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From the 9/17/2021 release of VAERS data:

Found 15,386 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1235283 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cough, Fatigue, Laboratory test, Malaise, Pneumonia viral, Pyrexia, Respiratory failure, SARS-CoV-2 antibody test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 42
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart attack
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: temperture; Result Unstructured Data: Test Result:maintained; Comments: maintained until 20Feb2021; Test Date: 20210215; Test Name: temperture; Result Unstructured Data: Test Result:fever; Test Date: 202102; Test Name: tests; Result Unstructured Data: Test Result:done (unspecified results); Test Date: 202102; Test Name: COVID-19 test; Result Unstructured Data: Test Result:positive
CDC Split Type: PLPFIZER INC2021399736

Write-up: cough/choking cough; fever; very tiring; felt unwell/ill; pneumonia caused by a virus; severe respiratory failure; Covid-19; This is a spontaneous report from a contactable consumer. A 69-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 12Feb2021 (Lot Number: EL8723) as a single dose for covid-19 immunisation. Medical history included heart attack from 16Nov2020 to an unknown date. The patient''s concomitant medications were not reported. The reporter mentioned that her husband was vaccinated with the Pfizer Comirnaty vaccine and after the vaccination, he felt unwell sometime later, tests were done (unspecified results) on Feb2021, it turned out that the patient was ill, he has Covid. On 20Mar2021 (also reported as 16Mar2021), he was taken to hospital but unfortunately the patient died. The reporter confirmed that her husband had received the 1st dose of 12Feb21, lot number EL8723. From the third day (15Feb2021) after vaccination, a fever developed, and the patient was taking Teraflu. The temperature was maintained until 20Feb2021. Meanwhile a cough appeared. 25Feb2021, the cough worsened and the patient was referred for a COVID-19 test. The test came out positive on Feb2021. On 26Feb2021, the patient was in an ambulance but did not take him to the hospital. On 29Feb2021, the cough got worse and was very tiring. 01Mar2021 the patient was taken to hospital because of a choking cough. On 03Mar2021, the patient was connected to a respirator and on 16Mar2021, the patient died. The patient was not autopsied. Doctors cited COVID-19 as the cause of death, viral pneumonia and severe respiratory failure. The reporter mentioned that the patient on 16Nov2020 had a heart attack. He has been taking heart medications since then, but she has not stated what. The patient did not suffer from chronic diseases. The patient underwent lab tests and procedures which included COVID-19 test was positive on Feb2021, tests was done (unspecified results) on Feb2021 temperature was maintained until 20Feb2021 (Feb2021). The outcome of the events malaise and fatigue were unknown while the outcome of the other events was fatal. The patient died on 16Mar2021. An autopsy was not performed.; Reported Cause(s) of Death: pneumonia caused by a virus; severe respiratory failure; COVID-19


VAERS ID: 1235288 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Atrial flutter, Cerebral haemorrhage, Ischaemic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atherosclerosis; Cardiac insufficiency; Chronic renal failure; Diabetes; Hypertension; Persistent atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021409070

Write-up: ischemic stroke of the brain with secondary haemorrhage; atrial fibrillation and flutter; atrial fibrillation and flutter; Ischemic stroke of the brain; This is a spontaneous report from a contactable consumer (patient''s granddaughter) downloaded from the regulatory authority [PL-URPL-DML-MLP.4401.2.127.2021]. A 79-year-old male patient received BNT162B2 (COMIRNATY, Lot Number: EJ6136) intramuscular on 04Feb2021 at age of 79-year-old at single dose for COVID-19 immunisation. Medical history included ongoing atherosclerosis, ongoing hypertension, ongoing diabetes, ongoing persistent atrial fibrillation, ongoing cardiac insufficiency (heart failure), ongoing chronic renal failure. The patient''s concomitant medications were not reported. The patient experienced ischemic stroke on 06Feb2021. The patient died on 09Feb2021. An autopsy was not performed. Direct cause of death: ischemic stroke of the brain with secondary haemorrhage; initial cause of death: atrial fibrillation and flutter. The outcome of the events was fatal. The reporting person did not classify the severity of the report. Due to the nature of the side effects and the patient''s death, HA classified the report as serious. Sender Comment: The reported adverse reactions have not yet been included under these terms in the Summary of Product Characteristics of Comirnaty. It cannot be ruled out that the reported cardiovascular diseases of the patient contributed to his death. HA has no information on any additional circumstances (medications used, allergies, etc.) that could have resulted in death. The temporal relationship supports a cause-and-effect relationship. The reporting person did not classify the severity of the report. Due to the nature of the side effects and the patient''s death, regulatory authority classified the report as serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ischemic stroke of the brain with secondary haemorrhage; ischemic stroke of the brain with secondary haemorrhage; Atrial fibrillation and flutter; Atrial fibrillation and flutter


VAERS ID: 1235295 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-04
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Upper gastrointestinal haemorrhage
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   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: Medical History/Concurrent Conditions: Cardiac insufficiency (heart failure); COPD; Gastric disorder (recent gastric complaints); Hypertension arterial (high blood pressure); Prostate cancer (metastatic (bone) prostate carcinoma)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021409082

Write-up: Massive upper gastrointestinal bleeding; Acute cough; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority-WEB, Regulatory Authority number: PT-INFARMED-B202104-262. A 85-year-old male patient received the first dose of bnt162b2 (COMIRNATY, 30 mcg/0.3 ml), intramuscular on 25Mar2021 (Lot Number: ER9470) as 0.3 mL, single for covid-19 immunisation. Medical history included Cardiac insufficiency (heart failure), Gastric disorder (recent gastric complaints), Hypertension arterial (high blood pressure), Prostate cancer (metastatic (bone) prostate carcinoma), COPD; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced massive upper gastrointestinal bleeding and acute cough on 04Apr2021. The reporter described that the patient started, at home, a picture of an accessory cough, followed by massive upper gastrointestinal bleeding, with immediate death. The outcome of the events was fatal. The patient died on 04Apr2021. It was not reported if an autopsy was performed. Reporter comment: Other information-Patient with multipathologies: COPD, metastatic prostate carcinoma (bone), hypertension, HF and recent gastric complaints, vaccinated on 25Mar2021 at home, with the first dose of COMIRNATY vaccine, starts with cough followed by hemorrhage massive upper digestive tract, with immediate death. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Other information-Patient with multipathologies: COPD, metastatic prostate carcinoma (bone), hypertension, HF and recent gastric complaints, vaccinated on 25Mar2021 at home, with the first dose of COMIRNATY vaccine, starts with cough followed by hemorrhage massive upper digestive tract, with immediate death.; Reported Cause(s) of Death: Acute cough; massive upper gastrointestinal bleeding


VAERS ID: 1235308 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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: ENALAPRIL; PARACETAMOL; TATION; GABAPENTIN; MOMETASONE; TAMSULOSIN; FUROSEMIDE; CARVEDILOL; ALLOPURINOL; ASPIRINA; HYDROCORTISONE; PANTOPRAZOLE; BILAXTEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute myocardial infarction (history of acute myocardial infarction); Arterial hypertension; Benign prostatic hypertrophy; Cataract; Chronic sinusitis; Dyslipidemia; Gout; Impotence; Ischemic heart disease; Knee osteoarthritis; Obesity; Varicose veins of lower extremities
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021409087

Write-up: Myocardial infarction acute; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, Regulatory Authority number: PT-INFARMED-V202104-666. An 86-year-old male patient received bnt162b2 (Pfizer vaccine, Solution for injection), dose 2 intramuscular on 01Apr2021 (Lot Number: EW2239) as 0.3 mL, single for covid-19 immunisation. Medical history included cataract, chronic sinusitis, knee osteoarthritis, benign prostatic hypertrophy, varicose veins of the leg, impotence, gout, arterial hypertension, obesity, history of acute myocardial infarction, ischemic heart disease without angina, dyslipidemia. Concomitant medication included enalapril; paracetamol; torasemide (TATION); gabapentin; mometasone; tamsulosin; furosemide; carvedilol; allopurinol; acetylsalicylic acid (ASPIRINA); hydrocortisone; pantoprazole; bilastine. The patient previously received the first dose of Pfizer vaccine on 04Mar2021 for covid-19 immunisation. The patient experienced myocardial infarction acute (death) on 05Apr2021. The patient died on 07Apr2021. An autopsy was not performed. It was reported that the patient had an acute myocardial infarction associated with the use of Pfizer vaccine, with a 2-dose vaccination schedule with an interval of 27 days between each dose. The adverse reaction (ADR) appeared 4 days after the administration, lasting 2 days, and the patient died. There was no suspicion of interaction between drugs. Specific treatment of the reaction in the Cardiology Intensive Care Unit (the specific treatment is unknown). Reporter said that according to the information consulted in the CSR, he thinks that an autopsy was not performed. Evolution ad ADR was Death. Relatedness of drug to reaction(s)/event(s): Pfizer vaccine / Myocardial infarction acute, Source of assessment was Reporter. Method of assessment was Unknown. Result of Assessment was Possible. The outcome of the event was fatal. No follow-up attempts possible. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction acute


VAERS ID: 1235322 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-03
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cirrhosis of liver; Encephalopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ROPFIZER INC2021410553

Write-up: cerebrovascular accident followed by death; This is a spontaneous report from a contactable consumer. A 62-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 26Mar2021 12:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Cirrhosis of liver, encephalopathy. The patient''s concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY, lot number: EP2166) via an unspecified route of administration, administered in Arm Right on 05Mar2021 05:00 PM for covid-19 immunisation. The patient experienced cerebrovascular accident followed by death (death, hospitalization, life threatening) on 03Apr2021. The patient was hospitalized for cerebrovascular accident followed by death for 5 days. Therapeutic measures were taken as a result of the event included unspecified treatments. The patient died on an unspecified date. It was unknown if an autopsy was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, it was unknown if the patient was tested for COVID-19. The outcome of the event cerebrovascular accident was fatal. Information about lot number for second dose has been requested.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1235330 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: SERTRALIN HEXAL; ARANESP; PYRIDOXIN HCL; SUSCARD BUCCAL TABLETS; MIRTAZAPIN ACTAVIS; ACETYLCYSTEIN ALTERNOVA; ETALPHA; FORMOTEROL FUMARATE DIHYDRATE; DIAFER [IRON ISOMALTOSIDE 1000]; GLYCERYL TRINITRATE; GABAPENTIN ACTAVIS; CHOLECALCIFEROL;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Angina pectoris; Cardiac failure; Chronic kidney disease stage 5; Chronic obstructive pulmonary disease; Crohn''s disease; Haemodialysis; Intestinal stoma; Nerve pain; Shingles
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMPA1617195306721

Write-up: SEPSIS; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SEPSIS (SEPSIS) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300493) for COVID-19 vaccination. The patient''s past medical history included Chronic kidney disease stage 5, Haemodialysis in 2016, Anaemia, Cardiac failure, Nerve pain, Crohn''s disease, Chronic obstructive pulmonary disease, Intestinal stoma, Shingles and Angina pectoris. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALIN HEXAL) from 23-Jul-2018 to an unknown date, DARBEPOETIN ALFA (ARANESP) from 22-Dec-2020 to an unknown date, PYRIDOXINE HYDROCHLORIDE (PYRIDOXIN HCL) from 18-Nov-2013 to an unknown date, GLYCERYL TRINITRATE (SUSCARD BUCCAL TABLETS) from 06-Apr-2017 to an unknown date, MIRTAZAPINE (MIRTAZAPIN ACTAVIS) from 29-Apr-2014 to an unknown date, ACETYLCYSTEINE (ACETYLCYSTEIN ALTERNOVA) from 25-Jul-2017 to an unknown date, ALFACALCIDOL (ETALPHA) from 09-May-2017 to an unknown date, FORMOTEROL FUMARATE DIHYDRATE from 18-Feb-2021 to an unknown date, IRON ISOMALTOSIDE 1000 (DIAFER [IRON ISOMALTOSIDE 1000]) from 30-Jun-2020 to an unknown date, GLYCERYL TRINITRATE from 29-Dec-2020 to an unknown date, GABAPENTIN (GABAPENTIN ACTAVIS) from 24-Sep-2020 to an unknown date, CHOLECALCIFEROL from 22-Oct-2019 to an unknown date, ZOPICLONE (ZOPIKLON PILUM) from 28-Nov-2013 to an unknown date, PARACETAMOL (ALVEDON DOS) from 06-Dec-2018 to an unknown date, METOCLOPRAMIDE HYDROCHLORIDE (PRIMPERAN) from 12-Mar-2019 to an unknown date, OXAZEPAM (OXASCAND) from 04-Dec-2015 to an unknown date, SALBUTAMOL SULFATE (BUVENTOL) from 02-Jan-2020 to an unknown date, LOPERAMIDE HYDROCHLORIDE (DIMOR) from 15-Nov-2013 to an unknown date and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY ELLIPTA) from 14-Mar-2019 to an unknown date for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In March 2021, the patient experienced SEPSIS (SEPSIS) (seriousness criterion death). The patient died in March 2021. The reported cause of death was Sepsis. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. Company comment: This is a case of death in a 85-year-old female subject with a medical history of CKD on hemodialysis, Anaemia, Cardiac failure, Nerve pain, Crohn''s disease, Chronic obstructive pulmonary disease, Intestinal stoma, Shingles and Angina pectoris, who died after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Sender''s Comments: This is a case of death in a 85-year-old female subject with a medical history of CKD on hemodialysis, Anaemia, Cardiac failure, Nerve pain, Crohn''s disease, Chronic obstructive pulmonary disease, Intestinal stoma, Shingles and Angina pectoris, who died after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: SEPSIS


VAERS ID: 1235350 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acquired immunodeficiency syndrome; Haemodialysis; Kidney transplant; Wegeners granulomatosis
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021399134

Write-up: fell ill with pneumonia with ground glass appearance; This is a spontaneous report from a contactable physician downloaded from the regulatory authority SE-MPA-2021-024620. A 57-year-old male patient received second dose of bnt162b2 (COMIRNATY; lot number and expiration date unspecified), intramuscular on Mar2021 as single dose for COVID-19 immunisation. Medical history included acquired immunodeficiency syndrome, Wegeners granulomatosis, haemodialysis, and kidney transplant. The patient''s concomitant medications were not reported. The patient received first dose of bnt162b2 for COVID-19 immunisation on an unspecified date. In Mar2021, the patient fell ill with pneumonia with ground glass appearance. The patient underwent lab test on an unspecified date which included COVID-19 PCR test which was negative. The patient died in Mar2021 due to the pneumonia 10 days after the second dose of the vaccine was given. It was not reported if an autopsy was performed. No follow-up attempts possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: pneumonia


VAERS ID: 1235351 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, C-reactive protein, Cardiac arrest, Gastroenteritis, Haemoglobin, Haemorrhage, Heart rate, Oropharyngeal pain, Oxygen saturation, Platelet count, Pulmonary embolism, Septic shock, Vomiting, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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), Toxic-septic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (broad), Respiratory failure (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: EPIPEN; GAVISCON [ALGINIC ACID;ALUMINIUM HYDROXIDE;SODIUM ALGINATE;SODIUM BICARBONATE]; BUVENTOL; ALVEDON; IMIGRAN [SUMATRIPTAN SUCCINATE]; NEXIUM [ESOMEPRAZOLE SODIUM]; BETAPRED; OVIXAN; SUMATRIPTAN; BUFOMIX EASYHALER; HORMONAL CONTRACEPTI
Current Illness: ADHD; Asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Tonsillectomy
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:148; Test Name: potassium; Result Unstructured Data: Test Result:3.2; Test Name: CRP; Result Unstructured Data: Test Result:85; Test Name: HB; Result Unstructured Data: Test Result:167; Test Name: pulse; Result Unstructured Data: Test Result:160; Test Name: desaturated; Test Result: 70 %; Test Name: pH; Result Unstructured Data: Test Result:6.6; Test Name: Thrombocyte particle count; Result Unstructured Data: Test Result:100; Test Date: 202010; Test Name: Thrombocyte particle count; Result Unstructured Data: Test Result:310; Test Name: White blood cell count; Result Unstructured Data: Test Result:2.1
CDC Split Type: SEPFIZER INC2021409102

Write-up: gastroenteritis; sore throat; HEART STOP; BLEEDING under Cardiopulmonary resuscitation; VOMITATION; Possible pulmonary embolism or septic shock; Possible pulmonary embolism or septic shock; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority numberSE-MPA-2021-025189. Other Case identifier number: SE-VISMA-1617760688582. An 18-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration in Mar2021 at single dose for COVID-19 immunisation. Medical history included ongoing asthma, ongoing attention deficit hyperactivity disorder (ADHD), tonsillectomy stopped on an unspecified date. Concomitant medications included epinephrine (EPIPEN); alginic acid, aluminium hydroxide, sodium alginate, sodium bicarbonate (GAVISCON); salbutamol sulfate (BUVENTOL); paracetamol (ALVEDON); sumatriptan succinate (IMIGRAN); esomeprazole sodium (NEXIUM); betamethasone sodium phosphate (BETAPRED); mometasone furoate (OVIXAN); sumatriptan; budesonide, formoterol fumarate (BUFOMIX EASYHALER); hormonal contraceptives for systemic use; naproxen (PRONAXEN); hydrocortisone (MILDISON); hydroxyzine hydrochloride (ATARAX); melatonin; urea (CANODERM); lisdexamfetamine mesilate (ELVANSE); cortisone acetate (CORTISON, spray); P-piller and eye drops. The patient experienced heart stop (death) in Apr2021, bleeding under cardiopulmonary resuscitation (death) in Apr2021, vomitation (death) in Apr2021. The patient also developed possible pulmonary embolism or septic shock in Apr2021, gastroenteritis in Apr2021. Clinical course as reported: Reported suspect adverse events were vomiting, cardiac arrest and bleeding tendency during CPR (cardiopulmonary resuscitation), 19 days after vaccination. Last week had throat symptoms. Sought hospital for vomiting, diarrhea and sore throat. Assessed as gastroenteritis. TPK (Thrombocyte particle count) 100 (TPK 310 in October 2020), Hb (Haemoglobin) 167, LPK (LPK - White blood cell count) 2.1, CRP (C Reactive Protein) 85, creatinine 148, potassium 3.2, pulse 160. Vomited severely and became agitated. Desaturated with 70% saturation and had cardiac arrest on ward, no aspiration. Possible pulmonary embolism or septic shock according to the reporter. Long CPR (Cardiopulmonary resuscitation) for two hours but dies. pH 6.6 an hour into CPR (Cardiopulmonary resuscitation). Bleeding during CPR (Cardiopulmonary resuscitation), which has not been noticed before. Bleeding at inserted venous catheter, develops nose bleeding and bleeding from the mouth. Outcome: Fatal. Report assessed as serious, death. The patient will be autopsied. A regulatory authority have requested medical records and autopsy report. The patient died on an unspecified date in Apr2021. It was not reported if an autopsy was performed. The outcome of the event gastroenteritis was unknown, of the other events was fatal. No follow-up attempts possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: HEART STOP; BLEEDING under Cardiopulmonary resuscitation; VOMITATION; Possible pulmonary embolism or septic shock; Possible pulmonary embolism or septic shock


VAERS ID: 1235876 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   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: LAMIVUDINE; ABACAVIR SULPHATE; DOLUTEGRAVIR SODIUM; LERCANIDIPINE HYDROCHLORIDE; CARVEDILOL; CHLORPROTHIXENE HYDROCHLORIDE; OXAZEPAM; MIRTAZAPINE; SODIUM BICARBONATE; COLECALCIFEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathy; CDC Group III HIV infection; Chronic hepatitis C; Haematuria; Mitral insufficiency; Personality disorder; Stage 3 acute kidney injury; Substance use; Thrombocytopenia; Ulcus cruris
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 56-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042723) for an unknown indication. The patient''s past medical history included HIV infection, Chronic hepatitis C, Stage 3 acute kidney injury, Haematuria, Mitral insufficiency on 12-Aug-2016, Arteriopathy in February 2017, Ulcus cruris, Substance use, Personality disorder and Thrombocytopenia. Concomitant products included LAMIVUDINE from an unknown date to 13-Feb-2021, ABACAVIR SULFATE (ABACAVIR SULPHATE) from an unknown date to 13-Feb-2021, DOLUTEGRAVIR SODIUM from an unknown date to 13-Feb-2021, LERCANIDIPINE HYDROCHLORIDE from an unknown date to 13-Feb-2021, CARVEDILOL from an unknown date to 13-Feb-2021, CHLORPROTHIXENE HYDROCHLORIDE from an unknown date to 13-Feb-2021, OXAZEPAM from an unknown date to 13-Feb-2021, MIRTAZAPINE from an unknown date to 13-Feb-2021, SODIUM BICARBONATE from an unknown date to 13-Feb-2021 and COLECALCIFEROL from an unknown date to 13-Feb-2021 for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 13-Feb-2021 The patient died on 13-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. Treatment information was not provided. Reporter did not allow further contact; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1235909 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-04-21
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: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Knee operation; Reanimation
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Cardiac arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DEATH (Cardiac arrest) in a 91-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Reanimation in 2011 and Knee operation in 2019. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on February 2021 The patient died in February 2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This is a case of death in a 91-year-old male subject with a medical history of Reanimation in 2011 and Knee operation in 2019., who died after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible. Reporter did not allow further contact; Sender''s Comments: This is a case of death in a 91-year-old male subject with a medical history of Reanimation in 2011 and Knee operation in 2019., who died after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1235924 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-30
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Sopor
SMQs:, Dementia (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic renal insufficiency; Dilated cardiomyopathy; Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: 02/04/2021; This case was received via agency (Reference number: 710323) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence (02/04/2021) in an 88-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Dilated cardiomyopathy, Atrial fibrillation, Vascular dementia and Chronic renal insufficiency. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .5 milliliter in total. On 30-Mar-2021, the patient experienced SOPOR (02/04/2021) (seriousness criterion death). The patient died on 02-Apr-2021. The reported cause of death was Sopor. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided. Company Comment: Very limited information regarding the event of sopor has been provided at this time. No further information has been requested. Elderly age along with multiple comorbidities may have been contributory. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event of sopor has been provided at this time. No further information has been requested. Elderly age along with multiple comorbidities may have been contributory.; Reported Cause(s) of Death: Sopor


VAERS ID: 1235938 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Cerebrovascular disorder; Chronic lymphocytic leukaemia; Chronic obstructive pulmonary disease; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20210

Write-up: Sudden death; This case was received via a regulatory authority (Reference number: 021745) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of SUDDEN DEATH (Sudden death) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Cerebrovascular disorder, Chronic obstructive pulmonary disease, Chronic lymphocytic leukaemia, Hypertension and Asthma. Concomitant products included CLOPIDOGREL for an unknown indication. In March 2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. The patient died in March 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was reported. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on unknown date in Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown. Very limited information regarding the event of sudden death has been provided at this time. However, patient''s elderly age along with underlying comorbidities may have been contributory. No further information has been requested. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event of sudden death has been provided at this time. However, patient''s elderly age along with underlying comorbidities may have been contributory. No further information has been requested.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1236007 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Hypotonic-hyporesponsive episode, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Respiratory failure (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: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20210

Write-up: Hypotonic-hyporesponsive episode with loss of consciousness; Circulatory arrest; Hypotonic-hyporesponsive episode with loss of consciousness; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic-hyporesponsive episode with loss of consciousness), CARDIAC ARREST (Circulatory arrest) and LOSS OF CONSCIOUSNESS (Hypotonic-hyporesponsive episode with loss of consciousness) in a 76-year-old patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic-hyporesponsive episode with loss of consciousness) (seriousness criterion death), CARDIAC ARREST (Circulatory arrest) (seriousness criterion death) and LOSS OF CONSCIOUSNESS (Hypotonic-hyporesponsive episode with loss of consciousness) (seriousness criterion death). The reported cause of death was hypotonic-hyporesponsive episode with loss of consciousness, circulatory arrest and Loss of consciousness. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CARDIAC ARREST (Circulatory arrest) and LOSS OF CONSCIOUSNESS (Hypotonic-hyporesponsive episode with loss of consciousness) to be possibly related. No further causality assessment was provided for HYPOTONIC-HYPORESPONSIVE EPISODE (Hypotonic-hyporesponsive episode with loss of consciousness). No concomitant medication reported. No treatment information was provided. Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Translation received; Sender''s Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient''s pre-existing comorbidities; Reported Cause(s) of Death: Hypotonic-hyporesponsive episode with loss of consciousness; Circulatory arrest; Loss of consciousness


VAERS ID: 1236426 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   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: Prostatic neoplasm NOS
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Aortic surgery; Comments: Npl. prostatae, St.p. Bauchaortenaneurysma -Op 2018
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: (Moderna) am 20.03.2021; This regulatory authority case was reported by a physician and describes the occurrence of PULMONARY EMBOLISM ((Moderna) am 20.03.2021) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Npl. prostatae, St.p. Bauchaortenaneurysma -Op 2018. The patient''s past medical history included Aneurysm aortic in 2018 and Aortic surgery in 2018. Concurrent medical conditions included Prostatic neoplasm NOS. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PULMONARY EMBOLISM ((Moderna) am 20.03.2021) (seriousness criterion death). The patient died on 29-Mar-2021. The reported cause of death was Pulmonary embolism. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. The treatment information included reanimation on 29 Mar 2021. Action taken with mRNA-1273 in response to the events was not applicable.; Sender''s Comments: This is a case of death in a 57-year-old male subject with a medical history of AAA, Ca Pancreas, who died 9 days after receiving the first dose of vaccine. Based on information received, death was due to pulmonary embolism, which is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1236429 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Hypertension; Peripheral arterial occlusive disease (PAOD); Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021414217

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA). The regulatory authority report number is AT-BASGAGES-2021-22006. A 94-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 01Apr2021 (Lot Number: ET7205) at single dose for covid-19 immunisation. Medical history included ongoing peripheral arterial occlusive disease (PAOD), ongoing Renal insufficiency, ongoing diabetes mellitus, ongoing hypertension. The patient''s concomitant medications were not reported. The patient experienced death on 04Apr2021. It was not reported if an autopsy was performed. The patient''s outcome was: fatal for Death. "Summary (full translation available upon request)". Sender''s comments: comment: Follow-up information requested. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: death


VAERS ID: 1236435 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-07
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration, Malaise, Oxygen saturation decreased, Pulmonary congestion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418791

Write-up: Dyspnoea; General physical health deterioration; Malaise; Oxygen saturation decreased; Pulmonary congestion; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory authority report number is 534410. A 99-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration, on an unspecified date, as single dose, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Apr2021 (unspecified number of days after vaccination), the patient experienced dyspnoea, general physical health deterioration, malaise, oxygen saturation decreased, and pulmonary congestion, all leading to death on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Dyspnoea; General physical health deterioration; Malaise; Oxygen saturation decreased; Pulmonary congestion


VAERS ID: 1236482 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Insulin dependent diabetic (without control or monitoring of diet and treatment)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CRPFIZER INC2021433084

Write-up: heart attack; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided), via an unspecified route of administration on an unspecified date (at unknown age) at single dose for COVID-19 immunisation. Medical history included Insulin-dependent diabetic without control or monitoring of diet and treatment. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number not provided) at single dose for Covid-19 immunisation and experienced Fainting, Myalgia, Fatigue and Dyspnea. The patient''s concomitant medications were not reported. The patient received the second dose of the vaccine and two days later the patient died of a heart attack. The outcome was fatal. It was unknown if Autopsy was Done. information on the lot/batch number has been requested.; Reported Cause(s) of Death: heart attack


VAERS ID: 1236489 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac arrhythmia (NOS); Failure kidney (on dialysis); Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021414911

Write-up: Myocardial infarction; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is CZ-CZSUKL-21003913. An 80-year-old (also reported as "76-year-old") male patient received the second dose (dose 2) of BNT162B2 (COMIRNATY), via intramuscular (IM) on 01Apr2021 (Lot Number: ET7205) as single dose for covid-19 immunisation. Medical history included ongoing Type II diabetes mellitus, ongoing failure kidney on dialysis, ongoing cardiac arrhythmia (NOS). There were no concomitant medications. The patient received the first dose of BNT162B2 (COMIRNATY), via intramuscular on 04Mar2021 (lot number unknown) as single dose for covid-19 immunisation. The patient experienced myocardial infarction on 01Apr2021. The event reported as serious and caused death outcome, hospitalization, medically significant, life threatening. The patient was hospitalized for myocardial infarction from 01Apr2021. Myocardial infarction 45 minutes after the administration of the 2nd dose of vaccine. The patient has never had an infarction before. After the repeated resuscitation and subsequent operation, the patient died on 01Apr2021 due to myocardial infarction. An autopsy was not performed. ; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1236493 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Chills, Cough, Drug ineffective, Dyspnoea, Fatigue, Peripheral circulatory failure, Pyrexia, Somnolence
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   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: Arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409245

Write-up: A.R.D.S.; COVID-19; COVID-19; Dyspnoea; Shivering; Coughing; Fever; peripheral circulatory failure; exhaustion; Groggy; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100032679. A 61-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Jan2021 (Batch/Lot Number: EJ6797) as 0.3 mL, single for COVID -19 immunization. Medical history included ongoing Arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced shivering, fever, exhaustion, groggy, coughing, peripheral circulatory failure on 07Jan2021, Dyspnoea and COVID-19 on 11Jan2021 (both hospitalization), experienced ARDS on 02Feb2021 (hospitalization). The patient died on 02Feb2021 caused by ARDS. An autopsy was not performed. The event outcome was not recovered for shivering, fever, exhaustion, groggy, coughing, peripheral circulatory failure, dyspnoea, COVID-19, fatal for ARDS. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: ARDS


VAERS ID: 1236494 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021414219

Write-up: Sudden cardiac death suspected 24 hours after the 2nd vaccination; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100034101. An 84-year-old female patient received second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 08Apr2021 as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient received first dose of Comirnaty on an unspecified date in Mar2021. The patient experienced Unwitnessed cardiac death that described as "sudden cardiac death suspected 24 hours after the 2nd vaccination" on 09Apr2021. The patient died on 09Apr2021. It was not reported if an autopsy was performed. Sender''s comment: On the evening of the 2nd vaccination on 08Apr2021, patient was fine. Found dead the next day (living alone). Cause of death ultimately unclear. Previous illnesses existed. External inquest with no clear cause of death. Notification due to temporal connection. Criminal police tasked with further clarification. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: On the evening of the 2nd vaccination on 08Apr2021. reported to relatives that she is fine. Found dead the next day (living alone). Cause of death ultimately unclear. Previous illnesses existed. External inquest with no clear cause of death. Notification due to temporal connection. Criminal police tasked with further clarification.; Reported Cause(s) of Death: Sudden cardiac death suspected 24 hours after the 2nd vaccination


VAERS ID: 1236495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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 INC2021414222

Write-up: Unknown cause of death; Diarrhoea; Vomiting; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100034110. A 94-year-old female patient received second dose of bnt162b2 (COMIRNATY, Lot Number: ER7812) via an unspecified route of administration on 26Mar2021 as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient received first dose of Comirnaty on an unspecified date. The patient experienced diarrhea, vomiting, and unknown cause of death on an unspecified date. Outcome of diarrhea, vomiting was not recovered. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1236501 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Asthenia, Eastern Cooperative Oncology Group performance status, Eastern Cooperative Oncology Group performance status worsened, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: ECOG; Result Unstructured Data: Test Result:general condition worsened
CDC Split Type: DEPFIZER INC2021414227

Write-up: myocardial infarction; about nausea, weakness and recurrent vomiting, as well as associated deterioration of the general condition; about nausea, weakness and recurrent vomiting, as well as associated deterioration of the general condition; about nausea, weakness and recurrent vomiting, as well as associated deterioration of the general condition; about nausea, weakness and recurrent vomiting, as well as associated deterioration of the general condition; This is a spontaneous report received from a non-contactable consumer downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-CADR2021045796, Safety report unique identifier DE-PEI-202100033606. A 94-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 06Apr2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for Prophylactic vaccination. The patient medical history and concomitant medications were not reported. On 06Apr2021 the patient experienced acute myocardial infarction, nausea, weakness, vomiting, ECOG performance status; general condition worsened. The patient underwent lab tests and procedures which included eastern cooperative oncology group performance status: general condition worsened on 06Apr2021. The patient died on 10Apr2021. It was not reported if an autopsy was performed. Outcome of acute myocardial infarction was fatal, remaining events was not recovered. Case was reported as serious. Sender''s comments: Are you or the person concerned known of any allergies? If yes, which? unknown Information on risk factors or previous illnesses. Not known to me as an emergency doctor, Probably quite "sprightly" for his age ... / Patient became more and more weakened after a second vaccination, on 09Apr2021. Found on the morning of the 10Apr2021 sitting "hanging" on the chair, unconscious - short-term Cardiopulmonary resuscitation and termination in the presence of a living will, after consultation with the supervisor and in the alleged will of the patient. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1236502 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-04-02
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, General physical health deterioration, Haemorrhage, Hepatic cirrhosis, Multiple organ dysfunction syndrome, Respiratory distress
SMQs:, Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021414231

Write-up: Cirrhosis of the liver; Bleeding (took blood thinners) and heavily faeced.; general deterioration; Multifunction failure; heart failure; breathing difficulties; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021046038. Other case identifier numbers: DE-CADRPEI-2021046038 and DE-PEI-202100033818. A 93-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing atrial fibrillation, ongoing diabetes. The patient''s concomitant medications were not reported. Patient previously received bnt162b2 (COMIRNATY) on 17Feb2021 for covid-19 immunization. On 09Apr2021 the patient experienced Multi-organ failure , Heart failure. On 02Apr2021 the patient experienced Cirrhosis of the liver, impaired breathing. The general deterioration on an unspecified date. Bleeding (took blood thinners) and heavily faeced. The patient died on 09Apr2021. An autopsy was not performed. Outcome of Multi-organ failure, Heart failure was fatal, outcome of Cirrhosis of the liver, impaired breathing, and General condition decreased was not recovered, outcome of bleeding was unknown. The seriousness criteria of Cirrhosis of the liver was reported as hospitalization provided by RA. Case was reported as serious. Sender Comment (verbatim): Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses Diabetes, atrial fibrillation / 3 weeks after the 2nd vaccination. the general condition was probably a little worse, 4 weeks after that he had a strong one. Bleeding (took blood thinners) and heavily faeced. On the Intensive care unit was Multifunctional failure detected. All organs broken. 1 Dead a week later. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac failure; Multi organ failure


VAERS ID: 1236510 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Creutzfeldt-Jakob disease, Headache
SMQs:, Dementia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
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 INC2021415168

Write-up: Creutzfeldt-Jakob disease; headache; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 39961], license party for Comirnaty. A non-contactable consumer (patient''s neighbour) reported that a 61-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration as single dose for covid-19 immunisation, dose 1 in Mar2021 (beginning of March) (Lot number was not reported), dose 2 on an unspecified date (one- three weeks after dose 1) (Lot number was not reported). The patient medical history and concomitant medications were not reported. The patient was healthy before the vaccination. The patient had headache, went to hospital and died of creutzfeldt-jakob disease 07Apr2021 (four weeks after the first dose). It was not reported if an autopsy was performed. The outcome of event creutzfeldt-jakob disease was fatal. The outcome of event headache was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Creutzfeldt-Jakob disease


VAERS ID: 1236646 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-04-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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: COVID-19; Exertional dyspnea; Hypertension (HTA); Comments: HTA COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021414246

Write-up: Sudden death; malaise; vomiting; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA) manufacturer report number ES-AEMPS-819239. A 82-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 05Apr2021 (Batch/Lot Number: EW2239) as single dose for covid-19 immunisation. Medical history included covid-19 from Jan2021 to an unknown date, mild exertional dyspnoea, HTA for years (did not use the public system and there is no record in his history except for the administration of this vaccine). The patient''s concomitant medications were not reported. The patient experienced sudden death on 07Apr2021, malaise and vomiting on 06Apr2021. It is reported unexpected death on 07Apr2021 with no suspected diagnosis. He presented with non-specific symptoms such as malaise and vomiting the following day (06Apr2021), which a private doctor related to the vaccine dose of the previous day. It seems that days before the vaccination he presented mild exertional dyspnoea which was not studied, according to his family. According to his family, until yesterday he lived a normal independent life. Yesterday he was assessed by his usual private doctor. It seems that they related the symptoms to the recent vaccination. This morning he vomited on 2 occasions. Assessment at home at 09:45. On 07Apr2021, patient with clear signs of death. Lying supine in his bed. they report that the last time they saw him alive was at 5 am. At 7 am they found him on the sofa, lying on his right side (he had lividity in the right costal area) and then moved him to his bed. No signs of violence were observed, exits with no history or known immediate cause. The patient died on 07Apr2021. It was not reported if an autopsy was performed. The outcome of the event sudden death was fatal, outcome of the other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1239373 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood corticotrophin, Coma scale, Computerised tomogram, Epilepsy, Generalised tonic-clonic seizure, Heart rate increased, Hypercapnia, Hypoxia, Loss of consciousness, Magnetic resonance imaging, SARS-CoV-2 test, Tachycardia, Wheezing
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LASILIX [FUROSEMIDE]; DIFFU K; XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (COPD under O2); Oxygen therapy; Pulmonary embolism; Tobacco user
Allergies:
Diagnostic Lab Data: Test Name: CRH; Result Unstructured Data: Test Result:unknown; Test Name: glasgow; Result Unstructured Data: Test Result:3; Comments: At the entrance; Test Name: CT scan; Result Unstructured Data: Test Result:nothing acute; Test Name: tachycardia; Result Unstructured Data: Test Result:160/min; Test Name: MRI; Result Unstructured Data: Test Result:nothing acute; Test Name: COVID test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021380416

Write-up: epileptic seizures; 2 tonic-clonic seizures; lost consciousness; hypoxia; hypercapnia with wheezing; hypercapnia with wheezing; tachycardia at 160/min; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MA20211071. An 80-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunization. Medical history included tobacco user, COPD ( Chronic obstructive pulmonary disease) under O2, pulmonary embolism in 2018. Concomitant medications included furosemide (LASILIX), potassium chloride (DIFFU K) and rivaroxaban (XARELTO)'' all taken for an unspecified indication, start and stop date were not reported. The patient presented with epileptic seizures following vaccination with COMIRNATY on 09Mar2021. Also, on 09Mar2021, the patient lost consciousness at home and the ambulance service observed 2 tonicoclonic seizures. The patient received RIVOTRIL and was taken to the emergency room. At the entrance, the patient had Glasgow at 3, CT (computed tomography) scan and MRI ( magnetic resonance imaging) nothing acute, the patient wakes up gradually. COVID test negative. Subsequently, the patient was transferred to intensive care for hypoxia, hypercapnia with wheezing and tachycardia at 160/min. No more information on CRH. The evolution will be unfavorable thereafter, with death on 16Mar2021. The patient died on 16Mar2021 due to epileptic seizures, tonic-clonic seizures, lost consciousness and hypoxia. It was not reported if an autopsy was performed. The outcome of the events hypercapnia with wheezing and tachycardia at 160/min was unknown. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: epileptic seizures; tonic-clonic seizures; lost consciousness; hypoxia


VAERS ID: 1239465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Dementia Alzheimer''s type; Hypertension arterial; Thromboembolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021409426

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20211723. A 76-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 01Apr2021 (Lot Number: ET7205) as 0.3 mL, single for covid-19 immunization. Patient with advanced Alzheimer''s dementia for which she lives in a protected living unit, arterial hypertension and thromboembolic disease. She has been treated with rivaroxaban for upper limb thrombosis for a few months and presented with symptomatic Covid-19 infection in December 2020. Concomitant medications included rivaroxaban taken for thrombosis. The patient previously took rivaroxaban for deep vein thrombosis. No fall, no discomfort, no bleeding, no headache or other neurological sign. No digestive disturbances, no febrile episode, no abnormal signs were reported. The patient experienced sudden death on 03Apr2021 05:00. No particular sign on external examination of the body, no externalized bleeding. It was not reported if an autopsy was performed. The outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1239704 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative
CDC Split Type: GBPFIZER INC2021416276

Write-up: Clot blood; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104150730180020. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1688) first dose, via an unspecified route of administration on 07Jan2021, as a single dose for covid-19 immunisation. The patient medical history was not reported. It was unsure if the patient has had symptoms associated with COVID-19 and the patient was not enrolled in a clinical trial. Concomitant medications were not reported. The patient experienced clot blood on an unspecified date. It was reported that the paramedics tried to save the patient''s life. The patient underwent lab tests and procedures, which included a negative COVID-19 virus test on an unspecified date. The patient had not tested positive for covid-19 since having the vaccine. The patient died on 01Mar2021. It was not reported if an autopsy was performed and the reported cause of death was blood clot. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: blood clot


VAERS ID: 1239867 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Loss of consciousness, Vaccination complication
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: 2021-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; ATACAND; BELOC ZOK; FLUDEX [INDAPAMIDE]
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: No adverse event, Continue: [UNK], Comment: No significant Medical History
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Lost consciousness; Did not feel well; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Lost consciousness) and VACCINATION COMPLICATION (Did not feel well) in a 92-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300042460) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No significant Medical History). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN CARDIO), CANDESARTAN CILEXETIL (ATACAND), METOPROLOL SUCCINATE (BELOC ZOK) and INDAPAMIDE (FLUDEX [INDAPAMIDE]) for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Lost consciousness) (seriousness criterion death) and VACCINATION COMPLICATION (Did not feel well) (seriousness criterion death). The patient died on 10-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Resuscitation attempted after the patient lost consciousness was ineffective and the patient died approximately 3 hours after not feeling well. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a 92 year-old, male patient who received mRNA-1273 Vaccine and experienced malaise and loss of consciousness with a fatal outcome, a day after receiving first dose of vaccine. No medical hx or conmeds were provided. The fatal outcome may be related to the patient''s pre-existing comorbidities Very limited information has been reported at this time. No further information is expected. Reporter did not allow further contact; Sender''s Comments: This is a 92 year-old, male patient who received mRNA-1273 Vaccine and experienced malaise and loss of consciousness with a fatal outcome, a day after receiving first dose of vaccine. No medical hx or conmeds were provided. The fatal outcome may be related to the patient''s pre-existing comorbidities Very limited information has been reported at this time. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1240077 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-13
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Fall, Fibrin D dimer, Platelet count, Pulmonary embolism
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Accidents and injuries (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210314; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:$g20000 ng/ml; Test Date: 20210313; Test Name: Platelet count; Result Unstructured Data: Test Result:155 x10 9/l; Test Date: 20210319; Test Name: Platelet count; Result Unstructured Data: Test Result:120 x10 9/l; Test Date: 20210326; Test Name: Platelet count; Result Unstructured Data: Test Result:160 x10 9/l; Test Date: 20210329; Test Name: Platelet count; Result Unstructured Data: Test Result:235 x10 9/l
CDC Split Type: LUPFIZER INC2021414224

Write-up: cerebral haemorrhage caused by the fall; right upper lobe dorsal cruoric pulmonary embolism; fall caused by pulmonary embolism; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA). The regulatory authority report number is LU-ALMPS-202102221. A 91-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 06Mar2021 (Lot Number: EP2163) as 30 ug, single for covid-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient was with no medical history and no long term treatment at all. He lived autonomous at home. On 13MAr2021, he experienced right upper lobe dorsal cruoric pulmonary embolism leading to a fall. The patient was hospitalized. He received 2 doses of CLEXANE 40. The patient was diagnosed with cerebral haemorrhage close to admission, so CLEXANE was stopped and non anticoagulation was continued. On admission platelets were 155 G/L. It was stated that the fall had resulted in a cerebral haemorrhage. On 14Mar2021 : D-dimer $g 20000 ng/mL. On 19Mar2021 : lower value of platelets: 120 G/L. Then on 26Mar2021, Platelet count was 160 G/L, on 29Mar2021, platelets had increased to 235 G/L. The patient was hospitalized from 13Mar2021 to an unknown date. The patient experienced cerebral haemorrhage caused by the fall (death, hospitalization) on 13Mar2021 , right upper lobe dorsal cruoric pulmonary embolism (hospitalization, life threatening) on 13Mar2021 with outcome of not recovered , fall caused by pulmonary embolism (death, hospitalization) on 13Mar2021. On 07Apr2021, patient died. It was not reported if an autopsy was performed. comment: Further information asked about clinical evolution during hospital stay. Drug reaction for all reported events: Did reaction recur on readministration? NO. Assessment: Source, Method IMPUTABILITY METHOD. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fall caused by pulmonary embolism; cerebral haemorrhage caused by the fall


VAERS ID: 1240078 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-04-07
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIGOXIN; SPIRONOLACTONE; ATORVASTATIN; BUMETANIDE; APIXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cerebrovascular accident; Chronic heart failure; Diverticulosis; Osteoarthritis; Peripheral vascular disease; Senile amyloidosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC2021414230

Write-up: pulmonary embolism; This is a spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is MT-ADM-15042021. A 92-years-old male patient received bnt162b2 (Pfizer vaccine), via an unspecified route of administration on 21Mar2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 vaccination. Medical history included peripheral vascular disease, atrial fibrilation, cerebrovascular accident, chronic heart failure, senile amyloidosis, diverticulosis, osteoarthritis, all from an unknown date and unknown if ongoing. Concomitant medications included digoxin taken for atrial fibrillation; spironolactone taken for heart failure; atorvastatin taken for hypercholesterolaemia; bumetanide taken for heart failure; apixaban taken for atrial fibrillation. The patient experienced pulmonary embolism on 07Apr2021. Clinical course reported as follow: patient woke up in the morning and went to the bathroom and suffered a sudden death which was clinically highly suggestive of a dislodged thrombus resulting in massive/fatal pulmonary embolism. The suspect adverse drug reactions was fatal. The adverse drug reaction was not caused by a medication error. The patient died on 07Apr2021. It was not reported if an autopsy was performed. Sender''s Comments: Pulmonary embolism - unexpected, challenge: compatible, Re-challenge: RO, De-challenge: incocnlusive, Outcome C1. Sign and symptoms - compatible, lab test: L0. Alternate non-drug explanation; present. Outcome S1, outcome I1 uncertain. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1240322 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-03-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

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: COVID-19; Hemodialysis
Allergies:
Diagnostic Lab Data: Test Date: 20210329; Test Result: Lab test; Inconclusive; Test Date: 20201019; Test Name: corona (SARS-CoV-2 test positive) (23.1); Test Result: Positive; Result Unstructured Data: positive for COVID
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Apr-2021 and was forwarded to Moderna on 12-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Overlijden) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 19-Oct-2020 and Hemodialysis. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on 30-Mar-2021 The patient died on 30-Mar-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 19-Oct-2020, SARS-CoV-2 test positive: positive Positive. On 29-Mar-2021, Laboratory test: inconclusive (Inconclusive). For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1240323 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3647 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; CARVEDILOL; LANOXIN; INSPRA; ENTRESTO; FUROSEMIDE
Current Illness: Atrial fibrillation (Family History: false); Cardiac failure (Family History: false)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021409116

Write-up: Death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number NL-LRB-00502735. An 81-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Lot Number: ET3647) as single dose for covid-19 immunization. Medical history included ongoing atrial fibrillation, ongoing cardiac failure, both Family History: false. Concomitant medication included edoxaban tosilate (LIXIANA, tablet, 15mg) taken for atrial fibrillation from 2019; carvedilol (tablet, 3,125mg) taken for cardiomyopathy, atrial fibrillation from 2019; digoxin (LANOXIN, tablet, 0.125mg) taken for atrial fibrillation from 2019; eplerenone (INSPRA, tablet 25mg) taken for cardiomyopathy from 2019; sacubitril valsartan sodium hydrate (ENTRESTO, 24/26mg) taken for cardiomyopathy from 2019; furosemide taken for an unspecified indication from 2019. Past drug therapy included covid-19 vaccine Pfizer injection fluid 0.3ml on 19Feb2021 for covid-19 immunisation. The patient experienced death on 31Mar2021. The patient died on 31Mar2021. It was not reported if an autopsy was performed. The outcome of death is fatal. No follow-up attempts possible. No further information expected; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 19Feb2021 Death: Additional information ADR: died in his sleep Confounding factors : confounding factors: heart failure, atrial fibrillation COVID19: Previous COVID-19 infection: No; Reported Cause(s) of Death: death


VAERS ID: 1240324 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-03-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HALOPERIDOL; COLECALCIFEROL; LACTULOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210112; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021414334

Write-up: acute cardiac asthma; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00502974. A 93-years-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Mar2021 (Batch/Lot Number: ET3674) as single dose for covid-19 immunisation. Patient received the first dose on 04Mar2021. Medical history included covid-19 from 12Jan2021 to an unknown date. Concomitant medications included haloperidol; colecalciferol; lactulose. The patient experienced acute cardiac asthma (death, life threatening) on 31Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Jan2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Cardiac asthma


VAERS ID: 1240325 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-02
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Obesity (Family History: false)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021414337

Write-up: Sudden death; This is as spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is NL-LRB-00503149. An 84-years-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 27Mar2021 (Lot Number: ET3674) as single dose for covid-19 immunisation. Medical history included obesity. Family History was false. The patient''s concomitant medications were not reported. In all the years that the reporter had been a general practitioner, the reporter had never had an acute death. This woman was found dead in bed 5 days after Pfizer vaccine, no pre-existing disease. No Previous COVID-19 infection. The patient died on 02Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1240327 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: AMLODIPINE; COLECALCIFEROL; FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]; CYANOCOBALAMIN; TIOTROPIUM; AZELASTINE;FLUTICASONE; VENTOLIN [SALBUTAMOL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021414307

Write-up: Brain hemorrhage; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00504166. A 69-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included amlodipine, colecalciferol, beclometasone dipropionate, formoterol fumarate (FOSTER), cyanocobalamin, tiotropium, azelastine;fluticasone, salbutamol (VENTOLIN). The patient experienced brain hemorrhage on 09Apr2021 which resulting in death. The patient was dead on unspecified date. It was unknown if autopsy was done. The outcome of event brain hemorrhage was fatal. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Brain hemorrhage


VAERS ID: 1240328 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-03-09
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral amyloid angiopathy, Cerebral haemorrhage, Computerised tomogram
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210309; Test Name: CT scan; Result Unstructured Data: Test Result:a large intracerebral bleeding; Comments: Intracerebral bleeding deep in brain, possibly also cerebral amyloidangiopathy
CDC Split Type: NLPFIZER INC2021414321

Write-up: Intracerebral bleed; cerebral amyloid angiopathy; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is NL-LRB-00504560 A 89-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 22Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; rivaroxaban (tablet, Strength: 15mg), via an unspecified route of administration from 2018 (Batch/Lot number was not reported) to an unspecified date, at 1 dosage form (DF), 1x/day for Heart failure. Medical history included Heart failure, hypertension. Concomitant medication included lisinopril. The patient experienced intracerebral bleed (death) on 09Mar2021, cerebral amyloid angiopathy on 09Mar2021. The patient underwent lab tests and procedures which included computerised tomogram: a large intracerebral bleeding on 09Mar2021 (Intracerebral bleeding deep in brain, possibly also cerebral amyloid angiopathy). The action taken in response to the events for rivaroxaban was not applicable. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event intracerebral bleed was fatal. The outcome of event cerebral amyloid angiopathy was unknown. The clinical course was reported as follows: This serious spontaneous report from a physician concerns a female aged 89 years, with intracerebral bleed (death) following administration of covid-19 vaccine pfizer injection solution for covid 19 immunisation and rivaroxaban tablet 15mg for heart failure. The outcome of intracerebral bleed is fatal. CT scan showed a large intracerebral bleeding and possibly also cerebral amyloid angiopathy. Physician describes that hypertension and/or this amyloid angiopathy and/or the use of rivaroxaban all could be the cause of the bleeding. Reporter Comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; Intracerebrale bloeding; Additional information adverse reaction: large intracerebral haemorrhage deep in the brain, which may also occur with hypertension or possibly amyloid angiopathy (that is independent of vaccination) and aggravated by rivaroxaban use. confounding factors: hypertension, based on brain CT and age possibly also amyloid angiopathy; Previous COVID-19 infection: No; diagnostic procedures: CT scan brain. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no; Intracerebrale bloeding; Additional information adverse reaction: large intracerebral haemorrhage deep in the brain, which may also occur with hypertension or possibly amyloid angiopathy (that is independent of vaccination) and aggravated by rivaroxaban use. confounding factors: hypertension, based on brain CT and age possibly also amyloid angiopathy; Previous COVID-19 infection: No; diagnostic procedures: CT scan brain.; Reported Cause(s) of Death: intracerebral bleed


VAERS ID: 1240329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-13
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021414330

Write-up: cardiac arrest/passed away in her sleep; Nose bleeding; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00504985. An 87-year-old female patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunization; and second dose of BNT162B2 (COMIRNATY, batch/lot number and expiration date not provided), via an unspecified route of administration, on 11Mar2021, at single dose, for COVID-19 immunization. Co-suspect drugs included acenocoumarol (tablet) from 2000 and ongoing at 1 mg, 1 or 2 a day for heart rhythm disorder; verapamil (tablet) from 2000 and ongoing at 40 mg, three times a day for heart rhythm disorder. Medical history was not reported. Concomitant medications included paracetamol (tablet). On 13Feb2021 (9 days after the 1st vaccination) and 16Feb2021 patient had a nosebleed. Patient placed in hospital tampon that was removed by general practitioner on 16Feb2021. The bleeding on 13Feb2021 was severe. On 13Mar2021 (2 days after the 2nd vaccination) patient had a nosebleed again. On 21Mar2021 04:00 thereafter. On 23Mar2021 at 02:00, 06:40 and 11:50. Patient was able to stop this herself without a tampon. The patient passed away in her sleep on 24Mar2021 around 02:00. The action taken in response to event for acenocoumarol and verapamil was dose not changed. The outcome of event "nose bleeding" was unknown, of event "cardiac arrest" was fatal. The medical examiner has established cardiac arrest as the cause of death. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1240330 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-05
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder (Confounding factors)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021414326

Write-up: My mother passed away; This is as spontaneous report received from a contactable consumer downloaded from the Medicine Agency (MA) -WEB NL-LRB-00505367. An 89-year-old female patient received the second dose of BNT162b2 (COMIRNATY; lot number: ER7812), on 25Mar2021 at single dose for COVID-19 immunisation. Medical history included confounding factors: with cardiological burden. Concomitant medications were not reported. The patient previously took the first dose of BNT162b2 injection fluid 0,3ml on 16Feb2021 for covid-19 immunisation and experienced no ADRs. The patient passed away on 05Apr2021, 11 days after start. The patient died on 05Apr2021. Diagnostic procedures: no, but the reporter did pass it on to the General practitioner, who said that it was unrelated. Reporter thought it was worth mentioning because it was 10 days after the vaccination (as reported) that the mother died. There was no proof that it was not related to the vaccination. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: My mother passed away


VAERS ID: 1240331 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Dyspnoea, Inappropriate schedule of product administration, Malaise, Off label use, SARS-CoV-2 test, Swelling face
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL TARTRATE; NORTRIPTYLINE HYDROCHLORIDE; EUTHYROX; OMEPRAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (disease symptoms: quite)
Allergies:
Diagnostic Lab Data: Test Date: 20200430; Test Name: corona, confirmed with test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021414344

Write-up: Heart failure; Dyspnoea; Swelling face; Not feeling well; 1st dose on 09Feb2021, 2nd dose on 23Feb2021; 1st dose on 09Feb2021, 2nd dose on 23Feb2021; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00505445. This is first of two reports. An 82-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 23Feb2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included covid-19 from 30Apr2020 (disease symptoms: quite). Concomitant medications included metoprolol tartrate; nortriptyline hydrochloride; levothyroxine sodium (EUTHYROX); omeprazole (OMEPRAZOL). The patient previously received the first dose of bnt162b2 on 09Feb2021 at 0.3ml single for COVID-19 immunization, and experienced dyspnoea and swollen. The patient experienced heart failure (death) on 01Mar2021, dyspnoea (death) on 01Mar2021, swelling face (death) on 01Mar2021, not feeling well (death) on 01Mar2021. The patient underwent lab tests and procedures which included corona, confirmed with test: positive on 30Apr2020. Therapeutic measures were taken as a result of heart failure, dyspnoea, swelling face, which included treatment with Furosemide. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021420247 same patient, different dose; Reported Cause(s) of Death: Heart failure; Dyspnoea; Swelling face; Not feeling well


VAERS ID: 1240334 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-30
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Depressed level of consciousness, Hemiplegia, Platelet count, Pneumonia, Respiratory failure, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), 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 (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: LIPITOR [ATORVASTATIN]; ESBRIET; PROSCAR; ACETYLSALISYLSYRE ACTAVIS; NEXIUM [ESOMEPRAZOLE MAGNESIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal); Fibrosis lung; Hypercholesterolaemia; Hyperplasia of prostate; Platelet abnormalities
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:120 x10 9/l; Test Date: 20210401; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:60 x10 9/l; Test Date: 20210330; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: NOPFIZER INC2021414237

Write-up: Admission with severe pneumonia 3 weeks after the last vaccine dose.; dies of respiratory failure; After 2 days of ongoing antibiotics, there is a decrease in consciousness and half-sided paralysis; After 2 days of ongoing antibiotics, there is a decrease in consciousness and half-sided paralysis; thrombocytopenia, intracerebral thrombosis; thrombocytopenia, intracerebral thrombosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NO-NOMAADVRE-FHI-2021-Ug4wdy Safety Report Unique Identifier NO-NOMAADVRE-E2B_00025961. A 75-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 10Mar2021 12:00 (Batch/Lot Number: EP9605) as SINGLE DOSE for covid-19 immunization, at the age of vaccination of 75 years old. Medical history included FIBROSIS LUNG from 2019 to an unknown date, hypercholesterolaemia, HYPERPLASIA OF PROSTATE , antiplatelet and ACID REFLUX (ESOPHAGEAL). Historical vaccine included first dose of comirnaty for covid-19 immunisation. Concomitant medications included atorvastatin (LIPITOR) taken for hypercholesterolaemia; pirfenidone (ESBRIET) taken for FIBROSIS LUNG from 2019 to 31Mar2021; finasteride (PROSCAR) taken for HYPERPLASIA OF PROSTATE; acetylsalicylic acid (ACETYLSALISYLSYRE ACTAVIS) taken for antiplatelet therapy; esomeprazole magnesium (NEXIUM) taken for ACID REFLUX (ESOPHAGEAL). The patient experienced admission with severe pneumonia 3 weeks after the last vaccine dose on 30Mar2021, thrombocytopenia, intracerebral thrombosis on 30Mar2021, died of respiratory failure on 01Apr2021, after 2 days of ongoing antibiotics, there was a decrease in consciousness and half-sided paralysis on 01Apr2021, thrombocytopenia, intracerebral thrombosis on 01Apr2021. The patient underwent lab tests which included platelet count: 120 x10 9/l on 30Mar2021, platelet count: 60 x10 9/l on 01Apr2021, COVID-19 PCR TEST: negative on 30Mar2021. Therapeutic measures were taken as a result of admission with severe pneumonia 3 weeks after the last vaccine dose. The patient died on 01Apr2021. It was not reported if an autopsy was performed. Reported on 30Mar2021 the patient developed severe PNEUMONIA and was admitted to the hospital. The thrombocyte count was 120 x 10 9/L. On 01Apr2021, after two days with antibiotic therapy, the patient developed DEPRESSED LEVEL OF CONSCIOUSNESS, PARALYSIS ONE SIDE OF BODY, THROMBOCYTOPENIA, CEREBRAL THROMBOSIS. The patient was not susceptible for thrombectomy due to widespread infarction changes at the time of diagnosis. Terminated intensive care therapy due to poor prospects for survival. The patient died of RESPIRATORY FAILURE. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. This case was received from a Physician. The reporting physician states that the event was reported due to pronounced thrombosis with low platelet count. Relatedness of drug to reactions:Source of assessment: Regional Pharmacovigilance Center. COMIRNATY the Result of Assessment was Possible for ALL EVENTS. Sender Comment: Since the vaccine is new, it is subject to special surveillance to detect new safety information as quickly as possible. It is especially important that serious and / or unusual side effects are reported. Your message is therefore important to increase knowledge about side effects that have not been discovered in the studies, and is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports after coronary vaccination in the adverse reaction register are processed by the agency in collaboration with the information service. The agency publishes weekly summaries of reports of suspected side effects after vaccination. As additional information about the incident has been requested, the adverse reaction message is currently being processed. When new information is received, we will update the message. Reporter comment: 08Apr2021 agency/information service: requested additional information. If new medical information is received, report will be updated.Information in product tab:Dose no. in series: 2 Vaccination site: LeftArm. 10Mar2021:12:00. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: RESPIRATION FAILURE


VAERS ID: 1240342 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hospice care; Idiopathic pulmonary fibrosis
Preexisting Conditions: Medical History/Concurrent Conditions: Oxygen therapy (home oxygen therapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021414229

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is PL-URPL-3-511-2021. A 71-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 01Apr2021 16:47 (Batch/Lot Number: EW8904; Expiration Date: 04Apr2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hospice care , ongoing idiopathic pulmonary fibrosis , oxygen therapy with home oxygen therapy. The patient''s concomitant medications were not reported. A patient with multimorbidity, including spontaneous pulmonary fibrosis, under home hospice care on home oxygen therapy, died after returning home from vaccination, which the family informed the management of the clinic today and presented a certificate from the doctor stating the death. The patient died on 01Apr2021 at 18:00. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1240344 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Essential hypertension, Type 2 diabetes mellitus, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 24
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 INC2021414226

Write-up: Vomiting; - non-insulin dependent diabetes mellitus; - essential hypertension; This is as spontaneous report received from a contactable Physician downloaded from a regulatory authority-WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.1.210.2021. An 83-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 25Mar2021 09:57 (Lot Number: ET3674; Expiration Date: 28Mar2021) as 0.3 mL, single for covid-19 immunisation. The patient was not Pregnant at Time of Vaccination. The patient medical history and the concomitant medications were not reported. On 26Mar2021, the patient died on the first day after vaccination. Cause of death: - non-insulin dependent diabetes mellitus; - essential hypertension. The patient was accompanied by vomiting on 26Mar2021. An autopsy was not performed. The reporting physician assessed the side effects as serious. URPL classified the application as heavy. URPL''s comments: Vomiting is an unexpected adverse reaction. The temporal relationship speaks for a cause-and-effect relationship. The reporting physician assessed the side effects as serious. URPL classified the application as heavy. Relatedness of drug to reaction(s)/event(s) by a regulatory authority; Reported Cause(s) of Death: Vomiting; Essential (primary) hypertension; Type 2 diabetes mellitus


VAERS ID: 1240345 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Epigastric discomfort, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021414232

Write-up: Sudden death; Epigastric discomfort; This is as spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.1.53.2021. A 60-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 intramuscular on 10Feb2021 (Batch/Lot number was not reported) as 0.3 mL, single for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of COMIRNATY intramuscular at 0.3 ml on 20Jan2021 for COVID-19 IMMUNISATION. The patient''s brother died suddenly probably several years earlier. The patient was not pregnant during the period of use of the drug. On 11Feb2021, the patient experienced epigastric discomfort (death), Sudden death (death). The patient died on 11Feb2021. It was unknown if an autopsy was performed. It was reported that the patient received Comirnaty vaccine (0.3ml, intramuscular, dosing - interval 3 weeks) from 20Jan2021 to 10Feb2021. The drug was not used in the past. Sudden death. The patient, a (polish nursing home) worker, was vaccinated in the presence of the reporting physician with the 2nd dose of Comirnaty, 0.3ml. No side effects on the day of administration. On the following day at work she reported epigastric discomfort, which she associated with a heavy meal. She returned home on her own power. She probably did not report her complaints to her physician (the reporting person was not her family physician). She was found by her family at home on the floor with no signs of life. The reporting person did not know if the patient was treated for chronic conditions and what medications she used. Family history - brother died suddenly probably several years earlier. Result: death. The reporting physician assessed the adverse reaction as serious (death). polish HA classified the report as serious. The outcome of the events was fatal. Health Authority Comment: Epigastric pain is an unexpected adverse reaction not reported in section 4.8 of the summary of product characteristics of Comirnaty. Reported by a physician who was at the time of vaccination of the patient, does not have information on possible chronic medical conditions and medication used, does not know if an autopsy was performed, and does not provide the lot number and expiry date of the vaccine. The description provided includes the occurrence of an adverse reaction, but this cannot be confirmed due to insufficient information - data cannot be completed or verified. Association not assessable /not classifiable. The reporting physician assessed the side effect as serious (death). Polish HA classified the report as serious. No follow-up attempts are possible. Information on lot/batch numbers cannot be obtained. ; Reported Cause(s) of Death: Epigastric discomfort; Sudden death


VAERS ID: 1240346 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Body temperature, Body temperature increased, COVID-19, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (from 30 years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20210306; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade
CDC Split Type: PLPFIZER INC2021414332

Write-up: COVID-19 virus test positive; Weakness; Body temperature increased/ 38 centigrade; This is a spontaneous report received from a contactable consumer (patient''s son) downloaded from the Regulatory Authority (RA). The regulatory authority report number is PL-URPL-DML-MLP.4401.2.190.2021. A 73-years-old female patient received BNT162B2 (COMIRNATY), intramuscular on 03Mar2021 (Batch/Lot Number: ER2659) as single dose for covid-19 immunisation. Medical history included diabetes from 30 years ago. The patient''s concomitant medications were not reported. Patient was not pregnant during the period of taking the drug. From 06Mar2021 there was a weakening, increased body temperature 38 centigrade. On 08Mar2021, a medical rescue team performed the COVID-19 virus test (positive), did not take the patient to the hospital. On 12Mar2021 21:00 (9 days from the administration) patient died. An autopsy was not performed. The reporting person did not classified seriousness of the adverse reactions. The event outcome for events was fatal. Sender comment: On 26Mar2021, additional information was obtained during a telephone conversation (it was added to the notification) and the statistical number of the death was sent by e-mail. Until 29Mar2021 no response was received. Pyrexia is an expected adverse reaction listed in section 4.8 of COMIRNATY Summary of Product Characteristics. Asthenia is an unexpected side effect not included in the Summary of the Suspected Drug. There is a time relationship between drug administration and the occurrence of side effects. Due to the lack of detailed information (autopsy results, health history, medications taken, etc.), it cannot be ruled out that a factor other than the administered vaccine may have contributed to the death. The reporting person did not classify the seriousness of the adverse reactions. Company classified the notification as serious (death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Weakness; Body temperature increased; COVID-19 virus test positive


VAERS ID: 1240347 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Dyspnoea, Feeling abnormal, Pneumonia
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: chest x-ray; Result Unstructured Data: Test Result:Good condition
CDC Split Type: PLPFIZER INC2021414327

Write-up: Suspicion of mild pneumonia; Brain fog; Breathing problems/Respiratory problems; This is a spontaneous report received from a contactable consumer (the son of the patient) downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is PL-URPL-DML-MLP.4401.2.23.2021. A 85-year-old male patient received the first dose of bnt162b2 (Pfizer vaccine), via an unspecified route of administration on 18Jan2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced suspicion of mild pneumonia, brain fog and breathing problems on 18Jan2021. The patient developed respiratory problems, brain fog on 18Jan2021. The doctor recommended a chest X-ray (good condition), a strong antibiotic, as mild pneumonia was suspected. The patient underwent lab tests and procedures which included chest x-ray: good condition in 2021. The outcome of the events was fatal. The patient died on 09Feb2021 due to events. An autopsy was not performed. Sender comment: Respiratory problems, brain fog, pneumonia are unexpected adverse reactions not reported in section 4.8 of the Pfizer vaccine summary of product characteristics. There is a temporal relationship between the administration of the medicine and the occurrence of the adverse reactions. The possibility that a factor other than the suspected medication may have contributed to the reported adverse reactions cannot be excluded. The reporter did not classify the seriousness of the side effect. URPL classified the report as severe (death). Assessment for all reported events: Source NCA, Method WHO-UMC, Result Possible.; Reported Cause(s) of Death: Suspicion of mild pneumonia; Brain fog; Breathing problems/Respiratory problems


VAERS ID: 1240370 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMIODARONE; ALLOPURINOL; FLUOXETINE; ACETYLSALICYLIC ACID; PANTOPRAZOLE; DIAZEPAM; FUROSEMIDE; SPIRONOLACTONE; ATORVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021409144

Write-up: Anaphylactic reaction; This is a spontaneous report from a contactable physician and an other HCP downloaded from a regulatory authority-WEB. The Regulatory Authority number: PT-INFARMED-J202104-629. A 61-year-old female patient received first dose of bnt162b2 (COMIRNATY; solution for injection; Batch/Lot Number: EW2243) via intramuscular on 08Apr2021 at 0.3 mL single for COVID-19 immunisation. The patient medical history included advanced stage cardiac disease. The patient was being followed at a palliative care unit of a central hospital. Concomitant medication included amiodarone, allopurinol, fluoxetine, acetylsalicylic acid, pantoprazole, diazepam, furosemide, spironolactone, atorvastatin. The patient was schedule for two doses of vaccine with an interval of at least 21 days between each dose. On 08Apr2021 after receiving the first dose, the patient experienced anaphylaxis reaction. A history of adverse reaction for any drug is unknown. There was no medication error. The event treatment was implemented through the specific anaphylaxis treatment protocol. The adverse picture lasted 2 hours, ending up the patient dying. Evolution of ADR: Death. The patient died on 08Apr2021. It was reported that an autopsy will be performed to determine the cause of death. Autopsy results were not available at the time of the report. Reporter comments: Concomitant Medication-Furosemide, Spironolactone, Amiodarone, ASA, Atorvastatin, Diazepam, fluxetina, pantolprazole, alop. Did Medication Error occur? -No. The reporter assessed relatedness of COMIRNATY to anaphylactic reaction as probable, method of assessment was unknown. No follow-up attempts possible. No further information expected. Follow-up (14Apr2021 and 15Apr2021): This follow-up report is being submitted to amend previously reported information: Listedness amendment. This is a follow-up to notifiy that case 2021409144 and 2021390006 are duplicates. All subsequent follow-up information will be reported under manufacturer report number AER 2021409144. New Information received from the regulatory authority, includes confirmation that cases 2021409144 and 2021390006 correspond to the same case. New information also included: reporter data, suspect drug data, medical history and clinical course details. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Anaphylactic reaction


VAERS ID: 1240371 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Death, Diarrhoea, Dyspnoea, Hyperhidrosis, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 9
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: ZOLPIDEM; QUETIAPINE; LORAZEPAM; PANTOPRAZOLE; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bedridden (totally dependent for activities of daily living with feeding by nasogastric tube); Dementia (probable diagnosis - awaiting neurological consultation)
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: oxygen saturation; Result Unstructured Data: Test Result:low
CDC Split Type: PTPFIZER INC2021414336

Write-up: Death; Bulky liquid ejection; Intense sweating; Difficulty in breathing; Low oxygen saturation; Apathetic, little response to external stimuli; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is PT-INFARMED-R202104-584. A 87-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 25Mar2021 (Lot Number: ER9470) as 0.3mL, single for covid-19 immunisation. Medical history included atrial fibrillation; suspected dementia (probable diagnosis - awaiting neurological consultation); bedridden user, totally dependent for activities of daily living with feeding by nasogastric tube. Concomitant medications included zolpidem; quetiapine; lorazepam; pantoprazole; apixaban (ELIQUIS), all taken for an unspecified indication, start and stop date were not reported. 48 hours after vaccination on 27Mar2021, the patient was apathetic, responding little to external stimuli. She did not present fever or other clinical alterations. On the 10th day after the vaccination on 04Apr2021, she presented bulky liquid discharge, intense sweating and difficulty breathing. The caregiver reported low oxygen saturation, so she called emergency services and the patient was hospitalized. Death occurred the following day, 11 days after the administration of the vaccine on 05Apr2021. The patient died on 05Apr2021. 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: Death; Apathetic, little response to external stimuli; Bulky liquid ejection; Intense sweating; Difficulty in breathing; Low oxygen saturation


VAERS ID: 1240407 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FURIX [FUROSEMIDE]; OXYCODONE; ENALAPRIL; VOLTAREN [DICLOFENAC SODIUM]; METFORMIN; TOUJEO; OMEPRAZOLE; INSULIN LISPRO SANOFI
Current Illness: Hypertension; Multiple sclerosis; Obesity; Pancreatic cancer metastatic (liver and spleen); Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Impaired liver function; Skin disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021414361

Write-up: thrombocytopenia; bilateral high deep vein thrombosis of both veins saphena magna; This is a spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is SE-MPA-2021-026203, other case identifier is SE-VISMA-1618071388697. This physician reported events for both doses. This is first of two reports. A 62-year-old female patient received the second dose of BNT162B2 (COMIRNATY, batch/lot number: unknown), via an unspecified route of administration on 2021 (at an unspecified age) at single dose for COVID-19 immunisation. Medical history included pancreatic cancer metastatic (liver and spleen) detected in Feb2021 and ongoing, ongoing type 2 diabetes mellitus, ongoing hypertension, ongoing obesity, ongoing multiple sclerosis, skin disease with blisters on the skin. The patient did not have any treatment for the multiple sclerosis and she had impaired liver function so she had not started any cancer treatment. Concomitant medications included furosemide (FURIX), oxycodone, enalapril, diclofenac sodium (VOLTAREN), metformin, insulin glargine (TOUJEO), omeprazole, insulin lispro (INSULIN LISPRO SANOFI). The patient previously took the first dose of BNT162B2 (COMIRNATY, batch/lot number: unknown), via an unspecified route of administration on 2021 (at an unspecified age) at single dose for COVID-19 immunisation, and experienced thrombocytopenia. The patient experienced trombocytopenia (death) on 2021, bilateral high deep vein thrombosis of both veins saphena magna (death) on 2021. The reporter stated that the thrombocytopenia started 8 days after the first dose of BNT162B2. Four weeks after the first dose the patient received the second dose of BNT162B2 and four days after that the patient started to get pain in her legs. A large bluish swelling was detected on the right thigh which has ruptured and emptied of blood and pus, the patient was inserted on ceftriaxone. The patient has previously had a skin disease with blisters on the skin. Suspicion initially of erysipelas. Three days later (one week after the second dose of BNT162B2) multiple thromboses in legs are detected bilaterally. Sharp deterioration of physical general condition. Large hematoma with thrombosis. According to the reporter DIC is suspected. Systemic organ failure. Rapid deterioration the next 1-2 days and the patient died 9 days after the second dose of BNT162B2. The outcome of the events was fatal. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. Report was assessed as serious due to death. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021420065 the same reporter/patient, different event/dose; Reported Cause(s) of Death: Thrombocytopenia; bilateral high deep vein thrombosis of both veins saphena magna


VAERS ID: 1240408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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: FURIX [FUROSEMIDE]; OXYCODONE; ENALAPRIL; VOLTAREN [DICLOFENAC SODIUM]; METFORMIN; TOUJEO; OMEPRAZOLE; INSULIN LISPRO SANOFI
Current Illness: Hypertension; Multiple sclerosis; Obesity; Pancreatic cancer metastatic (liver and spleen); Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Skin disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021420065

Write-up: Thrombocytopenia; This is a spontaneous report from a contactable physician. This is the second of two reports. The first report is a report downloaded from a regulatory authority-WEB. The regulatory authority report number is SE-MPA-2021-026203, other case identifier is SE-VISMA-1618071388697. A 62-year-old female patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number: unknown), via an unspecified route of administration on 2021 (at an unspecified age) at single dose for COVID-19 immunisation. Medical history included pancreatic cancer metastatic (liver and spleen) detected in Feb2021 and ongoing, ongoing type 2 diabetes mellitus, ongoing hypertension, ongoing obesity, ongoing multiple sclerosis, skin disease with blisters on the skin. The patient did not have any treatment for the multiple sclerosis and she had impaired liver function so she had not started any cancer treatment. Concomitant medications included furosemide (FURIX), oxycodone, enalapril, diclofenac sodium (VOLTAREN), metformin, insulin glargine (TOUJEO), omeprazole, insulin lispro (INSULIN LISPRO SANOFI). The patient experienced thrombocytopenia on 2021. The reporter stated that the thrombocytopenia started 8 days after the first dose of BNT162B2. The outcome of the event was fatal. The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. Report was assessed as serious due to death. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021414361 the same patient/reporter, different event/dose; Reported Cause(s) of Death: Thrombocytopenia


VAERS ID: 1241407 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / 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: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: SARS-CoV-2 test positive (on 29Dec she was discharged with a high titer); Comments:17.12.20 CoV positiv (155cm, 50kg; 2. )
Allergies:
Diagnostic Lab Data: Test Date: 20201217; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: ATPFIZER INC2021420726

Write-up: Death; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority (RA), regulatory authority number AT-BASGAGES-2021-21955. A 94-year-old female patient received the second dose of BNT162B2 (COMIRNATY) on 03Feb2021 via Intramuscular at single dose for COVID-19 immunisation. The patient ''was Covid-19 positive on 17Dec2020, on 29Dec she was discharged with a high titer. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 13Jan2021 for COVID-19 immunisation. On 05Feb2021 00:15, the patient experienced death. Outcome of the event was fatal. It is unknown if autopsy was done. The pharmacist stated the connection between the side effects as ''possible / not assessable''. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1241416 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEBIVOLOL; TEMESTA [LORAZEPAM]; ORAP; BURINEX; L-THYROXINE [LEVOTHYROXINE SODIUM]; QUETIAPINE; SEDISTRESS; OXYBUTYNIN; MONURIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021420712

Write-up: died in her sleep; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB BE-FAMHP-DHH-N2021-87115. A 63-year-old female patient received second dose of BNT162B2 (COMIRNATY, Lot: ET3674) on 01Apr2021 09:30 at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included nebivolol, lorazepam (TEMESTA), pimozide (ORAP), bumetanide (BURINEX), levothyroxine sodium (L-THYROXINE), quetiapine, passiflora incarnata (SEDISTRESS), oxybutynin, fosfomycin trometamol (MONURIL). The patient experienced died in sleep on 02Apr2021. It was reported that patient lived in an institution for disabled people. She spends the day normally without side effects and was found dead at the end of the night around 6 a.m. The patient died on 02Apr2021. It was unknown if autopsy was performed. Event assessment: Regulatory authority/Comirnaty/Death/unclassified. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: died in her sleep


VAERS ID: 1241417 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemoptysis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COVERAM; METOPROLOL; SPIRIVA; SERETIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COPD; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021420704

Write-up: found lifeless, massive hemoptysis; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB BE-FAMHP-DHH-N2021-87182. An 82-year-old male patient received first dose of BNT162B2 (COMIRNATY) on 01Apr2021 at single dose for COVID-19 immunisation. Medical history included COPD, arterial hypertension, obesity. Concomitant medications included amlodipine besilate, perindopril arginine (COVERAM), metoprolol, tiotropium bromide (SPIRIVA), fluticasone propionate, salmeterol xinafoate (SERETIDE). The patient experienced hemoptysis and was died on 02Apr2021, reported as found lifeless, massive hemoptysis. The patient died on 02Apr2021. Autopsy was performed and result was not available. Relatedness of drug to reaction/event for COMIRNATY: Source of assessment: a regulatory authority, unclassified. Reporter comment: Treatment - Yes resuscitation standard ALS protocol. Evolution of the ADR- Died. Situations - Other: I suspect no relationship with the vaccine. Examinations - Autopsy is performed. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reporter''s Comments: Treatment - Yes resuscitation standard ALS protocol Evolution of the ADR - Died Situations - Other: I suspect no relationship with the vaccine Examinations - Autopsy is performed.; Sender''s Comments: Based on the current available information, the event hemoptysis is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: found lifeless, massive hemoptysis


VAERS ID: 1241418 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, venous (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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: METOPROLOL; COVERAM; SERETIDE; SPIRIVA HANDIHALER; LORMETAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Hypertension; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Covid test; Test Result: Positive ; Comments: After death COVID positivity determined
CDC Split Type: BEPFIZER INC2021420699

Write-up: Acute pulmonary embolism resulting in death; COVID positivity; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is BE-FAMHP-DHH-N2021-87195. An 81-years-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (Lot Number: ER9480) as single dose for COVID-19 vaccination. Medical history included COPD, hypertension and obesity. Concomitant medication(s) included metoprolol; amlodipine besilate, perindopril arginine (COVERAM); fluticasone propionate, salmeterol xinafoate (SERETIDE); tiotropium bromide (SPIRIVA HANDIHALER); lormetazepam. The patient experienced acute pulmonary embolism resulting in death on 02Apr2021. There was no treatment. After death COVID positivity determined (Apr2021). The patient died on 02Apr2021. An autopsy was performed and results were not provided. The outcome of COVID positivity was unknown. Reporter''s comments: Treatment - No Evolution of the ADR - Deceased Examinations - autopsy performed After death COVID positivity determined No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: acute pulmonary embolism


VAERS ID: 1241420 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Chest discomfort
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Clotting disorder (Was followed cardiologically before the vaccine due to clotting issues in the family)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021423351

Write-up: Something with her heart?; She apparently had complaints of pressure on the chest and died afterwards; This is a spontaneous report from a contactable consumer. An elderly female patient received bnt162b2 (COMIRNATY), at single dose on Apr2021 (Batch/Lot Number: Unknown as it was not available/provided to reporter at the time of report completion) for covid-19 immunisation. Medical history included being followed cardiologically before the vaccine due to clotting issues in the family. The patient''s concomitant medications were not reported. The patient died 4 days after administration of the Pfizer-Biontech COVID vaccine. She apparently had complaints of pressure on the chest in Apr2021 with outcome of unknown. The patient died on unknown date in Apr2021. The cause of death was reported by the reporter as ''something with her heart?''. It was unknown if autopsy was performed. Event occurred in a country different from that of the reporter. This may be a duplicate if the reporter also submitted directly to his/her local agency. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: Something with her heart?


VAERS ID: 1241450 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Asthenia, Death, Diarrhoea, General physical health deterioration, Nausea
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021420822

Write-up: death/collapsed tonight; severe joint discomfort/joint pain; general weakness; Very limited AZ/general condition reduced; Diarrhoea; Nausea; This is a spontaneous report from a contactable physician downloaded from the regulatory authority DE-PEI-202100034460. An 82-year-old female patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 06Apr2021 at single dose for COVID-19 immunisation. Medical history included COVID-19 from Apr2020. Concomitant medications were unknown. On 06Apr2021, the patient experienced nausea, diarrhoea, severe joint discomfort/joint pain, general weakness, general condition reduced/ very limited AZ. On 12Apr2021 the patient experienced death/collapsed tonight. It was unknown if autopsy was performed. Outcome of the events severe joint discomfort/joint pain, general weakness, very limited AZ/general condition reduced, Diarrhoea, Nausea was unknown, of the event death/collapsed tonight was fatal. This report was serious - death, medically significant. Sender Comment: No fever (under paracetamol/ibu/novalgin). The vital parameters on Friday were normal. Over the weekend, very reduced AZ, collapsed last night, the emergency doctor could only determine death. Relatedness of drug to reaction(s)/event(s) for all events: Source of assessment regulatory authority, Result of Assessment D. Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1241454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021431608

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. This is a report received from Regulatory Authority, Regulatory authority report number: DE-PEI-202100035806.This spontaneous report was received from a Physician and concerns a patient (Male), age: 86 years.This report is serious - death. The patient''s medical history and concurrent conditions included: no relevant medical history reported. The patient''s weight was not reported, and height was not reported. The patient was treated with Comirnaty (mRNA TOZINAMERAN), at 0.3ml single dose on 24Mae2021.Concomitant medications were: no concomitant medication reported.On 25Mar2021 the patient experienced death. The patient''s outcome was: fatal for death.Causality assessment was provided as Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1241460 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Death, Decreased appetite, Dyspnoea, Fatigue, Peripheral circulatory failure
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Rheumatism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021420808

Write-up: Unknown cause of death; circulation complaints/ Peripheral circulatory failure/ Collapse circulatory peripheral; Pronounced fatigue, extremely tired/ fatigue/ Tiredness; dyspnoea/ breathing problems/ Shortness of breath; loss of appetite/ had little appetite/ Anorexia; pain in the abdomen shortly before death/ stomach ache/ Belly ache/ Abdominal pain; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021046493. An 87-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 17Mar2021 as single dose for covid-19 immunisation. Medical history included ongoing rheumatism. The patient''s concomitant medications were not reported. The patient previously took 0.3 ML bnt162b2 (COMIRNATY) for covid-19 immunisation on 04Feb2021. The patient experienced unknown cause of death (death) (death) on 11Apr2021, pronounced fatigue, extremely tired/ fatigue/ tiredness, dyspnoea/ breathing problems/ shortness of breath, loss of appetite/ had little appetite/ anorexia, circulation complaints/ peripheral circulatory failure/ collapse circulatory peripheral, and pain in the abdomen shortly before death/ stomach ache/ belly ache/ abdominal pain and all on 18Mar2021. Patient had breathing problems after the second vaccination. he was extremely tired and had little appetite. The evening before his death, he complained of stomach ache. In general, patient was a very active retiree. He had a balanced diet and had been cycling and walking a lot. The outcomes of events fatigue, dyspnoea, decreased appetite, peripheral circulatory failure and abdominal pain were not recovered. The patient died on 11Apr2021. An autopsy was not performed. Information on the lot/batch number has been requested. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No, no history of allergies.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1241461 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-04
Onset:2021-04-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Chest pain, Dyspnoea, Incorrect route of product administration, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021420802

Write-up: inappropriate route of administration; The patient had received the first Biontech vaccination on 04Apr2021. No previous illness, no long-term medication. On 08Apr2021 there was pulseless electrical activity with 1.5h resuscitation DD LAE; Dyspnoea; Backache; Thorax pain; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021046517. A 71-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intravenous on 04Apr2021 (Batch/Lot Number: Unknown) as SIGNLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced the patient had received the first biontech vaccination on 04apr2021. no previous illness, no long-term medication. on 08apr2021 there was pulseless electrical activity with 1.5h resuscitation dd lae, dyspnoea on 07Apr2021, backache on 07Apr2021, thorax pain on 07Apr2021, inappropriate route of administration on an unspecified date. At the 07Apr2021 Back pain, chest pain, dyspnoea, no evidence of cardiac genesis at the family doctor.On 08Apr2021 PEA, 1.5h resuscitation without ROSC. If there is no CO2 via the endotracheal tube Especially LAE, start of lysis. The patient died on 08Apr2021. It was not reported if an autopsy was performed. Outcome of for Pulmonary embolism was fatal, of Back pain, chest pain and dyspnoea was not recovered. The seriousness criteria of Pulmonary embolism was death. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1241462 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Blood pressure measurement, Cardiac failure, Peripheral circulatory failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:high; Comments: well controlled
CDC Split Type: DEPFIZER INC2021420798

Write-up: Collapse circulatory peripheral; Aortic dissection Exitus letalis; death after aortic dissection; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, regulatory authority number DE-PEI-CADR2021046597. A 77-years-old male patient received bnt162b2 (COMIRNATY), intramuscular on 17Mar2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing hypertension. Person was not concerned known of any allergies. The patient''s concomitant medications were not reported. The patient experienced aortic dissection exitus letalis on 18Mar2021, death after aortic dissection on 18Mar2021, collapse circulatory peripheral on 18Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: high with well controlled. The patient died on 18Mar2021. It was not reported if an autopsy was performed. Outcome of heart failure and aortic dissection was fatal, of peripheral circulatory failure was not recovered.Well controlled high blood pressure / one day after vaccination retrosternal. Pain, emergency in clinic, and Circulatory failure and death. Seriousness criteria of heart failure and aortic dissection was death, of others was hospitalized. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1241464 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ; Blood pressure high
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021399605

Write-up: Corona infection 4 days after 2nd vacination; Corona infection 4 days after 2nd vacination; This is a spontaneous report based on information received by Pfizer from Biontech, manufacturer control number: 34674, license party for Comirnaty. An 82-year-old female patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY) first dose on an unspecified date (lot number and expiry date unknown) and second dose on 28Feb2021 (lot number and expiry date unknown) both taken via unspecified routes of administration, at single doses, for COVID-19 immunization. Medical history included and high blood pressure. The patient''s concomitant medications were not reported. The patient previously received influenza vaccine for flu vaccination. The consumer reported that her 82-year-old grandmother was fighting for her life for 22 days in the hospital in the intensive care unit. She was vaccinated against flu and twice against this virus, with the Biontech vaccine. She followed all rules. Every couple of weeks she went for shopping (most likely buying food) (the last time 4 weeks before the vaccination), did not meet any people and only went to the family doctor at most. On 28Feb2021, she was vaccinated against Corona for the second time and the first symptoms appeared 4 days later (unspecified date in Mar2021). The consumer stated that nobody assumed that it was Corona. She stated "as you tell the people in your educational video that cold symptoms were normal. After a week it turned out that she was infected with the "normal" coronavirus. How can a person has such a heavy corona course and will eventually die from this vaccination? Apart from and high blood pressure, my grandmother had no previous illnesses. She was fully in life. Why do the women in our acquaintances exclusively have severe side effects after vaccination with Biontech and men do not? We just want to understand why? Do we now have to assume, if it is genetic, that we will suffer the same fate?". It was further reported that the patient died on an unknown date. It was unknown if an autopsy was performed. The events were considered serious due to fatal outcome, hospitalization on an unspecified date and life threatening condition. Information on lot/batch number has been requested. Follow-up (17Apr2021): New information reported from a contactable consumer includes: the patient died on an unspecified date. The reported events were considered to be fatal. Information on lot/batch number has been requested.; Reported Cause(s) of Death: Corona infection 4 days after 2nd vacination; Corona infection 4 days after 2nd vacination


VAERS ID: 1241486 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-31
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000494 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20210

Write-up: Cardio-respiratory arrest; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Apr-2021 and was forwarded to Moderna on 19-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000494) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 31-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criterion death). The patient died on 31-Mar-2021. The reported cause of death was parada cardiorrespiratoria (10007617). It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not Applicable. Company comment: Based on the current available information and temporal association between the use of the product and the date of the event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Parada cardiorrespiratoria (10007617)


VAERS ID: 1241488 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADIRO 100
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial (HT); Comments: HTA
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021420686

Write-up: Sudden cardiac death; caused by a cardiac rupture and hemopericardium; hemopericardium; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB , Regulatory Authority number: ES-AEMPS-820639. A 79-years-old female patient received first dose of bnt162b2 (Pfizer vaccine, Formulation: Solution for injection, Lot Number: EW2246, expiration date not reported) via an unspecified route of administration on 06Apr2021 at a single dose for covid-19 immunisation. Medical history included hypertension arterial. Concomitant medication included Adiro 100 . The patient had sudden cardiac death on 07Apr2021.There is no causality between inoculation and death, which was caused by a cardiac rupture and hemopericardium, in the context of a hypertensive woman, in pharmacological treatment for years. The patient died on 07Apr2021. An autopsy was performed and results were not provided. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiac rupture and hemopericardium; cardiac rupture and hemopericardium


VAERS ID: 1241490 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, CSF test, Chronic kidney disease, Depressed level of consciousness, Disorientation, Glomerular filtration rate, Gram stain, Heart rate, Herpes zoster, Hypertensive encephalopathy, Lumbar puncture, Meningitis herpes, Pyrexia, SARS-CoV-2 test, Scan brain, Somnolence
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hypertension (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Opportunistic infections (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 10
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: Arthropathy psoriatic; Chronic renal failure; Diabetes mellitus non-insulin-dependent; Dyslipidaemia; Hypertension arterial; Obesity; Sarcoidosis; Uveitis
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Test Result:around 6 mg/dl; Test Date: 20210326; Test Name: Creatinine; Test Result: 6 mg/dl; Test Date: 20210402; Test Name: Creatinine; Test Result: 6.49 mg/dl; Test Date: 20210402; Test Name: K; Result Unstructured Data: Test Result:4.4; Test Date: 20210402; Test Name: BP; Result Unstructured Data: Test Result:203/108; Test Date: 20210402; Test Name: Na; Result Unstructured Data: Test Result:138; Test Date: 20210402; Test Name: Urea; Result Unstructured Data: Test Result:181; Test Date: 20210326; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210402; Test Name: Biochemical CSF; Result Unstructured Data: Test Result:59.4 mg / dL protein; Comments: 59.4 mg / dL protein, 73 mg / dL blood glucose, 52 x 1 / L WBC with 92% mononuclear cells; Test Name: GFR; Result Unstructured Data: Test Result:15; Test Date: 20210326; Test Name: GFR; Result Unstructured Data: Test Result:6; Test Date: 20210402; Test Name: CSF gram stain; Result Unstructured Data: Test Result:Negative; Test Date: 20210402; Test Name: HR; Result Unstructured Data: Test Result:107 bpm; Test Date: 20210402; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:Clear CSF; Test Date: 20210402; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:Negative; Test Date: 20210402; Test Name: Skull CT; Result Unstructured Data: Test Result:Study with poor image quality.; Comments: Study with poor image quality. No images of acute intra- or extraxial bleeding are displayed. The ventricular system is enlarged, but consistent with the enlargement of the cortical sulci. Hypodense, patchy, white matter lesions compatible with chronic small-vessel ischemic lesions. Hypodense right cerebellar area suggestive of chronic infarction. Centered midline structures. Wide and free base cisterns. Frontal hyperostosis. Images suggestive of earwax plugs in both external auditory canals. Fronto-parietal extracranial nodular soft tissue lesions, with microcalcifications. DIAGNOSTIC IMPRESSION Cortico-subcortical atrophy. Signs of cerebral microangiopathy. Chronic cerebellar infarction.
CDC Split Type: ESPFIZER INC2021420680

Write-up: possible herpetic meningitis/Suspicion of HZ encephalitis; Herpes zoster; Fever/Febrile syndrome; low level of consciousness; Chronic flare-up renal disease; Hypertensive encephalopathy; sudden deterioration with disorientation; drowsiness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, Regulatory Authority number: ES-AEMPS-823493. An 87-years-old female patient received the second dose of BNT162B2 (COMIRNATY) (Lot Number: ET3620) via an unspecified route of administration on 23Mar2021 at single dose for COVID-19 immunisation. Medical history included hypertension arterial, sarcoidosis, dyslipidaemia, type 2 DM (diabetes mellitus non-insulin-dependent), obesity, psoriatic arthropathy, uveitis, chronic renal failure with Glomerular Filtrate 15 and Cr figures around 6 mg/dl. The patient''s concomitant medications were not reported. The patient previously received the first dose of Comirnaty (lot: EP2163) on 02Mar2021 for COVID-19 immunisation. On 26Mar2021, the emergency department was notified of a regular general condition, neck and shoulder pain, she presented erythematous lesions in the retroauricular region with confluent vesicles from the occipital region to the anterior face of the neck, and left retro-auricular. Pain on touch and rubbing. Great renal insufficiency Cr 6, GFR 6. Sleepy, although not uncoordinated. She was diagnosed with herpes zoster and treated with metamizole and valaciclovir for 7 days. On 31Mar2021 they contacted the hospital''s internal medicine for persistent drowsiness. They request urgent renal function analysis. On 02Apr2021, she went to the hospital emergency room due to sudden deterioration with disorientation and low level of consciousness. Febrile syndrome from a few days ago (26Mar2021) up to 38 Centigrade. Other lab data on 02Apr2021 includes: Urea = 181; Creatinine = 6.49; K = 4.4; Na = 138; Gram negative CSF; BP 203/108; HR 107 bpm; Skull CT: Study with poor image quality. No images of acute intra- or extraxial bleeding are displayed. The ventricular system is enlarged, but consistent with the enlargement of the cortical sulci. Hypodense, patchy, white matter lesions compatible with chronic small-vessel ischemic lesions. Hypodense right cerebellar area suggestive of chronic infarction. Centered midline structures. Wide and free base cisterns. Frontal hyperostosis. Images suggestive of earwax plugs in both external auditive conducts. Fronto-parietal extracranial nodular soft tissue lesions, with microcalcifications. Diagnostic impression: Cortico-subcortical atrophy. Signs of cerebral microangiopathy. Chronic cerebellar infarction. Rapid COVID-19 antigen test result: Negative. Lumbar puncture: clear CSF. Biochemical CSF: 59.4 mg / dL protein, 73 mg / dL blood glucose, 52 x 1 / L WBC with 92% mononuclear cells. Clinical Trials: Suspicion of HZ encephalitis. Emergency HT. Chronic flare-up renal disease. Hypertensive encephalopathy. On 05Apr2021, they warn of cardiorespiratory arrest. Exitus at 9:15 am due to possible herpetic meningitis. Events seriousness criteria death and hospitalization reported for meningitis herpes, fever, and herpes zoster. Cardiorespiratory arrest also reported as death cause. The patient died on 05Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: possible herpetic meningitis; Herpes zoster; Fever; Parada cardiorrespiratoria


VAERS ID: 1241492 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary haemorrhage, Pulmonary thrombosis, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CO-DIOVAN; SIMVASTATINA; AMLODIPINO [AMLODIPINE]; ENANTYUM; ADIRO; FUROSEMIDA [FUROSEMIDE]; DILIBAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthralgia; Chronic renal failure; Chronic venous insufficiency; COVID-19; Gonarthrosis; Hypercholesterolemia; Hypertension arterial; Morbid obesity (predominantly abdominal); Subclinical hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021420766

Write-up: Sudden death; pulmonary hemorrhage associated mostly in the right lung; massive pulmonary thrombosis predominantly in the right lung; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB manufacturer report number ES-AEMPS-824376. A 77-year-old female patient received first dose of bnt162b2 (COMIRNATY, Lot Number: EW2243) on 09Apr2021 as single dose for covid-19 immunisation. Medical history included morbid obesity (predominantly abdominal), arterial hypertension and hypercholesterolemia, Gonarthrosis, Arthralgia, Chronic renal failure, Subclinical hypothyroidism, Chronic venous insufficiency, covid-19. Concomitant medications included hydrochlorothiazide, valsartan (CO-DIOVAN); simvastatina; amlodipino [amlodipine] (AMLODIPINO); dexketoprofen trometamol (ENANTYUM) from 30Mar2021; acetylsalicylic acid (ADIRO); furosemida [furosemide] (FUROSEMIDA); paracetamol, tramadol hydrochloride (DILIBAN). The patient previously took Nolotil and experienced pruritus. On 09Apr2021 patient experienced sudden death, pulmonary hemorrhage associated mostly in the right lung, massive pulmonary thrombosis predominantly in the right lung. Patient who had main personal history included morbid obesity, arterial hypertension and hypercholesterolemia, was polymedicated for her pathologies and for pain. The patient suffers syncope and subsequent sudden death approximately one hour after vaccination with the Pfizer''s Covid-19 vaccine. The main cause of death identified at the autopsy was the presence of a possible massive pulmonary thrombosis predominantly in the right lung and a haemorrhage right lung and an associated pulmonary haemorrhage also predominantly in the right lung. The patient''s baseline status with respect to procoagulant risk or hypercoagulability is likely to have been high due to the personal history described, as well as the possible systemic infection or sepsis of probable urological origin. The patient had also COVID-19 infection as she had positive IgG antibodies. The autopsy ruled out an immediate anaphylactic reaction after vaccination. Although there is suspicion, it is not possible to an obvious link between the vaccination, the pulmonary haemorrhage and the thrombogenesis observed. Nevertheless, the case is reported to the Pharmacovigilance Service. Autopsy Report: Digestive system: Oesophagus with food content, oesophageal mucosa whitish without ulcerations or varicose lesions. Stomach with food content, pink mucosa without macroscopic alterations. The intestinal tract presents faecaloid contents, a brownish polyp is identified in the distal colon. The distal colon has a 1 cm brownish polyp with a 0.9 cm pedicle, as well as diverticula. Liver, vesicle and biliary tract: Liver weight: 1755 g. Smooth liver capsule. In section Parenchyma brown, without nodulations or masses. Gall bladder with greenish-green velvety mucous membrane. Bile duct permeable. PANcreas: 190 g. Parenchyma of usual pink colour, with abundant fatty infiltration, without nodulations. Breast: 110 g. Consistency completely unstructured and malleable. Suprarenal Glands: Good corticomedullary demarcation, friable, without nodulations. Kidneys: Right: 115g. Left: 150 g. Decapsulated without difficulty. Smooth surface. Good Cortico-medullary delimitation, with the presence of cysts, the largest one being identified in the right kidney in the lower pole of 5 cm. Renal pelvis without alterations. Bladder and urinary tract: Ureters permeable throughout. Bladder mucosa of whitish colour without ulcerations. Whitish bladder mucosa without ulcerations or excrescent lesions. Urine of cloudy appearance. Internal genitals: Weight of the uterus and appendages: 65g. Adnexa without findings of interest. Endometrium Uniform, 0.1-0.2 cm thick with no excrescent lesions. Vessels: Multiple yellowish plaques in the abdominal aorta and iliac arteries, as well as in the root of the thoracic aorta, some of them calcified, without signs of rupture or intraplaque haemorrhage. Gangles: No findings of interest. ADDITIONAL TESTS: Covid test. Covid 19 test (Blood sample: Presence of positive IgG antibodies for Covid-19 compatible with past infection. See IgM antibodies are ruled out. DRUGCHECK 10 urine drug test: negative.Alcohol breath test in saliva BAC: negative. Macroscopic diagnoses: congestion and petechial pulmonary haemorrhage predominantly in the right lung. possible massive pulmonary thromboembolism in evolution, predominantly in the right lung (microscopic study pending). acute non-specific splenitis or spleen sepsis of probable urological origin. (very cloudy urine) complete costal fractures at the level of the angle area in both hemitorax (compatible with cpr) simple renal cysts. bilateral thyroid nodules. colonic polyp. diverticulitis. No follow-up attempts possible. No further information expected.; Autopsy-determined Cause(s) of Death: The main cause of death identified at autopsy was the presence of a possible massive pulmonary thrombosis predominantly in the right lung and an associated pulmonary hemorrhage, also mainly in the right lung.; The main cause of death identified.


VAERS ID: 1241494 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cardiovascular disease, unspecified; Diabetes; Dyslipidaemia; Prostate neoplasia; Vascular device user (stent in 2007)
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: CT scan; Result Unstructured Data: Test Result:typical image of COVID-19; Comments: typical image of COVID-19 with severe involvement, dilated cardiomyopathy and "small" pleurisy.; Test Date: 20210326; Test Name: saturation; Test Result: 94 %; Test Date: 20210326; Test Name: PCR Covid; Test Result: Positive
CDC Split Type: FRPFIZER INC2021420747

Write-up: COVID-19 aggravated/ positive COVID-19 test with symptoms; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-2021035128. A 97-year-old male patient received first dose of bnt162b2 (COMIRNATY, Lot ER9470) intramuscular on 23Mar2021 at single dose for COVID-19 immunisation (vaccination against covid-19). Medical history included prostate neoplasia, arterial hypertension, vascular device user from 2007 (stent in 2007), dyslipidaemia, cardiovascular disease and diabetes. Concomitant medications were not provided. On 19Mar2021, the patient was in contact with a non-symptomatic person carrying the variant who found out after, the patient was vaccinated. On 24Mar2021 (also reported as two days after the beginning of drug administration), the patient developed COVID-19 aggravated which led to death on 29Mar2021 (the event was reported that lasted for 7 days). On 24Mar2021, onset of fever with dyspnea (cough) and fatigue. On 26Mar2021, patient hospitalized with an OAP (Acute pulmonary edema). On admission, patient placed on high flow Optiflow with 94% saturation under 100% FiO2, corticosteroid therapy, antibiotic therapy, furosemide (ES) and hydration. No indication for heavy resuscitation. CT scan, typical image of COVID-19 with severe involvement, dilated cardiomyopathy and "small" pleurisy. PCR Covid positive. Event was reported as life threatening. Unfavorable evolution leading to the death of the patient on 29Mar2021. Conclusion: Covid-19 associated with PDO in patient 2 days after a first vaccination. Patient died on 29Mar2021. An autopsy was performed and the reported cause of death was covid-19, autopsy result was covid-19 and acute pulmonary edema. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19; Autopsy-determined Cause(s) of Death: covid-19 and Acute pulmonary edema; covid-19 and Acute pulmonary edema


VAERS ID: 1241496 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-04-04
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   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: Arterial hypertension (borderline untreated blood pressure); Coronary artery disease (hereditary coronary artery disease); Glaucoma; Recovered smoker (smoking weaned two months ago)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: ECG; Result Unstructured Data: Test Result:Acute coronary syndrome
CDC Split Type: FRPFIZER INC2021420769

Write-up: Fibrillation ventricular; Acute coronary syndrome; Cardio-respiratory arrest; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-AN20211203, Safety report unique identifier FR-AFSSAPS-2021035306. A 51-years-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 04Mar2021 (Lot Number: EP9598) as SINGLE DOSE for covid-19 immunisation. Medical history included Arterial hypertension (borderline untreated blood pressure), Glaucoma, Recovered smoker (smoking weaned two months ago) and hereditary coronary artery disease (myocardial infarction in her father at the age of 65). The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 intramuscular on 14Feb2021 (Lot Number: EJ6789) as SINGLE DOSE for covid-19 immunisation.The patient experienced fibrillation ventricular on 04Apr2021 , acute coronary syndrome on 04Apr2021 , cardio-respiratory arrest on 04Apr2021. The patient died on 04Apr2021. An autopsy was not performed. All the events were assessed serious as death. Clinical course: On 04Apr2021 the patient presented with typical chest pain suggestive of Acute coronary syndrome, at Emergency medical services treatment, demonstrated by an acute coronary syndrome (ACS) with ST-segment overshoot in the past. Immediately after the ECG the patient presented with cardiorespiratory arrest by shocked large mesh ventricular fibrillation then small mesh. Treatment included Failure of cardiopulmonary resuscitation (total duration 1h15) with external cardiac massage, adrenaine, cordarone, metalysis leading to the death of the patient. Documentation pending pending additional information, in particular on recent hypertension (post-vaccination?) CONCLUSION: Acute coronary syndrome with ventricular fibrillation and death of a smoking patient with familial history of myocardial infarction who received a second dose of comirnaty 31 days earlier. SUMMARY: fatal acute coronary syndrome with ventricular fibrillation in a woman vaccinated 31days before with comirnaty vaccine. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fibrillation ventricular; Acute coronary syndrome; Cardio-respiratory arrest


VAERS ID: 1241499 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-03-08
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Epilepsy, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cerebral infarct
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021420805

Write-up: status epilepticus; Epileptic fit; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) FR-AFSSAPS-BX20212962 and received via Regulatory Authority . A 93-year-old female patient received second dose of BNT162B2 (Pfizer vaccine, lot number: EP9598) via intramuscular in left arm on 23Feb2021 at single dose for COVID-19 immunisation. Medical history included Cerebral infarction in Aug2020 and arterial hypertension. Concomitant medications were not reported. The patient historically received first single dose of Pfizer vaccine via an unspecified route of administration on 20Jan2021 for COVID-19 immunisation and experienced epileptic seizure. The patient experienced epileptic fit on 08Mar2021 with outcome of fatal. It was mentioned that on 08Mar2021, on day 13 of the second dose, new epileptic seizure. Evolution towards status epilepticus with emergency hospitalization on 08Mar2021, then put in palliative care. The patient died on 24Mar2021 at 23:15 (11: 15 PM). Cause of death was provided as status epilepticus. Autopsy was not done. NB: attribution made without prejudice to investigative elements which could be carried out within the framework of legal or amicable compensation procedures No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Status epilepticus; epileptic fit


VAERS ID: 1241509 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: KEPPRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Anaemia; Cerebral amyloid angiopathy; CVA (stopping anticoagulants since 2017); Deglutition disorder (swallowing disorder with multiple pneumonia); Inflammation (Antritis under proton pump inhibitors); Mixed dementia; Osteoporosis; Partial epilepsy; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021420744

Write-up: Death unexplained; This is a spontaneous report from a contactable physician downloaded from a regulatory authority FR-AFSSAPS-LY20212870 and received via a regulatory authority. A 90-year-old female patient received first dose of bnt162b2 (COMIRNATY, Lot: ET7205) intramuscular in left arm on 01Apr2021 at single dose for COVID-19 immunisation. Medical history included mixed dementia, partial epilepsy, CVA (cerebrovascular accident) and AVC (stroke) from 2000, 2005 and not ongoing, ACFA (AFib ,complete arrhythmia by atrial fibrillation) old, stopping anticoagulants since 2017, deglutition disorder (swallowing disorder with multiple pneumonia), osteoporosis, anaemia, cerebral amyloid angiopathy, antritis under PPI (proton pump inhibitors). No covid history. Concomitant medications included levetiracetam (KEPPRA), PPI proton pump inhibitors (unspecified). On 03Apr2021, in the evening, the patient took her meal in the chair and then went back to bed. 10min later, death was declared. She had no significant acute pathology, and had not presented any signs of vomiting, nor painful facies. The patient experienced unexplained death, the declarant mentions the multiple chronic pathologies that can lead to death, a possible massive stroke, and questions the role of the vaccine. The patient died on 03Apr2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1241511 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-04-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210401; Test Name: PCR COVID 19 by RT PCR; Test Result: Positive
CDC Split Type: FRPFIZER INC2021420738

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MP20211103, Safety report unique identifier FR-AFSSAPS-2021036865. An 84-year-old female patient received bnt162b2 (COMIRNATY) intramuscular, first dose on 11Feb2021 at single dose, second dose on 04Mar2021 at single dose as COVID-19 vaccination. Medical history was not provided. Concomitant medications were not provided. The vaccination was desaturation supported by attending physician. Patient was considered to be at risk of developing a severe form of COVID-19 disease, COVID-19 confirmed by positive COVID-19 test. Search for the viral variant not specified. The patient underwent lab tests and procedures, which included on 01Apr2021, PCR COVID 19 by RT PCR positive. It was confirmed vaccination failure. Patient was hospitalized in a COVID unit on 04Apr2021. Patient died on 07Apr2021. An autopsy was not performed, the reported cause of death was COVID-19 aggravated and vaccination failure. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Vaccination failure; COVID-19 aggravated


VAERS ID: 1241517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-23
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood urea, C-reactive protein increased, COVID-19, Coma scale, Computerised tomogram thorax, Electrocardiogram, Haemoglobin, Investigation, Oxygen saturation, PCO2, PO2, Platelet morphology abnormal, Pneumonia bacterial, Troponin, pH body fluid
SMQs:, Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: MOLSIDOMINE; TAHOR; KARDEGIC; BETATOP; VELMETIA; AMLOR; ECAZIDE; DIAMICRON; GLUCOPHAGE [METFORMIN]
Current Illness: Arterial hypertension; Hypercholesteremia; NIDDM
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic cardiomyopathy (ischemic heart disease); Leg amputation (right trans-tibial amputation (following an accident at work))
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: creatinine; Result Unstructured Data: Test Result:92.3 umol/l; Test Date: 20210323; Test Name: urea; Result Unstructured Data: Test Result:13.19 mmol/L; Test Date: 20210323; Test Name: Glasgow scale; Result Unstructured Data: Test Result:15; Test Date: 20210323; Test Name: Lung CT scan (not injected); Result Unstructured Data: Test Result:no pulmonary embolism; Test Date: 20210323; Test Name: CRP; Result Unstructured Data: Test Result:167 mg/l; Test Date: 20210323; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm, without other abnormality; Comments: regular sinus rhythm, without other abnormality; Test Date: 20210323; Test Name: Hb; Result Unstructured Data: Test Result:13.7 g/dl; Test Date: 20210323; Test Name: GB; Result Unstructured Data: Test Result:7.3 g/l; Test Date: 20210323; Test Name: O2 saturation; Test Result: 85 %; Test Date: 20210323; Test Name: pCO2; Result Unstructured Data: Test Result:32 mmHg; Test Date: 20210323; Test Name: pH; Result Unstructured Data: Test Result:7.42 pH units; Test Date: 20210323; Test Name: platelets; Result Unstructured Data: Test Result:209 g/l; Test Date: 20210323; Test Name: pO2; Result Unstructured Data: Test Result:53 mmHg; Test Date: 20210323; Test Name: troponin; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021420792

Write-up: COVID-19 aggravated; bacterial right lower lobe superinfection; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB manufacturer report number FR-AFSSAPS-NY20210690 . Sender''s (Case) Safety Report Unique Identifier FR-AFSSAPS-2021035236 An 85-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 15Mar2021 (Lot Number: EP9605) as single dose for COVID-19 immunisation. Medical history included ongoing Type 2 diabetes mellitus (NIDDM), Ischemic cardiomyopathy, ongoing Arterial hypertension, ongoing hypercholesterolemia, ischemic heart disease, right trans-tibial amputation (following an accident at work). Concomitant medications included molsidomine ; atorvastatin calcium (TAHOR); acetylsalicylate lysine (KARDEGIC); atenolol (BETATOP); metformin hydrochloride, sitagliptin phosphate (VELMETIA); amlodipine besilate (AMLOR); captopril, hydrochlorothiazide (ECAZIDE); gliclazide (DIAMICRON); metformin (GLUCOPHAGE). The patient experienced covid-19 aggravated on 23Mar2021. The event was assessed serious as death, hospitalization. On 23Mar2021, 9 Day after the last drug administration, the patient developed COVID-19 infection which required hospitalization or prolongation of hospitalization. The patient died on 31Mar2021. It was not reported if an autopsy was performed. Imputability : I1 (dubious) for COMIRNATY Reporters comment: File from the 20210330154320877 85-year-old patient. History: DNID, hypertension, hypercholesterolemia, ischemic heart disease, right trans-tibial amputation (following an accident at work). 15Mar2021, first injection of the COMIRNATY vaccine (batch EP9605) in the right arm. On 23MAr2021, occurrence of COVID-19 pneumonia. Patient hospitalized for treatment. No indication for heavy resuscitation. 29Mar2021, patient transferred for further care and implementation of palliative care in the event of clinical deterioration. On the respiratory level, presence of dyspnea with indrawing. No cough. Limit ambient air saturation under 15L of O2. On auscultation, bi-basal crackles without other anomaly. Cardiovascularly, no chest pain. Regular heart sounds, without audible murmur. No sign of right or left cardiac decompensation. No edema. Neurologically, Glasgow 15/15. No disturbance of higher functions. No respiratory encephalopathy.Note since the COVID-19 infection marked asthenia with reduced autonomy. To biology, GB 7.3 G / L, Hb 13.7 g / dL, platelets 209 G / L. Urea 13.19, mmol / L, creatinine 92.3 ?mol / L. CRP 167 mg / L. Normal troponin and BNP. Gas without under 12L of O2: pH 7.42, pCO2 32 mmHg, pO2 53 mmHg for 85% saturation. ECG: regular sinus rhythm, without other abnormality. Lung CT scan (not injected): no pulmonary embolism. COVID-19 pneumonia occupying 40% of the lung volume bilaterally associated with a focus of superadded bacterial right lower lobe superinfection. Management with increased oxygen therapy, IV hydration, antibiotic therapy with AUGMENTIN, corticosteroid therapy with dexamethasone. Unbalanced diabetes treated with NOVORAPID. Evolution marked by a stability of the patient''s condition for 24 hours. Despite the absence of any sign of worsening of his clinical condition, the patient died in his sleep on 31Mar2021. Conclusion: COVID-19 lung disease in an 85-year-old patient, 8 days after a first injection of the COMIRNATY vaccine (batch EP9605). Hospitalized patient. Unfavorable evolution leading to the death of the patient. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Conclusion: COVID-19 lung disease in an 85-year-old patient, 8 days after a first injection of the COMIRNATY vaccine (batch EP9605). Hospitalized patient. Unfavorable evolution leading to the death of the patient.; Sender''s Comments: There is not a reasonable possibility that events COVID-19 aggravated and pneumonia bacterial are related to BNT162B2. The events are more likely intercurrent medial conditions. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1241518 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-05-20
Onset:2021-01-28
   Days after vaccination:253
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebellar haematoma, Computerised tomogram, Platelet count, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CORDARONE; RISPERDAL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (complete atrial fibrillation arrhythmia); Dementia NOS; Hypertension arterial; Joint pain; Rectal neoplasm NOS (rectal tumor leading to a stop of DOAs and switch to LMWH)
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: CT scan; Result Unstructured Data: Test Result:found a large acute cerebellar hematoma; Comments: found a large acute cerebellar hematoma Secondary to the fall? spontaneous?; Test Date: 20210129; Test Name: platelets; Result Unstructured Data: Test Result:282000
CDC Split Type: FRPFIZER INC2021420705

Write-up: Cerebellar haematoma; food vomiting; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) FR-AFSSAPS-PA20210456 and received via Regulatory Authority . An 87-year-old male patient received first dose of BNT162B2 (Pfizer vaccine, Lot: EJ6795) via intramuscular on 12Jan2021 at single dose for COVID-19 immunisation, enoxaparin sodium (LOVENOX) via subdermal from 20May2020 to 29Jan2021 at 0.4 mL, 1x/day for Anticoagulant therapy. Medical history included Dementia NOS, AFib (complete atrial fibrillation arrhythmia), Rectal neoplasm NOS (rectal tumor leading to a stop of DOAs (direct oral anticoagulant) and switch to LMWH (low molecular weight heparin)), Hypertension arterial, joint pain. Concomitant medications included amiodarone hydrochloride (Cordarone) since at least Mar2019, risperidone (RISPERDAL) since at least Mar2019, paracetamol if joint pain. The patient experienced cerebellar haematoma on 29Jan2021 and food vomiting on 28Jan2021. Patient was died on 19Feb2021 due to cerebellar haematoma. It was reported that during the night of January 28th to 29th: the patient was found on the ground around 1:45 am with phasic expression disorders +/- comprehension and major balance disorders. Cerebral CT scan of 29Jan2021 found a large acute cerebellar hematoma. "Secondary to the fall? spontaneous?" LMWH (low molecular weight heparin) stop, platelets 282,000 on 29Jan2021. Recusal in major neurology surgery, the patient died on 19Feb2021. Request made to the notifier to have the complete biological assessment and in particular the renal assessment and dosage of anti Xa activity. Action taken for enoxaparin sodium was permanently withdrawn on 29Jan2021. The patient died on 19Feb2021. Outcome of food vomiting was unknown. It was unknown if autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Large cerebellar hematoma


VAERS ID: 1241519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-23
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 3
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: PREVISCAN [FLUINDIONE]; CRESTOR; ATENOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; Chronic obstructive pulmonary disease; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: thoracic scan; Result Unstructured Data: Test Result:severe form of COVID; Comments: severe form of COVID (65% invasion on the thoracic scan).; Test Date: 20210323; Test Name: Covid-19 PCR test; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021420806

Write-up: severe form of COVID; vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PA20210461. Safety Report Unique Identifier FR-AFSSAPS-2021036800. A 93-years-old male patient (Husband of a resident) received bnt162b2 (COMIRNATY), dose 2 intramuscular on 05Mar2021 (Batch/Lot Number: EP2166) as 0.3 ml, single, dose 1 via an unspecified route of administration on 09Feb2021 (Batch/Lot Number: EJ6795) as single dose for covid-19 immunisation. Medical history included Chronic obstructive pulmonary disease, Cardiac insufficiency, Hypertension arterial. No previous history of covid. Concomitant medication included fluindione (PREVISCAN [FLUINDIONE]); rosuvastatin calcium (CRESTOR); atenolol (ATENOLOL), Izaar. The patient had good tolerance for the first dose. The patient experienced severe form of covid and vaccination failure on 23Mar2021, which required hospitalization in Mar2021 and death on 26Mar2021. Clinical detail was reported as: the patient had respiratory symptoms about 7/8 days after the second dose of vaccine which the patient neglected. Then he presented with asthenia, fever and respiratory discomfort around 15 March 2021. He was hospitalised following his visit to the emergency room and died on 26 March 2021 of a severe form of COVID (65% invasion on the thoracic scan). The PCR done on 23Mar2021 showed an variant. IN TOTAL, severe SARS COV2 infection variant B117 resulting in the death of an elderly man with a risk factor for developing a severe form of the disease. The patient underwent lab tests and procedures which included thoracic scan: severe form of COVID (65% invasion on the thoracic scan) on Mar2021, Covid-19 PCR test: positive on 23Mar2021 variant. The patient died on 26Mar2021. An autopsy was not performed. NB: Imputation made "without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures". Reported Cause(s) of Death: SEVERE FORM OF COVID


VAERS ID: 1241521 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Magnetic resonance imaging head, Myocardial infarction, Scan myocardial perfusion
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; TANGANIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Glaucoma; Hypertension arterial (moderate arterial hypertension); Memory impairment; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data: Test Name: brain MRI; Result Unstructured Data: Test Result:deficiency in the central nucleus which may corres; Comments: deficiency in the central nucleus which may correspond to an old TIA (Transient ischemic attack); Test Date: 20190118; Test Name: myocardial scintigraphy for chest pain; Result Unstructured Data: Test Result:had a myocardial scintigraphy for chest pain; Comments: had a myocardial scintigraphy for chest pain on 18Jan2019 without specificity, has not seen the cardiologist since
CDC Split Type: FRPFIZER INC2021420730

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority FR-AFSSAPS-PO20211727 and received via Regulatory Authority. An 84-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via Intramuscular on 03Mar2021 left arm at single dose (Lot EP2166) for COVID-19 immunisation. Medical history included fitted sleep apnea syndrome, moderate arterial hypertension, glaucoma, onset of non-Alzheimer''s memory disorder, had a myocardial scintigraphy for chest pain on 18Jan2019 without specificity, has not seen the cardiologist since, had a Brain MRI: deficiency in the central nucleus which may correspond to an old TIA (Transient ischemic attack), did not have the Covid. Concomitant medications included long term with Atorvastatin 10 mg / day, indapamide, perindopril arginine (BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]) 5, acetylsalicylic acid, ascorbic acid (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) 100, and acetylleucine (TANGANIL)100. The patient previously received the first dose of BNT162B2 (COMIRNATY) for COVID-19 immunisation, presented a small rash on the first injection that he did not want to report waiting for information from cardiology intensive care. On 04Mar2021 of a severe myocardial infarction supported by intensive cardio care death on 07Mar2021 at 5:45 a.m. No autopsy was done. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1241524 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Blood pressure measurement, Computerised tomogram, Condition aggravated, Heart rate, Hemiplegia, Hypertensive crisis
SMQs:, Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL; SIMVASTATIN
Current Illness: Arterial hypertension; Dyslipidaemia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210325; Test Name: blood pressure; Result Unstructured Data: Test Result:180/70 mmHg; Test Date: 20210325; Test Name: Cerebral CT; Result Unstructured Data: Test Result:Left hemispherical lobar intraparenchymal hematoma; Comments: Left hemispherical lobar intraparenchymal hematomas, with probable component of associated subarachnoid hemorrhage. Left fronto-parietal subdural hematoma, extraaxial hemorrhagic suffusion interhemispherical and along the tent of the cerebellum. Sub-factorial engagement (deviation of the midline to the right of 10 mm), signs of HTIC and early exclusion hydrocephalus of the right lateral ventricle. No indication for neurosurgical management. Transfer of the patient to a specialized unit.; Test Date: 20210325; Test Name: Heart rate; Result Unstructured Data: Test Result:50; Comments: units: bpm
CDC Split Type: FRPFIZER INC2021420799

Write-up: hemiplegia with aphasia; hemiplegia with aphasia; Aggravation of existing disorder; Crisis hypertensive; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20211050. A 79-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 19Mar2021 (Batch/Lot Number: ET3620) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, ongoing dyslipidaemia. No COVID-19 history. Concomitant medication(s) included bisoprolol taken for an unspecified indication, start and stop date were not reported; simvastatin taken for an unspecified indication, start and stop date were not reported. The patient experienced crisis hypertensive on 25Mar2021, hemiplegia with aphasia on an unspecified date, aggravation of existing disorder on 25Mar2021. The patient was hospitalized for hemiplegia with aphasia from 25Mar2021 to an unknown date. The patient was hospitalized for hemiplegia with aphasia from 25Mar2021 to an unknown date. The patient underwent lab tests and procedures which included blood pressure measurement: 180/70 mmhg on 25Mar2021, computerised tomogram: left hemispherical lobar intraparenchymal hematoma on 25Mar2021 Left hemispherical lobar intraparenchymal hematomas, with probable component of associated subarachnoid hemorrhage. Left fronto-parietal subdural hematoma, extraaxial hemorrhagic suffusion interhemispherical and along the tent of the cerebellum. Sub-factorial engagement (deviation of the midline to the right of 10 mm), signs of HTIC and early exclusion hydrocephalus of the right lateral ventricle. No indication for neurosurgical management. Transfer of the patient to a specialized unit, heart rate: 50 on 25Mar2021 units: bpm. Patient did not do test for COVID19. The patient died on 26Mar2021. It was not reported if an autopsy was performed. All event outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhagic stroke


VAERS ID: 1241525 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardiopulmonary failure, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: AFib (complete atrial fibrillation arrhythmia); Arrhythmia; Bronchitis chronic; Cognitive impairment
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; CVA (stroke)
Allergies:
Diagnostic Lab Data: Test Date: 202011; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021420659

Write-up: Decompensation cardiac; cardio-respiratory decompensation; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority WEB, regulatory authority number FR-AFSSAPS-RN20211052. A 94-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 31Mar2021 (Batch/Lot Number: ET7205) as single dose for covid-19 immunisation. Medical history included ongoing cognitive impairment, ongoing atrial fibrillation(complete atrial fibrillation arrhythmia), cerebrovascular accident(stroke), covid-19 from Nov2020 to an unknown date, ongoing bronchitis chronic, ongoing arrhythmia, long-term treated with an anticoagulant (specialty not specified). The patient''s concomitant medications were not reported. The patient experienced decompensation cardiac (death) on 05Apr2021, cardio-respiratory decompensation with sudden desaturation in post-meal on 05Apr2021 all with outcome of fatal. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Nov2020. The patient died on 06Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory decompensation; Cardio-respiratory decompensation


VAERS ID: 1241529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-30
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: HYTACAND; NEBIVOLOL; LEVOTHYROX; CERIS; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hypothyroidism; NIDDM; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021420666

Write-up: sudden loss of consciousness with a punch without shouting or gesture; Cardio-respiratory arrest; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-SE20210824, Safety report unique identifier FR-AFSSAPS-2021035695. A 74-years-old female patient received the first dose of BNT162B2 (COMIRNATY) (Lot Number: EP9605) intramuscular in right arm on 12Mar2021 at single dose for COVID-19 immunisation. Medical history included obesity, arterial hypertension (HTA), non-insulinodependant diabetes (NIDDM), hypothyroidism. The patient has not been tested for COVID 19. Concomitant medication(s) included candesartan cilexetil, hydrochlorothiazide (HYTACAND), nebivolol, levothyroxine sodium (LEVOTHYROX), trospium chloride (CERIS), paracetamol. The patient was death from cardiopulmonary arrest on 30Mar2021. According to her husband, the day of 30Mar2021 had gone well, they had taken a walk in the afternoon without discomfort, dyspnea or pain. Around 6:45 p.m., while she was on the phone with her sister, on/off effect with sudden loss of consciousness with a punch without shouting or gesture. Call from Emergency medical services, arrival of a neighbor with the start of the external cardiac massage quickly, arrival of the paramedics, defibrillator which would not have shocked but injection of 2 doses of adrenaline (2mgx2) allowing a resumption of a precarious heartbeat during 20 to 30 minutes minutes. Then the patient died around 7:30 p.m. at her home. Clinically no complaints since vaccination according to her husband. No acute pathology, no decompensation or aggravation of a chronic pathology. The case severity was reported as urgent medical intervention/life threatening/death. Conclusion reported as sudden death from cardiopulmonary arrest 18 days after first dose of Comirnaty, with no other known adverse effects occurring between the day of vaccination and death. The patient died on 30Mar2021. It was not reported if an autopsy was performed. Event outcome of loss of consciousness was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1241530 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-08
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021420682

Write-up: Thrombosis carotid artery/2 massive bi-carotid ischemic strokes; This is a spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority -WEB. The regulatory authority report number is FR-AFSSAPS-TO20212489, Safety report unique identifier FR-AFSSAPS-2021036811. A 79-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced thrombosis carotid artery /2 massive bi-carotid ischemic strokes on 08Apr2021. The patient died on 08Apr2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Thrombosis carotid artery


VAERS ID: 1244158 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Computerised tomogram, Hypersomnia, Hypokinesia, Odynophagia, Pain, Pain in extremity, Thrombosis, Urinary incontinence
SMQs:, Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SINEMET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; Parkinson''s disease; Stroke
Allergies:
Diagnostic Lab Data: Test Name: CAT Scan; Result Unstructured Data: Test Result:she didn''t have a stroke and the scan didn''t show; Comments: she didn''t have a stroke and the scan didn''t show anything that would cause the pain
CDC Split Type: GBPFIZER INC2021386907

Write-up: blood clot; She didn''t seem to be able to control her bladder; with no movement in her legs and she was admitted to hospital.; she was sleeping a lot after the vaccine.; pain; Leg pain; Back pain; Swallowing painful; Ache; This is a spontaneous report from a contactable consumer received from the Medicines Healthcare products Regulatory Agency . Regulatory authority report GB-MHRA-WEBCOVID-202104070950023390, Safety Report Unique Identifier GB-MHRA-ADR 25093246. An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included arthritis, Stroke, Parkinsons. Concomitant medications included carbidopa, levodopa (SINEMET) taken for an unspecified indication, start and stop date were not reported. The patient experienced leg pain, back pain and swallowing painful all on 22Mar2021, ache on 22Jan2021, blood clot and pain on an unspecified date. The events seriousness was reported as medically significant and hospitalization (as reported). Clinical course: The patients son had phoned to log the side effects report as his mam had passed away and thinks the vaccine may have caused her death. The patient had aches all around her body that were painful and did get a check from her Parkinsons nurse and put her on a paracetamol product, which didn''t seem to help. She didn''t seem to be able to control her bladder while she was sleeping and she was sleeping a lot after the vaccine. Her husband contacted 111 as the patient was in really bad pain in her lower back with no movement in her legs and she was admitted to hospital. The patient was having difficulties taking her tablets and the hospital stated giving them to her via other methods. A patch was given to try and administer her parkinsons medication. The hospital did a CAT scan to check she didn''t have a stroke and the scan didn''t show anything that would cause the pain. The hospital found a blood clot in her arm where she had her vaccine administered. The sons had stated that the hospital stated the cause of death was caused by blood clots. The outcome of ache, leg pain, back pain and swallowing painful was not recovered, blood clot was fatal, while for other events was unknown. It was unknown if autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: blood clot


VAERS ID: 1244465 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-17
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Autopsy, Blood pressure measurement, Computerised tomogram abdomen, Heart rate, Hypotension, Intestinal ischaemia, Laparotomy, Mesenteric vein thrombosis, Platelet count, SARS-CoV-2 test, Tachycardia, Thrombocytopenia
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain; Colon adenoma; Gastrointestinal disorder; Intestinal malrotation (Known congenital malrotation of gut); Laparotomy (Previous neonatal laparotomy)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: post-mortem; Result Unstructured Data: Test Result:revealed thrombosis of abnormal small bowel venous; Comments: revealed thrombosis of abnormal small bowel venous drainage (no superior mesenteric vein (SMV) and small bowel draining via dialted inferior mesenteric vein (IMV) into portal vein) with no obvious surgical cause; Test Date: 2021; Test Name: blood pressure; Result Unstructured Data: Test Result:hypotension; Test Name: Abdomen CT; Result Unstructured Data: Test Result:revealed abnormal venous drainage of small bowel,; Comments: revealed abnormal venous drainage of small bowel, Absent SMV with main drainage of small bowel via tortuous/dilated IMV to portal vein; Test Date: 2021; Test Name: heart rate; Result Unstructured Data: Test Result:tachycardia; Test Date: 2021; Test Name: re-look laparotomy; Result Unstructured Data: Test Result:unknown results; Test Name: Platelet count; Result Unstructured Data: Test Result:<150 A-109/L; Test Name: Platelet count; Result Unstructured Data: Test Result:Lowest platelet count before vaccine - 279; Test Date: 20210318; Test Name: Platelet count; Result Unstructured Data: Test Result:ICU - 35; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021422400

Write-up: Intestinal ischaemia/Bowel ischaemia; Thrombosis mesenteric vein/Mesenteric venous thrombosis; hypotension; abdominal pain; tachycardia; Thrombocytopenia; This is a spontaneous report from a contactable Physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104121512339200, Safety Report Unique Identifier GB-MHRA-ADR 25126179. A 55-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: not known), via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 vaccination. Medical history included gastrointestinal disorder, laparotomy (Previous neonatal laparotomy), intestinal malrotation (Known congenital malrotation of gut, unknown if ongoing), colon adenoma (unknown if ongoing), recurrent abdominal pain after food. Otherwise fit and well. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced thrombosis mesenteric vein on 17Mar2021, intestinal ischaemia on 21Mar2021, hypotension, abdominal pain, tachycardia and thrombocytopenia in 2021. Patient having laparoscopic right hemicolectomy for large colonic adenoma. History of malrotation of gut (congenital). Straightforward surgery, no intraoperative complications. Within 2 hours of surgery patient had deteriorated with worsening abdominal pain, hypotension and tachycardia and was taken back to theatre. This revealed global ischaemia of small bowel, cause not evident. Developed low platelet count in intensive care unit (ICU) (35). Subsequently died 4 days later. Post-mortem in 2021 revealed thrombosis of abnormal small bowel venous drainage (no superior mesenteric vein (SMV) and small bowel draining via dialted inferior mesenteric vein (IMV) into portal vein) with no obvious surgical cause. Patient has not tested positive for COVID-19 since having the vaccine. Reaction: this report was related to possible blood clots or low platelet counts. Thromboembolic event / Thombocytopenia additional questions: the specific details of the thromboembolic event was Mesenteric venous thrombosis diagnosed by Post-mortem. Platelet count was less than 150 A-109/L. It was unknown if the D-dimer more than 4000, if anti-PF4 antibodies identified. There was not any additional medical history, not already provided, that relates to previous venous or arterial thromboses, but patient had been investigated for recurrent abdominal pain after food. Patient had not had any previous reactions to medications, especially heparin or anticoagulants. Patient did not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. Patient did not have history of, or current, malignancy. Patient did not currently smoke. The lowest platelet count after vaccine (usual normal range 150-450) was 35 measured on 18Mar2021. The last platelet count (usual normal range 150-450) before vaccine was 279. Patient was not reviewed by a haematologist. No haemorrhage was identified. Patient did not have a history of, or concurrent, intracranial malignancy. Not have concurrent or recent intracranial infections. Patient had not have recent surgical or medical interventions to the central nervous system (including lumbar puncture). Patient had not have a recent trauma/head injury. The patient also underwent lab tests and procedures which included Abdomen CT: revealed abnormal venous drainage of small bowel, Absent SMV with main drainage of small bowel via tortuous/dilated IMV to portal vein; re-look laparotomy: unknown results in 2021; platelet count (normal range: 150-450): lowest platelet count before vaccine - 279 and less than 150 A-109/L on unspecified dates, in ICU - 35 on 18Mar2021; COVID-19 virus test: No - Negative COVID-19 test on an unspecified date; blood pressure: hypotension and heart rate: tachycardia both in 2021. The patient died on 21Mar2021. An autopsy was performed. The outcome of the event thrombocytopenia was unknown, outcome of the other events was fatal. This report was reported as serious with seriousness criteria death and Other medically important condition. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Intestinal ischaemia/Bowel ischaemia; Thrombosis mesenteric vein/Mesenteric venous thrombosis; hypotension; abdominal pain; tachycardia


VAERS ID: 1244472 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-11
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1749 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021422488

Write-up: Pulmonary embolus; Thromboembolic event; This is a spontaneous report from a contactable Physician. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104151312511840, Safety Report Unique Identifier GB-MHRA-ADR 25144894. A 72-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER1749), via an unspecified route of administration on 31Mar2021 at single dose for COVID-19 immunisation. Relevant medical history and concurrent conditions reported as none. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced pulmonary embolus (PE) on 11Apr2021, thromboembolic event in 2021. Patient was found dead at home. Cause of death by on post mortem PE. No underlying health conditions. Patient has not tested positive for COVID-19 since having the vaccine. Reaction: this report was related to possible blood clots or low platelet counts. Thromboembolic event / Thombocytopenia additional questions: the specific details of the thromboembolic event was found dead at home, post mortem confirmed PE. This was diagnosed by post mortem on 11Apr2021. It was unknown that if the platelet count (less than) 150 A 109/L, if the D-dimer (greater than) 4000 and if anti-PF4 antibodies identified or not. The patient died on 11Apr2021 due to pulmonary embolus. An autopsy was performed. The outcome of event pulmonary embolus was fatal, outcome of thromboembolic event was unknown. This report was reported as serious with seriousness criteria death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1244537 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-07
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOX; LUVION [CANRENOIC ACID]; ELIQUIS; ZYLORIC; TRIATEC [RAMIPRIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Decompensation cardiac; Diabetes; Hypertension; Mastitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021420811

Write-up: Cardiocirculatory arrest; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-713935. A contactable physician reported that a 92-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: ET3620; expiration date: 30Jun2021 ), intramuscular, administered in the left deltoid on 26Mar2021 at 12:23 as single dose for COVID-19 immunization. Medical history included diabetes from an unknown date, hypertension from 01Jan2008, decompensation cardiac from 08Mar2021, mastitis from 01Feb2021, atrial fibrillation (AFib) from 08Mar2021, all unknown if ongoing. Concomitant medications included lansoprazole (LANSOX); canrenoic acid (LUVION [CANRENOIC ACID]); apixaban (ELIQUIS); allopurinol (ZYLORIC) and ramipril (TRIATEC [RAMIPRIL]) all taken for an unspecified indication, start and stop date were not reported. The patient experienced cardiocirculatory arrest on 07Apr2021. The patient died on 07Apr2021. It was not reported if an autopsy was performed. Reporter comment: Inoculation site: deltoid left, diagnosed in Mar2021: right heart failure (first episode), bradycardic atrial fibrillation, new findings, PM positioning for alternate branch block. Left mastitis, recent type 2 diabetes mellitus. Left nostril lesion subjected to biopsy Sender comment: 8Apr2021 Regulatory Authority: requests for further information from the reporter. 12Apr2021 Regulatory Authority enters clinical report. it is updated with concomitant therapies; Reporter''s Comments: Inoculation site: deltoid left, diagnosed in Mar2021: right heart failure (first episode), bradycardic atrial fibrillation, new findings, PM positioning for alternate branch block. Left mastitis, recent type 2 diabetes mellitus. Left nostril lesion subjected to biopsy; Reported Cause(s) of Death: Cardiocirculatory arrest


VAERS ID: 1244541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-09
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ovarian cancer metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021420795

Write-up: Death after vaccination against covid-19 (Pfizer - 2 days before) and course of chemotherapy for metastatic ovarian K (1 day before).; This is a spontaneous report received from a contactable physicain downloaded from a regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-714214. A 72-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 07Apr2021 16:30 (Lot Number: ET7205) as single dose for SARS-CoV-2 immunisation. Medical history included metastatic ovarian K. The patient''s concomitant medications were not reported. The patient experienced death after vaccination against covid-19 (pfizer - 2 days before) and course of chemotherapy for metastatic ovarian k (1 day before) on 09Apr2021. The patient died on 09Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death after vaccination against covid-19 (Pfizer - 2 days before) and course of chemotherapy for metastatic ovarian K (1 day before).


VAERS ID: 1244545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-23
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Sepsis
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: Medical History/Concurrent Conditions: Decompensation cardiac; Renal failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021420850

Write-up: sepsis of unknown origin with hospitalization of the patient; This is a spontaneous report received from a contactable physician downloaded from the Medicine Agency (MA) Database-WEB. The regulatory authority report number is IT-MINISAL02-714232. A 91-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via Intramuscular on 17Mar2021 at single dose (Lot: ET1831, Expiration Date: 30Mar2021) for COVID-19 immunisation. Medical history included Renal failure and Decompensation cardiac all unknown if ongoing. Sepsis of unknown origin with hospitalization of the patient on 23Mar2021, with subsequent death the day after returning home on 08Apr2021. It is unknown if autopsy was done. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sepsis of unknown origin with hospitalization of the patient


VAERS ID: 1244549 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   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: Medical History/Concurrent Conditions: Heart disease, unspecified
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021420771

Write-up: death carried out pfizer vaccine four days earlier; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-714496. A 79-years-old male patient received bnt162b2 (COMIRNATY), on 11Mar2021 (Lot Number: ET1831) as single dose for covid-19 immunisation. Medical history included heart disease. The patient''s concomitant medications were not reported. The patient experienced death carried out pfizer vaccine four days earlier on 15Mar2021. It was not reported if an autopsy was performed. Reporter''s comments: heart disease Sender''s comments: Contacted several times the reporter (citizen) to request additional information and the possibility to contact the doctor for clinical report: no feedback received. No follow-up attempts possible. No further information expected.; Reporter''s Comments: heart disease; Reported Cause(s) of Death: death carried out pfizer vaccine four days earlier


VAERS ID: 1244574 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021436355

Write-up: Death (Geromarasmus); This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A female patient in her 90''s received BNT162B2 (COMIRNATY, Lot unknown, first dose) solution for injection intramuscular on 19Apr2021 at 16:00 (at the age of 90''s) as a single dose for COVID-19 vaccination. Medical history and concomitant medications were not reported. On 20Apr2021 at 05:30 (13 hours and 30 minutes after the vaccination), the patient died (geromarasmus). The outcome of the event was fatal. It was not reported if an autopsy was performed. The pharmacist stated/reported that the primary physician considered that the event was unrelated to BNT162b2 and stated that the cause of death was geromarasmus. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information the event geromarasmus is attributed to an underlying medical condition and assessed Unrelated to BNT162B2 (COMIRNATY) vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: geromarasmus


VAERS ID: 1244575 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LBPFIZER INC2021424576

Write-up: death post vaccine; This is a spontaneous report from a contactable physician received via Pfizer colleague reporting same event under the same suspect product for 10 patients. This is one of 10 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. The patient''s medical history was not reported. The patient''s concomitant medications were not reported. The patient died on an unspecified date post vaccine. It was not reported if an autopsy was performed. The information on Lot/ batch number has been requested.; Reported Cause(s) of Death: died on an unspecified date post vaccine


VAERS ID: 1244813 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Depressed level of consciousness, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210213; Test Name: body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 20210217; Test Name: body temperature; Result Unstructured Data: Test Result:38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC2021420823

Write-up: Fever: 38 to 40.5 degrees Celsius; had suffered a huge mental blow. She barely responded and just looked at the floor.; Fever: 38 to 40.5 degrees Celsius; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00505685. A 77-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included alzheimer''s disease. Previous COVID-19 infection: No. Confounding factors: Alzheimer. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on 19Jan2021 for COVID-19 immunization and experienced no adverse event. The patient experienced had suffered a huge mental blow. she barely responded and just looked at the floor on 16Feb2021, fever: 38 to 40.5 degrees celsius on 17Feb2021, fever: 38 to 40.5 degrees celsius on 13Feb2021. The patient died on 22Feb2021. It was not reported if an autopsy was performed. Outcome of fever: 38 to 40.5 degrees celsius on 13Feb2021 was recovered on 16Feb2021. Outcome of had suffered a huge mental blow. she barely responded and just looked at the floor and fever: 38 to 40.5 degrees celsius on 17Feb2021 was fatal. No follow-up attempts are possible, information on batch number cannot be obtained; Reported Cause(s) of Death: had suffered a huge mental blow. She barely responded and just looked at the floor.; Fever: 38 to 40.5 degrees Celsius


VAERS ID: 1244820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: Corona test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021420828

Write-up: Positive corona test 1 day after completion of vaccination and death on 09Apr2021 as a result of Covid; Positive corona test 1 day after completion of vaccination and death on 09Apr2021 as a result of Covid; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, received from Regulatory Authority. The regulatory authority report number is NL-LRB-00505868. A 96-year-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Mar2021 (Lot Number: ER7812) as single dose, first dose was administered via an unspecified route of administration on 20Feb2021 (Lot number was not reported) as 0.3 mL, single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 28Mar2021 patient experienced covid 19 following administration of covid-19 vaccine pfizer Injectable solution. Patient was admitted on unknown date in response to the event. Patient had positive corona test one day after completion of vaccination (on 28Mar2021) and death on 09Apr2021 as a result of Covid-19. The patient underwent laboratory tests and procedures which included sars-cov-2 test: positive on 28Mar2021. The patient died on 09Apr2021 due to Covid-19. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: Unknown Date: 20Feb2021. - Positive corona test 1 day after completion of vaccination and death on 09Apr21 as a result of Covid. Hospitalization information: Covid Additional information ADR: not applicable. Batch/lot number: ER7812 Lack Of Efficacy: Drug ineffective. No follow-up attempts possible. No further information expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: Unknown Date: 20Feb2021. - Positive corona test 1 day after completion of vaccination and death on 09Apr21 as a result of Covid. Hospitalization information: Covid Additional information ADR: not applicable. Batch/lot number: ER7812 Lack Of Efficacy: Drug ineffective. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: covid; Drug ineffective


VAERS ID: 1244833 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Basophil count, Blood albumin, Blood alkaline phosphatase, Blood calcium, Blood creatinine, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, C-reactive protein, Eosinophil count, Epilepsy, Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Investigation, Lymphocyte count, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, Neutrophil count, Platelet count, Red blood cell count, Red blood cell sedimentation rate, Renal function test, White blood cell count
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (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: CLOZAPINE; DEPAKINE [VALPROIC ACID]; IRBESARTAN; DOMPERIDON [DOMPERIDONE]; HYDROCHLOORTHIAZIDE; LEVODOPA/CARBIDOPA; DUODOPA INTESTINAL GEL; CLOZAPINE; DOMPERIDON [DOMPERIDONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: Alanine transaminase; Result Unstructured Data: Test Result:15 IU/l; Test Date: 20210402; Test Name: Aspartate transaminase; Result Unstructured Data: Test Result:20 IU/l; Test Date: 20210402; Test Name: Basophiles; Result Unstructured Data: Test Result:0; Comments: unit: 10^9/L; Test Date: 20210402; Test Name: albumine; Result Unstructured Data: Test Result:30 g/l; Comments: 30 = low; Test Date: 20210402; Test Name: Alk.pho; Result Unstructured Data: Test Result:177 IU/l; Test Date: 20210402; Test Name: Calcium; Result Unstructured Data: Test Result:2.32 mmol/L; Test Date: 20210402; Test Name: creatinine; Result Unstructured Data: Test Result:38 umol/l; Test Date: 20210402; Test Name: potassium; Result Unstructured Data: Test Result:3.1 mmol/L; Comments: 3.1= low; Test Date: 20210402; Test Name: Sodium; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210402; Test Name: TSH; Result Unstructured Data: Test Result:0.91 MiU/L; Test Date: 20210402; Test Name: c-reactive protein; Result Unstructured Data: Test Result:<4 mg/l; Test Date: 20210402; Test Name: Eosinophiles; Result Unstructured Data: Test Result:0.1; Comments: unit: 10^9/L; Test Date: 20210402; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:18 IU/l; Test Date: 20210402; Test Name: Haematocrit; Result Unstructured Data: Test Result:0.34; Comments: 0.34 = low; Test Date: 20210402; Test Name: Hemoglobine; Result Unstructured Data: Test Result:6.5 mmol/L; Comments: 6.5 = low; Test Date: 20210402; Test Name: Red blood cell distribution width; Test Result: 14.6 %; Test Date: 20210402; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.6; Comments: 0.6 = low unit: 10^9/L; Test Date: 20210402; Test Name: mean corpuscular hemoglobin concentration; Result Unstructured Data: Test Result:19.3 mmol/L; Test Date: 20210402; Test Name: mean cell volume; Result Unstructured Data: Test Result:94; Test Date: 20210402; Test Name: Monocytes; Result Unstructured Data: Test Result:0.5; Comments: unit: 10^9/l; Test Date: 20210402; Test Name: Absolute neutrophil count; Result Unstructured Data: Test Result:2.3; Comments: unit: 10^9/l; Test Date: 20210402; Test Name: platelets; Result Unstructured Data: Test Result:231; Comments: 231 = normal (range 150-400 unit: 10^9/L; Test Date: 20210402; Test Name: erythrocytes; Result Unstructured Data: Test Result:3.6; Comments: 3.6 = low unit: 10^12/l; Test Date: 20210402; Test Name: erythrocyte sedimentation rate; Result Unstructured Data: Test Result:2 mm/h; Test Date: 20210402; Test Name: eGFR (CKD-EPI); Result Unstructured Data: Test Result:96 ml/min; Test Date: 20210402; Test Name: leukocytes; Result Unstructured Data: Test Result:3.4; Comments: 3.4 = low unit: 10^9/L
CDC Split Type: NLPFIZER INC2021420868

Write-up: Epileptic seizure; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA). The regulatory authority report number is NL-LRB-00506254. An 80-year-old female patient received her first dose of BNT162B2 (COMIRNATY, Lot Number: ET3674), via an unspecified route of administration on 01Apr2021 at single dose for COVID-19 vaccination. Medical history included parkinson''s disease. Concomitant medications included clozapine tablet 25mg, valproic acid (DEPAKINE) tablet gastro-resistant tablet 300mg, irbesartan tablet 150mg, domperidone tablet 10mg, hydrochlorothiazide tablet 12.5mg, carbidopa, levodopa (LEVODOPA/CARBIDOPA) tablet 100/25mg, carbidopa, levodopa (DUODOPA INTESTINAL GEL) 20/5mg/ml, clozapine tablet 6.25mg and domperidone. There was no past drug therapy BioNTech / Pfizer vaccine (Comirnaty). There was no previous COVID-19 infection. The patient experienced epileptic seizure on 02Apr2021. The patient underwent lab tests included alanine transaminase: 15 IU/l (0-34IU/L), aspartate transaminase: 20 IU/l (0-31 IU/l), basophiles: 0 (0-0.15 unit 10^9/L), albumine: 30 g/l (35-52 g/l), Alk.pho: 177 IU/l (0-125 IU/l), calcium: 2.32 mmol/l (2.18-2.55 mmol/l), creatinine: 38 umol/l (48-113 umol/l), potassium: 3.1 mmol/l (3.5-5.3 mmol/l), sodium: 140 mmol/l (135-145 mmol/l), TSH: 0.91 MiU/L (0.4-4.0 MiU/L), c-reactive protein: <4 mg/l (0-10 mg/l), eosinophiles: 0.1 (0-0.7 unit:10^9/L), gamma-glutamyltransferase: 18 IU/l (0-38 IU/l), haematocrit: 0.34 (0.36-0.47), Hemoglobine: 6.5 mmol/l (7.5-10 mmol/l), Red blood cell distribution width: 14.6% (12-14%), lymphocytes:0.6 (1.5-4 unit: 10^9/L), mean corpuscular hemoglobin concentration: 19.3 mmol/L (19.3-22.5 mmol/L), mean cell volume: 94 (80-100), Monocytes: 0.5 (0.2-1.0 unit: 10^9/l), Absolute neutrophil count: 2.3 (1.8-7.3 unit: 10^9/l), platelets: 231 (150-400 unit: 10^9/L), erythrocytes: 3.6 (4.2-5.4 unit: 10^12/l), erythrocyte sedimentation rate: 2mm/h (1-30), eGFR (CKD-EPI): 96 ml/min, leukocytes: 3.4 (4.3-10 unit: 10^9/L), all on 02Apr2021. Epileptic seizure was treated with Depakine. The outcome of event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Case Summary and Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Seizures Additional information ADR: 1-2x per day confounding factors confounding factors: Parkinson''s disease COVID-19 Previous COVID-19 infection: No. Other: diagnostic procedures: blood tests: erythrocyte sedimentation rate 2 mm / h 1 30 BSE B 1U HEMOGLOBIN * 6.5 mmol / l 7.5 10.0 HB B HEMATOCRITE * 0.34 l / l 0.36 0.47 HT B ERYTHROCYTES * 3.6 10! 12 / l 4.20 5.40 ERY B MT mean cell volume (MCV) 94 fl 80 100 MCV B mean corpuscular hemoglobin concentration (MCHC) 19.3 mmol / l 19.3 22.5 MCHCB Red blood cell distribution width (RDW )14.6% 12.0 16.0 RDW B MD PLATELS 231 10! 9 / l 150 400 TROMB MT LEUCOCYTES * 3.4 10! 9 / l 4.3 10.0 LEUKB MT Absolute neutrophil count 2.3 10! 9 / l 1.8 7.3 NEUTB MT LYMFOCYTES * 0.6 10! 9 / l 1.5 4.0 LYMFB MT MONOCYTES 0.5 10! 9 / l 0.2 1.0 MONOB MT EOSINOPHILES 0.1 10! 9 / l 0 0.7 EO B MT BASOPHILES 0.0 10! 9 / l 0 0.15 BASOB MT CLINICAL CHEMISTRY NAME N RESULT REF. VALUES G C SODIUM 140 mmol / l 135 145 NA B POTASSIUM * 3.1 mmol / l 3.5 5.3 K B CALCIUM 2.32 mmol / l 2.18 2.55 CA B CREATININ * 38 umol / l 48 113 KREAB Assessment of kidney function (eGFR (CKD-EPI)) 96 ml / min$g 60 KRECO FB Aspartate transaminase (AST (GOT)) 20 U / l 0 31 ASATB Alanine transaminase (ALT (GPT)) 15 U / l 0 34 ALATB Gamma-glutamyltransferase (GAMMA-GT_ 18 U / l 0 38 GGT B Alk.Pho * 177 U / l 0 125 AF B ALBUMIN * 30 g / l 35 52 ALB B C-REACTIVE PROTEIN CRP <4 mg / l 0 10 CRP B THYROID STIM.HORM. (TSH) 0.91 mE / l 0.4 4.0 TSH B No follow-up attempts possible. No further information expected. Information on lot# obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Seizures Additional information ADR: 1-2x per day confounding factors confounding factors: Parkinson''s disease COVID-19 Previous COVID-19 infection: No. Other: diagnostic procedures: blood tests: erythrocyte sedimentation rate 2 mm / h 1 30 BSE B 1U HEMOGLOBIN * 6.5 mmol / l 7.5 10.0 HB B HEMATOCRITE * 0.34 l / l 0.36 0.47 HT B ERYTHROCYTES * 3.6 10! 12 / l 4.20 5.40 ERY B MT mean cell volume (MCV) 94 fl 80 100 MCV B mean corpuscular hemoglobin concentration (MCHC) 19.3 mmol / l 19.3 22.5 MCHCB Red blood cell distribution width (RDW )14.6% 12.0 16.0 RDW B MD PLATELS 231 10! 9 / l 150 400 TROMB MT LEUCOCYTES * 3.4 10! 9 / l 4.3 10.0 LEUKB MT Absolute neutrophil count 2.3 10! 9 / l 1.8 7.3 NEUTB MT LYMFOCYTES * 0.6 10! 9 / l 1.5 4.0 LYMFB MT MONOCYTES 0.5 10! 9 / l 0.2 1.0 MONOB MT EOSINOPHILES 0.1 10! 9 / l 0 0.7 EO B MT BASOPHILES 0.0 10! 9 / l 0 0.15 BASOB MT CLINICAL CHEMISTRY NAME N RESULT REF. VALUES G C SODIUM 140 mmol / l 135 145 NA B POTASSIUM * 3.1 mmol / l 3.5 5.3 K B CALCIUM 2.32 mmol / l 2.18 2.55 CA B CREATININ * 38 umol / l 48 113 KREAB Assessment of kidney function (eGFR (CKD-EPI)) 96 ml / min$g 60 KRECO FB Aspartate transaminase (AST (GOT)) 20 U / l 0 31 ASATB Alanine transaminase (ALT (GPT)) 15 U / l 0 34 ALATB Gamma-glutamyltransferase (GAMMA-GT_ 18 U / l 0 38 GGT B Alk.Pho * 177 U / l 0 125 AF B ALBUMIN * 30 g / l 35 52 ALB B C-REACTIVE PROTEIN CRP <4 mg / l 0 10 CRP B THYROID STIM.HORM. (TSH) 0.91 mE / l 0.4 4.0 TSH B; Reported Cause(s) of Death: epileptic seizure


VAERS ID: 1244847 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, Body temperature, C-reactive protein, Chest X-ray, Dyspnoea, Echocardiogram, Electrocardiogram, Fatigue, Fibrin D dimer, General physical health deterioration, Heart rate, Oxygen saturation, Oxygen saturation abnormal, Platelet count, Pulmonary embolism, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATINE; ASCAL CARDIO; CALCI CHEW D3; LISINOPRIL; SOTALOL; AMLODIPINE; PANTOPRAZOL [PANTOPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Atrial fibrillation; Benign mammary dysplasia; Cataract; Coronary artery disease (PTCA and stent placement); Gamma-glutamyltransferase increased (isolated ggt increase); Hysterectomy; Ischemic heart disease (Exercise-related ischemia in the posterior wall); Pneumonia (repetitive); Radius fracture; Tracheobroncheopathia osteoclastica (actually tracheobronchopatia ostronchondroplastica)
Allergies:
Diagnostic Lab Data: Test Name: systolic blood pressure; Result Unstructured Data: Test Result:50 mmHg; Test Name: body temperature; Result Unstructured Data: Test Result:36.7; Test Date: 20210320; Test Name: X Thorax; Result Unstructured Data: Test Result:blaterally enhanced lung vasculature; Test Date: 20210320; Test Name: crp; Result Unstructured Data: Test Result:23; Test Name: echocardiogram; Result Unstructured Data: Test Result:atrial flutter; Test Date: 20210320; Test Name: Ecg; Result Unstructured Data: Test Result:Atrial fibrillation; Test Date: 20210320; Test Name: di dimer; Result Unstructured Data: Test Result:2520 g/l; Test Name: heart rate; Result Unstructured Data: Test Result:40; Comments: / min; Test Date: 20210320; Test Name: heart rate; Result Unstructured Data: Test Result:90; Comments: / min; Test Name: saturation; Test Result: 94 %; Comments: at 7 L CPAP (Continuous positive airway pressure); Test Date: 20210320; Test Name: saturation; Test Result: 70 %; Test Date: 20210325; Test Name: saturation; Test Result: 95 %; Test Date: 20210320; Test Name: thombocyte; Result Unstructured Data: Test Result:322; Comments: normal; Test Date: 20210320; Test Name: COVID-19 test; Test Result: Negative ; Comments: twice
CDC Split Type: NLPFIZER INC2021420839

Write-up: Lung embolism; progressive dyspnea; General physical health deterioration; Fatigue aggravated; low saturation 70%; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00506312. A 95-year-old female patient received second dose of BNT162B2 (COMIRNATY) on 12Mar2021 as single dose for covid-19 immunisation. Medical history included coronary artery disease in 1996 (PTCA and stent placement), tracheobroncheopathia osteoclastica in 2012 (actually tracheobronchopatia ostronchondroplastica), ischemic heart disease in 2017, benign mammary dysplasia in 2017, hysterectomy in 2017, appendectomy in 2017, gamma glutamyltransferase increased in 2017 (isolated ggt increase), radius fracture in 2016, cataract in 2016, atrial fibrillation in 2021, pneumonia in 2012. Concomitant medication included simvastatine, carbasalate calcium (ASCAL CARDIO), Calcium carbonate/ cholecalciferol (CALCI CHEW D3), lisinopril, sotalol, amlodipine, pantoprazol (PANTOPRAZOLE). On 05Feb2021, the patient received first dose of BNT162B2 (COMIRNATY) for covid-19 immunisation. On 20Mar2021, the patient experienced dyspnoea, fatigue aggravated, lung embolism, of oxygen saturation abnormal; the patient was hospitalized for lung embolism and dyspnea and the events were considered life-threatening. On unknown date, the patient experienced general physical health deterioration. Dyspnoea was treated with ontstolling and lung embolism was treated with ontstolling (as reported). Physical examination on unknown date: heart rate 40/min, Saturation 94% at 7 L Continuous positive airway pressure (CPAP), vesicular breath sounds with over all fields humming rhonchi and bibasal track gross crepitations, symmetrical excursions, Temperature 36.7, no skin abnormalities, no oedemas, supple calves; Echocardiogram: atrial flutter left atrium (LA) seems normal right Atrium (RA): no obvious abnormalities left ventricular (LV) seems good right ventricular (RV)looks wide mitral valve (MV): no obvious abnormalities aortic valve (AoV): not in view, Tricuspid valve (TV): moderate Tricuspid Insufficiency (TI) right ventricular systolic pressure (RVSP) 45 mmHg, pulmonary vein ( PV): not in view. vena cava inferior: narrow and collapses well Aorta: no obvious abnormalities. good to very good Left ventricular function LVF. RV dilated. Spetal D-sign; Estimated systolic pulmonary pressure 50mmHg. On 20Mar2021, X thorax showed bilaterally enhanced lung vasculature (anatomy and physiology landscape view; bilaterally enhanced lung vasculature with focal consolidation right basal.; unchanged compared to 21Feb2021) configuration of heart and mediastinum; suspicion of pleural fluid left basal), C-reactive protein was 23, ECG: atrial fibrillation (Atrial fibrillation 90/min, intermediate cardiac axis, normal conduction times, no ST deviations, normal T buds.), D dimer 2520, saturation 70%, thrombocyte 322, sars-cov-2 test resulted negative. On 25Mar2021, saturation was 95% (without O2). Conclusion: mild pulmonary hypertension with lung emboli. Conclusion at discharge: Mild pulmonary hypertension with suspected pulmonary emboli, COVID 19 in sputum ruled out because of additional lung embolism (LE); no treatment consequences seen, good left ventricle function on heart. Atrial fibrillation de novo already started NOAC (novel oral antocoagulants). The patient died on 09Apr2021 due to general deterioration (woman did not want to be treated any more, 95-year-old), dyspnoea, fatigue aggravated, lung embolism, of oxygen saturation abnormal. It was unknown if an autopsy was performed. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained. No further information expected. ; Reported Cause(s) of Death: lung embolism; dyspnea; fatigue aggravated; oxygen saturation abnormal; general deterioration, woman did not want to be treated any more, 95 years old


VAERS ID: 1244855 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure decreased, Blood pressure measurement, Cold sweat, Depressed level of consciousness, Malaise, Pharyngeal swelling, Stridor
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased
CDC Split Type: NLPFIZER INC2021420845

Write-up: less approachable; Not feeling well; Anaphylaxis; snoring breathing; Blood pressure decreased; swelling in the throat on inspiration; Clammy, sweaty; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number NL-LRB-00506316. A 77-year-old male patient received first dose of BNT162B2 (Pfizer vaccine, Solution for injection, Lot Number: EW9127), via an unspecified route of administration on 12Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced less approachable, not feeling well, anaphylaxis, snoring breathing, blood pressure decreased, swelling in the throat on inspiration, clammy, sweaty on 12Apr2021, 20 minutes after vaccination. Seriousness criteria reported as death and life threatening for all events. Events Anaphylaxis, blood pressure decreased, clammy, consciousness decreased, malaise, stridor and throat swelling were treated with epipen and resuscitation. Additional information reported as Heard via ambulance about swelling in the throat on inspiration. No diagnostic procedures were performed. The patient died on 12Apr2021. It was not reported if an autopsy was performed. The outcome of all the events was reported as fatal. Sender Comment: These symptoms are considered to be part of a syndrome, therefore the events were coded as anaphylactic reaction by the Center laboratory. Case Summary and Reporter''s Comments Text : BioNTech / Pfizer vaccine : Past drug therapy BioNTech / Pfizer vaccine : no Clammy, sweaty, less approachable, decreased blood pressure and snoring breathing: No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: less approachable; Not feeling well; Anaphylaxis; snoring breathing; Blood pressure decreased; swelling in the throat on inspiration; Clammy, sweaty


VAERS ID: 1244857 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-02
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMINE [METFORMIN HYDROCHLORIDE]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021420827

Write-up: Death: cardiac arrest; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority NL-LRB-00507098. A 10-weeks male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: Unknown), via an unspecified route of administration on 31Mar2021 (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Historical vaccine include: COMIRNATY via an unspecified route of administration on 23Feb2021 as 0.3 ml, single. Concomitant medications included: metformin hydrochloride, non-specified insulin, non-specified blood thinner and non-specified cholesterol lowering drug (all started on an unspecified date in 2000 and taken for an unspecified indication). The patient had no COVID-19 infection in past. On 02Apr2021, 2 days after vaccination, the patient had cardiac arrest and died. The outcome of cardiac arrest was fatal. Batch/Lot# and expiry date not provided and not possible to obtain.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): yes adverse drug reaction (ADRs): My answer to the next question is ''don''t know'' Date: 23Feb2021 personal number (BSN) available: yes COVID19 Previous COVID-19 infection: No; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1244859 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Cardiac pacemaker evaluation, Inappropriate schedule of product administration, Loss of consciousness, Off label use, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Medication errors (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 69
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Coronary disease; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Broken heart syndrome; Cardiac pacemaker insertion; General physical health deterioration (the patient was in good general condition until he underwent UTI); Heart disease, unspecified; Near syncope (not as frequently); UTI (Treated with antibiotics, but the patient never reached the same level of function as before the UTI)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: pacemaker check; Result Unstructured Data: Test Result:everything was fine
CDC Split Type: NOPFIZER INC2021420856

Write-up: (near) syncope x several; gradually became weaker; loss of consciousness; patient was frail and in a reduced state therefore they chose not to give dose 2; patient was frail and in a reduced state therefore they chose not to give dose 2; DROP IN BLOOD PRESSURE; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uwzrg2. A 92-year-old male patient received first dose of bnt162b2 (Pfizer vaccine) intramuscular on 13Jan2021 at single dose for COVID-19 immunisation. The medical history included UTI (urinary tract infection) from Jan2021 which treated with antibiotics, but the patient never reached the same level of function as before the UTI, general physical health deterioration from Jan2021 (the patient was in good general condition until he underwent UTI at the end of January), heartbroken (had pre-existing heart disease) and also had near syncope episodes but not as frequently ; ongoing living in nursing home and ongoing coronary disease, pacemaker. The patient developed syncope on an unspecified date, drop in blood pressure on 17Jan2021, the events reported as caused death and were medically significant. Following the vaccine and UTI, patient had several episodes of (near) syncope. After the vaccine, he had 5-6 episodes of loss of consciousness / blood pressure drop. Patient had a pacemaker and it was checked at the heart ward in the Feb2021, everything was fine. The reporting physician suspected a link between the vaccine and frequent syncopes. The patient was frail and in a reduced state therefore they (the reporting physician) chose not to give dose 2. He gradually became weaker, stopped drinking / eating / taking medication, he was put on palliative care and died on 28Mar2021. It was reported that event drop in blood pressure had a stop date 28Mar2021 with an outcome fatal. The case was considered to be serious. The outcome of the events drop in blood pressure and syncope was fatal, while other events was unknown. It was unknown if an autopsy was performed, the reported cause of death was syncope and drop in blood pressure. Senders comment: Relatedness of drug to reaction(s)/event(s) (syncope, drop in blood pressure): Source of assessment - Regional Pharmacovigilance Center, Result of Assessment - Possible. Information about lot/batch number was requested.; Reported Cause(s) of Death: syncope; Drop in blood pressure


VAERS ID: 1244865 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2243 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Cardio-respiratory arrest
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), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; FUROSEMIDE; HYDROCHLOROTHIAZIDE;LISINOPRIL; FERROUS SULPHATE + FOLIC ACID; PANTOPRAZOLE; SERENAL [OXAZEPAM]; OLANZAPINE; CARVEDILOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia normocytic; Atrial fibrillation; COVID-19; Dyslipidaemia; Hypertension arterial; Stenosis aortic valve; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021420858

Write-up: Anaphylactic reaction/anaphylaxis was characterised by sudoresis, bradycardia, filiform pulse, hypotension, wheezing and agonal respiration; cardiopulmonary arrest; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is PT-INFARMED-B202104-814. An 87-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via intramuscular on 09Apr2021 (Batch/Lot Number: EW2243, CAUL:17621) as 0.3mL, single for COVID-19 immunisation. Medical history included COVID-19 and stroke, both from Jan2021 to 2021, atrial fibrillation, hypertension arterial, anaemia normocytic, aortic valve stenosis and dyslipidaemia, all from an unknown date and unknown if ongoing. Concomitant medications included apixaban, furosemide, hydrochlorothiazide/lisinopril, ferrous sulfate/folic acid, pantoprazole, oxazepam (SERENAL [OXAZEPAM]), olanzapine and carvedilol, all taken for product used for unknown indication, start and stop date were not reported. The adverse reaction (ADR) anaphylaxis was characterised by sudoresis, bradycardia, filiform pulse, hypotension, wheezing and agonal respiration and started approximately 25 minutes after vaccination. The patient was immediately assisted by the medical and nursing team where she lived. Adrenaline and oxygen therapy were administered. The emergency medical service was called and a venous access was used to infuse 0.9% NaCl saline and prednisolone (SOLU-DACORTINA). Approximately 60 to 70 minutes after the onset of ADR the patient went into cardiorespiratory arrest and died. The patient died on 09Apr2021. An autopsy was performed and results were not provided. Outcome of the event was fatal. Reporter causality was possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Anaphylactic reaction to vaccine; Cardio-respiratory arrest


VAERS ID: 1244899 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: FINASTERID STADA; METFORMIN MYLAN; MIRTAZAPIN ACTAVIS; TROMBYL; CITALOPRAM MYLAN; ATORVASTATIN KRKA
Current Illness: Claudication intermittent; Depressed mood; Type II diabetes mellitus; Urination difficulty
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021414369

Write-up: HEART STOP; ventricular fibrillation; collapsed; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-026251. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration in Apr2021 (Lot Number: EW2239) as single dose for covid-19 immunisation. Medical history included ongoing Urination difficulty, ongoing depressed mood, ongoing Claudication intermittent, ongoing Type II diabetes mellitus. Concomitant medications included finasteride (FINASTERID STADA) taken for an unspecified indication from 2020 to an unspecified stop date; metformin hydrochloride (METFORMIN MYLAN) taken for an unspecified indication from 2012 to an unspecified stop date; mirtazapine (MIRTAZAPIN ACTAVIS) taken for an unspecified indication from 2017 to an unspecified stop date; acetylsalicylic acid (TROMBYL) taken for an unspecified indication from 2012 to an unspecified stop date; citalopram hydrobromide (CITALOPRAM MYLAN) taken for an unspecified indication from 2015 to an unspecified stop date; atorvastatin calcium (ATORVASTATIN KRKA) taken for an unspecified indication from 2017 to an unspecified stop date. Reported suspected adverse event was cardiac arrest. Vaccination with dose no 2 in April 2021. The next day, the man was standing outside waiting for transportation when he suddenly collapsed. Bystanders contacted an ambulance and started CPR (Cardiopulmonary resuscitation). When the ambulance arrived, the man initially had ventricular fibrillation. Defibrillated twice but never developed a sustaining heart rhythm. Initially pulseless electrical activity and later on, asystole. Treated multiple times with adrenaline. Arrived at the emergency room after CPR (Cardiopulmonary resuscitation) had been ongoing for 30 minutes, including mechanically with LUCAS (chest compression system). A decision was made to terminate CPR (Cardiopulmonary resuscitation) and the man was pronounced dead. The patient experienced heart stop in Apr2021. The patient died of heart stop on an unspecified date in Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ventricular fibrillation; collapsed; Cardiac arrest


VAERS ID: 1244901 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Hyperhidrosis, Hypertension, Rash, Solar dermatitis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Hypertension (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS; METOPROLOL TEVA
Current Illness: Atrial fibrillation; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021420892

Write-up: Hypertension triggered cerebral hemorrhage; Cerebral haemorrhage; skin rash on the legs; solar dermatitis; sweating; This is a spontaneous report received from a contactable physican downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-026651, other case identifier SE-VISMA-1618220565573. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration in Mar2021 (Lot Number: ER9470) at single dose for covid-19 immunisation. Medical history included ongoing atrial fibrillation and ongoing hypertension. Concomitant medications included apixaban (ELIQUIS) 5 MG Film-coated tablet and metoprolol tartrate (METOPROLOL TEVA) 50 MG Prolonged-release tablet. Reported suspected adverse events were cerebral haemorrhage due to hypertension (Hypertension triggered cerebral hemorrhage) and skin rash on both legs. Vaccination in March 2021 with the first dose. Three days later in Apr2021, debut of rash on both legs. The rash occurred after the man sat outside in short pants. Also developed sweating during the night. Interpreted as solar dermatitis. Nine days after the vaccination in Apr2021, the man developed a sudden cerebral haemorrhage and died two days later. Submitted outcome for both cerebral haemorrhage due to hypertension and rash on both legs was fatal. Outcome of solar dermatitis was considered fatal and of sweating was unknown. Submitted cause of death was cerebral haemorrhage due to hypertension (as reported). Report was assessed as serious, death. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral haemorrhage; Hypertension triggered cerebral hemorrhage; rash on both legs; solar dermatitis


VAERS ID: 1244905 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Hemiparesis, Peripheral swelling, Thrombophlebitis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Noninfectious encephalitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALFACALCIDOL; KALCIPOS; DUROFERON; FURIX [FUROSEMIDE]; FURIX [FUROSEMIDE]; MIRTAZAPIN; ARITAVI; WARAN; BUPREFARM; INNOVAIR; SPIRIVA; PRIMPERAN; CILAXORAL; OXASCAND; VENTOLINE [SALBUTAMOL]; ARTELAC [HYPROMELLOSE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Kidney failure; Pulmonary failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021422928

Write-up: headache; weakened right hand and leg; thrombophlebitis in right arm and leg; swollen legs; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) for covid-19 immunisation. Medical history included heart failure, lung failure and kidney failure, all from an unknown date and unknown if ongoing. The patient was not pregnant at the time for the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the Covid vaccination. Patient had no known allergies. Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested positive since the vaccination. Concomitant medications included alfacalcidol; calcium carbonate (KALCIPOS), ferrous sulfate (DUROFERON), furosemide (FURIX) tablet formulation, furosemide (FURIX) unknown formulating, mirtazapine; duloxetine hydrochloride (ARITAVI), warfarin sodium (WARAN), buprenorphine (BUPREFARM), beclometasone dipropionate, formoterol fumarate (INNOVAIR), tiotropium bromide (SPIRIVA), metoclopramide hydrochloride (PRIMPERAN), sodium picosulfate (CILAXORAL), oxazepam (OXASCAND), salbutamol (VENTOLINE), hypromellose (ARTELAC), all from an unknown date for an unspecified indication. The patient experienced headache, weakened right hand and legs, thrombophlebitis in right arm and leg and swollen legs on an unspecified date. Therapeutic measures were taken as a result of headache, weakened right hand and leg, thrombophlebitis in right arm and leg, swollen legs in the form of increased dose of diuretics and compression of the legs. The patient died on 31Mar2021. The events were reported with seriousness criteria disabling and resulting in death. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: weakened right hand and leg; thrombophlebitis in right arm and leg; swollen legs; headache


VAERS ID: 1246031 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-02
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 31
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: in a great condition no prblom at all pragnet womams diney Dead in all ages there are many cases are not reporting tney hide tne resuolts
Allergies: No daby have allerges pepole after ingeqction 3 or four days Dead
Diagnostic Lab Data: 02-Jan-2021
CDC Split Type:

Write-up: There a big forblem they forcing as to vacasin pepoele are dieng no bady stop tnem not the mdia no gavrment there is choaos in tne country help as.


VAERS ID: 1245538 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Mesenteric artery thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Hypothyroidism; Osteoarthritis; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: Mesenteric artery thrombosis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MESENTERIC ARTERY THROMBOSIS (Mesenteric artery thrombosis) in an 80-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Hypothyroidism, Osteoarthritis and Osteoporosis. On 17-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced MESENTERIC ARTERY THROMBOSIS (Mesenteric artery thrombosis) (seriousness criterion death). The patient died on 01-Apr-2021. The reported cause of death was mesenteric ischemia. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. sender''s case number 2021035738 Company comment: This case refers to an 80 year-old elderly female patient, with a history of hypertension and hypothyroidism, who died due to mesenteric artery thrombosis 15 days after receiving the first dose of mRNA-1273 vaccine. Very limited information has been provided at this time. Reporter did not allow further contact; Sender''s Comments: This case refers to an 80 year-old elderly female patient, with a history of hypertension and hypothyroidism, who died due to mesenteric artery thrombosis 15 days after receiving the first dose of mRNA-1273 vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: mesenteric ischemia


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