructured Data: Test Result:86 mmHg; Test Date: 20210708; Test Name: ph; Result Unstructured Data: Test Result:4.27; Test Date: 20210708; Test Name: po2; Result Unstructured Data: Test Result:56.7 mmHg; Test Date: 20210708; Test Name: prothrombin ratio; Test Result: 37 %; Test Date: 20210628; Test Name: troponin; Result Unstructured Data: Test Result:62.2
CDC Split Type: FRPFIZER INC202101045352

Write-up: This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number FR-AFSSAPS-PA20211343. A 67-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 05Jul2021 (Batch/Lot Number: Unknown) as DOSE 1, 0.3 mL, single for covid-19 immunisation. Medical history included gross obesity (overweight = 180 kg) (ongoing), non-insulin dependent diabetes, Atrial fibrillation (Afib), Pulmonary embolism, ongoing hypothyroidism, and amputation of the 2 lower limbs. Patient lives at home with assistance; autonomous for the toilet. Concomitant medications included gliclazide (DIAMICRON); levothyroxine sodium (LEVOTHYROX); valsartan (TAREG); spironolactone (ALDACTONE [SPIRONOLACTONE]); pravastatin sodium (ELISOR); omeprazole (MOPRAL [OMEPRAZOLE]); fluindione (PREVISCAN [FLUINDIONE]); paracetamol (DAFALGAN); and sitagliptin phosphate (XELEVIA). The patient fell at home on 28Jun2021, emergency room visit: ECG(Echocardiogram): T wave negative in D3, CPK = 1531, troponin = 62.2 , normal brain scan; rhabdomyolysis with hyperkalemia (K = 5.3 mol/L), fracture of the vertebral body of D12; indication to wear a corset; no surgery. On 05Jul2021, patient received the first dose of COMIRNATY. On 08Jul2021, Blood count (CBC) normal, PT = 37%, D-Dimer (STA R Max2 technique) = 3500 ng/mL (N < 500=); Blood gases: ph = 4.27, p CO2 = 86 mm Hg, pO2 = 56.7 mm Hg, bicarbonates = 39.9 mmol/L; creatinine = 84 umol/L GFR = 82 ml/mn/1.73 m2. During hospitalization: put on Kayexalate and switched to insulin. Notion of encephalopathy. On 09Jul2021: death by probable respiratory arrest due to false routes. In total: Death due to respiratory arrest on false routes, 5 days after Dose 1 in a 67-year-old man with multiple co-morbidities. The event respiratory arrest was considered serious (fatal, hospitalization, and life-threatening) by the regulatory authority. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: probable respiratory arrest on a false route.


VAERS ID: 1592724 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-08-06
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8244 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101056232

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20212466. Case from a health professional report via the Ministry portal number 20210806094252940. A 31-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: FE8244), intramuscularly administered in left arm on 28Jul2021 as dose 2, single for COVID-19 immunisation. The patient had no medical history. The patient had no history of COVID-19 and had not been tested for COVID 19. The patient was treated with the daily pill long-term since 12Jan2021. The patient previously received first dose of BNT162B2 (COMIRNATY) and no notion of adverse reaction during the 1st injection of COMIRNATY. On 06Aug2021 in the morning: patient found in bed in cardiorespiratory arrest in asystole not recovered by the medical emergency services team. No notion of toxic intake. No notable personal or family cardiovascular history. No functional complaint reported by the relatives in the previous days. In total, a 31-year-old patient with no history of illness died 10 days after the 2nd dose of COMIRNATY vaccine, with no obvious cause found. The outcome of the event "Cardio-respiratory arrest" was not recovered. The patient died on 06Aug2021. It was unknown if an autopsy was done.; Reported Cause(s) of Death: Death unexplained.


VAERS ID: 1592747 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0680 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-08-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: feverish; Result Unstructured Data: Test Result:feverish
CDC Split Type: FRPFIZER INC202101055179

Write-up: Sudden death; feverish patient; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the RA, regulatory authority number FR-AFSSAPS-TO20216527. A 69-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 30Jul2021 (Batch/Lot Number: FF0680) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus and Hodgkin''s lymphoma. The patient''s concomitant medications were not reported. 01Aug2021, feverish patient. During the night, the female patient called the firefighters: they find her dead. Death of unknown cause. The patient died on 02Aug2021. An autopsy was not performed. Outcome of feverish was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause


VAERS ID: 1593404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test, Transient ischaemic attack
SMQs:, Myocardial infarction (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC202101040969

Write-up: Heart attack; transient ischaemic attack; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202108101124436550-DX5CE, Safety Report Unique Identifier (GB-MHRA-ADR 25778984) An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 08Feb2021 (Lot Number: Not known) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. The patient experienced transient ischaemic attack on 14Feb2021, heart attack on an unspecified date. The patient underwent lab tests included Negative COVID-19 test. The outcome of events was fatal. The patient died on 15Feb2021. It was not reported if an autopsy was performed. Transient ischaemic attack followed by a heart attack, which led to death. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Transient ischaemic attack; heart attack


VAERS ID: 1593425 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Breathing arrested; This case was received via Regulatory Authority (Reference number: 25784244) on 12-Aug-2021 and was forwarded to Moderna on 12-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (Breathing arrested) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RESPIRATORY ARREST (Breathing arrested) (seriousness criteria death and medically significant). The reported cause of death was Breathing arrested. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. Company Comment:Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: Breathing arrested


VAERS ID: 1593519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC202101068333

Write-up: This is a spontaneous report from a non-contactable healthcare professional via Regulatory Authority (regulatory authority number: not provided) based on information received by Pfizer from BioNtech SE (manufacturer control number: HK-Fosun-2021FOS003036), license party for BNT162B2 (COMIRNATY). An 82-year-old male patient received BNT162B2 (COMIRNATY), via unknown route of administration on 09Jul2021 (Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient''s medical history, concomitant medications, and past product were not reported. Previously, the patient experienced unknown adverse event(s) and was hospitalized on an unknown date. The patient experienced intracerebral hemorrhage (unspecified date in Jul2021). The patient died on 14Jul2021 due to intracerebral haemorrhage. It was unknown if an autopsy was performed. Intracerebral haemorrhage met the seriousness criterion of death. The regulatory authority considered there was no clinical evidence to indicate the event was caused by vaccine. This case would be included in the COVID-19 vaccines Adverse events Response and Evaluation Programme of the University of Hong Kong for analysis. Relatedness of drug to reaction/event: Source of Assessment: Reporter; Result of Assessment: Possible Source of Assessment: Company; Result of Assessment: Possible. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: INTRACEREBRAL HAEMORRHAGE


VAERS ID: 1593536 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Throat irritation, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: ITJNJFOC20210831407

Write-up: This spontaneous report received from a consumer via a company representative concerned an 80 year old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced throat problems, covid 19 infection, and suspected clinical vaccination failure, and was hospitalized for 6 days (date unspecified). Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. On an unspecified date, the patient died from covid 19, and throat problems. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of covid 19 infection, throat problems and suspected clinical vaccination failure on an unspecified date. This report was serious (Death, and Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000189701. The suspected product quality complaint that reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender''s Comments: V0: 20210831407- COVID-19 VACCINE AD26.COV2.S- Throat problems, COVID 19. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210831407-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS; Reported Cause(s) of Death: Covid 19; THROAT PROBLEMS


VAERS ID: 1593589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-07-12
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC2336 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Branchial cyst, Chest pain, Lymphadenitis, Lymphadenopathy, Pericarditis, Ultrasound scan
SMQs:, Systemic lupus erythematosus (broad), Congenital, familial and genetic disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease
Allergies:
Diagnostic Lab Data: Test Name: ultrasound; Result Unstructured Data: Test Result:swollen and inflamed lymph node detected; Comments: shows it in very bad condition
CDC Split Type: ITPFIZER INC202101045692

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-768842. A 75-year-old male patient received bnt162b2 (COMIRNATY, lot number: FC2336), dose 2 intramuscular, administered in arm left on 09Jun2021 as dose 2, 0.3 mL, single for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient previously took acetylsalicylic acid and experienced drug allergy. The patient previously received first dose of bnt162b2 (COMIRNATY, lot number: FA4597) on 19May2021 for COVID-19 Immunization. On 12Jul2021 swollen and inflamed lymph node detected by ultrasound, that show it in very bad condition. Pericarditis detected by immediate entry into emergency room privacy and hospitalization. After two days death occurred. - Actions taken (Immediate help by 112, accompanied by his daughter, always present, and hospitalized as quickly as possible in the aforementioned hospital, UTIC(intensive care unit) department.) - Impact on quality of life (10/10) - COVID 19 COMIRNATY VACCINE ( PFIZER): Administration site (left shoulder) Booster dose number (2) Description of reaction (Enlarged and inflamed lymph node detected by ultrasound, that show it in very bad condition. Pericarditis detected by immediate entry into the emergency room of privacy and subsequent hospitalization in UTIC ) On 19May2021 first dose Janssen Lotto FA4597, on 09Jun2021 second dose Janssen batch FC2336, on 12Jul2021 pericarditis detected in the emergency room, suspected branchial cyst, liquid leaks from the neoformation, treatment with antibiotic and surgical evaluation. on 28Jul2021 chest pain, hospitalization in UTIC, coronary angiography. on 29Jul2021 death. Reports are awaited. the notification V-202108-032654-2 is canceled as it is the same patient but the family members have not been able to insert everything in a single card. The patient died on 29Jul2021. It was unknown if an autopsy was performed. Reporter comment: Chronic obstructive pulmonary disease, acetylsalicylic acid allergy, wearer of tibial intramedullary nail due to road polytrauma.; Reported Cause(s) of Death: Swollen and inflamed lymph node; suspected branchial cyst; Pericarditis; Pain chest; Swollen and inflamed lymph node.


VAERS ID: 1593591 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-27
Onset:2021-07-17
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2625 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLINA [FOLIC ACID]; ATORVASTATINA EG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypercholesterolemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101056205

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-769580. A 49-year-old male patient received first dose of BNT162B2 (COMIRNATY), via intramuscular, administered in left arm on 27Jun2021 (Lot Number: FE2625) as 0.3 ml single dose for covid-19 immunisation. Medical history included slight hypercholesterolemia. Concomitant medications included folic acid (FOLINA) from 01Feb2020 to 17Jul2021; atorvastatin calcium (ATORVASTATINA EG) from 01Feb2020 to 17Jul2021. On 17Jul2021, the patient experienced irreversible cardio-circulatory arrest from acute coronary syndrome. The outcome of the events was fatal. The patient died on 17Jul2021. It was not reported if an autopsy was performed. Reporter Comment: Contacted the reporter, he did not report particular previous pathologies, if not slight hypercholesterolemia, on a family basis. Sender Comment: 11Aug2021: death ISTAT card loaded.; Reporter''s Comments: Contacted the reporter, he did not report particular previous pathologies, if not slight hypercholesterolemia, on a family basis.; Reported Cause(s) of Death: Irreversible cardio-circulatory arrest from Acute coronary syndrome; Irreversible cardio-circulatory arrest from Acute coronary syndrome.


VAERS ID: 1593592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse, Fall, Fatigue, Investigation, Platelet count, Platelet count decreased, Pyrexia, Sepsis, Spinal fracture
SMQs:, Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; ASPIRINETTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: platelet count; Result Unstructured Data: Test Result:low; Test Name: impact on quality of life; Result Unstructured Data: Test Result:10; Comments: 10/10
CDC Split Type: ITPFIZER INC202101055013

Write-up: This is a spontaneous report from contactable consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-769734. A 90-yeaer-old male patient received 2nd dose of BNT162B2 (COMIRNATY, lot number FA5831) at single dose on 08May2021 intramuscular in right arm for COVID-19 immunisation. Medical history included mild heart failure and allergy to penicillin. Concomitant drugs included clopidogrel and acetylsalicylic acid (ASPIRINETTA). Serious adverse event was reported as "healthy person, after second dose Pfizer sudden collapse, fever for 3 days, fall, hospitalization for fracture and platelet collapse. Death from blood sepsis after 4 days of hospitalization" with onset date of 12May2021 and seriousness criterion of death. The clinical course was reported as follows: after 2 days from the second vaccine dose the dynamic patient until that moment was fatigued and tired, after 5 days the fever also rises and following a nocturnal fall with a fracture of a vertebra and was hospitalized. Low platelet values were found during hospitalization. Lab data included impact on quality of life : 10/10. Outcome of healthy person, after second dose Pfizer sudden collapse, fever for 3 days, fall, hospitalization for fracture and platelet collapse. Death from blood sepsis after 4 days of hospitalization was fatal. Outcome of the other event was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: healthy person, after second dose Pfizer sudden collapse, fever for 3 days, fall, hospitalization for fracture and platelet collapse. Death from blood sepsis after 4 days of hospitalization; healthy person, after second dose Pfizer sudden collapse.


VAERS ID: 1593593 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-04-20
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Biopsy pancreas, Carbohydrate antigen 19-9, Carcinoembryonic antigen, Computerised tomogram, Computerised tomogram abdomen, Gamma-glutamyltransferase, Metastases to liver, Metastases to lung, Metastases to lymph nodes, Metastases to the mediastinum, Pancreatic carcinoma, Tumour marker test, Ultrasound abdomen
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 54
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EFFICIB
Current Illness: Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Biopsy pancreas; Result Unstructured Data: Test Result:no information; Test Name: ca; Result Unstructured Data: Test Result:23446 ng/ml; Test Name: Carcino-fetal antigen; Result Unstructured Data: Test Result:12.06 ng/ml; Test Name: ct; Result Unstructured Data: Test Result:Shows ascitic effusion, mass of pancreatic tail (d; Comments: Shows ascitic effusion, mass of pancreatic tail (d = 10cm), mesenteric lymphadenomegalies. Peritoneal carcinosis. Neoplastic ascites. Hepatic, pulmonary metastases; Test Date: 20210505; Test Name: Abdomen CT; Result Unstructured Data: Test Result:no information; Test Name: gt range; Result Unstructured Data: Test Result:314 IU/l; Test Date: 20210515; Test Name: Tumour marker test; Result Unstructured Data: Test Result:no information; Test Date: 20210420; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:no information
CDC Split Type: ITPFIZER INC202101056418

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-769755. An 82-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Right on 20Mar2021 09:00 (Batch/Lot Number: ET3620) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included type 2 diabetes mellitus from 12Jan2018 to 14Jul2021. Concomitant medication included metformin hydrochloride, sitagliptin phosphate (EFFICIB) taken for diabetes mellitus. The patient previously received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 20Feb2021 15:00 (Batch/Lot Number: EP9598) as single dose for covid-19 immunisation. On 20Apr2021, the patient experienced rapidly progressing pancreatic tail carcinoma (d= 9cm), immediately complicated with carcinosis, neoplastic ascites, liver and lung metastases, and mediastinal lymph nodes (ca 19.9 = 23,446, x 600 nn), Liquid formation between spleen and left kidney (d = 9 cm) of indeterminate nature (dilated splenic flexure of the colon? Other). No other abdominal injuries; Ca 19.9 = 23446 (normal value & lt; 37 ng / ml) Cea = 12.06 (normal value & lt; 7 ng / ml) GT range = 314 (normal value & lt; 55 U / L; CT scan performed + 15 days from abdominal ultrasound examination. Shows ascitic effusion, mass of pancreatic tail (d = 10cm), mesenteric lymphadenomegalies. Peritoneal carcinosis. Neoplastic ascites. Hepatic, pulmonary metastases and mediastinal lymph nodes (Ca 19.9 = 23,446, x 600 NN). The patient underwent lab tests and procedures which included biopsy pancreas: no information on unknown date, carbohydrate antigen 19-9: 23446 ng/ml on unknown date, Carcino-fetal antigen: 12.06 ng/ml on unknown date, computerized tomogram: Shows ascitic effusion, mass of pancreatic tail (d = 10cm), mesenteric lymphadenomegalies. Peritoneal carcinosis. Neoplastic ascites. Hepatic, pulmonary metastases on unknown date, Abdomen CT: no information on 05May2021, gamma-glutamyltransferase: 314 iu/l on unknown date, Tumour marker test: no information on 15May2021, ultrasound abdomen: no information on 20Apr2021. The patient died on 13Jun2021. It was not reported if an autopsy was performed. Sender Comment: Initial information of 10Aug2021: since it is a clinical picture of dubious attributability to one of the two doses received, I left the two doses as suspicious, as the doctor stated. Information dated 11Aug2021: clinical report of the referring physician is attached. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Ascites; Hepatic metastases; Lymph node metastases; Metastases to the mediastinum; Pulmonary metastases; Pancreatic carcinoma.


VAERS ID: 1593595 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-29
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101055050

Write-up: This is a spontaneous report from contactable Consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-769783. A 67-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via intramuscular in arm/shoulder left on 24May2021 (Lot Number: FC3558) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 03May2021 (Lot Number: EX7389) as single dose for COVID-19 immunization. The patient experienced fulminant leukemia with cerebral hemorrhage on 29Jun2021. The invention included ambulance intubation of the terminal ileum (TI). After a few hours, the patient experienced death. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fulminant leukemia with cerebral hemorrhage; Fulminant leukemia with cerebral hemorrhage


VAERS ID: 1593708 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-15
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Cerebral infarction, Magnetic resonance imaging head, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Head MRI; Result Unstructured Data: Test Result:the finding of acute cerebral infarction; Comments: in the left corona radiata
CDC Split Type: JPPFIZER INC202101042056

Write-up: This is a spontaneous report from a contactable pharmacist received via Medical Information Team and a physician from the Regulatory Authority, Regulatory authority report number: v21123327. An 84-years-and 1-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Jun2021 at 16:00 (Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) as dose 2, single (at the age of 84-years-old) for Covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Family history was not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EY0779, expiration date: 31Aug2021) as dose 1, single for Covid-19 immunisation. The course of the event ''sudden death'' was as follows: On 09Jun2021, the patient received the first vaccination. On 30Jun2021, the patient received the second vaccination. On 15Jul2021 at 15:00, inarticulateness and right hemiplegia appeared. Head Magnetic Resonance Imaging (MRI) showed the finding of acute cerebral infarction in the left corona radiata, for which the patient was emergently admitted to the neurosurgery department of the reporting hospital and conservative therapy was initiated. The patient was hospitalized for acute cerebral infarction (cerebral infarction) from Jul2021 to an unknown date. On 31Jul2021 at 11:20, a nurse visited the patient''s room and found that the patient was in cardio-respiratory arrest. Lifesaving measures was performed; however, on the same day at 12:12, death was confirmed. Therapeutic measures were taken as a result of sudden death, acute cerebral infarction and cardio-respiratory arrest. The patient died on 31Jul2021. The outcome of the event sudden death was fatal while the outcome of the rest of the events was unknown. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: the patient developed cerebral infarction 15 days after the second vaccination, and experienced sudden death 31 days after the second vaccination. Although causality between the event and the vaccine was unknown, the case involved no comorbidity that could directly result in death.; Reported Cause(s) of Death: Sudden death.


VAERS ID: 1593709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Decreased appetite, Embolic cerebral infarction, Investigation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep venous thrombosis NOS; Dyslipidaemia; Hypertension; Hyperuricaemia; Vertigo
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Imaging test; Result Unstructured Data: Test Result:brain stem infarction
CDC Split Type: JPPFIZER INC202101044140

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123298. The patient was an 88-year and 2-month-old female. Body temperature before vaccination was not reported. Medical history included hypertension, dyslipidaemia, hyperuricaemia, deep venous thrombosis and benign paroxysmal vertigo. Concomitant medications and family history were not provided. On 11Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose (dose 1, single) for COVID-19 immunization. On 02Jul2021 in the afternoon (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose (dose 2, single) for COVID-19 immunization. On 05Jul2021 at 09:00 (3 days after the vaccination), the patient experienced embolic cerebral infarction (cerebral infarction caused by arrhythmia) . The patient was admitted to the reporter''s hospital on the same day (05Jul2021). On 08Jul2021 (6 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: According to the patient''s family, after the vaccination, the patient had lost appetite. On 05Jul2021 at 07:30, the patient had a conversation with her son and thereafter her son confirmed (illegible). The patient had no symptoms at this time. The shuttle bus of the senior day care center came, but they could not get hold of her, so they contacted her son. The son found that the patient collapsed at home, and then she was transferred to the reporter''s hospital. Since her respiratory status was unstable, intubation was performed. Imaging test showed finding of brain stem infarction (on 05Jul2021). Based on the result, embolic cerebral infarction was diagnosed. Conservative therapy was performed. On 08Jul2021, the patient died. It was not reported if an autopsy was performed. Outcome of the event decreased appetite was unknown while outcome of the remaining events was fatal. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the event and BNT162b2 as unassessable. Cerebral infarction caused by arrhythmia was considered as an other possible cause. The reporting physician commented as follows: After the vaccination, decreased appetite was noted, and the possibility that it (illegible) circulatory dynamics could not be denied. Therefore, the causal relationship with BNT162b2 could not be proved.; Reported Cause(s) of Death: embolic cerebral infarction (cerebral infarction caused by arrhythmia); embolic cerebral infarction (cerebral infarction caused by arrhythmia)


VAERS ID: 1593710 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-22
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Bacterial test, Cardiovascular disorder, Enterocolitis, Intestinal perforation, Peritonitis, Pyrexia, Vasculitis, Viral test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal perforation (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Vasculitis (narrow), Noninfectious diarrhoea (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 26
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: Aortic aneurysm; Hypertension; Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: bacterial type; Test Result: Negative ; Test Date: 20210623; Test Name: viral type; Test Result: Negative
CDC Split Type: JPPFIZER INC202101044364

Write-up: Abdominal pain/Enterocolitis; Pyrexia; Intestinal perforation; enterocolitis originating from vasculitis; Peritonitis perforative; arteriosclerosis was severe; potential blood flow disorder; This is a spontaneous report from a contactable physician received from the RA. The regulatory authority report number is v21123299. An 85-year and 10-month-old male patient received bnt162b2 (COMIRNATY; Batch/Lot number was not reported), via an unspecified route of administration, on 13Jun2021 (the day of the vaccination, at the age of 85 years old) as dose number unknown, single for COVID-19 immunisation. Body temperature before vaccination and family history were not reported. Medical history included hypertension and aortic aneurysm (a stent was placed). Concomitant medications were not reported. On 22Jun2021 at 22:30 (9 days after the vaccination), the patient experienced enterocolitis and pyrexia. On 23Jun2021 at unknown time (10 days after the vaccination), the patient was admitted to the hospital because of abdominal pain and pyrexia. On 18Jul2021 at unknown time (35 days after the vaccination), the patient experienced intestinal perforation. On 18Jul2021 (35 days after the vaccination), the outcome of the events was fatal. The cause of death was reported as peritonitis perforative. The course of the events was as follows: On 23Jun2021 (10 days after the vaccination), the patient was admitted to the hospital because of abdominal pain and pyrexia. There were findings of enterocolitis; viral type and bacterial type were negative. The symptoms were temporarily alleviated. However, the patient repeatedly had a relapse of the symptoms when starting to eat, due to which vaccination-associated enterocolitis originating from vasculitis was diagnosed. Steroid was started. The symptoms had improved, but a sudden change occurred on 18Jul2021; even intestinal perforation was noted, risk was high, therefore the patient did not wish for surgical treatment. On 18Jul2021 at 16:21 (35 days after the vaccination), the patient died. The reporting physician classified the event enterocolitis and pyrexia as serious (death) and assessed that the events enterocolitis and pyrexia were related to BNT162b2. The seriousness and causality of the other events were not clearly reported. Other possible causes of the events such as any other diseases: Aside from aortic aneurysm, arteriosclerosis was severe, and there was potential blood flow disorder. The outcome of the events was fatal. The patient died on 18Jul2021. It was not reported if an autopsy was performed. Reporter''s comment: Although peritonitis perforative was the cause of death, enterocolitis or vasculitis was considered as the underlying cause. This case was considered consistent with post-vaccination death cases.; Reported Cause(s) of Death: Peritonitis perforative


VAERS ID: 1593711 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-13
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Pallor, Respiratory arrest, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Left hemiplegia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101045201

Write-up: This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21123339. An 84-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC5295; Expiration Date: 30Sep2021), via an unspecified route of administration on 03Aug2021 13:30 as dose 1, single for COVID-19 immunisation. Medical history included cerebral haemorrhage and left hemiplegia. The family history was not provided. The patient''s concomitant medications were not reported. Body temperature before vaccination was not provided. 10 days after the vaccination, on 13Aug2021 at 06:30, the patient experienced vomiting; at 07:00, the patient experienced pallor facial, respiratory arrest and loss of consciousness. The course of the event was as follows: On 13Aug2021, at 06:30 (10 days after vaccination), the patient experienced vomiting. At 07:00, the patient experienced pallor facial, respiratory arrest, and loss of consciousness. At 07:20, although cardiopulmonary resuscitation (CPR) was performed, the patient was confirmed to die at 07:49. The patient died on 13Aug2021. An autopsy was not performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Reporter Comment: On 03Aug2021, after the vaccination, the patient''s physical condition was favorable. However, the condition suddenly changed, and he died. Although the assessment was impossible, the event onset was 10 days after the vaccination and no other specified findings were observed.; Reporter''s Comments: On 03Aug2021, after the vaccination, the patient''s physical condition was favorable. However, the condition suddenly changed, and he died. Although the assessment was impossible, the event onset was 10 days after the vaccination and no other specified findings were observed.; Reported Cause(s) of Death: Vomiting; Pallor facial; Respiratory arrest; loss of consciousness.


VAERS ID: 1593712 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome
SMQs:, Myocardial infarction (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Aortic valve replacement; Atrial fibrillation; End stage renal failure; Haemodialysis (Monday, Wednesday, Friday)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101048557

Write-up: This is a spontaneous report from a contactable physician received via Regulatory Authority. A non-pregnant 80-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 18Jun2021 09:45 (the day of vaccination) (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included aortic valve replacement, angina pectoris, atrial fibrillation, and end stage renal failure. The patient received hemodialysis (Monday, Wednesday, and Friday) within 2 weeks of vaccination. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient''s concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically received the first dose of COMIRNATY (Lot number EY0779; Expiration Date 31Aug2021) on 28May2021 for COVID-19 immunisation. On 20Jun2021 at 09:00 (one day/23 hours/15 minutes after the vaccination), the patient experienced acute coronary syndrome. The event resulted in emergency room/department or urgent care, hospitalization on an unspecified date in 2021. The reported event was as follows: On 21Jun2021 (three days after vaccination), the patient died. Duration of hospitalization was 2 days. Death cause was acute coronary syndrome. Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was fatal with treatment including a drip infusion of morphine. The reporting physician assessed the event as serious (life-threatening, hospitalization, and death).; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event acute coronary syndrome (fatal) the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. Reported Cause(s) of Death: Acute coronary syndrome.


VAERS ID: 1593714 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   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: Depression
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: Body temperature; Result Unstructured Data: Test Result:unknown; Comments: Body temperature before vaccination was not reported
CDC Split Type: JPPFIZER INC202101049790

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority; the Regulatory Authority report number is v21123437. A 49-year and 1-month-old male patient received the first dose of BNT162b2 (COMIRNATY) Solution for injection (batch/lot number and expiration date were unknown) via an unspecified route of administration on 12Aug2021 at 11:00 (the day of vaccination), as DOSE 1, SINGLE for COVID-19 immunization at 49 years and 1 month old (age at vaccination). Body temperature before vaccination was not reported. The patient''s medical history included depression from an unknown date. Family history and concomitant medications were not reported. On 14Aug2021 at around 08:00 (around 1 day 21 hours after the vaccination), the patient experienced cardio-respiratory arrest. On 14Aug2021 (2 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 14Aug2021 at around 08:00, the patient was found lying in the living room at home by his family, who requested an ambulance. The patient was in cardio-respiratory arrest. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: Autopsy at a medical examiner''s office was requested. The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.; Reported Cause(s) of Death: Cardio-respiratory arrest.


VAERS ID: 1593715 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Artery dissection, Autoimmune haemolytic anaemia, Blood bilirubin, Blood creatinine, Blood test, Blood urea, C-reactive protein, Computerised tomogram, Coombs direct test, Fall, Haemoglobin, Haptoglobin, Hepatic infarction, Investigation, Liver disorder, Metabolic acidosis, Mouth haemorrhage, Multiple organ dysfunction syndrome, Pain, Plasminogen activator inhibitor, Platelet count, Platelet count decreased, Pneumonia, SARS-CoV-2 test, Splenic infarction, Thrombin-antithrombin III complex, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haemolytic disorders (narrow), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Systemic lupus erythematosus (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-12
   Days after onset: 24
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: PREDONINE [PREDNISOLONE]; ACELIO; ZOSYN; PRALIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fish allergy; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: Bilirubin total; Test Result: 0.9 mg/dl; Test Date: 20210729; Test Name: Bilirubin total; Test Result: 1 mg/dl; Test Date: 20210804; Test Name: Bilirubin total; Test Result: 7.3 mg/dl; Test Date: 20210808; Test Name: Bilirubin total; Test Result: 16.6 mg/dl; Test Date: 20210809; Test Name: Bilirubin total; Test Result: 19.9 mg/dl; Test Date: 20210531; Test Name: Creatinine; Test Result: 1.1 mg/dl; Test Date: 20210724; Test Name: Creatinine; Test Result: 1.48 mg/dl; Test Date: 20210725; Test Name: Creatinine; Result Unstructured Data: Test Result:Cr was aggravated from 1.9 to 4.5 mg/dl; Test Date: 20210729; Test Name: Creatinine; Test Result: 5.85 mg/dl; Comments: 5.8 revealed renal failure; Test Date: 20210804; Test Name: Creatinine; Result Unstructured Data: Test Result:2.2 (under dialysis) mg/dl; Test Date: 20210808; Test Name: Creatinine; Result Unstructured Data: Test Result:1.2 (under dialysis) mg/dl; Test Date: 20210809; Test Name: Creatinine; Result Unstructured Data: Test Result:1.2 (under dialysis) mg/dl; Test Date: 20210812; Test Name: Blood test; Result Unstructured Data: Test Result:autoimmune haemolytic anaemia was also noted; Test Date: 20210729; Test Name: BUN; Result Unstructured Data: Test Result:121.2; Comments: revealed renal failure; Test Date: 20210808; Test Name: Contrast-enhanced CT; Result Unstructured Data: Test Result:hepatic infarction and splenic infarction; Comments: revealed thrombus in the coeliac artery and superior mesenteric artery with findings of hepatic infarction and splenic infarction; Test Date: 20210721; Test Name: CT; Result Unstructured Data: Test Result:pneumonia; Test Date: 2021; Test Name: Coombs direct test; Result Unstructured Data: Test Result:positive; Test Date: 20210729; Test Name: CRP; Result Unstructured Data: Test Result:ranged between 6 and 8 showing persistently high i; Comments: ranged between 6 and 8 showing persistently high inflammatory markers; Test Date: 20210531; Test Name: Haemoglobin; Result Unstructured Data: Test Result:12.2 g/dl; Test Date: 20210724; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.6 g/dl; Test Date: 20210729; Test Name: Haemoglobin; Result Unstructured Data: Test Result:8.7 g/dl; Test Date: 20210804; Test Name: Haemoglobin; Result Unstructured Data: Test Result:8.7 g/dl; Test Date: 20210808; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.6 g/dl; Test Date: 20210809; Test Name: Haemoglobin; Result Unstructured Data: Test Result:9.1 g/dl; Test Date: 2021; Test Name: Haptoglobin; Result Unstructured Data: Test Result:decreased; Test Date: 2021; Test Name: ADAMTS-13 activity; Test Result: 13 %; Test Date: 2021; Test Name: PAI-1; Result Unstructured Data: Test Result:19.1; Test Date: 20210531; Test Name: Platelet; Result Unstructured Data: Test Result:434000 /mm3; Test Date: 20210724; Test Name: Platelet; Result Unstructured Data: Test Result:226000 /mm3; Test Date: 20210729; Test Name: Platelet; Result Unstructured Data: Test Result:42000 /mm3; Test Date: 20210804; Test Name: Platelet; Result Unstructured Data: Test Result:60000 /mm3; Test Date: 20210808; Test Name: Platelet; Result Unstructured Data: Test Result:28000 /mm3; Test Date: 20210809; Test Name: Platelet; Result Unstructured Data: Test Result:12000 /mm3; Test Date: 2021; Test Name: platelets; Result Unstructured Data: Test Result:ranged from 26000 to 88000; Comments: showing platelets decreased; Test Date: 20210721; Test Name: platelets; Result Unstructured Data: Test Result:decreased; Test Date: 20210729; Test Name: platelets; Result Unstructured Data: Test Result:decreased; Comments: from 400000 to 50000; Test Date: 20210729; Test Name: SARS-COV-2 PCR; Result Unstructured Data: Test Result:negative; Test Date: 2021; Test Name: TAT; Result Unstructured Data: Test Result:5.2; Test Date: 20210531; Test Name: White blood cell; Result Unstructured Data: Test Result:12400 /mm3; Test Date: 20210724; Test Name: White blood cell; Result Unstructured Data: Test Result:36000 /mm3; Test Date: 20210729; Test Name: White blood cell; Result Unstructured Data: Test Result:18730 /mm3; Test Date: 20210804; Test Name: White blood cell; Result Unstructured Data: Test Result:25850 /mm3; Test Date: 20210808; Test Name: White blood cell; Result Unstructured Data: Test Result:23670 /mm3; Test Date: 20210809; Test Name: White blood cell; Result Unstructured Data: Test Result:25820 /mm3
CDC Split Type: JPPFIZER INC202101049799

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is i21103089 and v21123371. An 82-year-old non-pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC9909, Expiration date 30Sep2021), dose 2 intramuscular on 19Jul2021 (the day of vaccination, at the age of 82-year-old) as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included rheumatoid arthritis. It was unknown whether the patient had drinking and smoking habits. The patient had allergy to mackerel. Concomitant medications included prednisolone (PREDONINE) taken for rheumatoid arthritis; paracetamol (ACELIO); piperacillin sodium, tazobactam sodium (ZOSYN); denosumab (PRALIA). The patient was on treatment of rheumatoid arthritis since in her 40s (started using prednisolone at 2 mg in ''Sep2021'' (as reported)). On 14Jun2021 at unknown time, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) at a dose of 0.3 ml intramuscularly as a single dose for COVID-19 immunization. On 21Jul2021 at unknown time (2 days after the vaccination), the patient experienced pneumonia, acute renal failure, platelets decreased, and autoimmune haemolytic anaemia. On 29Jul2021 at unknown time (10 days after the vaccination), the patient experienced intra-abdominal artery dissection, hepatic infarction, and splenic infarction. On 12Aug2021 (24 days after the vaccination), the outcome of all the events was fatal. It was unknown whether autopsy was done. The course of the events was as follows: Body temperature before vaccination was unknown. On 19Jul2021 (the day of vaccination), the patient fell, had pain, and was admitted to the previous hospital. On 21Jul2021 (2 days after the vaccination), the patient was pointed out to have pneumonia and was treated, but no improvement was obtained, and progression of renal failure was noted. On 21Jul2021 (2 days after the vaccination), CT revealed pneumonia, and tazobactam sodium was started. On 22Jul2021 (3 days after the vaccination), MINOMYCIN was added. On 25Jul2021 (6 days after the vaccination), the regimen was changed to MEROPEN + MINOMYCIN. The creatinine (Cr) was aggravated from 1.9 to 4.5. On 29Jul2021 (10 days after the vaccination), the patient was transferred to the reporting hospital. Platelets decreased (from 400000 to 50000) was noted with oral mucosa bleeding (onset on 21Jul2021). The patient was mechanically ventilated. Continuous hemodiafiltration was started. Pneumonia slightly improved temporarily, and the mechanical ventilator was removed, but the C-reactive protein (CRP) ranged between 6 and 8 (under administration of PREDNISOLONE 40 mg) showing persistently high inflammatory markers. Management with a mechanical ventilator was required. On 29Jul2021 (10 days after the vaccination), SARS-COV-2 polymerase chain reaction (PCR) test was negative. On the same date, the patient was transferred to the reporting hospital. Treatment indicated for pneumonia bacterial was continued, but the imaging findings of pneumonia showed little improvement. On 29Jul2021, the blood urea nitrogen (BUN) was 121.2 and the Cr was 5.8, which revealed renal failure; continuous hemodiafiltration was performed. The platelets (PLT) ranged from 26000 to 88000, showing platelets decreased in 2021. On 08Aug2021 (20 days after the vaccination), marked aggravation of liver disorder was noted, and contrast-enhanced computerised tomography (CT) revealed thrombus in the coeliac artery and superior mesenteric artery with findings of hepatic infarction and splenic infarction. Radical treatment was difficult under the general condition, and the patient was mechanically ventilated again and received blood purification therapy. On 08Aug2021 (20 days after the vaccination), aggravation of liver disorder and acidosis was observed. An intensive care was given in the intensive care unit (ICU), but acidosis progressed. However, metabolic acidosis did not improve, and the general condition worsened. On 12Aug2021 (24 days after the vaccination), the patient died. Autoimmune haemolytic anaemia was also noted on a blood test. Lab data was as follows: on 31May2021, white blood cell 12400/ul, platelet 434000/ul, haemoglobin 12.2 g/dL, creatinine 1.1 mg/dL; on 24Jul2021, white blood cell 36000/ul, platelet 226000/ul, haemoglobin 11.6 g/dL, creatinine 1.48 mg/dl, bilirubin total 0.9 mg/dL; on 29Jul2021, white blood cell 18730/ul, platelet 42000/ul, haemoglobin 8.7 g/dL, creatinine 5.85 mg/dl, bilirubin total 1 mg/dL; on 04Aug2021, white blood cell 25850/ul, platelet 60000/ul, haemoglobin 8.7 g/dL, creatinine 2.2 mg/dl (under dialysis), bilirubin total 7.3 mg/dL; on 08Aug2021, white blood cell 23670/ul, platelet 28000/ul, haemoglobin 11.6 g/dL, creatinine 1.2 mg/dl (under dialysis), bilirubin total 16.6 mg/dL; on 09Aug2021, white blood cell 25820/ul, platelet 12000/ul, haemoglobin 9.1 g/dL, creatinine 1.2 mg/dl (under dialysis), bilirubin total 19.9 mg/dL. There were no other procedure/diagnosis besides the above drugs. On 12Aug2021 (24 days after the vaccination), the patient died (a complication of autoimmune haemolytic anaemia was also noted based on haptoglobin decreased in 2021 and positive coombs direct test in 2021). On unspecified date in 2021, the patient experienced multi-organ failure. Cause of death included Pneumonia, acute renal failure, platelets decreased, Autoimmune haemolytic anaemia, Intra-abdominal artery dissection, hepatic infarction, splenic infarction and multi-organ failure (respiratory failure, renal failure, hepatic failure). The outcome of the remaining events was unknown. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unknown. The reporting physician commented as follows: The patient with underlying condition of rheumatoid arthritis experienced symptoms including pneumonia, renal failure, platelets decreased, and oral mucosal disorder on the second day from the coronavirus vaccination and ultimately died of multi-organ failure (respiratory failure, renal failure, hepatic failure) about 19 days later. Coombs direct test was positive and haptoglobin decreased was present; manifestation of autoimmune haemolytic anaemia was considered, but at the time of diagnosis, aggressive therapeutic intervention was difficult because of progressing irreversible organ disorder. For differentiation of thrombotic microangiopathy, ADAMTS-13 activity was measured (13%) but did not meet the diagnosis criteria. Regarding the platelets decreased, the thrombin antithrombin complex (TAT) and plasminogen activator inhibitor-1 (PAT-1) (TAT 5.2, PAI-1 19.1) were not high enough to consider septic disseminated intravascular coagulation (DIC), and a pathology that was different from typical septic DIC was suspected. Considering that the present underlying disease of rheumatoid arthritis had been reportedly stable under outpatient treatment and that the symptoms occurred 2 days after the vaccination, the possible relation with the vaccination could not be denied. The reporting physician commented as follows: The patient died of pneumonia, acute renal failure, platelets decreased, coagulation disorder, and multi-organ failure including hepatic failure. The relation with the vaccine was also conceivable considering that the symptoms developed 2 days after the vaccination against the coronavirus.; Reported Cause(s) of Death: Pneumonia; Autoimmune haemolytic anaemia; Intra-abdominal artery dissection; hepatic infarction; splenic infarction; acute renal failure; platelets decreased; multi-organ failure (respiratory failure, renal failure, hepatic failure)


VAERS ID: 1593716 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood test, Body temperature, Condition aggravated, Decreased appetite, Glycosylated haemoglobin, Hepatic failure
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-05
   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: JARDIANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic; Diabetes mellitus aggravated; Heavy drinker; Hepatic failure
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: Glu; Result Unstructured Data: Test Result:156; Test Date: 20210615; Test Name: Blood test; Result Unstructured Data: Test Result:revealed diabetes mellitus aggravated; Test Date: 20210804; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210615; Test Name: HbA1c; Test Result: 8.2 %
CDC Split Type: JPPFIZER INC202101049806

Write-up: This is a spontaneous report from a contactable nurse received from the Regulatory Authority. Regulatory authority report number is v21123875. An 81-year-old (81-year and 5-month-old) male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: FD1945; Expiration Date: 31Oct2021), via an unspecified route of administration on 04Aug2021 at 14:40 (at the age of 81-years-old) as dose 2, single for COVID-19 immunisation, body temperature before vaccination was 36.6 degrees centigrade. Medical history included end stage alcoholic hepatic failure, alcoholic, heavy drinker who regularly drank 2 bottles of whisky a week from an unknown date, diabetes mellitus aggravated from 15Jun2021 to an unknown date. Concomitant medication included empagliflozin (JARDIANCE) taken for an unspecified indication from 15Jun2021 to an unspecified stop date. The patient previously received the first dose of COMIRNATY on 15Jul2021 for COVID-19 immunisation. The patient experienced inappetence on 05Aug2021 at 16:51, further aggravation of the general condition on 05Aug2021 (1 day after the vaccination) and hepatic failure associated with chronic alcohol poisoning on an unspecified date. The clinical course of the events was as follows: The patient was an alcoholic and a heavy drinker who regularly drank 2 bottles of whisky a week. The family did not wish for a hospital treatment. The previous hospital considered it difficult to continue the treatment; the patient was referred to the reporting clinic and was receiving a home-visit medical care. There had been fluctuation in his dietary intake. On 15Jun2021, a blood test revealed diabetes mellitus aggravated. The HbA1c was 8.2%, and the glucose (Glu) was 156. Empagliflozin 10 mg was added. On 15Jul2021, the patient received the first vaccination at his and his family''s request. No significant change was noted after the vaccination. On 04Aug2021 (the day of vaccination), a home visit was made for the vaccination. Since a week before, the patient had experienced decreased appetite and had tended to have aggravated general condition, but no pyrexia occurred, and the vital signs showed no abnormalities. The vaccination was done after a consultation with the patient and his family. On 05Aug2021 (1 day after the vaccination), further aggravation of the general condition was reported. On the same date at 16:45, an irregular house visit was made, and at 16:51, the patient was attended on his deathbed at home. The cause of death was diagnosed as hepatic failure associated with chronic alcohol poisoning. The patient died on 05Aug2021. It was unknown if an autopsy was performed. The reporting nurse classified the event inappetence as serious (death) and assessed that the event inappetence was unrelated to BNT162b2. The seriousness and causality of the other events were not clearly reported. Other possible causes of the event inappetence such as any other diseases included aggravated condition associated with alcoholic hepatic failure. The reporting nurse commented as follows: Despite the course of aggravated general condition, the second BNT162b2 vaccination was performed after a consultation with the patient and his family. Under the present exacerbation of the underlying disease, poor dietary intake and others were also noted in the morning on the same day, but the BNT162b2 vaccination was given as there was no significant changes in the vital signs. On the next day, the patient died, but the patient had no symptoms like allergic reaction and pyrexia that were suggestive of BNT162b2-related side effects. Based on the course, death due to hepatic function aggravated associated with chronic alcohol poisoning was considered.; Reported Cause(s) of Death: Hepatic failure associated with chronic alcohol poisoning.


VAERS ID: 1593717 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-04
Onset:2021-08-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9880 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101050089

Write-up: This is a spontaneous report from a contactable physician (inoculator) received via Regulatory Authority. This report received from the Regulatory Authority. Regulatory authority report number is v21123499. A non-pregnant 57-year and 9-month-old female patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC9880, Expiration date 30Sep2021) intramuscularly in the left arm on 04Aug2021 at 12:30 (the day of vaccination; at the age of 57-year and 9-month-old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included diabetes mellitus. Body temperature before vaccination was 37.0 degrees centigrade on 04Aug2021. The patient family history was unknown. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no known allergies. Concomitant medications were not reported. On 14Jul2021 (at the age of 57 years old), the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number EW0203, Expiration date 30Sep2021) intramuscularly in the left arm as single dose for COVID-19 immunisation. On 14Aug2021 at unspecified time (9 days 11 hrs 30 min after the vaccination), the patient died (death). The event resulted in department or urgent care, death. Cause of death, if autopsy performed, if treatment received for the event, if the patient was diagnosed with COVID-19 prior to vaccination, if the patient had been tested for COVID-19 since the vaccination were unknown. The course of the event was as follows: The patient condition changed suddenly at home, she was transported to another hospital and confirmed dead. It was reported by police, therefore details including time was unknown. Because the patient had not received the diabetes management at the reporter hospital, it was unknown if there were other possible causes of the event. The reporting physician assessed the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. The reporting physician did not provide any further comment. Outcome of the event was fatal. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death/condition changed suddenly at home.


VAERS ID: 1593718 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure abnormal, Blood pressure measurement, Body temperature, Cardiac arrest, Chills, Coma scale, Dizziness, Dyspnoea, Fall, Head injury, Heart rate, Heart rate decreased, Interstitial lung disease, Loss of consciousness, Oxygen saturation, Oxygen saturation decreased, Pneumothorax, Respiratory rate decreased, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BAYASPIRIN; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder; Hospitalisation; Interstitial pneumonia; Renal disease; Restlessness
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: BP; Result Unstructured Data: Test Result:not increased easily; Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210712; Test Name: JCS; Result Unstructured Data: Test Result:100; Comments: During computerised tomography; Test Date: 20210712; Test Name: JCS; Result Unstructured Data: Test Result:300; Test Date: 20210712; Test Name: HR; Result Unstructured Data: Test Result:decreased; Test Date: 20210712; Test Name: SpO2; Result Unstructured Data: Test Result:70s %; Comments: with oxygen mask at 10 L; Test Date: 20210712; Test Name: Xp; Result Unstructured Data: Test Result:right pneumothorax; Test Date: 20210712; Test Name: Xp; Result Unstructured Data: Test Result:Alleviated pneumothorax
CDC Split Type: JPPFIZER INC202101051319

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123477. An 87-year and 5-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0201, Expiration date 30Sep2021) via an unspecified route of administration on 09Jul2021 (the day of vaccination, at age of 87 years old) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included heart disease and kidney disease. The patient had been admitted and treated for interstitial pneumonia from 03Jun2021 to 25Jun2021; patient with strong restlessness was discharged. Body temperature before vaccination was 36.3 degrees Centigrade on 09Jul2021. The patient family history was not reported. Concomitant medications included acetylsalicylic acid (BAYASPIRIN) as a blood thinner, and oral prednisolone (PSL; PREDNISOLONE). On 18Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 10Jul2021 (1 day after the vaccination), the patient experienced interstitial pneumonia. On 11Jul2021 (2 days after the vaccination), the patient was admitted to the reporting physician''s hospital. On 12Jul2021 (3 days after the vaccination), the patient died. The outcome of the event was fatal. The course of the event was as follows: On 09Jul2021 (the day of vaccination), the patient received the second dose of COVID-19 vaccine. On 10Jul2021 (1 day after the vaccination), the patient presented with dizziness, chills and dyspnoea. The patient fell down three times, and hit the back of the head. Neither wound nor queasy was present. On 11Jul2021 (2 days after the vaccination), dizziness, chills and dyspnoea persisted. However, the patient did not visit hospital or consult on the phone. He kept an eye on his own symptoms. As the symptoms persisted even at night, the patient visited the reporting physician''s hospital after contacting by phone. On 12Jul2021 at 03:00 (3 days after the vaccination), after hospitalization, respiratory condition was gradually aggravated. Oxygen saturation (SpO2) was 70s% even with oxygen mask at 10 L, so nurse call was answered. A call was made to the patient''s eldest son. Informed consent (IC) was done, and Do Not Attempt Resuscitation (DNAR) was reaffirmed. Central venous catheter (CV) was inserted. After CV insertion, right pneumothorax was revealed through X-ray photograph (Xp) performed for confirmation. During computerised tomography (CT), level of consciousness depressed at 100 on Japan Coma Scale (JCS). Shortly after returning the room, drainage for right pneumothorax was performed using a CV tube. Approximately 500 cc air was drained. Pneumothorax was confirmed to be alleviated by Xp later. Urgent drainage made lung expansion. However, blood pressure (BP) was not increased easily, level of consciousness was at 300 on JCS, heart rate (HR) decreased, breathing became feeble. Then, the patient went into cardiac arrest (arrest). Despite DNAR, cardiopulmonary resuscitation (CPR) was performed; however, the patient did not come back to life. As natural course, the death was confirmed at 07:03. Events Interstitial pneumonia, dizziness, chills, dyspnoea reported hospitalized from 11Jul2021 to 12Jul2021. Events Interstitial pneumonia, dizziness, chills, dyspnoea, right pneumothorax resulted in physician office visit. Treatment received for events Interstitial pneumonia, cardiac arrest, dizziness, chills, dyspnoea, right pneumothorax, Oxygen saturation (SpO2) was 70s%. The outcome of events Interstitial pneumonia and cardiac arrest was fatal, the event right pneumothorax was recovering, while of the other events was unknown. It was not reported if an autopsy was performed. The reporting physician classified the event interstitial pneumonia as serious (hospitalization) and assessed it was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was interstitial pneumonia. Reporter comment: The patient had been admitted and treated for interstitial pneumonia from 03Jun2021 to 25Jun2021. Then, the patient with strong restlessness was discharged. Due to aggravated respiratory condition, he was readmitted on 11Jul2021. The patient had been taking oral prednisolone (PSL; PREDNISOLONE).; Reported Cause(s) of Death: cardiac arrest; Interstitial pneumonia.


VAERS ID: 1593719 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure decreased, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, Computerised tomogram, Heart rate, Ileus, Radioallergosorbent test, Vital signs measurement, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal obstruction (narrow), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: Medical History/Concurrent Conditions: Blister (blisters of lower limbs (unknown cause)); Epilepsy; Ileus (At the age of 25, the patient had undergone laparotomy for ileus due to pica.); Ileus adhesive; Laparotomy (At the age of 25, for ileus due to pica.); Pica (At the age of 25, the patient had undergone laparotomy for ileus due to pica.); Psychomotor development impaired; Psychosomatic disease; Seafood allergy (possibility of seafood allergy (3.56 for shrimps and 3.60 for crabs on RAST)
Allergies:
Diagnostic Lab Data: Test Date: 20210801; Test Name: auscultation; Result Unstructured Data: Test Result:Sound in the abdomen was weak; Comments: with metallic sound; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:75/44; Comments: after examinations; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:97/64; Test Date: 20210801; Test Name: BP; Result Unstructured Data: Test Result:decreased were noted during the surgery; Test Date: 20210731; Test Name: Na; Result Unstructured Data: Test Result:140; Test Date: 20210726; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Test Date: 20210801; Test Name: CT; Result Unstructured Data: Test Result:ileus was diagnosed; Comments: At 10:45; Test Date: 20210731; Test Name: CRP; Result Unstructured Data: Test Result:1.52; Test Date: 20210731; Test Name: HR; Result Unstructured Data: Test Result:70s; Test Date: 20210731; Test Name: pH; Result Unstructured Data: Test Result:7.389; Test Name: RAST; Result Unstructured Data: Test Result:3.56 for shrimps and 3.60 for crabs; Test Date: 20210801; Test Name: vital signs; Result Unstructured Data: Test Result:poor vital signs; Comments: such as blood pressure decreased; during the surgery; Test Date: 20210731; Test Name: WBC; Result Unstructured Data: Test Result:9500
CDC Split Type: JPPFIZER INC202101056683

Write-up: This is a spontaneous report from a contactable physician received via Regulatory Authority; the Regulatory Authority report number is v21123584. A 50-year and 7-month-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 26Jul2021 09:52 (Batch/Lot Number: EY4834; Expiration Date: 31Aug2021) at the age of 50-year-old as single dose for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications including antiepileptic agent within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included repeated blisters of lower limbs (unknown cause), suggestive of a possibility of seafood allergy (3.56 for shrimps and 3.60 for crabs on radioallergosorbent test [RAST]) (no history of immediate reaction). Other medical history included delayed psychomotor development of unknown cause, severe psychosomatic disease, epilepsy, ileus, pica, and ileus adhesive. At the age of 25, the patient had undergone laparotomy for ileus due to pica. After that, the patient had a history of several episodes of ileus adhesive, which had been improving with conservative therapy at each time. The patient family history has nothing in particular. On 05Jul2021, at the age of 50-year-old, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. On 26Jul2021 at 09:52 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection. Body temperature before vaccination was 36.1 degrees Centigrade. On 31Jul2021, the patient experienced ileus. The event resulted in emergency room/department or urgent care, hospitalization and death. The patient was hospitalized on 01Aug2021 and discharged on 02Aug2021. On 01Aug2021 (6 days after the vaccination), the patient died. The outcome of the event was fatal with treatment including partial intestinal tract resection, and the intensive care such as artificial respiration management and vasopressor administration. The course of the event was as follows: On 31Jul2021 at around 05:00 (5 days after the vaccination), 2 episodes of yellow bloody vomiting, and abdominal distension developed. Enema administration enabled a large amount of soft feces excretion. Body temperature (BT) was 36.2 degrees Centigrade, and heart rate (HR) was 70s. Laboratory data included that white blood cell count (WBC) was 9500, C-reactive protein (CRP) 1.52, pH 7.389, and sodium (Na) 140. Fluid replacement was initiated, and then the patient was given nothing to eat. In the afternoon, enema was administered again, but there was a small amount of feces reaction. Although abdominal distension was improved, tense abdomen persisted. On 01Aug2021 at 01:25, enema was administered as tense abdomen persisted, and a large amount of normal feces was observed. Afterward, the patient had 4 episodes of bile-like vomiting. At 06:00, gastric tube was inserted. Air and 590 mL of bile-like fluid were drained. Sound in the abdomen was weak with metallic sound. Fluid replacement challenge was initiated. At 10:45, computerised tomography (CT) was performed, and ileus was diagnosed. After examinations, blood pressure (BP) decreased to 75/44, for which extracellular fluid challenge was given at the maximum dose, then BP was improved to 97/64. The patient was transported to another hospital, where he underwent laparotomy for partial intestinal tract resection. However, poor vital signs such as blood pressure decreased were noted during the surgery. Despite the intensive care including catecholamine at higher than maximum dose, the patient could not be saved. On 02Aug2021, the patient was discharged dead from the hospital. Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (Death, Hospitalized) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases: ''''At the age of 25, the patient had undergone laparotomy for ileus due to pica. After that, the patient had a history of several episodes of ileus adhesive, which had been improving with conservative therapy at each time. '''' The reporting physician commented as follows: With having delayed psychomotor development of unknown cause, he was a severe psychosomatic disease patient, currently treated with bed rest and in need of total assistance. The patient had a history of laparotomy, and ileus was repeated. For that, bowel management such as enema and faecal disimpaction was continued for days. At this time, the event abruptly occurred without any symptoms until the previous day. Causality with BNT162b2 vaccine was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: blood pressure decreased; ileus


VAERS ID: 1593720 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-08-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, 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: 2021-08-03
   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: Angina pectoris; Cardioembolic stroke; Ischaemic heart disease; Stent placement (4 to 5 years before)
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101058245

Write-up: This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123517. The patient was an 83-year and 1-month-old male. Body temperature before vaccination was 36.3 degrees centigrade on 27Jul2021. The family history was not provided. The patient had medical histories of cardioembolic stroke, cardiac stent placement, ischaemic heart disease, and angina pectoris. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunisation. On 27Jul2021 at 10:48 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) via an unspecified route of administration as a single dose at the age of 83-year-old for COVID-19 immunization. On 03Aug2021 at 04:00 (6 days/17hours/12 minutes after the vaccination), the patient experienced dyspnoea. On 03Aug2021 (7 days after the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: The patient underwent cardiac stent placement 4 to 5 years before. After the patient was admitted to the reporting hospital, he complained of chest pressure sensation several times; however, the symptom did not persist, and he was followed up. On 02Aug2021 (6 days after vaccination), in the morning, although the patient had chest symptom, no obvious objective findings were observed. On 03Aug2021, at around 04:00 (6 days, 17 hours, and 12 minutes after vaccination), the patient complained of dyspnoea. At 04:10 (6 days, 17 hours, and 22 minutes after vaccination), when the patient was examined by the doctor on duty, he had cardio-respiratory arrest. Although cardiopulmonary resuscitation (CPR) was performed for approximately 1 hour, no return of spontaneous circulation was obtained. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was ischaemic heart disease. The reporting physician commented as follows: The patient had medical history of ischaemic heart disease. However, the event occurred 1 week after the vaccination, and thus, it could not be ruled out that the event was a side reaction.; Reported Cause(s) of Death: Dyspnoea; Cardio-respiratory arrest


VAERS ID: 1593721 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-14
   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: JPPFIZER INC202101058278

Write-up: This is a spontaneous report from a contactable physician received via sales representative. A 58-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration on 14Aug2021 at age of 58-year-old as single dose for covid-19 immunisation. The patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) on unknown date for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 14Aug2021 (the same day of the vaccination), the patient experienced death. The outcome of the event was fatal. Cause of death was not reported. It was not reported if an autopsy was performed. The reporting physician''s seriousness and causality assessment of the event was not reported. The lot number for BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death.


VAERS ID: 1593722 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8736 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Blood glucose abnormal, Blood pressure fluctuation, Blood pressure measurement, Body temperature, Chills, Fatigue, Heart rate, Oxygen saturation, Pyrexia, Respiratory arrest, Tremor, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   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: TRAZENTA; THYRADIN S; POLYFUL; CALCIUM LACTATE; CELECOXIB; REBAMIPIDE; FUROSEMIDE; AZILVA; AMLODIPINE BESILATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoporosis; Trochanteric femoral fracture (was admitted to the reporting hospital on 22Jun2021 for rehabilitation after surgery); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210813; Test Name: blood sugar; Result Unstructured Data: Test Result:245; Comments: at 22:30; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:101/56; Comments: at 08:00; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:75/50; Comments: at 20:00; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:85/66; Comments: at 21:20; Test Date: 20210813; Test Name: blood pressure; Result Unstructured Data: Test Result:131/70; Comments: at 22:30; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: at 15:00; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Comments: at 16:35; Test Date: 20210812; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: at 20:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: at 07:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: at 10:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 14:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Comments: at 20:00; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Comments: at 21:20; Test Date: 20210813; Test Name: body temperature; Result Unstructured Data: Test Result:37.8 Centigrade; Comments: at 22:30; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:120; Comments: at 20:00; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:67; Comments: at 22:30; Test Date: 20210813; Test Name: pulse rate; Result Unstructured Data: Test Result:40s; Comments: at 22:45; Test Date: 20210812; Test Name: SpO2; Test Result: 97 %; Comments: at 20:00; Test Date: 20210813; Test Name: SpO2; Test Result: 97 %; Comments: at 07:00; Test Date: 20210813; Test Name: SpO2; Test Result: 99 %; Comments: at 08:00; Test Date: 20210813; Test Name: SpO2; Test Result: 88 %; Comments: at 20:00; Test Date: 20210813; Test Name: SpO2; Result Unstructured Data: Test Result:88 to 94 %; Comments: at 21:20; Test Date: 20210813; Test Name: SpO2; Result Unstructured Data: Test Result:88 to 96 %; Comments: at 22:30
CDC Split Type: JPPFIZER INC202101058606

Write-up: Respiratory arrest; blood pressure was 101/56, 75/50, 85/66, 131/70; upper navel pain; Pyrexia of 39.4 degrees Celsius; Chills; Tremor; Fatigue; Vomiting; This is a spontaneous report from a contactable nurse received from the Regulatory Authority. The regulatory authority report number is v21123564. An 89-year and 1-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 12Aug2021 at 10:10 (the day of vaccination) (Lot number FC8736, Expiration date 30Sep2021) at the age of 89 years, as dose 1, single for COVID-19 immunization. The patient had medical histories of type 2 diabetes mellitus, osteoporosis, and hypertension. On 22Jun2021, the patient was admitted to the reporting hospital for rehabilitation after surgery for right trochanteric femoral fracture (at another hospital). The concomitant medications included oral linagliptin (TRAZENTA), oral levothyroxine sodium (THYRADIN-S), oral polycarbophil calcium (POLYFUL), oral calcium lactate, oral celecoxib, oral rebamipide, oral furosemide, oral azilsartan (AZILVA), and oral amlodipine besilate. Body temperature before vaccination was 36.3 degrees centigrade. On 12Aug2021 at 16:35 (6 hours and 25 minutes after the vaccination), the patient experienced pyrexia of 39.4 degrees Celsius, chills, fatigue, tremor, and vomiting. On 13Aug2021 at 07:00 (20 hours 50 minutes after the vaccination), the patient experienced upper navel pain. On 13Aug2021 at 22:47 (one day and 12 hours 37 minutes after the vaccination), the patient experienced respiratory arrest. On 13Aug2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 12Aug2021, 11:30, the patient took one pack of Mei Balance Mini as a side dish. At 15:00, the body temperature was 37.3 degrees Celsius, and the patient had no symptoms. At 16:35, the body temperature was 39.4 degrees Celsius, and the patient had chills, tremor, and fatigue, and she vomited a small amount of food component. The patient was instructed to orally take acetaminophen (CALONAL). The patient had vomiting again, and she was unable to orally take the drug. The patient did not eat dinner. At 20:00, the body temperature was 37.8 degrees Celsius, and the SpO2 was 97%, and no fatigue, queasy, or vomiting was noted. On 13Aug2021, at 07:00, the body temperature was 38.3 degrees Celsius, the SpO2 was 97%. No pulmonary sound was heard, no queasy was noted, and upper navel pain was noted. At 08:00, when the patient drunk a half bottle of milk for breakfast, she vomited a small amount. The blood pressure was 101/56, the SpO2 was 99%. At 10:00, the body temperature was 37.3 degrees Celsius. The patient took a pack of Mei Balance Mini and a pudding for lunch. At 11:30, administration of TRIFLUID 500 and metoclopramide hydrochloride was performed. At 14:00, the body temperature was 37.9 degrees Celsius, and no queasy was noted. Administration of SOLULACT 500 was performed. At 20:00, the body temperature was 38.9 degrees Celsius, the pulse rate was 120, the blood pressure was 75/50, and the SpO2 was 88%. The patient responded to being called. Pulmonary sound were observed and aspiration was performed. An oxygen 5 L was initiated with reservoir. At 21:20, the body temperature was 38.5 degrees Celsius, the SpO2 was 88-94%, the blood pressure was 85/66. The patient had nodding of head. Administration of meropenem hydrate (MEROPENEM) 0.5 g was performed. At 22:30, the body temperature was 37.8 degrees Celsius, the SpO2 was 88-96%, the blood pressure was 131/70, and the pulse rate was 67. The respiration was calm. The blood sugar was 245. At 22:45, the pulse rate was 40s on the monitor. At 22:47, the patient had respiratory arrest. Cardiac massage was performed, and administration of (illegible character), VEEN-D 500, an intravenous injection of etilefrine hydrochloride (EFFORTIL) 1/2 A, administration of physiological saline 100, and dopamine hydrochloride (INOVAN INJECTION) 1A were initiated. At 23:26, the patient was confirmed to die (at 23:20, the family members arrived). Outcome of respiratory arrest was fatal, of all other events was unknown. The reporting other healthcare professional (nurse) classified the event as serious (death) and assessed that the event was related to BNT162B2. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: respiratory arrest


VAERS ID: 1593723 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101070070

Write-up: This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 73-year-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 03Aug2021 (the day of vaccination), as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Aug2021, the patient died. The cause of death was not reported. It was unknown if an autopsy was performed. The inoculator (physician) requested the detail information to the patient family. Information regarding lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of unknown cause of death cannot be excluded.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1593809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, International normalised ratio increased, Rash macular
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101045730

Write-up: This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00661089. An 81-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 14Apr2021 as dose 2, single for COVID-19 immunization. Medical history included myocardial infarction from an unknown date. Concomitant medications include unspecified anticoagulants from 2015. The patient had no previous COVID-19 infection. The patient previously received the first dose of BNT162B2 (COMIRNATY), on 10Mar2021, for COVID-19 immunization and experienced INR increased. The patient experienced cerebral bleeding, blood values too high after first and second vaccination/INR increased, and little red dots on his skin on an unspecified date. The patient was hospitalized for the events. The patient died in the hospital on 02May2021. It was not reported if an autopsy was performed. Information on the batch/lot number has been requested.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty):yes. ADRs: Blood values at thrombosis clinic too high Date:10Mar2021 Diagnostic procedures:No, the sudden death from the brain haemorrhage has not been associated with the vaccination by the hospital.I did see that after the first injection my father''s blood values started to fluctuate and after the second he died.After his death I saw small red dots on his skin.; Reported Cause(s) of Death: INR increased; Little red dots on his skin; cerebral hemorrhage


VAERS ID: 1593811 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF0688 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chills, Fatigue, Gastrointestinal haemorrhage, Malaise, Mouth haemorrhage, Myalgia, Pulmonary haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (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), Gastrointestinal haemorrhage (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   Days after onset: 29
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADALAT; LORAZEPAM; VITAMIN D [COLECALCIFEROL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol abuse (no longer since Sep2020 after osmotic demyelination); Cardiac disorder; Hyponatraemia; Osmotic demyelination syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101054646

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00662069. A 46-year-old male patient received the second dose of bnt162b2 (COMIRNATY) on 21Jul2021 (lot number: FF0688) via unknown route of administration at single dose for COVID-19 immunisation. Medical histories included hyponatraemia; Osmotic demyelination syndrome; Alcohol abuse from unknown date to Sep2020 (no longer since Sep2020 after osmotic demyelination); Cardiac disorder. Concomitant medications included nifedipine (ADALAT); lorazepam; colecalciferol (VITAMIN D). Previous COVID-19 infection was reported as No. Patient received the first dose of bnt162b2 (COMIRNATY) on 16Jun2021 via unknown route of administration at single dose for covid-19 immunisation and experienced No adverse event. Patient experienced Myalgia, Not feeling well, Cold chills, Fatigue; both on 28Jul2021. See above, possible gastrointestinal/lung hemorrhage, although no blood seen in bed or on outside. DD cardiac arrest. Patient was found deceased 9 days on 30Jul2021 after 2nd vaccination, old blood in mouth, possible gastric bleeding. 2 days before death not well with earlier mentioned complaints, patient did not want to see a general practitioner despite family contacting the practice about this. Of course it cannot be determined that there is a relation with the (2nd) vaccination. Patient also used nifedipine, vitamin D and once daily Lorazepam. Patient had no cardiac history, but was familiar with rehabilitation after osmotic demyelination upon correction of hyponatremia. Could live independently again. In history alcohol abuse, but not since Sep2020 after osmotic demyelination. The outcome of events Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding/ possible gastrointestinal/lung hemorrhage; lung hemorrhage; cardiac arrest was fatal. The outcome of other events was unknown. At autopsy no striking findings, mortician found old blood in mouth. Differential diagnosis: gastric bleeding? Sender Comment: Although vaccination date was given as 28Jul all reactions were reported with latency times in days, that consistently pointed towards a vaccination date of 21Jul, therefore adapted. Reporter''s Comments Text: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding.; Reported Cause(s) of Death: Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding; lung hemorrhage; cardiac arrest; Patient was found deceased 9 days after 2nd vacc, old blood in mouth, possible gastric bleeding/ possible gastrointestinal.


VAERS ID: 1593812 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-07-15
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7082 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   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: LOSARTAN; ALLOPURINOL; DISTIGMINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101056223

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00664825. A 74-year-old male patient received second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on 23May2021 (Batch/Lot Number: FA7082) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient did not have COVID-19 infection previously. Concomitant medication included losartan; allopurinol and distigmine. The patient previously took first dose of BNT162B2 (COMIRNATY, strength: 0.3ml), via an unspecified route of administration on 18Apr2021 as single dose for covid-19 immunisation. On 15Jul2021, patient experienced sudden hard death: sudden death, without any reason/sudden cardiac death. The outcome of the event was fatal. The patient died on 15Jul2021. 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: sudden hard death: Sudden death, without any reason/Sudden cardiac death


VAERS ID: 1593832 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838682

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA, PH-PHFDA-300098943) concerned a 63 year old male with an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213C21A expiry: Unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021, the patient experienced cough, difficulty breathing, covid infection. On an unspecified date, the patient died due to cough, (difficulty breathing), and covid infection. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210838682-COVID-19 VACCINE AD26.COV2.S- cough, (dob) difficulty breathing, COVID infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; DOB; COVID INFECTION


VAERS ID: 1593837 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cough
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: Blood pressure; Result Unstructured Data: ELEVATED
CDC Split Type: PHJNJFOC20210838885

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099469] concerned a 71 year old male of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, and expiry: unknown) dose was not reported, with frequency time 1 total administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-JUL-2021, at 11:23 the patient experienced hypertension and cough. Laboratory data included: Blood pressure (NR: not provided) elevated. On an unspecified date, the patient died due to hypertension and cough. It was unknown, if an autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210838885-COVID-19 VACCINE AD26.COV2.S-Hypertension, Cough. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HYPERTENSION; COUGH.


VAERS ID: 1593840 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-14
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Death, Dyspnoea
SMQs:, Anaphylactic reaction (broad), Taste and smell disorders (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-18
   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: Diabetes mellitus; Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838972

Write-up: This spontaneous report received from a patient via a company representative concerned a 40 year old Asian male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension, and diabetes mellitus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 14-AUG-2021, the patient experienced loss of smell and taste. On 18-AUG-2021, the patient experienced sudden breathing difficulty, rushed to the hospital and died on arrival at hospital due to unknown cause. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sudden difficulty of breathing, loss of smell and loss of taste was not reported. This report was serious (Death).; Sender''s Comments: V0: 20210838972-Covid-19 vaccine ad26.cov2.s-Death . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1593842 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Cough, Dyspnoea, Fatigue, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839013

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098732] concerned a 74 year old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUL-2021 at 08:00, the patient experienced cough, fever, chest heaviness, easy fatigability, dyspnea and was hospitalized (date unspecified). On an unspecified date, the patient died from cough, fever, chest heaviness, easy fatigability, and dyspnea. It was unspecified whether the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839013-COVID-19 VACCINE AD26.COV2.S- cough, fever, chest heaviness, easy fatigability, dyspnea . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; FEVER; CHEST HEAVINESS; EASY FATIGABILITY; DYSPNEA.


VAERS ID: 1593843 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839052

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098559] concerned a 39 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-JUL-2021, the patient experienced dyspnea. On an unspecified date, the patient died from dyspnea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0- 20210839052-covid-19 vaccine ad26.cov2.s-Dyspnea. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DYSPNEA


VAERS ID: 1593850 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Autonomic neuropathy
SMQs:, Peripheral neuropathy (broad), Guillain-Barre 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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839363

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098833] concerned a 71 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) frequency 1 total , dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. Initially patient did not reported any symptoms after vaccination. On 04 -AUG-2021, the partner of the patient came home and saw patient was lying on the floor presenting symptoms similar to stroke. On an unspecified date, the patient died from cardiovascular disease (CVD). It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210839363- COVID-19 VACCINE AD26.COV2.S- CVD. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: CARDIOVASCULAR DISEASE (CVD).


VAERS ID: 1593851 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Electrocardiogram, 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? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210803; Test Name: ECG; Result Unstructured Data: flat line
CDC Split Type: PHJNJFOC20210839598

Write-up: This spontaneous report received from a consumer via a Regulatory Authority [PHIFDA, PH-PHFDA-30009850] concerned an 82 year old female of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total, administered on 27-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 27-JUL-2021, the patient experienced no symptoms or side effect. On 03-AUG-2021, Laboratory data included: ECG (NR: not provided) with result as flat line. On an unspecified date, the patient died from unconsciousness. It was unknown whether autopsy done or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210839598- COVID-19 VACCINE AD26.COV2.S- no symptoms or side effect. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNCONSCIOUS


VAERS ID: 1593855 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210840799

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300098262] concerned a 77 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, 1 total administered on 06-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 08-AUG-2021, the patient was dead on arrival. The patient died from an unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210840799-covid-19 vaccine ad26.cov2.s-dead on arrival. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH.


VAERS ID: 1593857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-07
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Back pain, Chest pain, Decreased appetite, Diarrhoea, Irritability, Limb discomfort, Vaccination site pain
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838411

Write-up: This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099516] concerned a 68 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, with frequency 1 total administered on 06-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced abdominal pain, diarrhea, injection site soreness, heaviness at the injection site, chest pain, irritable, back pain, decreased in appetite. On an unspecified date, the patient died from abdominal pain, diarrhea, injection site soreness, heaviness at the injection site, chest pain, irritable, back pain, and decreased in appetite. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210838411-COVID-19 VACCINE AD26.COV2.S -abdominal pain, diarrhea, injection site soreness, heaviness at the injection site, chest pain, irritable, back pain, decreased in appetite. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: ABDOMINAL PAIN; DIARRHOEA; INJECTION SITE SORENESS; HEAVINESS AT THE INJECTION SITE; CHEST PAIN; IRRITABLE; BACK PAIN; DECREASED IN APPETITE


VAERS ID: 1593867 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE6029 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC202101056255

Write-up: This is a spontaneous report from a contactable consumer (patient''s son) downloaded from the Regulatory Authority-WEB [PL-URPL-DML-MLP.4401.2.514.2021]. A 60-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 14Jul2021 (Lot Number: FE6029) (at the age of 60-year-old) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient weight: 75 kg and height: 168 cm and very good health. The patient experienced asystolia (24 hours after vaccination), heart attack (24 hours after vaccination), acute cardiopulmonary failure (24 hours after vaccination), acute circulatory and respiratory failure on 15Jul2021. Ambulance Service - CPR (cardiopulmonary resuscitation) - Asystolia. An autopsy was not performed. Additional information: No medications, no diseases of any kind, condition. The patient died on 15Jul2021. An autopsy was not performed. Sender Comment: Due to the close time relationship between the administration of the vaccine and the occurrence of side effects and the lack of known comorbidities, a causal relationship was assessed as possible. URPL, taking into account the death of the patient and the nature of the side effects, classified the report as severe. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: acute cardiopulmonary failure; Acute Circulatory and respiratory failure; Acute Circulatory and respiratory failure; Heart attack; Asystolia


VAERS ID: 1593901 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-07-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EC5435 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiorenal syndrome
SMQs:, Cardiac failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202101054754

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received INFARMED regulatory authority report number PT-INFARMED-T202107-4277 with Safety Report Unique Identifier PT-INFARMED-T202107-4277. An 85-year-old female patient received bnt162b2 (COMIRNATY) (strength: 30 mcg/0.3 ml), intramuscular on 23Jun2021 (Batch/Lot Number: EC5435) as dose number unknown, 0.3ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cardiorenal syndrome on 01Jul2021. The patient presented a picture of cardiorenal syndrome associated with the use of bnt162b2 mRNA vaccine against COVID-19 (with modified nucleoside), 30 mcg/0.3 ml, concentrate for injectable dispersion, (lot EC5435), it is not known whether first or second dose, for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus, with dosage of two single doses of 0.3 mL (each), IM. Information on clinical history is unknown. Previous infection with the SARS-CoV-2 virus is unknown. The adverse reaction appeared approximately 8 days after the administration of the vaccine (01Jul2021) (it is not known whether in the first or second dose). According to the notifier, the reaction evolved to the patient''s death. Other information about patient admission, medical intervention/care, targeted treatment, or cause of death is unknown. The measure taken regarding suspension or compliance with the vaccination schedule is unknown. There is no suspicion of drug interactions. Information on previous reactions to other drugs or identified allergies is unknown. The need for specific treatment of the reaction is unknown. Additional data: No information on the cause of death was reported, or an autopsy report was made available. The patient died on 13Jul2021 (12 days after the reaction was identified). The type of relationship established by the notifier between the reported Cardiorenal syndrome reaction and the patient''s death is unknown. However, due to important information gaps, a request for clarification was made, with no response until the case was finalized. Evolution of ADR was death. The patient died on 13Jul2021. It was not reported if an autopsy was performed. The reporters assessment of the causal relationship of the [Cardiorenal syndrome] with the suspect product was [, Method of assessment: unknown, Result of Assessment: probable]. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiorenal syndrome.


VAERS ID: 1593902 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EC5435 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive lung disease
Allergies:
Diagnostic Lab Data: Test Date: 20210717; Test Name: CI; Result Unstructured Data: Test Result:Unknown results; Test Date: 20210717; Test Name: SARS-CoV2 PCR; Test Result: Positive
CDC Split Type: PTPFIZER INC202101054750

Write-up: This is a spontaneous report from a contactable health care professional (nurse) downloaded from the Regulatory Authority -WEB. This is a report received from INFARMED Regulatory authority report number PT-INFARMED-T202107-4395. An 83-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml), intramuscular on 22Apr2021 (Batch/Lot Number: ET6956) as dose number unknown (it is unknown whether the first or second dose), 0.3 ml, single, and intramuscular from unspecified date at as dose number unknown (it is unknown whether the first or second dose), 0.3 ml, single (Batch/Lot Number: EC5435) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. Spontaneous notification refers to a case sent by a nurse about an elderly, male, 83 years old, who presents a picture of probable vaccine failure associated with the use of Comirnaty/mRNA vaccine against a COVID-19 (with nucleoside modified), 30 mcg / 0.3 ml, Concentrate for Injectable Dispersion, (lot EC5435), it is unknown whether the first or second dose, for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus, with the dosage of two single doses of 0.3 mL (each), IM. Clinical Background: Chronic Obstructive Pulmonary Disease. Previous infection with the SARS-CoV-2 virus is unknown. Vaccine failure was identified approximately 3 months after vaccine inoculation. According to the notifier, the virus infection led to hospitalization, and the patient died following hospitalization. There is no suspicion of drug interactions. Information on previous reactions to other drugs or identified allergies is unknown. The need for specific treatment of the violation by SARS-CoV-2 is unknown. Additional data: a test for the Detection of Nucleic Acids (amplification by PCR) of SARS-CoV2 was performed in a biological sample, with a positive result on 17Jul2021. The risky contact that could have been at the origin of this contagion is unknown. There was no information on the cause of death, or an autopsy report made available. The following information was corrected: patient had COPD (Chronic Obstructive Pulmonary Disease), HF (Unknown meaning), worsening of usual dyspnea within 1 week of evolution, was admitted to the ER (emergency room) due to altered conscious status and prostration. The patient died in the hospital on 17Jul2021 (at dawn). As information gaps became important, a request for clarification was made, with no response until the case was finalized. Evolution of RAM: death on 17Jul2021. Outcome of COPD and HF was unknown. It was unknown if an autopsy was performed. Reporter comment: Other information-day 17Jul2021- records in Trace, "CLHO": COPD, CI, worsening of usual dyspnea with 1 week of evolution, 17Jul2021 was admitted today due to altered state of consciousness and prostration (from the last 3 days). died at dawn on 17Jul2021, The reporter assessment of the causal relationship of the vaccination failure and SARS-CoV-2 test positive with the suspect product was: Relatedness of drug to reaction(s)/event(s):Vaccination faiure (death) and SARS-CoV-2 test positive Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. No follow-up attempts are possible. No further information expected.; Reporter''s Comments: Other information-day 17Jul2021- records in Trace, CLHO : COPD, CI, worsening of usual dyspnea with 1 week of evolution, 17Jul2021 was admitted today to the SU HSFX due to altered state of consciousness and prostration (from the last 3 days). died at dawn on 17Jul2021; Reported Cause(s) of Death: SARS-CoV-2 test positive; vaccine failure probable.


VAERS ID: 1593921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute leukaemia, Death
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101037724

Write-up: This is a spontaneous report from a contactable physician received via a sales representative. A 65-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date in Jan2021 (batch/lot number was not reported) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After 5 days the patient was diagnosed with acute leukemia on an unspecified date in 2021. The patient''s medical history was not known if he had previous pathologies. The patient died on an unspecified date in 2021. The cause of death was unknown. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: The association between the event death and acute leukemia can not be fully excluded based on the temporal relationship and limited 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: unknown cause of death.


VAERS ID: 1593922 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute leukaemia, Death
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC202101037726

Write-up: died; acute leukemia; This is a spontaneous report from a contactable physician via a sales representative. A 70-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Jun2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration in Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included arterial hypertension. The patient''s concomitant medications were not reported. The patient had symptoms that required medical consult. He was diagnosed with acute leukemia. The relatives went to PRIVACY country with the patient for treatment. The outcome of acute leukemia was unknown. The patient died one month after vaccination. The patient died on an unspecified date. It was not reported if an autopsy was performed. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events of acute leukaemia and death cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: died


VAERS ID: 1593965 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-02
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW5279 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Drug-induced liver injury, Encephalitis, Hepatic failure, Liver function test
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Noninfectious encephalitis (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: 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: Malignant neoplasm of choroid; Metastases to kidney (choroidal malignant melanoma); Metastases to lung (choroidal malignant melanoma)
Preexisting Conditions: Medical History/Concurrent Conditions: Myocardial infarct
Allergies:
Diagnostic Lab Data: Test Date: 20210502; Test Name: Pathological liver tests; Result Unstructured Data: Test Result:drug-induced hepatitis; Comments: Assessed after investigation as drug-induced (ipilimumab/nivolumab) encephalitis and hepatitis.
CDC Split Type: SEPFIZER INC202101026740

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-067288. A 68-year-old male patient received a unknown dose number of bnt162b2 (COMIRNATY) via an unspecified route of administration on 28Apr2021 (Lot Number: EW5279) as single dose for covid-19 immunisation; nivolumab and ipilimumab both via intravenous from 01Apr2021 (Lot Number: unknown) to an unspecified date at an unknown dose and frequency for malignant melanoma. Medical history included myocardial infarction from 2014 and was not ongoing; he was diagnosed with choroidal malignant melanoma in the summer of 2019 (ongoing) and metastases to lung and kidney from Feb2021 and ongoing. The patient''s concomitant medications were not reported. The patient experienced drug-induced hepatitis and drug-induced encephalitis on 02May2021, and experienced liver failure in 2021. The action taken in response to the events for bnt162b2 was not applicable, for nivolumab and ipilimumab was unknown. Therapeutic measures were taken as a result of events drug-induced hepatitis and drug-induced encephalitis. The patient died from drug-induced hepatitis and drug-induced encephalitis and liver failure on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as follows: The patient was diagnosed with choroidal malignant melanoma in the summer of 2019. In February 2021, micro-metastases were found in a kidney and lungs. WHO.0. Tumor-inhibiting therapy with ipilimumab plus nivolumab was initiated. The first treatment was given in early April and the second three weeks later. Received Covid-19 vaccine six days after that. Admitted acutely to medical clinic four days after vaccination (on 02May2021) with headache, cognitive impairment and fever. Pathological liver tests. Assessed after investigation as drug-induced (ipilimumab/nivolumab) encephalitis and hepatitis. Encephalitis symptoms resolved on high-dose cortisone but liver function never recovered despite maximal braking therapy. Died in picture as liver failure about two months after hospitalization. Cared for last two weeks at home with support of home health care. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Liver failure; drug-induced hepatitis; drug-induced encephalitis.


VAERS ID: 1593996 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Hypopituitarism, Investigation, Magnetic resonance imaging, Magnetic resonance imaging head, Malignant hypertension, Metastases to pituitary gland, Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EPIRUBICIN; VINORELBINE; CAPECITABINE; CYKLOFOSFAMID; DOXORUBICIN; PACLITAXEL; ERIBULIN
Current Illness: Metastatic breast cancer (bilateral triple negative lobular type breast cancer)
Preexisting Conditions: Medical History/Concurrent Conditions: Bone metastases (skeletal metastasis); Gamma radiation therapy to breast (gamma knife treatment); Radiation therapy (radiation-treated against C1 and the pelvis in May 2020 and rib-irradiated in June 2021)
Allergies:
Diagnostic Lab Data: Test Name: MRI brain; Result Unstructured Data: Test Result:showed new metastasis in the hypothalamus; Comments: showed new metastasis in the hypothalamus with growth towards the pituitary gland.; Test Name: samples taken; Result Unstructured Data: Test Result:showed pituitary failure; Comments: showed pituitary failure and the woman received SoluCortef.; Test Name: MRI back; Result Unstructured Data: Test Result:no medullary process; Comments: showed no medullary process according to the attached medical record.
CDC Split Type: SEPFIZER INC202101055207

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-070404. A 50-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), via unspecified route of administration in Jun2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. The medical history included ongoing widespread metastatic breast cancer (bilateral triple negative lobular type breast cancer), Bone metastases (skeletal metastasis), gamma knife treatment in 2018, radiation treatment for c1, pelvis and ribs (radiation-treated against C1 and the pelvis in May2020 and rib-irradiated in Jun2021). The patient''s concomitant medications included cyclophosphamide (CYKLOFOSFAMID), epirubicin, capecitabine, doxorubicin, paclitaxel, vinorelbine, eribulin. The patient experienced progression of paralysis symptoms, pituitary insufficiency in Jun2021. The clinical course was reported as: The patient developed weakness and loss of sensation in her right arm already 6 days before the vaccination and MRI full back taken 2 days later at a doctor''s appointment showed no medullary process according to the attached medical record. It also appears in the medical record that the patient 8 days before the vaccination had started radiation treatment for cervical spine C1. About two days after the vaccination, the patient''s condition worsened with progressive neurological loss and according to the doctor, the patient could barely stand on her feet, had poor coordination, dizziness, nausea, had eye motor disorders and double vision. Examination with MRI brain showed new metastasis in the hypothalamus with growth towards the pituitary gland. Severe hypertension was also observed which was judged to be malignant hypertension where acute hypertension treatment was initiated, and samples taken showed pituitary failure and the patient received hydrocortisone sodium succinate (SOLUCORTEF). However, her condition gradually worsened with increasing awareness, and she switched to symptom treatment instead. The patient died about 16 days after the vaccination in Jun2021. The outcome of the events progression of paralysis symptoms, pituitary insufficiency and metastasis in the hypothalamus with growth towards the pituitary gland was fatal. The outcome of the other events was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: new metastasis in the hypothalamus with growth towards the pituitary gland; Cancer; Pituitary insufficiency; Progression of Paralysis symptoms


VAERS ID: 1594044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-15
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TRPFIZER INC202101055818

Write-up: My brother died of a heart attack on July 15,2021 after receiving his first dose of Biontech vaccine on June 21,2021; This is a spontaneous report based on information received by Pfizer from LLP Biontech 80109, license party for BNT 162B2. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Jun021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient died of a heart attack on July 15,2021 after receiving his first dose of Biontech vaccine on June 21,2021. The outcome of the event was fatal. The lot number for [bnt162b2 ], was not provided and will be requested during follow up; Reported Cause(s) of Death: My brother died of a heart attack on July 15,2021 after receiving his first dose of Biontech vaccine on June 21,2021


VAERS ID: 1617474 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213021A / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Dysphagia, Dysstasia, Eating disorder, Gait disturbance, Lymphocyte count, Monocyte count, Neutrophil count, Platelet count normal, Pyrexia, Syncope, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Aspirin Atorvastatim Amlodiphine Vitamin B complex
Current Illness: High blood pressure
Preexisting Conditions: Stroke patient
Allergies: None
Diagnostic Lab Data: Blood Chem Hemotocrit ~ 34.3 Hemoglobin ~ 11.4 Wbc ~ 6.2 Segmenters ~ 61 Lymphicyte ~ 38 Monocyte ~ 1 Platelet ~ 128
CDC Split Type:

Write-up: July 28 to Aug. 6 2021 Lbm ~ july 29 ~ Aug. 1/loperamide Difficulty swallowing ~ july 28 Difficuly eating ~ july 30 Difficulty standing and walking alone ~ july 28 onwards On and off high fever ~ july 27/7:00pm onwards Collapse while sitting ~ july 29 and 31


VAERS ID: 1620326 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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: 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: Cardiovascular disease, unspecified
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATJNJFOC20210836511

Write-up: This spontaneous report received from a patient via a company representative concerned a 36 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: cardiovascular illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced cerebral hemorrhage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0;20210836511 -COVID-19 VACCINE AD26.COV2.S-Cerebral haemorrhage. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1620331 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Decreased appetite, Dyspnoea, Nausea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: PHJNJFOC20210838808

Write-up: FEVER; LOSS OF APPETITE; LOSS OF TASTE; DIFFICULTY OF BREATHING; NAUSEA; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300099633] concerned a 73 year old female of unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A, expiry: unknown) dose was not reported,1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021 at 16:00, the patient experienced fever, loss of appetite, loss of taste, difficulty of breathing and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from fever, loss of appetite, loss of taste, difficulty of breathing and nausea on an unspecified date. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210838808-COVID-19 VACCINE AD26.COV2.S-Fever,Loss of appetite,Loss of taste,Difficulty breathing,Nausea. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; LOSS OF APPETITE; LOSS OF TASTE; DIFFICULTY OF BREATHING; NAUSEA


VAERS ID: 1622911 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-07-24
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This case was received via Regulatory Authority (Reference number: BX20217173) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death NOS) in an 84-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002616) for COVID-19 vaccination. No Medical History information was reported. On 18-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. Death occurred on 24-Jul-2021 The patient died on 24-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided by reporter. No treatment information was provided. Company Comment: Very limited information regarding this event has been provided at this time. However, patient''s advanced age remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. However, patient''s advanced age remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1622994 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Fatigue, Headache, Hyperpyrexia, Injection site haematoma, Injection site inflammation, Injection site pain, Injection site warmth, Malaise, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: hyperpyrexia; Result Unstructured Data
CDC Split Type: NLMODERNATX, INC.MOD20212

Write-up: This case was received via Regulatory Authority (Reference number: NL-LRB-00658719) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This Regulatory Authority case was reported by a consumer and describes the occurrence of DEATH, FATIGUE, CHILLS, HEADACHE, INJECTION SITE HAEMATOMA, MALAISE, HYPERPYREXIA, INJECTION SITE PAIN, INJECTION SITE INFLAMMATION, MYALGIA, ARTHRALGIA, INJECTION SITE WARMTH and NAUSEA in a 50-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 11-May-2021, the patient experienced FATIGUE, CHILLS, HEADACHE, INJECTION SITE HAEMATOMA, MALAISE, HYPERPYREXIA ), INJECTION SITE PAIN, INJECTION SITE INFLAMMATION, MYALGIA, ARTHRALGIA, INJECTION SITE WARMT and NAUSEA. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hyperpyrexia: high (High): 40.5, 42 degrees Celsius. Treatment information not provided. Concomitant medication not provided. This case refers to a 50-year-old female patient who died 16 days after receiving the dose 2 of the product mRNA-1273. Cause of death not reported. Very limited information regarding the event of death has been provided at this time insufficient for causality assessment. Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the remaining events, a causal relationship cannot be excluded.; Sender''s Comments: This case refers to a 50-year-old female patient who died 16 days after receiving the dose 2 of the product mRNA-1273. Cause of death not reported. Very limited information regarding the event of death has been provided at this time insufficient for causality assessment. Based on the current available information and temporal association between the use of the product mRNA-1273 and the start date of the remaining events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: (Body did not make antibodies against the corona virus (that is what the hospital claims)


VAERS ID: 1622999 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839035

Write-up: DEATH; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099533] concerned an 81-year-old female patient of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 24-JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 10-AUG-2021, the patient eventually died due to unknown cause. It was not reported if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause of death on 10-AUG-2021. This report was serious (Death).; Sender''s Comments: V0:20210839035- Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1623000 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-02
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Headache, Nausea, Syncope, Vaccination site pain, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839048

Write-up: FAINTING; HEADACHE; NAUSEA AND AMP; VOMITING; REDNESS; LOCAL SITE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300099287] concerned a 30 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 31-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-AUG-2021; 20:00, the patient experienced local site pain. On 03-AUG-2021; 20:00, the patient experienced redness. On 04-AUG-2021; 20:00, the patient experienced nausea and amp. On 04-AUG-2021; 20:00, the patient experienced vomiting. On an unspecified date, the patient experienced headache, and fainting. On an unspecified date, the patient died from local site pain, redness, nausea and amp, vomiting, headache, and fainting. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210839048-covid-19 vaccine ad26.cov2.s-Fainting, local site pain, redness, nausea and amp, vomiting, headache. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: LOCAL SITE PAIN; REDNESS; NAUSEA AND AMP; VOMITING; HEADACHE; FAINTING


VAERS ID: 1623001 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, 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: 2021-08-01
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839072

Write-up: Fever; Chills; Fatigue; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300098515] concerned a 77 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 213C21A expiry: UNKNOWN) dose was not reported, administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021, after vaccination at 8:00pm, the patient experienced mild fever and headache. On 27-JUL-2021, the patient also experienced chills and fatigue. On 29-JUL-2021, the patient experienced events of vomiting, diarrhea and nausea. On 01-AUG-2021, The patient daughter consulted in a private doctor via telephone and got all prescription. On 02-Aug-2021, the patient was stable but still have body weakness. On 03-AUG-2021, the patient was stable until the patient experienced hiccups on and off that last the whole night so the patient''s daughter called their private doctor and advised them to bring the patient to the nearest hospital, they went to 4 hospitals but not admitted because of full capacity, so they decided to bring the patient in their home until the patient died. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date of AUG-2021, the patient died from fever, chills and fatigue. It was unspecified if an autopsy was performed. This report was serious (Death).; Sender''s Comments: 20210839072- covid-19 vaccine ad26.cov2.s -Fever, chills & fatigue. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; CHILLS; FATIGUE


VAERS ID: 1623002 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Malaise, Toothache
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-10
   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: IVERMECTIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839109

Write-up: body malaise; loss of appetite; tooth ache; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099150] concerned a 72 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212C21A) dose was not reported, 1 total, administered on 29-JUL-2021 for prophylactic vaccination. Concomitant medications included ivermectin. The patient had no other complains except tolerable injection site pain after vaccination. On 03-AUG-2021, the patient experienced body malaise, loss of appetite and tooth ache. The caregiver tele-consulted the hospital for complains of toothache. On 04-AUG-2021, the patient complained of body malaise and loss of appetite, did not report to hospital. On 07-AUG-2021, the patient complained of abdominal pain. Ivermectin capsule given without prescription. The medicine acquired from relative. On 08-AUG-2021, the ivermectin given twice a day without prescription. On 09-AUG-2021, ivermectin given twice a day without prescription. The dark spots noted at the lower extremities. On 10-AUG-2021, around 01:00 AM, ivermectin given and unknown tablet given according to caregiver. At 08:35 AM, patient died at home. On 10-AUG-2021 08:35, the patient died from body malaise, and loss of appetite. It was not specified if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tooth ache was not reported. This report was serious (Death).; Sender''s Comments: V0; 20210839109 -covid-19 vaccine ad26.cov2. s - Body malaise, and Loss of appetite -. This events are considered unassessable. The events have a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: BODY MALAISE; LOSS OF APPETITE


VAERS ID: 1623003 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839148

Write-up: VOMITING; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300098973] concerned a 64 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021; 16:00, the patient experienced vomiting and was hospitalized (date unspecified). On an unspecified date, the patient died from vomiting. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839148-COVID-19 VACCINE AD26.COV2.S-Vomiting. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: VOMITING


VAERS ID: 1623004 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Nasopharyngitis, Pyrexia
SMQs:, Anaphylactic reaction (broad), 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: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839388

Write-up: COUGH; FEVER; COLDS; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300099020] concerned an 81 year old female of unspecified race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-AUG-2021, 07:00, the patient experienced cough, fever and colds. On an unspecified date in Aug-2021, the patient died from cough, fever, and colds. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0-20210839388-Covid-19 vaccine ad26.cov2.s-Cough, fever, and colds. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: COUGH; FEVER; COLDS


VAERS ID: 1623005 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-08
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839494

Write-up: LOSS OF CONSCIOUSNESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300099103] concerned a 40 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, at 01:00, the patient experienced loss of consciousness. On an unspecified date in AUG-2021, the patient died from loss of consciousness. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210839494 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- loss of consciousness (fatal outcome)-This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: LOSS OF CONSCIOUSNESS


VAERS ID: 1623023 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-05-02
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001938 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROMODERNATX, INC.MOD20212

Write-up: Myocardial infarction; This case was received via Regulatory Authority (Reference number: SPCOV12123) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) in a 44-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3001938) for Active immunisation. Concurrent medical conditions included Arterial hypertension. On 16-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-May-2021, after starting mRNA-1273 (Spikevax), the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria death and medically significant). The patient died on 09-May-2021. The reported cause of death was Myocardial infarction. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. Treatment information was not provided. The medical assessor of the Competent Authority requested the investigation of the case at National Centre for Communicable Diseases Surveillance and Control (CNSCBT), to no result yet. Company comment Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient''s underlying medical condition of arterial hypertension remains a contributory factor. Further information can''t be requested.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient''s underlying medical condition of arterial hypertension remains a contributory factor. Further information can''t be requested.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1623225 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: COJNJFOC20210840783

Write-up: DIED DUE TO COVID; LACK OF EFFICACY; SKIN STAINS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) 1 total dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patient died on an unspecified date due to covid, after having some skin stains because of the vaccine. The patient experienced the lack of efficacy. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the skin stains and lack of efficacy was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0:20210840783-covid-19 vaccine ad26.cov2.s-Died due to covid, Lack of efficacy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DIED DUE TO COVID


VAERS ID: 1624364 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for Prophylactic vaccination. The patient''s past medical history included Anorexia. On 28-Apr-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on 28-Apr-2021 The patient died on 28-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication not reported. Treatment medication not reported. Company comment: Based on the current available information and temporal association between the use of the product and the reported death of the patient, a causal relationship cannot be excluded. Event term, onset date and outcome captured per RA Authority reporting. Events seriousness per assessment by Authority and per IME list. Cause of death not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the reported death of the patient, a causal relationship cannot be excluded. Event term, onset date and outcome captured per RA Authority reporting. Events seriousness per assessment by Authority and per IME list. Cause of death not provided; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1624875 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-07-01
   Days after vaccination:122
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Emphysema pulmonary; Hypertension arterial; Liver cirrhosis
Preexisting Conditions: Medical History/Concurrent Conditions: Kidney failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: COVID-19 respiratory infection; Vaccination failure; This case was received via Regulatory Authority (Reference number: PA20211318) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (COVID-19 respiratory infection) and VACCINATION FAILURE (Vaccination failure) in a 77-year-old male patient who received mRNA-1273 (Spikevax) for Prophylaxis. The patient''s past medical history included Kidney failure. Concurrent medical conditions included Hypertension arterial, Emphysema pulmonary, Liver cirrhosis and Diabetes mellitus. In March 2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In July 2021, the patient experienced COVID-19 (COVID-19 respiratory infection) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion life threatening). The patient died on an unknown date. The reported cause of death was COVID-19 respiratory infection. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) had not resolved. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Very limited information regarding this event/s has been provided at this time. Further information has been requested. The causality for the event Covid-19 will be considered as "Not Applicable".; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. The causality for the event Covid-19 will be considered as "Not Applicable".; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1624882 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214010 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   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: Hypertension; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Arrest cardiac; This case was received via Regulatory Authority (Reference number: PB20215062) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Arrest cardiac) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214010) for COVID-19 vaccination. The patient''s past medical history included Hypertension and Obesity. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced CARDIAC ARREST (Arrest cardiac) (seriousness criteria death and medically significant). The patient died on 30-Jul-2021. The reported cause of death was Arrest cardiac. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported . Treatment information was not provided. Company comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Sender''s Comments: Very limited information regarding this event has been provided at this time. No further follow up information is expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1625406 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-23
Onset:2021-06-15
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction, SARS-CoV-2 test
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Suspected COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210615; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Heart attack; This case was received via Regulatory Authority (Reference number: GB-MHRA-ADR 25801136) on 15-Aug-2021 and was forwarded to Moderna on 15-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Suspected COVID-19 since 07-Jun-2021. On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died on 27-Jun-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. Concomitant product use was not provided by the reporter. Patient had blood clot caused heart attack. Patient is not enrolled in clinical trial. No treatment information was provided. This is a case of myocardial infarction with fatal outcome in a 37-year-old male who died 24 days after receiving one dose of vaccine. Very limited information regarding this event has been provided. No further information is expected at this time.; Sender''s Comments: This is a case of myocardial infarction with fatal outcome in a 37-year-old male who died 24 days after receiving one dose of vaccine. Very limited information regarding this event has been provided. No further information is expected at this time.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1625500 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dementia, Paranoia
SMQs:, Dementia (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (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: ELIQUIS
Current Illness: Unspecified paranoid state
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101027714

Write-up: suddenly aggravated paranoia; sudden appearance of symptoms of early dementia; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number HU-OGYI-672321. A 88-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW4815), dose 1 intramuscular, administered in Arm Left on 22Apr2021as Dose 1,0.3 mL single for covid-19 immunisation. Medical history included ongoing paranoia. Concomitant medications included apixaban (ELIQUIS) taken for deep vein thrombosis from 2017 to an unspecified stop date.The patient experienced suddenly aggravated paranoia, sudden appearance of symptoms of early dementia on 23Apr2021.The events were assessed as serious. The outcome of events was not recovered on unknown date. Sender''s comments: Dementia and aggravation of paranoia are neither listed nor expected after Comirnaty vaccination. TTO was 1 day. The causal relationship between the reported death and Comirnaty is unassessable. The case is serious due to medically important events. No follow-up attempts possible. No further information expected.


VAERS ID: 1625501 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002188 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Computerised tomogram head, Delirium tremens
SMQs:, Noninfectious encephalopathy/delirium (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol withdrawal syndrome; Alcoholic cardiomyopathy; Carotid artery stenosis; Cerebral atherosclerosis; Spondylosis; Syncope
Allergies:
Diagnostic Lab Data: Test Date: 20210602; Test Name: Brain CT; Result Unstructured Data: known carotid artery stenosis
CDC Split Type: HUMODERNATX, INC.MOD20212

Write-up: Delirium tremens; This case was received via Regulatory Authority (Reference number: 673521) on 13-Aug-2021 and was forwarded to Moderna on 13-Aug-2021. This regulatory authority case was reported by a physician and describes the occurrence of DELIRIUM TREMENS (Delirium tremens) in a 68-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002188) for COVID-19 vaccination. The patient''s past medical history included Spondylosis, Alcoholic cardiomyopathy, Syncope, Carotid artery stenosis, Alcohol withdrawal syndrome and Cerebral atherosclerosis. Concurrent medical conditions included Hypertension. On 01-Jun-2021, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 02-Jun-2021, after starting mRNA-1273 (Spikevax), the patient experienced DELIRIUM TREMENS (Delirium tremens) (seriousness criteria death, hospitalization and medically significant). The patient died on 10-Jun-2021. The reported cause of death was Delirium tremens. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2021, Computerised tomogram head: abnormal (abnormal) known carotid artery stenosis. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered DELIRIUM TREMENS (Delirium tremens) to be not related. There was no concomitant medication reported. There was no treatment medication reported. Company Comment : This is a case of death in a 68-year-old male subject, with a history of Alcoholic cardiomyopathy, Carotid artery stenosis, Cerebral atherosclerosis and Hypertension who died 9 days after receiving first dose of vaccine due to delirium tremens. Based on reporter''s causality, the event is assessed as unlikely related to mRNA-1273.; Reporter''s Comments: The patient died 9 days after vaccination with COVID-19 Vaccine Moderna due to delirium tremens. The event and the vaccine is considered not related. The case is serious due to hospitalization and fatal outcome.; Sender''s Comments: This is a case of death in a 68-year-old male subject, with a history of Alcoholic cardiomyopathy, Carotid artery stenosis, Cerebral atherosclerosis and Hypertension who died 9 days after receiving first dose of vaccine due to delirium tremens. Based on reporter''s causality, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Delirium tremens


VAERS ID: 1625720 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal death, Foetal heart rate abnormal, Maternal exposure before pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101060370

Write-up: Missed miscarriage discovered on 03Aug. At 8 weeks the heart stopped beating while I was 12 weeks pregnant. The exorcism has yet to take place.; Vaccination 3 months before pregnancy; fetal demise; This is a spontaneous report from a contactable consumer reported different events for different patients. This is second of two reports. This is the child case. The first report was downloaded from the Regulatory Authority-WEB [NL-LRB-00651922]. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via transplacental from a mother who received the dose 2 on 14Feb2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Patient''s mother previously took dose 1 on 24Jan2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fetal demise on an unspecified date, missed miscarriage discovered on 03aug2021 at 8 weeks the heart stopped beating while patient''s mother was 12 weeks pregnant and "the exorcism has yet to take place", vaccination 3 months before pregnancy. The patient died on an unspecified date. It was not reported if an autopsy was performed.Course of events: The patient''s mother missed abortion was discovered at a pregnancy duration of about 12 weeks. The fetal demise occurred at a pregnancy duration of about 8 weeks. Both Covid vaccinations took place a few months before pregnancy. It was found out that patient''s mother had a "missed miscarriage". At 8 weeks the heart stopped beating while patient''s mother was 12 weeks pregnant. The exorcism has yet to take place. Between 8 and 12 weeks. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101017609 mother/child case.; Reported Cause(s) of Death: Fetal heartbeat absent; fetal demise


VAERS ID: 1625759 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-30
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838944

Write-up: MUSCLE PAIN; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300099916] concerned a 72 year old male of unspecified race and ethnicity.. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total, administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, he experienced fever a day after immunization, body weakness and muscle pain at lower extremities, loss of consciousness, hypotension, coma. On 30-JUL-2021, the patient experienced muscle pain (in lower extremities) and on an unspecified date the patient died of it. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210838944 -covid-19 vaccine ad26.cov2.s- muscle pain. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: MUSCLE PAIN


VAERS ID: 1625760 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210838968

Write-up: LOSS OF CONSCIOUSNESS; This spontaneous report received from a health care professional via a Regulatory Authority (PHFDA-300098549) concerned a 20 year old male of an unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 205C21A, expiry: unknown) dose was not reported, with frequency time 1 total administered on 04-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-AUG-2021 at 08:00, the patient died from loss of consciousness was reported. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210838968 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- loss of consciousness (fatal outcome)-This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: LOSS OF CONSCIOUSNESS


VAERS ID: 1625764 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

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: 2021-08-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210809; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive
CDC Split Type: PHJNJFOC20210839223

Write-up: SUSPECTED SERIOUS AEFI; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300099152] concerned a 67 year old female of unspecified race and ethnic origin. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, and expiry: unknown) dose was not reported, 1 total administered on 27-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-AUG-2021 (Thursday) patient coordinate for ambulance assistance. She was admitted in hospital for Suspected Serious AEFI (adverse event following immunization). On 09-AUG-2021(Monday) her RT PCR (polymerase chain reaction) result received which was positive. On 12-AUG-2021 (Thursday) one of Regulatory Authority said that vaccine died (cause of death unknown). It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of unknown cause of death (Suspected Serious adverse event following immunization) on AUG-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210839223-Covid-19 vaccine ad26.cov2.s-Suspected Serious AEFI. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1625766 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-27
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 213C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Diarrhoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: PHJNJFOC20210839234

Write-up: FEVER; COUGH; DIARRHEA; This spontaneous report received from a health care professional via a Regulatory Authority (PHFDA-300098570)concerned a 70 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2. s (suspension for injection, intramuscular, batch number: 213C21A and expiry: unknown) dose was not reported, 1 total administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-JUL-2021 at 06:30, the patient died from fever, cough, colds and diarrhea were reported. It was unknown, if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2. s was not applicable. The patient died of fever, cough and diarrhea on 27-JUL-2021. This report was serious (Death).; Sender''s Comments: V0: 20210839234-Covid-19 vaccine ad26.cov2.s- Fever, Cough, Diarrhea . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: FEVER; COUGH; DIARRHEA


VAERS ID: 1625770 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-03
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 213C21A / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210839328

Write-up: NAUSEA; VOMITING; COUGH; DYSPNEA; BODY MALAISE; This spontaneous report received from a health care professional via a Regulatory Authority [PHFDA-300098970] concerned a 73 year old male. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213C21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 28-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-AUG-2021 10:00, the patient experienced nausea, vomiting, cough, dyspnea, and body malaise. The patient was hospitalized (date and duration unspecified). On AUG-2021, the patient died from nausea, vomiting, cough, dyspnea, and body malaise. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Hospitalization Caused / Prolonged, and Life Threatening).; Sender''s Comments: V0:20210839328- covid-19 vaccine ad26.cov2.s - nausea, vomiting, cough, dyspnea,body malaiseThis event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: NAUSEA; VOMITING; COUGH; DYSPNEA; BODY MALAISE


VAERS ID: 1625810 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anencephaly, Congenital central nervous system anomaly, Maternal exposure during pregnancy
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? Yes
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: FOLIC ACID; FERROUS SULFATE; CLOMID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SAPFIZER INC202101063129

Write-up: Anencephaly; Exencephaly; Maternal exposure during pregnancy; This is a spontaneous report from a contactable pharmacist. This pharmacist reported events for both the mother and baby. This is the report for the baby. A fetus patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 transplacental on 30Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation; clomifene citrate (CLOMID), transplacental from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for polycystic ovaries (PCOs). The patient medical history was not reported. Concomitant medications included folic acid and ferrous sulfate taken for an unspecified indication, start and stop date were not reported. The patient experienced maternal exposure during pregnancy on 30Apr2021, anencephaly and exencephaly (reported as Exanencephaly) on 29Jul2021. The mother''s ultrasound report showed Single viable fetus. FL: 11 mm = 13+4 weeks. Absent fetal cranium with hernation of brain tissue; IMP: Anencephaly and Exanencephaly. Therefore, she was admitted for pregnancy termination. This ADR may be related to the Clomid or the COVID19 vaccine. Therapeutic measures were taken as a result of anencephaly and exencephaly which included pregnancy termination. The action taken in response to the events for clomifene citrate was unknown. The events were considered to cause congenital anomaly and the patient died on an unspecified date. The outcome of the events was fatal. The lot number for bnt162b2, was not provided and will be requested during follow up; Sender''s Comments: The events anencephaly and congenital central nervous system anomaly are more likely related to the use of clomifene citrate, and are considered unrelated to the suspect drug. This case will be reassessed upon receipt of additional information.,Linked Report(s) : SA-PFIZER INC-202101048808 Mother case; Reported Cause(s) of Death: Anencephaly; Exanencephaly


VAERS ID: 1628956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-04
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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: MILGAMMA [BENFOTIAMINE;CYANOCOBALAMIN]; TAMSULOSIN HYDROCHLORIDE; FURORESE [FUROSEMIDE]; KALNORMIN
Current Illness: Alcoholic polyneuropathy; Alcoholism; Arterial hypertension; Cholecystectomy; Diabetes mellitus ((diet)); Fecal incontinence; Insufficiency cardiac; Liver cirrhosis; Multimorbidity; Osteoporosis; Smoker; Urinary retention (permanent urinary catheter); Vertebrogenic pain syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (not treated due to non compliance); Gastric ulcer surgery; Incisional herniorrhaphy; Lumbar spine compression fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZJNJFOC20210838247

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority concerned a 66 year old male of unknown race and ethnic origin. The patient''s weight was 75 kilograms, and height was 165 centimeters. The patient''s past medical history included: incisional herniorrhaphy, epilepsy, lumbar spine compression fracture, and gastric ulcer surgery, and concurrent conditions included: diabetes mellitus, alcoholism, vertebrogenic pain syndrome, alcoholic polyneuropathy, smoking, fecal incontinence, multimorbidity, liver cirrhosis, arterial hypertension, urinary retention, osteoporosis, insufficiency cardiac, and cholecystectomy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD974 expiry: UNKNOWN) 1 dosage forms, frequency one total, administered on 03-AUG-2021 for covid-19 immunization. Concomitant medications included benfotiamine/cyanocobalamin, furosemide, potassium chloride, and tamsulosin hydrochloride. On 04-AUG-2021, the patient experienced death. On 04-AUG-2021, the patient died from death from natural causes. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death, Other Medically Important Condition, and Life Threatening).; Sender''s Comments: V0: 20210838247- Covid-19 vaccine ad26.cov2.s- Death. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY; Reported Cause(s) of Death: DEATH FROM NATURAL CAUSES


VAERS ID: 1629000 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-09
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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: 2021-08-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210839152

Write-up: MYOCARDIAL INFARCTION; This spontaneous report received from a physician via a Regulatory Authority [DE-PEI-202100166172] concerned a 66 year old female of unknown ethnicity and race. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: XE393 expiry: unknown) dose was not reported, 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-AUG-2021, the patient experienced myocardial infarction and died. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210839152- Covid-19 vaccine ad26.cov2.s- Myocardial infarction. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: INFARCT MYOCARDIAL


VAERS ID: 1629122 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-08
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy brain, Blood test, Leukoencephalopathy, Lumbar puncture, Magnetic resonance imaging, Multiple organ dysfunction syndrome, Septic shock, Specialist consultation, Ultrasound scan
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalopathy/delirium (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: brain biopsy; Result Unstructured Data: Test Result:inconspicuous; Test Name: blood cultures; Result Unstructured Data: Test Result:showed the following; Comments: showed the following of S. marescens, the detection of S. hominis was seen as contamination; Test Date: 20210727; Test Name: blood cultures; Result Unstructured Data: Test Result:S.hominis in the blood cultures; Comments: S.hominis in the blood cultures; Test Name: lumbar puncture; Result Unstructured Data: Test Result:inconspicuous; Test Date: 20210709; Test Name: MRI; Result Unstructured Data: Test Result:pronounced generalised, partially diffusion-distur; Comments: pronounced generalised, partially diffusion-disturbed medullary edema supratentorially with involvement of the putamina.; Test Date: 20210715; Test Name: MRI; Result Unstructured Data: Test Result:increase of the extensive leukoencephalopathy wit; Comments: increase of the extensive leukoencephalopathy with progressive cytotoxic oedema; Test Name: experts in leukodystrophies and other metabolic myelin diseases; Result Unstructured Data: Test Result:genetic metabolic leukoencephalopathy could be rul; Comments: genetic metabolic leukoencephalopathy could be ruled out due to the acute course of the disease.; Test Name: neuroradiology department; Result Unstructured Data: Test Result:neuroradiology department was consulted; the colle; Comments: neuroradiology department was consulted; the colleague assumed a metabolic etiology; Test Name: Sonography; Result Unstructured Data: Test Result:pleural effusions showed a regressed; Comments: pleural effusions showed a regressed
CDC Split Type: DEPFIZER INC202101061868

Write-up: Multiorgan failure; Septic shock; Leukoencephalopathy; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, Safety Report Unique Identifier: DE-PEI-202100165293. A 38-year-old male patient received bnt162b2 (COMIRNATY mRNA TOZINAMERAN), dose 1 via an unspecified route of administration on 11Jun2021 at the age of 38-year-old (Batch/Lot Number: FC1526) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. 7 weeks after vaccination, on 02Aug2021 the patient experienced Multiorgan failure, Septic shock. On 08Jul2021 the patient experienced Leukoencephalopathy. Clinical course: Detection of Serratia marcencens and Staphylococcus hominis in the blood cultures. Excluded diagnoses: ADEM, leukodystrophies, MS, PMI, PRES, lymbic encephalitis, pathogen-induced leukoencephalopathy. The cMRI of 09Jul2021 showed a pronounced generalised, partially diffusion-disturbed medullary edema supratentorially with involvement of the putamina. A barrier disturbance is not recognizable. No haemorrhage. The MRI of 15Jul2021 shows an increase of the extensive leukoencephalopathy with progressive cytotoxic oedema. Further no barrier disturbances or haemorrhage. A reliable classification of this leukoencephalopathy is not possible morphologically. Due to the progressive nature of the findings, the neuroradiology department was consulted; the colleague assumed a metabolic etiology. For further clarification, a biopsy was discussed with them and considered useful. A telephone consultation with experts in leukodystrophies and other metabolic myelin diseases took place. In his opinion, a genetic metabolic leukoencephalopathy could be ruled out due to the acute course of the disease. Due to the inconspicuous lumbar puncture, MRI and brain biopsy, we considered an inflammatory event (as is the case with a vaccine-associated reaction) to be less likely. A tentative diagnosis of toxic leukoencephalopathy (e.g. due to syntetic cannabinoids) DD lmpfassociated leukoencephalopathy was made. On 31Jul2021 there was an increase in the infection parameters and fever. Renewed collection of material was carried out. Sedation was deepened during periods of stress. In CPAP mode, oxygenation and hypercapnia worsened, lactate increased slightly. There was a clearly negative balance under intensified diuretic therapy for pleural effusions. Sonographically, the pleural effusions showed a regressed. In the course of the study, the catecholamine requirement increased up to 0.9 mg noradrenalin/h. On detection of S.hominis in the blood cultures of 27Jul2021, antibiotic treatment with Unezolid was started, volume bolus of 1.51 was administered. 1.51 was administered, ventilation was continued in a lung-protective BIPAP mode. Thereafter, the catecholamine requirement initially showed a decrease to 0.5mg norepinephrine/h, lactate falling, oxygenation and decarboxylation improved. On 01Aug2021 the infection parameters showed a massive increase. Consultation with the microbiology colleagues. The blood cultures from the previous day showed the following of S. marescens, the detection of S. hominis was seen as contamination. On recommendation, the antibiotic treatment was changed to ceftazidime. In the course of the brain biopsy was performed by the neurosurgical colleagues during the course of the day. After transfer circulatory and respiratory situation essentially unchanged. As possible focus of the defect was considered to be an inserted Shaldon catheter and removed. Sedation was changed to isoflurane anaesthesia. On the evening of 01Aug2021 there was a massive acute deterioration of the respiratory and haemodynamic situation. Ventilation had to be intensified to the maximum with FiO2 of 100%. The treatment of the manifest septic shock with multiple organ failure was started with forced volume administration (5l full electrolyte solution) hydrocortisone and argipressin, and high doses of catecholamine. The antibiotic therapy was extended to include meropenem and vancomycin linezolid and ceftazidime were administered again. With maximally invasive ventilation ECMO was indicated, which was then performed in the event of further haemodynamic problems deterioration in the acute situation, ECMO could no longer be successfully performed in the acute situation. Despite the measures taken, the patient died on 02Aug2021 at 1:04. It was not reported if an autopsy was performed. This report is serious - death, hospitalization. The patient''s outcome was: fatal for Multiorgan failure, fatal for Septic shock, fatal for Leukoencephalopathy. Multiorgan failure/ PEI/ D. Unclassifiable; Septic shock/ PEI/ D. Unclassifiable; Leukoencephalopathy/ PEI/ D. Unclassifiable. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Multiorgan failure; Leukoencephalopathy; Septic shock


VAERS ID: 1629266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-08-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8142 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   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: ALENDRONAT AUROBINDO; ENALAPRIL KRKA; IBUPROFEN; FERRO DURETTER; KODEIN; CYMBALTA; PLAVIX; ZARATOR [ATORVASTATIN CALCIUM]; BETOLVEX [CYANOCOBALAMIN-TANNIN COMPLEX]; KALEORID; PANTOPRAZOL ACTAVIS; QUETIAPIN ACCORD; BRICANYL TURBUHALER
Current Illness: Bronchospasm; Chronic obstructive lung disease; Depression; Esophageal acid reflux; Hypercholesterolaemia; Hypertension; Iron deficiency; Osteoporosis; Tiredness (Contacted physician duo to tiredness (NOT ADR)); Vitamin B12 deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarct; Discoloured stools (Dark stool. Dark stools have ceased at the time of medical contact. (NOT ADR)); Headache (Was recomendented to use Ibuprofen instead of Kodein. (NOT ADR)); Potassium supplementation; Thrombosis prophylaxis
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.9; Comments: Unit not specified
CDC Split Type: DKPFIZER INC202101061613

Write-up: Found dead on 3Aug2021; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DK-DKMA-WBS-0082689. A 69-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: FA8142) as single dose for covid-19 immunisation. The patient previously took first dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation on 18Jun2021 (Batch/Lot Number: FC5295; Expiration Date: 30Sep2021). Medical history included discoloured stools from 2021 to 20Jul2021 (Dark stool. Dark stools have ceased at the time of medical contact. (NOT ADR)), cerebral infarction from Feb2021 to an unknown date, Tiredness from 20Jul2021 and ongoing (Contacted physician duo to tiredness (NOT ADR)), ongoing chronic obstructive pulmonary disease, headache from Jul2021 to an unknown date (Was recomendented to use Ibuprofen instead of Kodein. (NOT ADR)), ongoing osteoporosis, ongoing vitamin b12 deficiency, ongoing bronchospasm, ongoing depression, ongoing hypertension, ongoing Iron deficiency, ongoing Esophageal acid reflux, ongoing Hypercholesterolaemia, Potassium supplementation, thrombosis prophylaxis. The patient had no previous history of headache or migraine. Concomitant medications included alendronate sodium (ALENDRONAT AUROBINDO) taken for osteoporosis from 26Feb2020 to an unspecified stop date; enalapril maleate (ENALAPRIL KRKA) taken for hypertension from 16Jan2017 to an unspecified stop date; ibuprofen taken for headache from 20Jul2021 to an unspecified stop date; ferrous sulfate (FERRO DURETTER) taken for iron deficiency from 20Jul2021 to an unspecified stop date; codeine phosphate (KODEIN) taken for headache from 20Jul2021 to an unspecified stop date; duloxetine hydrochloride (CYMBALTA) taken for depression from 12Jul2016 to an unspecified stop date; clopidogrel bisulfate (PLAVIX) taken for thrombosis prophylaxis from 02Feb2021 to an unspecified stop date; atorvastatin calcium (ZARATOR) taken for hypercholesterolaemia from 01Feb2021 to an unspecified stop date; cyanocobalamin-tannin complex (BETOLVEX) taken for vitamin b12 deficiency from 12Jul2016 to an unspecified stop date; potassium chloride (KALEORID) taken for Potassium supplementation from 05Jan2017 to an unspecified stop date; pantoprazole sodium sesquihydrate (PANTOPRAZOL ACTAVIS) taken for esophageal acid reflux from 20Jul2021 to an unspecified stop date; quetiapine fumarate (QUETIAPIN ACCORD) taken for depression from 31May2018 to an unspecified stop date; terbutaline sulfate (BRICANYL TURBUHALER) taken for bronchospasm from 30Jan2019 to an unspecified stop date. The patient was found dead on 03Aug2021, 4 days after the 2nd vaccination. The patient underwent lab tests and procedures which included haemoglobin: 6.9 unit not specified on 20Jul2021. An autopsy was not performed (also reported an autopsy had been ordered. (Results awaits)). Causality: Reporter sees possible causal link to the COMIRNATY vaccination based on the short time from 2nd vaccination to death. The reporter describes the death as unexpectedly, despite the fact that the deceased was not "completely healthy". No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Found dead


VAERS ID: 1629274 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MAREVAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: EEPFIZER INC202101061501

Write-up: Ischaemic stroke; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the WEB, regulatory authority number EE-SAM-46702107313. A 90-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 04Jun2021 (Batch/Lot Number: Unknown) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included stroke from 2011 to 2011. Concomitant medication included warfarin sodium (MAREVAN) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of Comirnaty on unspecified date for COVID-19 immunisation and the patient had no special complaints. The patient was vaccinated with the second dose of Comirnaty vaccine on 04Jun2021. On the early morning of 14Jun2021, the patient died of a stroke. Disruption of blood supply to the brain, unconsciousness until death. Additional information on 05Aug2021: after vaccination with the first dose, the patient had no special complaints. After the second dose of the vaccine, only balance disorder occurred, but they had been also present before the vaccine, but not as frequently. 10 years ago, the patient had a stroke, from which he successfully recovered. There were no life-threatening complications. During the stroke, his mind was clear, but he could not speak, and his body was motionless. The patient used Marevan. According to the doctor who reported the situation, surprisingly, both arteries had closed at the same time and the brain had no blood supply, brain damage and death for about 12 hours. The patient experienced ischaemic stroke on 14Jun2021. Event seriousness criteria was death and medically significant. The patient died on 14Jun2021. It was not reported if an autopsy was performed. Sender''s comments: Serious, not listed side effect. The temporal relationship exists but the patient had previously taken blood thinners, in addition to old age. The causal link is considered doubtful. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Ischaemic stroke


VAERS ID: 1629436 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-08-04
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2083 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-04
   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: Valaciclovir
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Herpes genitalis; Overweight; Comments: herpes genital
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101055619

Write-up: Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency -WEB, regulatory authority number FR-AFSSAPS-BX20217294. A 34-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly on 16Jul2021 (Lot Number: FE2083) as dose 2, single for covid-19 immunisation; valaciclovir, oral from 30Jul2021 (Batch/Lot Number: Unknown) to 02Aug2021, at 1 DF, 1x/day for genital herpes. Medical history included herpes genitalis, overweight, both from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced severe ischemic stroke followed by death on 04Aug2021. The action taken in response to the event for valaciclovir was unknown. The patient died on 04Aug2021. It was unknown if an autopsy was performed. The outcome of event was fatal. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1629437 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-26
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Death NOS; This case was received via Agency (Reference number: FR-AFSSAPS-BX20217295) on 16-Aug-2021 and was forwarded to Moderna on 16-Aug-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Death NOS) in a 73-year-old male patient who received mRNA-1273 (Spikevax) (batch no. Not found) for COVID-19 immunization. No Medical History information was reported. On 13-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (Parenteral) 1 dosage form. Death occurred on 26-Jul-2021 The patient died on 26-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment- Very limited information regarding this event/s has been provided at this time. No further information is expected.; Sender''s Comments: Very limited information regarding this event/s has been provided at this time. No further information is expected.; Reported Cause(s) of Death: death NOS


VAERS ID: 1629438 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-06
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension arterial; Kidney disorder; Kidney transplant
Allergies:
Diagnostic Lab Data: Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202101055165

Write-up: Vaccination failure; COVID-19; third dose; third dose; intradermal third dose; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency-WEB, regulatory authority number FR-AFSSAPS-BX20217314. A 65-year-old male patient received BNT162B2 (COMIRNATY) single dose for COVID-19 immunisation, intradermal third dose on 06May2021 (Lot Number: EX2405; Expiration Date: 31Aug2021), unspecified route first and second dose on an unspecified date; at 65-year-old. Medical history included hypertension arterial, diabetes, kidney transplant, kidney disease. The patient''s concomitant medications were not reported. The patient experienced vaccination failure on 31Jul2021, COVID-19 on 31Jul2021. Vaccine failure was confirmed 2 and a half months after Dose 3 with death of a 65-year-old patient for serious infection by COVID. Hospitalization involved. Lab test included positive sars-cov-2 test. The patient died on an unspecified date. It was unknown if an autopsy was performed. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EX2405. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.; Reported Cause(s) of Death: COVID-19; Vaccination failure


VAERS ID: 1629441 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-08-03
   Days after vaccination:187
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOZAPINE; SERESTA; KARDEGIC
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210804; Test Name: Covid-19 virus test; Test Result: Positive ; Test Date: 2021; Test Name: RT-PCR Covid-19 virus test; Test Result: Positive ; Comments: Presence of the L452R mutation (suggestive of the Delta variant)
CDC Split Type: FRPFIZER INC202101061631

Write-up: COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine on 07Jan2021 and 28Jan2021/ Covid-19 virus test positive/ COVID-19 aggravated; COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine on 07Jan2021 and 28Jan2021/ Covid-19 virus test positive/ COVID-19 aggravated; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority FR-AFSSAPS-CF20212370. A 90-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular in arm on 28Jan2021 (Lot Number: EJ6788; Expiration Date: Apr2021) as dose 2, single, dose 1 intramuscular in arm on 07Jan2021 (Lot Number: EM0477; Expiration Date: Apr2021) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included clozapine (CLOZAPINE); oxazepam (SERESTA); acetylsalicylate lysine (KARDEGIC). The patient died on 07Aug2021 due to a COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine on 07Jan2021 and 28Jan2021. The patient presented a cough from 03 to 06 August and suddenly deteriorated on 07 August with predominant digestive signs (diarrhea and vomiting), COVID-19 aggravated on 07Aug2021. Call of the internist on duty on 07Aug2021. RT-PCR test result (2021): Presence of the L452R mutation (suggestive of the Delta variant). Confirmed vaccine failure. Management included Urgent medical intervention/Life threatening but death at home. No autopsy planned. The patient underwent lab tests and procedures which included Covid-19 virus test on 04Aug2021: positive, RT-PCR Covid-19 virus test in 2021: positive, presence of the L452R mutation (suggestive of the Delta variant). The outcome of the events was fatal. The patient died on 07Aug2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine on 07Jan2021 and 28Jan2021/ Covid-19 virus test positive/ COVID-19 aggravated; COVID-19 infection detected on 03Aug2021, although he had received 2 doses of vaccine


VAERS ID: 1629456 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-07-24
   Days after vaccination:165
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Drug ineffective, Oxygen saturation, SARS-CoV-2 test, Suspected COVID-19
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: 2021-07-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hand fracture (Hospitalization for a broken thumb + renal failure from 05Jul2021 to 20Jul2021); Obesity (Comorbidities linked to overweight); Renal insufficiency (Hospitalization for a broken thumb + renal failure from 05Jul2021 to 20Jul2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: Body temperature; Result Unstructured Data: Test Result:febrile; Test Date: 20210725; Test Name: Body temperature; Result Unstructured Data: Test Result:ok; Test Date: 20210725; Test Name: saturation; Result Unstructured Data: Test Result:ok; Test Date: 20210725; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101061595

Write-up: Vaccination failure; Vaccination failure; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-GR20213464. A 64-year-old female patient received BNT162B2 (COMIRNATY) dose 2 intramuscular on 09Feb2021 (Lot Number: EP2166; Expiration Date: 31May2021) as dose 2, 0.3 ml single, dose 1 intramuscular on 19Jan2021 (Lot Number: EJ6788; Expiration Date: 30Apr2021) as dose 1, 0.3 ml single for covid-19 immunisation. Medical history included obesity (Comorbidities linked to overweight), hospitalization for a broken thumb and renal insufficiency from 05Jul2021 to 20Jul2021. The patient''s concomitant medications were not reported. The patient experienced vaccination failure on 24Jul2021. The patient had resident febrile on 24Jul2021 in the evening. Generalized anxiety disorder on 25Jul2021. Temperature (Centigrade) and saturation were ok on 25Jul2021 at 19:00. Death certificate on 26Jul2021 at 00:45. Family visits on 23Jul2021. The patient underwent lab tests included sars-cov-2 test negative on 25Jul2021. The outcome of events was fatal. The patient died on 26Jul2021. An autopsy was not performed. Investigation results as follows: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot EP2166. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. The reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: vaccination failure; vaccination failure


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