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

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



Case Details

This is page 106 out of 172

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VAERS ID: 1231834 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-01
   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 - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Areflexia, Drooling, Dysarthria, Lethargy
SMQs:, Peripheral neuropathy (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418792

Write-up: Areflexia; Drooling; Dysarthria; Lethargy; This is a spontaneous report from a contactable HCP. This is a report received from Medical Agency. Regulatory authority report number 531686. A 91-year-old patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 30Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Apr2021 the patient experienced areflexia, drooling, dysarthria and lethargy. The patient died on an unspecified date in Apr2021. 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: Areflexia; Drooling; Dysarthria; Lethargy


VAERS ID: 1231835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-02
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed level of consciousness
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), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418793

Write-up: Depressed level of consciousness; This is a spontaneous report from a contactable other health professional via the Medical Agency. Regulatory authority report number is 531705. A 73-year-old male patient received BNT162b2 (vaccine, Lot # unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced a depressed level of consciousness on 02Apr2021. The event was serious as fatal. It was unknown whether an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Depressed level of consciousness


VAERS ID: 1231836 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418794

Write-up: Vomiting; This is a spontaneous report from a contactable other health professional via the Medical Agency. Regulatory authority report number is 532021. A 89-years-old female patient received bnt162b2 (vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced fatal vomiting on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Vomiting


VAERS ID: 1231837 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418795

Write-up: death; This is a spontaneous report from a contactable other hcp. received from the Medical Agency. Regulatory authority report number 534761. A 100-years- old female patient received BNT162B2 (vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1231838 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021418796

Write-up: Loss of consciousness; This is a spontaneous report from a contactable other health professional via the Medical Agency, Regulatory authority report number: 532790. An 82 years old male patient received BNT162B2 (vaccine, solution for injection) on an unspecified date at single dose, via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient experienced loss of consciousness on an unspecified date which let to patient''s death on an unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible. Information on batch cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Loss of consciousness


VAERS ID: 1231839 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-03
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418797

Write-up: Concomitant disease aggravated; Pyrexia; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 533124. A 69 year-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via an unspecified route of administration on an unspecified date (reported as "3 days") (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 03Apr2021 the patient experienced pyrexia and the aggravation of an unspecified concomitant disease, both reported as fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Concomitant disease aggravated; Pyrexia


VAERS ID: 1231840 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-07
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Dyspnoea, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418798

Write-up: Cyanosis; Dyspnoea; Respiratory distress; This is a spontaneous report from a contactable other health professional via the regulatory authority. Regulatory authority report number is 533147. An 82-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route of administration, at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 07Apr2021, the patient died due to cyanosis, dyspnoea and respiratory distress. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cyanosis; Dyspnoea; Respiratory distress


VAERS ID: 1231841 (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: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Depressed level of consciousness
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), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021418799

Write-up: Depressed level of consciousness; This is a spontaneous report from a contactable other healthcare professional via the Medical Agency. Regulatory authority report number is 533668. A 90-year-old female patient received BNT162b2 (vaccine), via an unspecified route of administration, on 01Apr2021, as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 04Apr2021, three days after vaccination, the patient experienced depressed level of consciousness resulting in death on 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: Depressed level of consciousness


VAERS ID: 1231868 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Septic shock
SMQs:, Toxic-septic shock conditions (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Axillary abscess; Chronic kidney disease stage 3; Diabetes mellitus; Dysphagia; Hypertensive cardiomyopathy; Metabolic syndrome; Peripheral arterial disease; Polyneuropathy; Spinal cord injury; Stroke
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Septic shock; 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 pharmacist (subsequently medically confirmed) and describes the occurrence of SEPTIC SHOCK (Septic shock) in a 69-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. Concurrent medical conditions included Spinal cord injury, Polyneuropathy, Diabetes mellitus, Dysphagia, Stroke, Hypertensive cardiomyopathy, Atrial fibrillation, Peripheral arterial disease, Metabolic syndrome, Chronic kidney disease stage 3 and Axillary abscess since February 2021. On 09-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) at an unspecified dose. On 14-Mar-2021, the patient experienced SEPTIC SHOCK (Septic shock) (seriousness criterion death). The patient died on 14-Mar-2021. The reported cause of death was Septic shock. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered SEPTIC SHOCK (Septic shock) to be unlikely related. Action taken with mRNA-1273 in response to the event was not applicable. No treatment information was provided. Reporter did not allow further contact; Sender''s Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment.; Reported Cause(s) of Death: Septic shock


VAERS ID: 1231874 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Acute pulmonary oedema, Atrial fibrillation, Cardiac failure acute, Delirium, Dyspnoea, Hypotension, Pneumonia, Tachycardia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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: ELIQUIS; ASPIRIN CARDIO; TOREM [TORASEMIDE]; QUETIAPIN MEPHA; METOPROLOL MEPHA ZOK
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Anemia normochromic (Date of diagnosis unknown.); Cardiomyopathy (Date of diagnosis unknown. Severe valvular and rhythmogenic cardiomyopathy with highly restricted left ventricular ejection fraction.); Chronic renal impairment (Status G4 (KDIGO)); Dementia (Date of diagnosis unknown.); Heart insufficiency (Date of diagnosis unknown. Severe valvular and rhythmogenic cardiomyopathy with highly restricted left ventricular ejection fraction.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021416450

Write-up: Acute AKI II on chronic renal failure (aetiology acute: prerenal IR chornic severe heart failure).; acute biventricular decompensation with pulmonary edema in hypertensive decompensation and tachycardic atrial fibrillation; bilateral pneumonia; acute biventricular decompensation with pulmonary edema in hypertensive decompensation and tachycardic atrial fibrillation; Dyspnea, hypotension, tachycardia; Dyspnea, hypotension, tachycardia; Dyspnea, hypotension, tachycardia; acute biventricular decompensation with pulmonary edema in hypertensive decompensation and tachycardic atrial fibrillation; hyperactive delir since 26Mar2021; This is a spontaneous report received from a contactable other HCP via the regulatory authority. Regulatory authority report number CH-SM-2021-14218. A 85-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Mar2021 (Batch/Lot Number: Unknown) as single for Covid-19 immunisation . Medical history included renal impairment (Status G4 KDIGO) , cardiomyopathy (Date of diagnosis unknown). Severe valvular and rhythmogenic cardiomyopathy with highly restricted left ventricular ejection fraction , cardiac failure (Date of diagnosis unknown). Normochromic anaemia (Date of diagnosis unknown) , dementia (Date of diagnosis unknown) , hypersensitivity. On 23Feb2021 the patient received the first dose of BNT162B2 without adverse effects. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASPIRIN CARDIO) taken for an unspecified indication, start and stop date were not reported; torasemide (TOREM) taken for an unspecified indication, start and stop date were not reported; quetiapine fumarate (QUETIAPIN MEPHA) taken for an unspecified indication, start and stop date were not reported; metoprolol succinate (METOPROLOL MEPHA ZOK) taken for an unspecified indication, start and stop date were not reported. Five days later, on 29Mar2021, dyspnea, tachycardia, hypotension and acute on chronic renal failure (AKI II) of prerenal etiology (severe chronic heart failure) were detected on admission to the hospital. Bilateral pneumonia was also observed and treated with antibiotics during hospitalization. During her stay in hospital, she suffered from hyperactive delirium on pre-existing dementia and acute biventricular decompensation with pulmonary edema with hypertensive peak and tachycardic atrial fibrillation. The patient died on 02Apr2021; no autopsy was performed. Acute renal failure, cardiac failure, pneumonia and acute pulmonary edema were considered cause of death. A causal relationship between Comirnaty and Death, Hypotension, Acute renale failure, Tachycardia, Dyspnoea, Acute heart failure, Hyperactive delirium, Bilateral pneumonia, Atrial fibrillation and Acute pulmonary oedema was assessed as being unlikely. No symptoms found in this patient are reported among the side effects in the RA of Comirnaty. The database, of 198,115 reports to the Comirnaty monograph, reports, 1,682 cases of death, 5,762 cases of dyspnea, 1,141 cases of hypotension, 3584 cases of tachycardia, 30 cases of pneumonia, 115 cases of acute renal failure, 2 cases of acute heart failure, 408 of atrial fibrillation, 3 of hyperactive delirium, 36 cases of acute pulmonary edema. In the light of these data and the available information, considering the age and comorbidities of the patient, we believe that all the acute symptoms reported may be related to complications in relation to bilateral pneumonia and pre-existing cardiac and renal failure. For this reason, despite the excellent temporal correlation, we believe that a direct correlation between the symptomatology developed by the patient and her subsequent death with Comirnaty is unlikely. However, this judgment of causality does not completely exclude the role of the vaccine.; Reporter''s Comments: Death on 02Apr2021 of 85 years old patient, second dose of Comirnaty 23Mar2021 and 5 days after hospitalization with dyspnea, tachycardia, hypotension and acute on chronic renal failure (AKI II) of pre-existing etiology (chronic heart failure). During hospitalization bilateral pneumonia, hyperactive delirium on pre-existing dementia, acute biventricular decompensation with pulmonary edema and hypertensive peak, tachycardic atrial fibrillation. Autopsy not performed.; Reported Cause(s) of Death: Acute pulmonary oedema; Pneumonia; Cardiac failure; Renal failure


VAERS ID: 1231917 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-17
   Days after vaccination:26
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: Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021398837

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100032182. An 89-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: unknown), dose 2 via an unspecified route of administration on 22Jan2021 (at the age of 89years) as 0.3 mL, single for Covid-19 immunization. The patient received the first dose of Comirnaty on 31Dec2020 for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. On 17Feb2021, the patient experienced unknown cause of death. The patient died on 17Feb2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s) (Source of assessment: PEI); 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: 1231918 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-03-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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: 2021-04-07
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409258

Write-up: Apoplexy; This is a spontaneous report received from a non-contactable physician downloaded from the Medicine Agency (MA) -WEB. The regulatory authority report number is DE-PEI-202100032667. An 81-year-old female patient received bnt162b2 (vaccine), via an unspecified route of administration on 20Mar2021 (Lot Number: ER7812) at age of 81 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced apoplexy (death, hospitalization, life threatening) on 27Mar2021. The patient''s outcome was fatal for Apoplexy. The patient died on 07Apr2021. It was not reported if an autopsy was performed. The causality assessment for suspect drug to event was reported as follows: Source of assessment was PEI, Result of Assessment was D. Unclassifiable. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: ischaemischer Apoplex


VAERS ID: 1231921 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-31
   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 ER7812 / 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:
Current Illness: Adipositas (Grad 3); Diabetes mellitus; Diabetic polyneuropathy (Grad 3); Gammopathy; Plasmacytoma; Renal insufficiency (Grade 3)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409242

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority. The regulatory authority report number is DE-PEI-202100032675. An 85-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 27Mar2021 (Lot Number: ER7812) at age of 85 years old as single dose for covid-19 immunisation. Medical history included ongoing diabetic polyneuropathy grad 3, ongoing plasmacytoma, ongoing diabetes mellitus, ongoing adipositas grad 3, ongoing gammopathy, ongoing renal insufficiency grade 3. The patient''s concomitant medications were not reported. On 31Mar2021 the patient experienced unknown cause of death. The patient died on 31Mar2021. An autopsy was not performed. The causality assessment for suspect drug to event was reported as follows: Source of assessment was regulatory authority, Result of Assessment was D. Unclassifiable. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231922 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   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 ER7812 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Vaccination complication
SMQs:

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409226

Write-up: Death; Vaccination reaction; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-202100032678. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 25Mar2021 (Lot Number: ER7812) at age of 83 years old as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 at age of 83 years old as single dose for covid-19 immunisation. On 25Mar2021 the patient experienced vaccination reaction. On 26Mar2021 the patient experienced unknown cause of death. The patient''s outcome was not recovered for impfreaktion, fatal for unknown cause of death. The patient died on 26Mar2021. 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: Unknown cause of death


VAERS ID: 1231928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   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: Arterial hypertension; Coronary heart disease; Diabetes mellitus; Hyperparathyroidism; Kidney failure; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409164

Write-up: Unknown cause of death; asystole; Occurrence of shortness of breath/Difficulty breathing; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority WEB, regulatory authority number DE-PEI-CADR2021044735, Safety Report Unique Identifier DE-PEI-202100032434. A 76-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 07Apr2021 12: 30 (Lot Number: EW8904) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing Coronary heart disease, ongoing Renal insufficiency, ongoing Arterial hypertension, ongoing Hyperparathyroidism, ongoing Diabetes mellitus, ongoing preterminal kidney failure. The patient''s concomitant medications were not reported. On 08Apr2021, the patient experienced occurrence of shortness of breath/ Difficulty breathing, asystole (medical significant), Unknown cause of death (death). The patient died on 08Apr2021. It was unknown if an autopsy was performed. It was reported that Information on risk factors or previous illnesses CHD, diabetes mellitus, preterminal kidney failure, arterial hypertension, secondary HPT / normal course with no symptoms after administration of the vaccine at 12:30 p.m. 07Apr2021 until late. Afternoon (until the son is present), Between 2 and 3 o''clock in the morning, those affected call their son with rattling breathing, asystole when the PRIVACY arrives, foamy, whitish sputum. No concerned known of any allergies. The outcome of cause of death unknown was fatal, of the other events was not recovered. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1231929 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Schizophrenia; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021409168

Write-up: COVID-19 PCR test positive; 06Mar21 died of virus flu with proven Covid-19 infection; Influenza A virus infection from Mar2021; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority, regulatory authority number is DE-PEI-CADR2021044761. Safety report unique identifier DE-PEI-202100032456. A 71-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 24Feb2021 (Lot Number: EP9598) as 0.3 mL, single for COVID-19 immunisation. Medical history included schizophrenia; type 2 diabetes mellitus and all unknown if ongoing. The patient''s weight was 70 kg, and height was 167 cm. Concomitant medications were not reported. The patient died of virus flu with proven covid-19 infection (unknown cause of death) on 06Mar2021. He had Influenza A virus infection from Mar2021. And he had cough on 04Mar2021 (2 days before death). Pulmonological clinically normal. The patient underwent lab tests and procedures which included COVID-19 PCR test with result of positive. The patient died on 06Mar2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Influenza A virus infection; Unknown cause of death; COVID-19 PCR test positive


VAERS ID: 1231930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-09
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Apoplexy; Arterial hypertension; Dementia; Depression; Hemiparesis; Osteoporosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409214

Write-up: Despite Covid-19 vaccination on 24Feb2021, the patient died according to the death certificate on 21Mar2021 of viral pneumonia with proven COVID-19 infection.; proven COVID-19 infection; vaccination on 24Feb2021, Covid-19 on 09Mar2021; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Agency-WEB DE-PEI-CADR2021044771, Safety Report Unique Identifier DE-PEI-202100032478. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly on 24Feb2021 (Lot Number: EP9598) as 0.3 mL, single for covid-19 immunisation. Medical history included ongoing arterial hypertension, ongoing depression, ongoing osteoporosis, ongoing apoplexy, ongoing dementia, ongoing hemiparesis. The patient''s concomitant medications were not reported. On 09Mar2021 the patient experienced pneumonia viral NOS, COVID-19. Despite Covid-19 vaccination on 24Feb2021, the patient died according to the death certificate on 21Mar2021 of viral pneumonia with proven COVID-19 infection. The patient''s outcome was fatal for Pneumonia viral NOS, not recovered for COVID-19. The patient died on 21Mar2021. An autopsy was not performed. Sender''s comments: "Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: known dementia, depression, condition after apoplexy with hemiparesis, arterial hypertension, osteoporosis / 09Mar21 cough, pulmonary increased vesicular breathing, weakness". The PEI assessed Pneumonia viral NOS and COVID-19 were D. Unclassifiable. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Pneumonia viral NOS


VAERS ID: 1231931 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-08
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Circulatory collapse, Drug ineffective, Respiratory tract infection viral, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   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: Arterial hypertension; Chronic renal insufficiency; Coronary heart disease; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021409172

Write-up: cardiovascular failure/Sudden cardiac death; cardiovascular failure/Sudden cardiac death; COVID-19; COVID-19; Viral infection of the respiratory tract; This is a spontaneous report from a non-contactable consumer downloaded from the Medicines Agency (MA) -WEB, regulatory authority number DE-PEI-CADR2021044779, Safety Report Unique Identifier DE-PEI-202100032482. A 74-year-old female patient received bnt162b2 (Pfizer vaccine, Solution for injection), intramuscular on 24Feb2021 (Lot Number: EP9598) as single dose for covid-19 immunisation. Medical history included ongoing Chronic renal insufficiency, ongoing Coronary heart disease, ongoing Arterial hypertension, ongoing Type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient''s weight was 72 kg, and height was 156 cm. On 08Mar2021, the patient experienced Viral infection of the respiratory tract, COVID-19. On 09Mar2021, the patient experienced cardiovascular failure/Sudden cardiac death. The patient died on 09Mar2021. No autopsy was performed. It was reported that Information on risk factors or previous illnesses arterial hypertension, coronary heart disease, Diabetes mellitus type 2, chronic renal insufficiency / one day before death in general. physical weakness, Pulmo exacerbated vesicular breathing. No concerned have any allergies. Relatedness of drug to reactions was assessed as D. Unclassifiable by PEI. The outcome of the events cardiovascular failure/Sudden cardiac death was fatal, of the other events was not recovered. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: cardiovascular failure; Sudden cardiac death


VAERS ID: 1231936 (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: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Covid-19 test; Test Result: Positive
CDC Split Type: DEPFIZER INC2021404402

Write-up: patient died approximately 1 week after first vaccination; Covid-19 test positive; This is a spontaneous report based on information received by Pfizer from a company [manufacturer control number: 38084], license party for Comirnaty. A non-contactable physician reported that a female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in Apr2021 at SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient''s medical history and concomitant medications were not reported. The patient has been vaccinated with bnt162b2 during Easter holidays. A few days later the COVID-19 test was positive in Apr2021. The patient died approximately 1 week after first vaccination according to the daughter in Apr2021. It was not reported if an autopsy was performed. The outcome of the event COVID-19 test was positive was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. COVID-19 is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. Individuals may not be protected until at least 7 days after their second dose of the vaccine. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: patient died approximately 1 week after first vaccination


VAERS ID: 1231937 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-09
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

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 INC2021409750

Write-up: infection; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 38624], license party for vaccine. This case referred to the female patient. A female patient of an unspecified age received bnt162b2 (vaccine), via an unspecified route of administration on 17Mar2021 08:00 (Batch/Lot Number: ER7812) as SINGLE DOSE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced infection (death) on 09Apr2021. The patient died on 09Apr2021. It was not reported if an autopsy was performed. Following was reported by a contactable physician: "My parents were vaccinated with COMIRNATY Ch.-B.: ER7812 on March, 17 th 2021 at 8:00 am. Neither of them had any acute illness. Both died on April, 09 th as a consequence of an infection (similar symptoms )."; Sender''s Comments: Based on limited data given, the event "infection" is assessed as possibly related to 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. Linked Report(s) : DE-PFIZER INC-2021409762 same Reporter, other patient, same event; Reported Cause(s) of Death: infection


VAERS ID: 1231938 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
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 INC2021409762

Write-up: infection; This is a spontaneous report based on information received by Pfizer from a company [manufacturer control number: 38404], license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Mar2021 08:00 (Lot Number: ER7812) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced infection on an unspecified date. The patient died on 09Apr2021. It was not reported if an autopsy was performed. The outcome of event infection was fatal.; Sender''s Comments: The Company considered there was not a reasonable possibility that the reported event Infection (with fatal outcome) was related to the suspect product BNT162B2 (COMIRNATY).,Linked Report(s) : DE-PFIZER INC-2021409750 same Reporter, other patient, same event; Reported Cause(s) of Death: infection


VAERS ID: 1231939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 2021-04-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021416607

Write-up: sudden death; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 40262], license party for Pfizer vaccine. A male patient of an unspecified age received bnt162b2 (Pfizer vaccine), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient suddenly died on 13Apr2021. It was not reported if an autopsy was performed. The information on the batch number has been requested; Sender''s Comments: Based on the limited information provided, temporal association and per company relatedness guidance the event "sudden death" is considered related to suspect product bnt162b2 (Pfizer vaccine), at this time in this patient. This case will be reassessed should additional information become available especially the cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1231944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-04-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: AMOXICILLIN TRIHYDRATE
Current Illness: Lung disorder (FEV 45% and FVC 47%, test results from 2019)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2019; Test Name: FEV; Test Result: 45 %; Test Date: 2019; Test Name: FVC; Test Result: 47 %
CDC Split Type: DKPFIZER INC2021409079

Write-up: Difficulty breathing; Hypoxic arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number DK-DKMA-WBS-0061121. A 54-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EP9605; Expiration Date: Jun2021) as single dose for covid-19 immunisation. Medical history included ongoing lung disorder FEV 45% and FVC 47%, test results from 2019. Concomitant medication(s) included amoxicillin trihydrate for pneumonia from 27Mar2021 to 01Apr2021. There is no information regarding past medication. The patient experienced hypoxic arrest on 01Apr2021, the event was reported as being Fatal; difficulty breathing on 2021 and was hospitalised. No treatment or medical procedure due to the ADRs were reported. Hypoxic arrest was fatal and the outcome of Difficulty breathing was unknown. The patient died on 01Apr2021. Reported cause of death was Hypoxic arrest. An autopsy was not performed. Causality: The reporter stated that the death has been reported to the police, but the police do not wish to proceed with an inquest. The physician reported this case due to the correlation in time between vaccine and fatale outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hypoxic arrest


VAERS ID: 1231946 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-03-21
   Days after vaccination:44
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: COVID-19, Death, Respiratory failure, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   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: Aneurysm aortic; Cardiac insufficiency; Chronic obstructive pulmonary disease; Hemodialysis; Hypertension not adequately controlled; Permanent atrial fibrillation; Terminal renal insufficiency (has been receiving hemodialysis for many years)
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: EEPFIZER INC2021398140

Write-up: Death; Respiratory failure; COVID-19/ SARS-CoV-2 PCR test was positive; Vaccination failure/ SARS-CoV-2 PCR test was positive; This is as spontaneous report received from a contactable Physician downloaded from the regulatory authority. The Regulatory Authority report number is EE-SAM-29862103261. A 72-year-old male patient received BNT126B2 (COMIRNATY), first dose intramuscular on 15Jan2021 (Batch/Lot number was not reported) as 0.3 mL, single and second dose intramuscular on 05Feb2021 (Batch/Lot number was not reported) as 0.3 mL, single for COVID-19 immunisation. Medical history included Aneurysm aortic, Cardiac insufficiency, Hypertension not adequately controlled, Permanent atrial fibrillation, Terminal renal insufficiency (has been receiving hemodialysis for many years), chronic obstructive pulmonary disease (COPD). The patient''s concomitant medications were not reported. The patient was vaccinated with the two doses of Comirnaty vaccine (on January 15th and February 5th). SARS-CoV-2 PCR test was positive on 21Mar2021. The patient is in the hospital since 21Mar2021, with severe respiratory failure. Exitus letalis 25 March 2021. Serious side effects, as a result of the ineffectiveness of the vaccine, the patient became ill with COVID-19. The patient died on 25Mar2021. It was not reported if an autopsy was performed. The causal link is considered possible. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death; Respiratory failure; COVID-19/ SARS-CoV-2 PCR test was positive; Vaccination failure/ SARS-CoV-2 PCR test was positive


VAERS ID: 1234324 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-11-01
Onset:2021-03-24
   Days after vaccination:143
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Blood creatinine, Blood glucose, Blood potassium, Blood sodium, Blood urea, Cerebral haemorrhage, Computerised tomogram head, Electrocardiogram, Haematocrit, Haemoglobin, International normalised ratio, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Platelet count, Plateletcrit, Prothrombin time, Red blood cell count, Red cell distribution width, SARS-CoV-2 test, Thrombin time, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 4
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: VALSARTAN/HIDROCLOROTIAZIDA KERN PHARMA; LYRICA; MEMANTINE HYDROCHLORIDE; ARICEPT; SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (treated with Aricept 10mg/d and Memantine 10mg/d); Chronic renal insufficiency; Cognitive impairment; Deep venous thrombosis femoral (for which she is anticoagulated with Sintrom); Hypertension (treated with valsartan/hdcltz Kern 160/25mg); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: aPTT; Result Unstructured Data: Test Result:1.01; Comments: RATIO; Test Date: 20210324; Test Name: ALT (GPT); Result Unstructured Data: Test Result:17 uiU/L; Test Date: 20210324; Test Name: AST (GOT); Result Unstructured Data: Test Result:20 uiU/L; Test Date: 20210324; Test Name: creatinine; Result Unstructured Data: Test Result:119 umol/l; Comments: 1.35 mg/100mL; Test Date: 20210324; Test Name: glucose; Result Unstructured Data: Test Result:6.8 mmol/L; Comments: 123.12 mg/100mL; Test Date: 20210324; Test Name: potassium; Result Unstructured Data: Test Result:4.5 mmol/L; Test Date: 20210324; Test Name: sodium; Result Unstructured Data: Test Result:140 mmol/L; Test Date: 20210324; Test Name: Urea; Result Unstructured Data: Test Result:10.3 mmol/L; Comments: 62 mg/100mL; Test Date: 20210324; Test Name: cranial CT; Result Unstructured Data: Test Result:extensive left frontoparietal lobar hematoma; Comments: showed extensive left frontoparietal lobar hematoma, very heterogeneous and with multiple satellite bleedings accompanied by perihemorrhagic edema and subarachnoid hemorrhage content, it causes a subfalcial herniation to the right of 1 cm without ventricular involvement; Test Date: 20210324; Test Name: ECG; Result Unstructured Data: Test Result:Sinus rhythm at 60 bpm; Comments: QRS greater than 120ms with complete right bundle branch block morphology and associated repolarization alterations; Test Date: 20210324; Test Name: Hematocrit; Result Unstructured Data: Test Result:0.39 L/L; Test Date: 20210324; Test Name: hemoglobin; Result Unstructured Data: Test Result:128 g/l; Test Date: 20210324; Test Name: INR; Result Unstructured Data: Test Result:unknown; Test Date: 20210324; Test Name: MCH; Test Result: 30.8 pg; Test Date: 20210324; Test Name: MCHC; Result Unstructured Data: Test Result:329 g/l; Test Date: 20210324; Test Name: MCV; Result Unstructured Data: Test Result:93.7 fL; Test Date: 20210324; Test Name: MPV; Result Unstructured Data: Test Result:9.3 fL; Test Date: 20210324; Test Name: Platelets; Result Unstructured Data: Test Result:218 x10 9/l; Test Date: 20210324; Test Name: Plateletcrit; Test Result: 0.30 %; Test Date: 20210324; Test Name: Prothrombin time; Result Unstructured Data: Test Result:1.87; Test Date: 20210324; Test Name: Red cells; Result Unstructured Data: Test Result:4.15 x10 12/l; Test Date: 20210324; Test Name: RDW; Test Result: 13.3 %; Test Date: 20210128; Test Name: SARS-CoV-2 test negative; Result Unstructured Data: Test Result:negative; Test Date: 20210324; Test Name: SARS-CoV-2 test negative; Result Unstructured Data: Test Result:negative; Test Date: 20210324; Test Name: Thrombin time; Test Result: 25.50 s; Test Date: 20210324; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.62 x10 9/l
CDC Split Type: ESPFIZER INC2021409283

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number ES-AEMPS-819699. A 85-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 24Mar2021 (Batch/Lot Number: ET7205) as 0.3 mL, single for covid-19 immunisation; acenocoumarol (SINTROM), oral from Nov2020 to an unspecified date, at 4 mg, 1x/day for deep vein thrombosis. Medical history included hypertension treated with valsartan/hdcltz Kern 160/25mg, type 2 diabetes mellitus, Alzheimer''s disease treated with Aricept 10mg/d and Memantine 10mg/d, chronic kidney disease, femoropopliteal Thrombosis deep vein from Nov2020 to an unknown date for which she is anticoagulated with Sintrom, moderate-severe cognitive impairment reported as on a socio-functional level, she lives at home with her husband, has a caregiver, is dependent for basic activities of daily life and has moderate-severe cognitive impairment. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN/HIDROCLOROTIAZIDA KERN PHARMA) taken for hypertension from 30Jul2020 to an unspecified stop date; pregabalin (LYRICA); memantine hydrochloride (MEMANTINE HYDROCHLORIDE) taken for dementia alzheimer''s type; donepezil hydrochloride (ARICEPT). The patient previously took the first dose of comirnaty (lot number: ET1831) on 03Mar2021 for covid-19 immunisation. The patient experienced cerebral haemorrhage (hemorrhage of the brain) on 24Mar2021. On 24Mar2021, after waking up well and having been vaccinated with the second dose of the Pfizer vaccine, she suddenly presented around 10:30 am with the onset of right hemiparesis and speech impairment. Event reported as serious with hospitalization and fatal outcome. The patient was hospitalized for cerebral haemorrhage from 24Mar2021 to an unknown date. In the emergency room, vitamin K and prothrombinic complex were administered. Admission to Neurology was decided. On arrival at the Neurology ward: low level of consciousness, with Glasgow Coma Scale of 5 (O2, V1, M2), forced oculocephalic deviation to the right, no speech or commands, right hemiplegia. Given the seriousness of the situation and the probable poor short-term vital prognosis, palliative medication was started. The patient underwent lab tests and procedures which included all on 24Mar2021: on arrival at the emergency room: Drowsy; disoriented. She is 3/3 and understands simple but not complex commands. Ocular preference to the left - Right homonymous hemianopsia by threat - right facial asymmetry - Brachial (0/5) - crural (2/5) right hemiparesis. Blood test: activated partial thromboplastin time (aPTT): 1.01 RATIO (0.75-1.30), alanine aminotransferase (GPT): 17 uiU/L (0-31), aspartate aminotransferase (GOT): 20 uiU/L (0-31), blood creatinine: 119 umol/l (1.35 mg/100mL) (50-98), blood glucose: 6.8 mmol/l (123.12 mg/100mL) (3.0-6.0), blood potassium: 4.5 mmol/l (3.50-5.10), blood sodium: 140 mmol/l (136-145), blood urea: 10.3 mmol/l (62 mg/100mL) (2.9-8.2), haematocrit: 0.39 L/L (0.35-0.45), haemoglobin: 128 g/l (120-150), Red cells: 4.15 x10E12/L (3.90-5.00), MCV: 93.7 fL (80.0-98.0), MCHC: 329 g/L (320 -360), MCH: 30.8 pg (27.0-32.0), RDW: 13.3% (12.0-15.0), Platelets: 218 x10E9/L (140-350), MPV: 9.3 fL (7.0-10.5), Plateletcrit: 0.30%, Leukocytes: 9.62 x10E9/L (3.80-11.00), Prothrombin time: 1.87, INR: unknown (0.75-1.20), Thrombin time: 25.50 s (17.00-24.00), SARS-CoV-2 test negative (PCR): negative (previous on 28Jan2021 negative). Cranial CT scan (computerised tomogram head): showed extensive left frontoparietal lobar hematoma, very heterogeneous and with multiple satellite bleedings accompanied by perihemorrhagic edema and subarachnoid hemorrhage content, it causes a subfalcial herniation to the right of 1 cm without ventricular involvement. ECG (electrocardiogram): sinus rhythm at 60 bpm, QRS greater than 120ms with complete right bundle branch block morphology and associated repolarization alterations. The action taken in response to the event for acenocoumarol was not applicable. The patient died on 28Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhage of the brain


VAERS ID: 1234326 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal X-ray, Abdominal discomfort, Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Blood creatinine, Blood gases, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Computerised tomogram, Dyspnoea, Electrocardiogram, Fibrin D dimer, Haemoglobin, Heart rate, PCO2, PO2, Platelet count, Prothrombin time, Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Urine analysis, Vomiting, White blood cell count, pH body fluid
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATINA NORMON; DISTRANEURINE [CLOMETHIAZOLE]; BUSCAPINA; CARVEDILOL; VIPDOMET; ADIRO; NABILA [MEMANTINE HYDROCHLORIDE]; OPTOVITE B12; PARACETAMOL; DELTIUS; ASTUDAL; PARIZAC [OMEPRAZOLE]; UNIKET; PREDNISONA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome (Acute coronary syndrome without ST elevation); Alcohol use (drinks a glass of wine a day); Appendectomy; Arterial stenosis (Mild carotid stenosis); B12 deficiency anemia; Chondropathy (Patellar chondropathy I.); Clostridium difficile infection (Admission in 2015 to facility for Clostridium difficile disease.); Dyslipidemia; Essential tremor; Ex-smoker (Former smoker of 20 c/day, for more than 30 years); Gait disorder; Myelopathy cervical (with pyramidal syndrome in the lower limbs and a probable component of neuropathy and steroid myopathy in the lower limbs.); Polymyalgia rheumatica; Rheumatoid arthritis; Rib fracture; Triple vessel disease (previous mean, Stable, partially revascularized three-vessel coronary disease having performed angioplasty with Zotarolimus STENT on Descending anterior proximal. performing descending STENT.); Type II diabetes mellitus (Oral anti-diabetics); Unstable angina
Allergies:
Diagnostic Lab Data: Test Name: abdomen x-ray; Result Unstructured Data: Test Result:no levels, distended loops of large I; Comments: no levels, distended loops of large I; Test Name: Activated partial thromboplastin time; Result Unstructured Data: Test Result:0.78; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:18; Test Name: urine; Result Unstructured Data: Test Result:28.0; Comments: ISOLATED URINE AMYLASE 28.0; Test Name: creatinine; Result Unstructured Data: Test Result:1.5; Test Name: blood gas; Result Unstructured Data: Test Result:pH 7.433, pCO2 33.2, pO2 69.1; Comments: Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1; Test Name: glu; Result Unstructured Data: Test Result:186; Test Name: Lactatodehydrogenase; Result Unstructured Data: Test Result:223; Test Name: potassium; Result Unstructured Data: Test Result:4; Test Name: blood pressure; Result Unstructured Data: Test Result:123/80 mmHg; Test Name: sodium; Result Unstructured Data: Test Result:140; Test Name: urea; Result Unstructured Data: Test Result:71; Test Date: 20210311; Test Name: body temperature; Result Unstructured Data: Test Result:37.6 Centigrade; Test Name: chest x-ray; Result Unstructured Data: Test Result:No acute pleuropulmonary alterations.; Comments: No acute pleuropulmonary alterations. Fracture callus in the left sixth costal arch.; Test Date: 20210313; Test Name: Computerized axial tomography; Result Unstructured Data: Test Result:No parenchymal condensations suggestive of COVID i; Comments: Repletion effects in segmental artery subsegmental anterior segment Right upper lobe in relation to acute pulmonary embolism thrombus, I do not see filling defects in main pulmonary arteries or in left hemithorax arteries, calcified plaques in coronary arteries. No parenchymal condensations suggestive of COVID infection.; Test Name: C-reactive protein; Result Unstructured Data: Test Result:24; Test Name: ecg; Result Unstructured Data: Test Result:Sinus ECG with Q in III; Test Name: ddimer; Result Unstructured Data: Test Result:10000; Test Name: hb; Result Unstructured Data: Test Result:15.8; Test Name: heart rate; Result Unstructured Data: Test Result:91; Comments: bpm; Test Name: pCO2; Result Unstructured Data: Test Result:33.2; Comments: Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1; Test Name: pH; Result Unstructured Data: Test Result:7.433; Comments: Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1; Test Name: platelets; Result Unstructured Data: Test Result:171000; Test Name: pO2; Result Unstructured Data: Test Result:69.1; Comments: Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1; Test Name: Prothrombin time; Result Unstructured Data: Test Result:1.16; Test Name: Sars antigen; Test Result: Negative ; Comments: SARS Antigen test: Negative; Test Name: SARS-cov-2 PCR; Result Unstructured Data: Test Result:Pending; Test Name: urine; Result Unstructured Data: Test Result:118.0; Comments: URINE COCENT AMYL/CREA URINE 118.0 U/g (58.0 - 283.0); Test Name: white blood cells; Result Unstructured Data: Test Result:12100
CDC Split Type: ESPFIZER INC2021409370

Write-up: Vomited; Lung embolism; Sudden dyspnea; FEVER 37.6?C; DYSNEA WITH ABDOMINAL WORK; Abdominal distress; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA). The regulatory authority report number is ES-AEMPS-821095. An 87-years-old male patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 10Mar2021 (Lot Number: ET1831) as single dose for covid-19 immunisation. Medical history included Former smoker of 20 c / day, for more than 30 years. He drinks a glass of wine a day. type 2 diabetes mellitus (Oral anti-diabetics). Dyslipidemia. Admission in 2015 to facility for Clostridium difficile disease. Acute coronary syndrome without ST elevation (2008). Previous mean. Stable, partially revascularized three-vessel coronary disease (2016). 3-vessel coronary disease having performed angioplasty with Zotarolimus STENT on Descending. Severe 3-vessel coronary disease performing descending STENT. anterior proximal. Unstable angina (2009). Rib fracture (2005). Rheumatoid arthritis.Polymyalgia rheumatica in Internal Medicine Consultation with B12 deficiency. Mild carotid stenosis. Essential tremor. Known from the Neurology consultation due to multifactorial gait disorder, cervicoarthrosic myelopathy with pyramidal syndrome in the lower limbs and a probable component of neuropathy and steroid myopathy in the lower limbs. Cognitive impairment Surgery: Appendectomy. Patellar chondropathy I. Concomitant medications included simvastatin (SIMVASTATINA NORMON); clomethiazole (DISTRANEURINE); hyoscine butylbromide (BUSCAPINA); carvedilol; alogliptin benzoate, metformin hydrochloride (VIPDOMET); acetylsalicylic acid (ADIRO); memantine hydrochloride (NABILA); cyanocobalamin (OPTOVITE B12); paracetamol; colecalciferol (DELTIUS); amlodipine besilate (ASTUDAL); omeprazole (PARIZAC); isosorbide mononitrate (UNIKET); prednisona. The patient previously took meloxicam and experienced allergy. The patient was admitted for dyspnea and fever with pulmonary embolism on CT. Clostridium studies were requested, anticoagulation was started in the emergency room. A week ago he started with diarrheal stools (he has them frequently). 24 hours ago he received the first dose of the SARS vaccine. It begins with fever, nausea and diarrhea on 11Mar2021 assessed by his Primary Care Physician who initiates buscopan. Today increased dyspnea persisting with fever. Diagnosis was pulmonary embolism, acute fever. Physical examination: Blood pressure 123/80, Heart rate 91 / m, Saturation 93% without O2. I see the patient after CT Angiography, he received agitation sedation. Sleepy, eye opening to the call. Tachypneic, not clear Jugular engorgement, noise of upper respiratory secretions Rhythmic coronary artery Pulmonary artery I do not hear added sounds. Distended abdomen does not seem painful, with abdominal breathing. No edema or sign of deep vein thrombosis in the lower extremities. Glu 186, Urea 71, Creatinine 1,5, EFG 42, Na 140, K 4 , Alanine aminotransferase (or TGP) 18, blood-retinal barrier 1,3, Lactatodehydrogenase 223, TpIUS 108, C-reactive protein 24, Hemoglobin 15,8, Leucocytes 12100, Platelets 171000. COAGULATION: RATE OF THE C.P. 79.0% FIBR 560. Activated partial thromboplastin time 0.78, Prothrombin time 1.16 DDIMER 10000. Arterial blood gas: pH 7.433, pCO2 33.2, pO2 69.1. URINE COCENT AMYL/URINE CREA 118.0 U/g (58.0 - 283.0), URINE ISOLATED AMYLASE 28.0 SEDIMENT 10-15 leukocytes/field. Sinus ECG with Q in III. Chest X-ray: No acute pleuropulmonary alterations. Fracture callus in the left sixth costal arch. Abdominal X-ray, no levels, distended loops of large I. AngioCT: Repletion effects in segmental artery subsegmental anterior segment Right upper lobe in relation to acute pulmonary embolism thrombus, I do not see filling defects in main pulmonary arteries or in left hemithorax arteries, calcified plaques in coronary arteries. No parenchymal condensations suggestive of COVID infection. SARS Antigen test was Negative. SARS-CoV2 PCR pending. Events outcome was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vomited; Lung embolism; Dyspnea; Febricula; Dyspnea; Abdominal distress


VAERS ID: 1234329 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood creatine phosphokinase, Blood creatinine, Blood pressure measurement, C-reactive protein, Cardio-respiratory arrest, Computerised tomogram, Haemoglobin, Haemorrhagic stroke, International normalised ratio, PCO2, Pneumonia, Pneumonia aspiration, Procalcitonin, Pulmonary sepsis, Red blood cell count, SARS-CoV-2 test, White blood cell count, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; COPD; Fibrillation atrial; Hypertension arterial; Hypothyroidism
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: CT; Result Unstructured Data: Test Result:descriptive; Comments: an acute intraparenchymal hematoma located at the level of the right thalamus and posterior arm of the right internal capsule, with approximate dimensions of 2.8 cm (LL) x 2.3 cm (AP) x 3 , 2 cm (CC). It is accompanied by minimal perilesional edema. It exerts a slight mass effect, with a deviation of the midline about 7 mm to the right; Test Name: CRP; Result Unstructured Data: Test Result:101.8 mg/l; Test Date: 20210403; Test Name: CRP; Result Unstructured Data: Test Result:73.1 mg/l; Test Name: Hb; Result Unstructured Data: Test Result:12.8 g/dl; Test Date: 20210403; Test Name: Hb; Result Unstructured Data: Test Result:12.8 g/dl; Test Name: INR; Result Unstructured Data: Test Result:2.01; Test Date: 20210403; Test Name: INR; Result Unstructured Data: Test Result:2.24; Test Date: 20210403; Test Name: pCO2; Result Unstructured Data: Test Result:33.3; Test Date: 20210403; Test Name: pH; Result Unstructured Data: Test Result:7.45; Test Date: 20210403; Test Name: PCT; Result Unstructured Data: Test Result:0.13; Test Date: 20210403; Test Name: platelets; Result Unstructured Data: Test Result:374000; Test Date: 20210403; Test Name: PCR SARS COV test; Test Result: Negative ; Test Date: 20210403; Test Name: leukocytes; Result Unstructured Data: Test Result:18480; Comments: with shift to the left; Test Date: 20210403; Test Name: hCO3; Result Unstructured Data: Test Result:23; Test Date: 20210403; Test Name: CK; Result Unstructured Data: Test Result:252; Test Name: creatinine; Test Result: 0.84 mg/dl; Test Date: 20210403; Test Name: blood pressure; Result Unstructured Data: Test Result:<180 mmHg; Comments: systolic; Test Name: CT; Result Unstructured Data: Test Result:descriptive; Comments: Gentle increase in size of the acute intraparenchymal hematoma of the right thalamus and posterior arm of the internal capsule, with current dimensions of 3.4 ( CC) x 2.4 (AP) x 3.1 cm (LL) (previously 3.2 x 2.3 x 2.8 cm), with minimal perilesional edema and a similar mass effect on the midline (deviation of approx. 7 mm towards the contralateral side). It also presents an opening to the ventricular system with ventricular hemorrhage in both greater occipital horns on the right side, without hydrocephalus.
CDC Split Type: ESPFIZER INC2021409280

Write-up: Haemorrhagic stroke; Cardiorespiratory arrest; Respiratory sepsis; nosocomial pneumonia; bronchial aspiration; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is ES-AEMPS-822426. An 80-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Apr2021 (Lot Number: EW2239) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma, hypothyroidism, atrial fibrillation, and hypertension arterial. The patient''s concomitant medications were not reported. The patient was found by his son lying on the floor next to the bed on 02Apr2021, he did not report fever, vomiting. On 03Apr2021: Control cranial CT: Patient with right thalamic hemorrhagic stroke with onset of symptoms the day before yesterday (as reported), a neurosurgery was consulted who rejected treatment for his part, yesterday a control CT scan was performed with a slight increase in bleeding with perilesional edema. Since its passage to observation of a patient with Glasgow Coma Scale: 15/15 persistence of the left hemiparesis, no headache. Hb 12.8 g/dl, platelets 374,000, leukocytes: 18,480 with shift to the left. INR: 2.24. CRP: 73.1, PCT: 0.13, CK: 252; Normal liver profile. Normal kidney profile. pH: 7.45, pCO2: 33.3, HCo3-: 23. Control AS: Hemoglobin 12.8 g/dL Creatinine 0.84 mg/dL 2.01 INR C-reactive protein 101.8 mg/L - First emergency CT. The study carried out showed an acute intraparenchymal hematoma located at the level of the right thalamus and posterior arm of the right internal capsule, with approximate dimensions of 2.8 cm (LL) x 2.3 cm (AP) x 3, 2 cm (CC). It is accompanied by minimal perilesional edema. It exerts a slight mass effect, with a deviation of the midline about 7 mm to the right. Second CT control. Gentle increase in size of the acute intraparenchymal hematoma of the right thalamus and posterior arm of the internal capsule, with current dimensions of 3.4 (CC) x 2.4 (AP) x 3.1 cm (LL) (previously 3.2 x 2.3 x 2.8 cm), with minimal perilesional edema and a similar mass effect on the midline (deviation of approx. 7 mm towards the contralateral side). It also presents an opening to the ventricular system with ventricular hemorrhage in both greater occipital horns on the right side, without hydrocephalus. Urgent PCR SARSCOV2 yesterday (unknown date) negative. Clinical Judgment: Spontaneous right thalamic hemorrhagic stroke with ventricular hemorrhage, probable of hypertensive origin. Acute confusional syndrome. Treatment: Start of corticosteroid therapy with dexamethasone 4mg/8h and control of Blood pressure not lowering <180 mmHg systolic. It was decided to keep anticoagulation suspended given the current risk/benefit of the patient. On 08Apr2021. Respiratory sepsis (SOFA score 6 points) in the context of nosocomial pneumonia Level II, possible bronchial aspiration origin. Extremely serious situation with probable bad evolution. Cause of the death: Cardiorespiratory arrest; Intermediate cause: Respiratory sepsis in response to nosocomial pneumonia Level II (probable bronchoaspiration origin); Main cause: Right thalamic hemorrhagic stroke. The patient died on 08Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Respiratory sepsis in response to nosocomial pneumonia Level II (probable bronchoaspiration origin); Hemorrhagic stroke


VAERS ID: 1234330 (history)  
Form: Version 2.0  
Age:   
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 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Dehydration (broad), Hypokalaemia (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: Type I diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021400115

Write-up: Unknown cause of death; Hypotension; This is a spontaneous report from a contactable reporter (patient''s daughter) received through Agency Regulatory Authority. An 87-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on Mar2021 (also reported as administered 5 weeks ago) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Type I Diabetes, with good health and controlled, from an unspecified date. The patient''s concomitant medications were not reported. The patient experienced hypotension on an unspecified date in 2021. She passed away the day after receiving the COMIRNATY vaccine (Mar2021). The patient died on Mar2021. An autopsy was not performed as the family did not want to do the autopsy. The cause of death was unknown. The outcome of hypotension was unknown. No follow-up attempts are possible. Information about the batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1234350 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-03-16
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EJ6795-EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Anxiodepressive syndrome; Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Peripheral arterial occlusive disease; Senile macular degeneration
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20210

Write-up: COVID-19 pneumonitis; Vaccination failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021. This regulatory authority case was reported by a pharmacist and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonitis) in a 93-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. EJ6795-EJ6789 and EJ6795-EJ6789) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Senile macular degeneration and Peripheral arterial occlusive disease. Concurrent medical conditions included Type 2 diabetes mellitus, Anxiodepressive syndrome and Hypertension arterial. On 22-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form every three weeks. On 12-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced VACCINATION FAILURE (Vaccination failure). On 26-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonitis) (seriousness criterion death). The patient died on 26-Mar-2021. The reported cause of death was COVID-19 pneumonitis. It is unknown if an autopsy was performed. At the time of death, VACCINATION FAILURE (Vaccination failure) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore, action taken with the drug in response to the event was not applicable. Based on information received, death was due COVID-19 pneumonitis, the event is assessed as unlikely related to mRNA-1273. Reporter did not allow further contact; Sender''s Comments: Based on information received, death was due COVID-19 pneumonitis, the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19 pneumonitis


VAERS ID: 1234363 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-15
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal pain (Notion of abdominal pain a few days before vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021409335

Write-up: coronary occlusion; malaise; Arrest cardiac; This is a spontaneous report received from a contactable consumer downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-BX20212886, Safety report unique identifier FR-AFSSAPS-2021035855. A 75-years-old male patient received bnt162b2 (COMIRNATY), first dose, unknown on 03Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history included Notion of abdominal pain a few days before vaccination. Concomitant medications were not reported. The patient experienced arrest cardiac on 15Feb2021 09:30. Reported as: The patient was with very good general condition, no particular history, who presented with malaise while gardening in the morning at 9:30 am, at D13 of vaccination. Found on the ground about 20 minutes later by a relative who undertook resuscitation maneuvers. No flow estimated at 20 minutes, patient in asystole on arrival of the firemen. Resuscitation measures undertaken, sedation, intubation, asystole despite the use of adrenaline (10 mg over 40 minutes) and intraosseous bicarbonate, death after 1h20 of cardiac massage. Evoked cause was reported as coronary occlusion. No medico-legal obstacle. "Notabene: Imputation made "without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable procedures of compensation". The patient died on 15Feb2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Arrest cardiac; Coronary occlusion; malaise


VAERS ID: 1234378 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-02
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cardiovascular disorder, Drug ineffective, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (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: 2021-02-02
   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: Auricular fibrillation; Breast cancer; Cognitive disorder (neurocognitive disorders); Renal failure; Starvation; Thyroid nodule
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: unmeasurable fever; Result Unstructured Data: Test Result:unmeasurable fever; Test Date: 20210202; Test Name: PCR covid 19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021409393

Write-up: drug ineffective; COVID-19 aggravated; unmeasurable fever; cardiovascular decompensation; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MA20211228, Safety report unique identifier FR-AFSSAPS-2021035332. A 93-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 19Jan2021 (Lot Number: EM0477) as SINGLE DOSE for covid-19 immunisation. Medical history included cognitive disorder/neurocognitive disorders, renal failure, breast cancer, atrial fibrillation, starvation, thyroid nodule. The patient''s concomitant medications were not reported. The patient experienced drug ineffective (death) on 02Feb2021, covid-19 aggravated (death) on 02Feb2021, unmeasurable fever (death) on 02Feb2021, cardiovascular decompensation(death) on 02Feb2021. On 02Feb2021, a unmeasurable fever, a cardiovascular decompensation. PCR Covid 19 test performed and result was positive on 02Feb2021. The patient died on 02Feb2021. It was not reported if an autopsy was performed. Time Interval between Beginning of Drug Administration and Start of Reaction / Event was 15 days. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: drug ineffective; COVID-19 aggravated; unmeasurable fever; cardiovascular decompensation


VAERS ID: 1234385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-28
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma, Ischaemic stroke
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Dyslipidaemia; Mitral incompetence
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021409397

Write-up: coma; Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-PA20210451. A 92-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 11Feb2021 (Lot Number: EJ6789) at single dose (0.3ml) for covid-19 immunisation. Medical history included ongoing dyslipidaemia , ongoing Arterial hypertension, ongoing Mitral incompetence. The patient previously administrated the first dose of BNT162B2 for covid-19 immunisation on unknown date. The patient''s concomitant medications were not reported. The patient experienced ischemic stroke on 28Feb2021, coma on 28Feb2021 lead to hospitalization on an unspecified date with outcome of unknown. The patient died of Ischemic stroke on 03Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1234389 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-27
   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 ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Oxygen saturation, Oxygen saturation decreased, Progressive supranuclear palsy, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 5
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: Progressive supranuclear palsy
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism pulmonary; Fractured neck of femur; Septicaemia; Thrombosis
Allergies:
Diagnostic Lab Data: Test Date: 20210331; Test Name: Arterial oxygen saturation; Test Result: 75 %; Test Date: 20210331; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021409466

Write-up: worsening of symptoms of an already existing pathology; worsening of symptoms of an already existing pathology; oxygen saturation: 75 % on 31Mar2021; She experienced worsening of her symptoms 4 days after vaccination, associated with fever, difficulty breathing and fatigue.; She experienced worsening of her symptoms 4 days after vaccination, associated with fever, difficulty breathing and fatigue.; She experienced worsening of her symptoms 4 days after vaccination, associated with fever, difficulty breathing and fatigue.; 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-PB20211982. Safety report unique identifier FR-AFSSAPS-2021035447. A 83-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 23Mar2021 (Lot Number: ER9470) as single dose for covid-19 immunisation. Medical history included pulmonary embolism from 2017 to an unknown date, septicaemia from 2017 to an unknown date, fractured neck of femur from 2019 to an unknown date, progressive supranuclear palsy from 2016 and ongoing, thrombosis from 2017 to an unknown date. The patient''s concomitant medications were not reported. The patient previously took modopar, scopoderm [hyoscine], ELIQUIS. The patient experienced worsening of symptoms of an already existing pathology (progressive supranuclear palsy) associated with fever, difficulty breathing and fatigue, all on 27Mar2021, oxygen saturation: 75 % on 31Mar2021. For event worsening of symptoms of an already existing pathology (progressive supranuclear palsy), the patient was taken into emergency care unit and hospitalized from 31Mar2021 to an unknown date. The patient underwent lab tests and procedures which included oxygen saturation: 75 % on 31Mar2021, COVID-19 PCR test: negative on 31Mar2021. The patient died on 01Apr2021 (1 a.m.). It was not reported if an autopsy was performed. The outcome of the event worsening of symptoms of an already existing pathology (progressive supranuclear palsy) was fatal, the outcome of the other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: worsening of symptoms of an already existing pathology (progressive supranuclear palsy); worsening of symptoms of an already existing pathology (progressive supranuclear palsy)


VAERS ID: 1234396 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Decreased appetite, Dyspnoea, Hypoxia, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia NOS; Colorectal adenocarcinoma (Lieberkuhnien carcinoma); Permanent cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021409446

Write-up: Embolism pulmonary; severe hypoxia; Alteration of the general condition with dyspnea and anorexia; Alteration of the general condition with dyspnea and anorexia; 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-RE20211026, Safety report unique identifier FR-AFSSAPS-2021036225. A 94-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 04Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included arrhythmia NOS, rhythmic heart disease with pacemaker, colorectal adenocarcinoma (lieberkuhnien carcinoma). The patient''s concomitant medications were not reported. The patient experienced embolism pulmonary (death, hospitalization) on 01Apr2021, severe hypoxia (death, hospitalization) on 01Apr2021, alteration of the general condition with dyspnea and anorexia (non-serious) on 25Mar2021 with outcome of unknown. On 25Mar2021, patient experienced alteration of the general condition with dyspnea and anorexia. 01Apr2021, she was hospitalization with an assessment of a left pulmonary embolism without cardiac repercussions, with oxygen dependence in front of a severe hypoxia. Implementation of an anti-coagulant treatment at an effective dose. Unfavorable evolution, increase in oxygen dependence. The patient died on 07Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: severe hypoxia; Embolism pulmonary


VAERS ID: 1234402 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-19
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Body temperature, COVID-19, Heart rate, Oxygen saturation, Physical examination, 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: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MODOPAR; DEROXAT; LEVOTHYROX; KARDEGIC; RAMIPRIL; SERESTA; FUROSEMIDE; TAMSULOSIN
Current Illness: Heart failure (1st outbreak of heart failure with secondary bronchial infection in Dec2016)
Preexisting Conditions: Medical History/Concurrent Conditions: Blindness, one eye (Left eye blindness due to tumor enucleation); Bronchial infection (1st outbreak of heart failure with secondary bronchial infection in Dec2016); Decompensation cardiac (Left ventricular decompensation in Jan2018, then Feb2018, then May2019); Depression NOS; Enucleation of eyeball (tumor enucleation); Extrapyramidal syndrome (Extra pyramidal syndrome without proper Parkinson''s disease); Eye prosthesis user (left eye prosthesis); Hashimoto''s thyroiditis (Hypothyroidism due to Hashimoto''s thyroiditis); Hypothyroidism (Hypothyroidism due to Hashimoto''s thyroiditis); Stroke (without sequelae)
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:crackles; Comments: Pulmonary auscultation in which crackles were found mid-field of ICG.; Test Date: 20210225; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:increased crackles; Test Date: 20210226; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:intercostal indrawing; Test Date: 20210227; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:severe crackles; Test Date: 20210303; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:reduction of crackles; Test Date: 20210305; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:no polypnea; Test Date: 20210323; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:polypnea, crackles; Comments: dry bi-basal, symmetrical crackles, wet cough; Test Date: 20210324; Test Name: Pulmonary auscultation; Result Unstructured Data: Test Result:slight polypnea; Test Date: 20210324; Test Name: blood pressure; Result Unstructured Data: Test Result:70/60 mmHg; Comments: hypotension; Test Date: 20210219; Test Name: body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210222; Test Name: body temperature; Result Unstructured Data: Test Result:apyrexia Centigrade; Test Date: 20210224; Test Name: body temperature; Result Unstructured Data: Test Result:39.1 Centigrade; Test Date: 20210225; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210227; Test Name: body temperature; Result Unstructured Data: Test Result:apyrexia Centigrade; Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:apyrexia Centigrade; Test Date: 20210323; Test Name: heart rate; Result Unstructured Data: Test Result:tachycardia; Test Date: 20210324; Test Name: heart rate; Result Unstructured Data: Test Result:tachycardia; Test Date: 20210219; Test Name: saturation; Test Result: 97 %; Comments: Oxygen requirement (saturation 97/3L).; Test Date: 20210303; Test Name: saturation; Test Result: 95 %; Comments: Saturation 95 / 5L.; Test Date: 20210323; Test Name: saturation; Test Result: 79 %; Comments: at 11 pm. hemodynamic and respiratory failure with desaturation to 79% under 15L; Test Date: 20210323; Test Name: saturation; Test Result: 84 %; Comments: at 5.30 pm saturation 84 / 2L; Test Date: 20210323; Test Name: saturation; Test Result: 93 %; Comments: Oxygen saturation increased to 93% under 10L.; Test Date: 20210324; Test Name: saturation; Test Result: 89 %; Test Date: 20210226; Test Name: physical examination; Result Unstructured Data: Test Result:cyanosis; Comments: cyanosis of the hands; Test Date: 20210227; Test Name: physical examination; Result Unstructured Data: Test Result:Oedema; Comments: very mild Oedema of the Lower Extremities; Test Date: 20210305; Test Name: physical examination; Result Unstructured Data: Test Result:no cyanosis; Test Date: 20210320; Test Name: physical examination; Result Unstructured Data: Test Result:very anxious; Comments: it was noted that the patient was very anxious; Test Date: 20210322; Test Name: physical examination; Result Unstructured Data: Test Result:very thirsty; Comments: the patient was very thirsty and a wrong route was observed during her hydration; Test Date: 20210323; Test Name: physical examination; Result Unstructured Data: Test Result:Cyanosis; Comments: the patient was still very anxious and dehydrated. Cyanosis. Wrong routes. Aspiration brings back milk-white mucous fluid.; Test Date: 20210219; Test Name: SARS-CoV2 PCR test; Test Result: Positive ; Comments: PCR V1 profile - initial strain
CDC Split Type: FRPFIZER INC2021409440

Write-up: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; 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-RS20210728, Safety report unique identifier FR-AFSSAPS-2021036243. A 98-year-old female patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly administered in Arm on 13Jan2021 (Batch/Lot Number: unknown) and the second dose of BNT162B2 intramuscularly administered in Arm on 03Feb2021 (Batch/Lot Number: Unknown), both as single dose for COVID-19 immunisation. Medical history included cardiac failure from Dec2016 and ongoing, bronchial infection from Dec2016 to an unknown date, decompensation cardiac from Jan2018 to May2019 (Left ventricular decompensation in Jan2018, then Feb2018, then May2019), Stroke in 2017 without sequelae, depression, Hypothyroidism due to Hashimoto''s thyroiditis, Extra pyramidal syndrome without proper Parkinson''s disease, Left eye blindness due to tumor enucleation, left eye prosthesis. Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR); paroxetine hydrochloride (DEROXAT); levothyroxine sodium (LEVOTHYROX); acetylsalicylate lysine (KARDEGIC); ramipril; oxazepam (SERESTA); furosemide; and tamsulosin. The patient has no history of COVID-19. On 19Feb2021, 16 days after the second dose of BNT162B2 injection, symptoms appeared. The patient complained of body aches. Pulmonary auscultation in which crackles were found mid-field of ICG. Hyperthermia at 38.6 T. Oxygen requirement (saturation 97/3L). SARS-CoV2 PCR positive the same day (PCR V1 profile- initial strain). On 22Feb2021, patient apyretic, reports feeling tired. On 24Feb2021, hyperthermia at 39.1T, headache. On 25Feb2021, hyperthermia at 39 T and increased crackles. On 26Feb2021, intercostal indrawing, cyanosis of the hands. On 27Feb2021, patient apyretic, severe crackles, very mild Oedema of the Lower Extremities.On 03Mar2021, reduction of crackles. Saturation 95/5L. On 05Mar2021, good clinical course with persistence of apyrexia, no polypnea or cyanosis. Subsequently, on 20Mar2021, it was noted that the patient was very anxious. On 22Mar2021, the patient was very thirsty and a wrong route was observed during her hydration. On 23Mar2021, at 5.30 p.m., the patient was still very anxious and dehydrated. Cyanosis, saturation 84/2L, polypnea, wet cough and wrong routes, dry bi-basal, symmetrical crackles. Oxygen saturation increased to 93% under 10L. The patient''s physician declares aspiration brings back milk-white mucous fluid. On 23Mar2021, at 11 p.m., hemodynamic and respiratory failure with desaturation to 79% under 15L. Patient in tachycardia. The patient''s physician declared Doubtful about pulmonary oedema in spite of dehydration and due to rapid installation, auscultation and history. On 24Mar2021, hypotension at 70/60, tachycardia with saturation at 89%, slight polypnea. The patient''s physician suggests cardiorespiratory failure due to hypovolemia. On 24Mar2021, collegial decision to stop the treatment, death of the patient on 26Mar2021 Overall, vaccine failure with a positive PCR 16 days after the second injection of the Comirnaty vaccine, improvement in symptoms of COVID infection on 05Mar2021. Subsequently, deterioration of the general condition with the onset of hemodynamic and respiratory failure on 23Mar2021 in a context of dehydration and possible aspiration. Death of the patient. Therapeutic measures were taken as a result of positive COVID-19 test with symptoms. The patient died on 26Mar2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: positive COVID-19 test with symptoms; Vaccination failure


VAERS ID: 1234831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Aphasia, Confusional state, Disorientation, Encephalitis, Headache, Hemiplegia, Illness, Investigation, SARS-CoV-2 test, Seizure, Tumefactive multiple sclerosis
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 84
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: Depression; Umbilical cord abnormality
Allergies:
Diagnostic Lab Data: Test Name: investigations; Result Unstructured Data: Test Result:infection and inflammation of the brain; Comments: infection and inflammation of the brain was diagnosed; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021405174

Write-up: became ill; infection and inflammation of the brain; Acute disseminated encephalomyelitis; Tumefactive multiple sclerosis; uncontrollable seizures; movement down one side; quickly lost her speech; disoriented; extremely confused; Frequent headaches; This is a spontaneous report from a contactable other healthcare professional received from a Regulatory Agency (RA); the Regulatory Authority report number is GB-MHRA-WEBCOVID-202104080817517910. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE); Dose 2 via an unspecified route of administration on 07Jan2021 (batch/lot number: EL0141) as a SINGLE DOSE for COVID-19 vaccination. The patient''s medical history included umbilical cord abnormality and depression, both from an unknown date. Patient had no medical history of MS or Encephalitis and had no health issues (as reported). The patient was not enrolled in clinical trial. Patient was not pregnant. Patient has not had symptoms associated with COVID-19. At the start of 2021, patient was a wife and mum of two young boys with everything to live for: working as a dedicated nurse in care homes for over a decade; she worked tirelessly throughout the pandemic. Concomitant medications included anti depression tablet from an unspecified date in 2021 for 3 months.The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 15Dec2020 (batch/lot number: EJ055) as single dose for COVID-19 vaccination.The patient has not tested positive for COVID-19 since having the vaccine; patient tested no - negative for COVID-19 virus test on an unspecified date. The patient experienced frequent headaches on 08Jan2021; tumefactive multiple sclerosis on 16Feb2021 (described as "very, very, very rare aggressive form of MS"); acute disseminated encephalomyelitis on 17Feb2021; and became ill (Illness) on Feb2021. On an unspecified date, the patient also experienced infection and inflammation of the brain (Encephalitis infection), quickly lost her speech (speech loss), movement down one side (paralysis one side of body), disoriented (disorientated), extremely confused (confused), and uncontrollable seizures (seizures). The patient was hospitalized for 46 days due to tumefactive multiple sclerosis, acute disseminated encephalomyelitis, and infection and inflammation of the brain. Event "became ill" caused hospitalization. Therapeutic measures were taken as a result of tumefactive multiple sclerosis, acute disseminated encephalomyelitis, became ill, infection and inflammation of the brain, and uncontrollable seizures. It was reported that in mid Feb2021, the patient suddenly became ill and was taken into hospital 1 with symptoms of a stroke. After lots of investigations and tests, a stroke was ruled out and an infection and inflammation of the brain was diagnosed on an unspecified date. Unsure of the cause, doctors treated her with steroid medications, none of which seemed to help. After a long wait at hospital 1 she was transferred to hospital 2 where she was assessed by specialists. The family was told that the patient had developed acute disseminated encephalomyelitis (ADEM) on 17Feb2021. ADEM is a rare inflammatory condition that affects the brain and spinal cord. This is the result of the immune system becoming mis-programmed and activating immune cells to attack the healthy myelin cells covering the nerves. Patient quickly lost her speech, movement down one side, and was disoriented, and extremely confused. She was given Plasmapheresis, a plasma exchange treatment to replace her white blood cells and give her immune system a chance to fight back. After weeks of being all alone in the hospital and unable to have her family by her side, she took a turn for the worse. The plasma exchange had not been successful. Her condition was still deteriorating, and she began having uncontrollable seizures. The patient was put into a medically induced coma and was started on a new treatment for Multiple Sclerosis (MS). She spent 2 weeks in Intensive Care on a ventilator. On Wednesday 24Mar2021, the family were told that the patient had developed a very, very, very rare aggressive form of MS and that nothing more could be done to help her. The patient spent a total of 46 days in hospital. On 03Apr2021, the patient passed away peacefully with her husband and her mum by her side. The patient died of tumefactive multiple sclerosis. It was not reported if an autopsy was performed. This report does not relate to possible blood clots or low platelet counts. Follow-up attempts are completed. No further information is expected; Reported Cause(s) of Death: Tumefactive multiple sclerosis


VAERS ID: 1234846 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-25
   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 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma scale, Haemorrhage intracranial, Inappropriate schedule of product administration, Off label use, SARS-CoV-2 test, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Medication errors (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:decreased; Test Name: COVID-19 virus test; Test Result: Inconclusive ; Comments: Inconclusive test
CDC Split Type: GBPFIZER INC2021411152

Write-up: hemorrhage; Intracranial hemorrhage; first dose BNT162B2 on 14Jan2021/ second dose on 25Mar2021; first dose BNT162B2 on 14Jan2021/ second dose on 25Mar2021; This is a spontaneous report from a contactable pharmacist received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104120936221340. An 82-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via unspecified route of administration on 25Mar2021 (lot number was not known) as a single dose for COVID-19 immunisation. Medical history included hypertension and chronic kidney disease, both from an unknown date and unknown if ongoing. It was unsure if the patient has had symptoms associated with COVID-19 and unsure if the patient was enrolled in clinical trial. Concomitant medications were not reported. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE ) on 14Jan2021 for COVID-19 immunisation. The patient was admitted to intensive treatment unit on Apr2021- subarrachnoid haemorrhage (hemorrhage) on 11Apr2021 in which was fatal. It was also noted that intracranial hemorrhage on Apr2021 with decreased Glasgow coma scale suddenly 2 weeks after 2nd dose; this event was reported as not recovered. Additional lab data included COVID-19 virus test: inconclusive test on unspecified date. The patient died on 11Apr2021 due to subarrachnoid haemorrhage. It was unknown if an autopsy was performed. It was unclear if related to vaccine. No follow-up attempts are possible; information about the lot/batch number cannot be obtained.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1234856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-03-24
   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 ER1749 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Activated partial thromboplastin time prolonged, Antibody test, Cardiac arrest, Circulatory collapse, Computerised tomogram, Epistaxis, Fibrin D dimer, Hypertension, Loss of consciousness, Platelet count, Prothrombin time, Pulmonary embolism, SARS-CoV-2 test, Scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 18
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: Coagulopathy; DVT (left leg); DVT; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: activated partial thromboplastin clotting time; Result Unstructured Data: Test Result:180; Test Date: 20210411; Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:not identified; Test Date: 20210411; Test Name: CTPA scan; Result Unstructured Data: Test Result:extensive hilar and peripheral PEs; Comments: thromboembolic event was PE; diagnosed; Test Date: 20210411; Test Name: D-dimer; Result Unstructured Data: Test Result:not higher than 4000; Test Date: 20210411; Test Name: platelet count; Result Unstructured Data: Test Result:not less than 150/L to 109/L; Test Date: 20200709; Test Name: Platelet count; Result Unstructured Data: Test Result:248; Test Date: 20210411; Test Name: Platelet count; Result Unstructured Data: Test Result:120; Test Name: PT; Result Unstructured Data: Test Result:64.5; Test Date: 20210411; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scans; Result Unstructured Data: Test Result:did not detect a problem
CDC Split Type: GBPFIZER INC2021411038

Write-up: collapsed; unconscious; activated partial thromboplastin clotting time (aPTT) was 180; pulmonary embolus; cardiac arrest; nose bleed; high BP; 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-202104121335362920. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 22Mar2021 (batch/lot number ER1749 and expiry date not reported) as single dose for covid-19 immunization. Medical history included coagulopathy, deep vein thrombosis (left leg, 3 m DOAC) from Mar2020. The reporter informed that further investigations with hematology team and no problems with coagulation. The patient''s persistent problem with swelling of leg but all scans did not detect a problem. The hematology concluded risk of further DVT very slightly higher due to DVT in Mar2020 and on balance and on discussion not for further prophylactic anticoagulation. The patient additional medical history included DVT from Mar2021 that was related to previous venous or arterial thromboses also experienced. The patient had not had any previous reactions to medications (especially heparin or anticoagulants). The patient did not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient did not have history of, or current, malignancy. The patient did not currently smoke. The patient has no haemorrhage identified. The patient has no history of, or concurrent, intracranial malignancy. The patient did not have concurrent or recent intracranial infections. The patient had not had recent surgical or medical interventions to the central nervous system (including lumbar puncture). The patient had not had a recent trauma/head injury. The patient has not had symptoms associated with COVID-19 and the physician was unsure if patient was enrolled in clinical trial. The patient''s concomitant medications were not reported. The physician informed that on 24Mar2021, the patient experienced spontaneous nose bleed, high BP and was sent home from work, patient saw GP. On 31Mar2021, the patient went back at work and seemed to be fine. On 09Apr2021, the patient at work seemed to be fine. On 11Apr2021, the patient collapsed suddenly in garden at home; the patient was transferred to hospital in ambulance unconscious. At 09:23 to 11:05, the patient experienced cardiac arrest at hospital (cardiac arrest intermittent but prolonged cycles of CPR). The patient recovered after CPR and thrombolysis but prolonged cardiac arrest. The patient was transferred to intensive care sedated, intubated and mechanical ventilated, kidney machine, medicines to support blood pressure and heart. The patient died 18:55 despite full support. The patient underwent lab tests and procedures which included CTPA scan: showed extensive hilar and peripheral PEs (pulmonary embolus). The physician informed that the thromboembolic event was PE (pulmonary embolus) on 11Apr2021 diagnosed with CTPA scan on 11Apr2021. The platelet count was not less than 150/L to 109/L on 11Apr2021. The D-dimer was not higher than 4000. The anti-PF4 antibodies was not identified. The physician informed that the lowest platelet count after vaccine (usual normal range 150 to 450) was 120 on 11Apr2021 14:36. The last platelet count before vaccine (usual normal range 150 to 450) was 248 on 09Jul2020. The patient''s PT (prothrombin time) was 64.5 (unspecified date). The activated partial thromboplastin clotting time (aPTT) was 180. The physician informed that the events was related to possible blood clots or low platelet counts. The patient also underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 11Apr2021. The patient has not tested positive for COVID-19 since having the vaccine. The outcome of the events cardiac arrest, activated partial thromboplastin clotting time (aPTT) was 180 was not recovered, collapsed, unconscious was unknown, nose bleed, high BP was recovering, pulmonary embolus was fatal. The patient died on 11Apr2021 18:55, it was unknown if an autopsy was performed. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolus


VAERS ID: 1234877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0724 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Enuresis, Fibrin D dimer, Investigation, Platelet count, Pulmonary embolism, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from recreational drugs; Alcohol use (Wine drinker); Basal cell carcinoma; Blepharoplasty; Breast implant user; Contraception; D & C; Eyelid operation NOS; Lipoma; Liposuction; Smoker (20 cigarettes'' a day)
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:Unknown; Test Name: anti-PF4 antibodies; Result Unstructured Data: Test Result:Unknown; Test Name: Platelet count; Result Unstructured Data: Test Result:Unknown
CDC Split Type: GBPFIZER INC2021410797

Write-up: Sudden death; acute pulmonary embolism; bed cold; DVT; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202104131438452890, Safety Report Unique Identifier GB-MHRA-ADR 25132819. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ0724, expiration date were not reported), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunisation. Medical history included other repair of eyelid in 13Jan2014, liposuction of subcutaneous tissue NEC in 04Apr2013, lipoma of other specified sites in 10Feb2013, blepharoplasty of upper eyelid in 24Sep2012, breast augmentation in 24Sep2012, basal cell carcinoma in 20Feb2012, contraception in 2005, dilation of cervix uteri and curettage of uterus in 1983, smoker (20 cigarettes'' a day), drinker (wine drinker). Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Unsure if patient is enrolled in clinical trial. Concomitant medication included citalopram. The patient experienced bed cold, acute pulmonary embolism and sudden death on an unspecified date. The events were reported as serious (Life-threatening and Fatal). It was reported that patient was found in bed cold and unresponsive on an unspecified date. Ambulance were called and attended and deemed CPR to be futile. No medical conditions that family are aware of. She smoked around 20 cigarettes per day. She drank wine but amount was unknown. No recreational drugs that family are aware of. It was reported that the report relate to possible blood clots or low platelet counts. The patient was diagnosed with acute pulmonary embolism due to DVT during post mortem examination. Platelet count, D-dimer and anti-PF4 anitbodies were unknown. The patient died on 14Jan2021. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Sudden death; Bed cold; Autopsy-determined Cause(s) of Death: Acute Pulmonary Embolism due to DVT; DVT


VAERS ID: 1234885 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-01
   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 EN3924 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chest pain, Death, Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker (from teens heavy smoker when younger, stopped 20+ years ago.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021410987

Write-up: hip pain; dvt; chest pains; Death; This is a spontaneous report from a contactable healthcare professional received from the Agency Regulatory Authority. Regulatory authority report number is GB-MHRA-WEBCOVID-202104131451180500, Safety Report Unique Identifier is GB-MHRA-ADR 25132875. An 81-year-old male patient received first dose of bnt162b2 (COVID-19 MRNA VACCINE BIONTECH), via unspecified route of administration on 28Jan2021 (lot number: EN3924, expiration date not reported), as single dose for COVID-19 immunization. Medical history included ex-tobacco user (from teens heavy smoker when younger, stopped 20+ years ago) and occasional drank whiskey. Concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced death. On an unspecified date, the patient experienced hip pain, dvt (deep vein thrombosis) and chest pains, all with outcome of unknown. The events hip pain, dvt and chest pains were reported as life-threatening. The patient died on an unspecified date in Feb2021. The clinical course was reported as follows: The patient had been complaining of chest pains over the last couple of days but wasn''t one to bother anyone or go to doctors. On 13Feb2021, he visited his daughter''s address as it was her birthday and seemed fine at that time. At approximately 17:00 hours that day, he was back home and spoke to his son and said he was having chest pains. At 1806 hours, he texted his daughter and it didn''t make sense but this wasn''t unusual. On 14Feb2021 at 10:30 am, a neighbour rang daughter to say that the downstairs blinds were still shut. Family attended home address and found him deceased sat in a chair in the living room. Family confirmed that the patient was mobile on his own using a stick, he would sometimes complain of hip pain if he''d been sat for a while. Patient was an ex-smoker - from teens heavy smoker when younger, stopped 20+ years ago. Alcohol - occasional whiskey. No recreational drug use. No industrial diseases/claims. It was unsure if patient has had symptoms associated with COVID-19. Patient had not had a COVID-19 test. It was unsure if patient was enrolled in clinical trial No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information provided is limited for reasonable medical assessment. There was no information provided regarding cause of death, autopsy results and diagnostic studies. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and re-assessed based on additional data. Queries are in place for the missing information. Other reported events are probably due to an underlying medical condition. This case will be updated once additional information is available.; Reported Cause(s) of Death: Death


VAERS ID: 1234894 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021411189

Write-up: Death; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number: GB-MHRA-WEBCOVID-202104131610048480, Safety Report Unique Identifier: GB-MHRA-ADR 25133023. A patient of unspecified age and gender received BNT162B2, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Not Known) as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19 Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications were not reported. The patient died on 01Apr2021. Cause of death was not reported. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1234914 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-18
Onset:2020-12-28
   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 EJO55J / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic stroke, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), 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: AMLODIPINE; ATORVASTATIN; CLOPIDOGREL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021416439

Write-up: Haemorrhagic stroke; This is a spontaneous report from a contactable consumer received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202104141137596280. Safety Report Unique Identifier GB-MHRA-ADR 25139081. A 64-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EJO55J), via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications included amlodipine, atorvastatin, clopidogrel and lansoprazole all for an unspecified indication. On 28Dec2020 the patient had haemorrhagic stroke, the event was reported as fatal. On 28Dec2020 the patient had a negative covid-19 test. The date of death was not reported. An autopsy was not performed.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1234958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-03-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PAA-156571 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cellulitis, Drug ineffective, Erysipelas, Respiratory failure, Thrombophlebitis
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021421597

Write-up: drug ineffective; COVID-19 induced respiratory insufficiency; respiratory insufficiency; thrombophlebitis; erysipelas; phlegmon; This is a spontaneous report from a contactable physician downloaded from the regulatory authority HU-OGYI-196821. Case narrative: This spontaneous, serious report received on 27Mar2021 from a physician describes the occurrence of adverse events after vaccination with COMIRNATY (tozinameran). On 13Feb2021 at 8:20 a.m., the 77 years old male patient received COMIRNATY (concentrate for dispersion injection; active substance: tozinameran - 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA vaccine; batch number: PAA156571, expiry date: Mar2021, MAH: BioNTech Manufacturing GmbH) applied intramuscularly to the left upper arm for COVID-19 immunisation. Following vaccination, in Mar2021, the patient reported to have erysipelas, thrombophlebitis and phlegmon. The patient was hospitalised, the symptoms were resolving, but in the hospital, the patient had acquired COVID-19 and developed respiratory insufficiency, and died. Discharge summary is not available. The patient general condition, medical history and concomitant medicines were not reported. Sender comment: Erysipelas, thrombophlebitis and phlegmon are not expected adverse events of COMIRNATY. Alternatively, they might have been in relation with the patient underlying diseases, but there is no detailed information about them. Time to onset might have been several weeks, it is not correctly known either. Causality between the adverse events and COMIRNATY is unlikely. The patient acquired COVID-19 infection in hospital several weeks after the presumably first dose of vaccine. Immunity might have not developed within this time frame. The case is serious because the patient died. Further information is expected.; Reported Cause(s) of Death: COVID-19 respiratory insufficiency; COVID-19 respiratory insufficiency; drug ineffective


VAERS ID: 1234962 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-03-26
   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 ET7205 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cough, Death, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   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: Non-smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021403430

Write-up: died; cough; Chills; subfebrility; This is a spontaneous report received from a contactable consumer (wife of the patient).A 65-year-old male patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Lot No: ET7205, expiration date: unknown) via an unspecified route of administration in left arm on 26-MAR-2021 at at single dose for COVID-19 immunization.Patient medical history included non-smoker, had known algopyrin allergy.on 26Mar2021 (Friday), patient experienced chills, subfebrility, little cough by Saturday, and dies on Sunday at dawn. She has not yet have information about the cause of death and the result of autopsy. The patient wife enquired about the presence of algopyrin in vaccine.The outcome of events was fatal.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1234964 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-28
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, General physical health deterioration, Oxygen saturation decreased, Respiratory rate decreased, Respiratory tract infection, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Respiratory failure (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aspiration; Lower respiratory tract infection (Secondary to aspirations); Oral cancer stage unspecified; Rectal cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: Oxygen saturation decreased; Result Unstructured Data: Test Result:Reduced O2; Test Date: 20210203; Test Name: Respiratory rate decreased; Result Unstructured Data: Test Result:Reduced respiratory rate; Test Date: 20210128; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive via PCR nasal / pharyngeal swab; Comments: Positive via PCR nasal / pharyngeal swab
CDC Split Type: IEPFIZER INC2021409448

Write-up: Respiratory tract infection; REDUCED RESPIRATION RATE, O2; REDUCED RESPIRATION RATE, O2; WEAK; PHYSICAL DETERIORATION; COVID-19; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-066080. An 88-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 21Jan2021 (Lot Number: EJ6134) as Single Dose for COVID-19 immunisation. Medical history included lower respiratory tract infection secondary to aspirations, rectal cancer from 2013, oral cancer stage unspecified from 2010. The patient''s concomitant medications were not reported. The reporter outlined that no adverse reactions were noted post vaccination. On 28Jan2021, the patient tested positive for COVID-19 via PCR nasal/pharyngeal swab. It was reported that the patient''s condition deteriorated in the days prior to his death (onset date: Feb2021). On 03Feb2021, the patient was last seen by his General Practitioner (GP). The patient''s condition was comfortable but weak and the patent experienced a reduced respiration rate and O2. The patient''s GP was contacted. Therapeutic measures were taken as a result of reduced respiration rate and O2. The patient was treated for a respiratory tract infection (RTI) (onset date not reported) with antibiotics, intramuscular Rocephin and oxygen (O2) therapy. The patient also experienced physical deterioration on Feb2021. On 04Feb2021, at 11:40 am, the patient died. It was reported that the patient did not have any COVID-19 symptoms prior to vaccination, however, his death occurred as a result of COVID-19 seven days later. Other causes of death reported included weak, reduced respiration rate and O2, and physical deterioration. It was unknown if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Linked Report(s) : IE-HPRA-2021-066081 HPRA; Reported Cause(s) of Death: REDUCED RESPIRATION RATE, O2; REDUCED RESPIRATION RATE, O2; PHYSICAL DETERIORATION; WEAK; COVID-19


VAERS ID: 1234965 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-17
   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 EP9605 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   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: ATORVASTATIN [ATORVASTATIN CALCIUM]; CLODEL [CLOPIDOGREL HYDROCHLORIDE]; OMESAR PLUS; PANTUP; NUPRIN [ACETYLSALICYLIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antiplatelet therapy; Carotid artery stenosis; Hypertension; Non-Hodgkin''s lymphoma (PAST HISTORY OF NON HODGKINS LYMPHOMA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021370917

Write-up: DEATH; ARRESTED; CHEST PAIN; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (regulatory authority number IE-HPRA-2021-070180). An 80-year-old male patient received BNT162B2 (COMIRNATY) dose 1 via an unspecified route of administration on 13Mar2021 (lot number EP9605) at 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, non-hodgkin''s lymphoma (past history of non hodgkins lymphoma), carotid artery stenosis, and on anti-platelet. Concomitant medications included atorvastatin calcium from 01Jan2020 to 17Mar2021 for an unspecified indication; clopidogrel hydrochloride (CLODEL) from 01Jan2020 to 17Mar2021 as anti-platelet; hydrochlorothiazide/olmesartan medoxomil (OMESAR PLUS) from 01Jan2020 to 17Mar2021 for hypertension; pantoprazole sodium sesquihydrate (PANTUP) from 01Dec2019 to 17Mar2021 for an unspecified indication; acetylsalicylic acid (NUPRIN) from 01Jan2020 to 17Mar2021 as anti-platelet. The patient experienced death, arrested, and chest pain on 17Mar2021 which were reported as fatal. On 17Mar2021, the patient passed away. It was reported that the patient had been taken to the Accident and Emergency (A+E) department with chest pain, then transferred to the catherterisation (cath) lab in a different hospital, where he arrested. It was reported that the patient was managed by the cardiology team and the duration of the reaction was a few hours. It was noted that time to onset was no reaction, but he died on 17Mar2021, "?cause". It was unknown if an autopsy was performed. The reporter did not know whether the patient''s vaccination with BNT162B2 was linked to his death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: DEATH; ARRESTED; Chest pain


VAERS ID: 1234966 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hip replacement (18 months previously); Living in residential institution; Renal disorder (Treatment in (Redacted name) Clinic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021409452

Write-up: DEVELOPED COVID 19; This is a spontaneous report from a contactable consumer or other non healthcare profesional downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-070505. A 88-years-old female patient received BNT162B2 (COMIRNATY, BioNTech Covid-19 mRNA vaccine), via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included living in residential institution, renal disorder receiving treatment in clinic; and hip arthroplasty from 2019 (18 months previously). Patient was recovering in nursing home after treatment in Clinic for kidney issues. The patient was not taking any concomitant medication. On 15Jan2021, the patient developed COVID-19. It was reported that the patient had been doing well in residential care but then crashed very quickly and it was decided not to send her to hospital as it was felt the patient would not have wanted that. The patient received palliative care for three days before she died. The patient died on 23Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1234967 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pH, Blood pH decreased, Carbon dioxide increased, Cardiac arrest, Nervous system disorder, Respiratory failure, Tidal volume, Tidal volume decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Lactic acidosis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZOLPIDEM; MAGNESIUM VERLA; CHLORHEXIDINE MOUTHWASH; MYCOSTATIN MOUTHWASH; OXYNORM LIQUID; LANSOPRAZOLE; FLUDROCORTISONE; ENOXAPARIN; PARACETAMOL; LEVETIRACETAM; NICOTINE PATCH; MELATONIN; SENNA; FERROUS FUMARATE; SODIUM CHLORIDE; SANDOS K;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asystole (Experiencing frequent episodes of asystole. 10/Mar/2021 or 11/Mar/2021- last episode of asystole); Bacterial endocarditis; Dependence on ventilator; Hospitalization (had been an in-patient for four months); Paralysed (quadriplegic secondary to septic embolus to high cervical cord, secondary to bacterial endocarditis); Respiratory disorder (Ventilation issues had occurred the previous weekend i.e. 14/Mar/2021.); Septic embolus
Allergies:
Diagnostic Lab Data: Test Date: 20210320; Test Name: pH; Result Unstructured Data: Test Result:Decreased; Test Date: 20210320; Test Name: Carbon dioxide increased; Result Unstructured Data: Test Result:raised; Test Date: 20210320; Test Name: Tidal volume; Result Unstructured Data: Test Result:Periods of very low
CDC Split Type: IEPFIZER INC2021409436

Write-up: PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; EPISODES OF ASYSTOLE; respiratory failure; respiratory failure secondary to severe neurological disease; This is a spontaneous from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. This is a report received from Regulatory authority report number IE-HPRA-2021-070650 with Safety Report Unique Identifier IE-HPRA-2021-070650. A 47-year-old male patient received bnt162b2 (COMIRNATY, Lot/Batch number: ER7812), dose 1 via an unspecified route of administration on 19Mar2021 15:45 as SINGLE DOSE for covid-19 immunisation. Medical history included septic embolus, experiencing frequent episodes of asystole with the last episode occurring on 10Mar2021 or 11Mar2021, dependence on ventilator, bacterial endocarditis, and paralysed. It was reported that the patient had been an in-patient for four months. The patient was ventilator dependent and quadriplegic secondary to septic embolus to high cervical cord, secondary to bacterial endocarditis. It was reported that the patient''s condition was extremely precarious and it was not considered likely that the patient would be discharged from hospital so a ceiling of care had been agreed upon. It was noted that the previous weekend, on 14Mar2021, these ventilation issues had also occurred. Concomitant medications included zolpidem from 23Feb2021 to 20Mar2021; magnesium aspartate (MAGNESIUM VERLA) from 17Mar2021 to 19Mar2021; chlorhexidine (CHLORHEXIDINE MOUTHWASH) and nystatin (MYCOSTATIN MOUTHWASH), both taken for mouthcare from 23Feb2021 to 20Mar2021; oxycodone hydrochloride (OXYNORM LIQUID) from 18Mar2021 to 18Mar2021; lansoprazole taken for gastroprotection from 23Feb2021 to 20Mar2021; fludrocortisone from 01Mar2021 to 20Mar2021; enoxaparin taken for venous thromboembolism (VTE) prophylaxis from 23Feb2021 to 20Mar2021; paracetamol from 18Mar2021 to 18Mar2021; levetiracetam from 23Feb2021 to 20Mar2021; nicotine (NICOTINE PATCH) from 04Mar2021 to 20Mar2021; melatonin from 23Feb2021 to 20Mar2021; sennoside a+b (SENNA) from 09Mar2021 to 20Mar2021; ferrous fumarate from 19Mar2021 to 20Mar2021; sodium chloride from 23Feb2021 to 20Mar2021; potassium bicarbonate, sodium bicarbonate, sodium phosphate monobasic (anhydrous) (SANDOS K) from 17Mar2021 to 19Mar2021; and midodrine from 12Mar2021 to 20Mar2021. The patient experienced problems with ventilation i.e. periods of very low tidal volumes with raised carbon dioxide (CO2) and decreased pH and episodes of asystole, all on 20Mar2021. The patient died on 20Mar2021 at 16:15. It was not reported if an autopsy was performed. It was outlined that the patient''s cause of death was captured in the notes as respiratory failure secondary to severe neurological disease. The patient''s death notification form recorded medical cause of death as "septic emboli to brain and spinal cord due to (or as a consequence of) bacterial endocarditis." The report outlined there was an interval of months between onset of this cause and death. The report outlined that the only link between the patient''s death and the vaccine was timing; there was no clinical suspicion of causation. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the limited information, a causal relationship between bnt162b2 and the reported events cannot be excluded based on temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate .; Reported Cause(s) of Death: PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW TIDAL VOLUMES WITH RAISED CO2 AND DECREASED PH.; PROBLEMS WITH VENTILATION I.E. PERIODS OF VERY LOW


VAERS ID: 1235025 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   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 - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Diarrhoea, Oxygen saturation, Pyrexia, Respiratory failure, SARS-CoV-2 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), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonectomy (From a previous malignancy the deceased had been subjected to the removal of a lung)
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210305; Test Name: body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Test Date: 20210305; Test Name: saturation; Result Unstructured Data: Test Result:76-80; Test Date: 20210316; Test Name: molecular swab for SARS CoV 2; Test Result: Positive
CDC Split Type: ITPFIZER INC2021408982

Write-up: After vaccine fever and respiratory crisis/fever 39 C/fever at 39.5; After vaccine fever and respiratory crisis; diarrhea; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB [IT-MINISAL02-711588]. An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via intramuscular at 0.3 mL single in right shoulder on 05Mar2021 for COVID-19 immunisation. Medical history included from a previous malignancy the deceased had been subjected to the removal of a lung. Concomitant medication was not reported. Patient experienced after vaccine fever and respiratory crisis on 05Mar2021. Patient also experienced diarrhea the same day. About one hour after the administration of the vaccine, patient had fever 39 C and respiratory crisis (the ambulance was called 3 times) and oxygen was administered. Then with the fourth ambulance he was transferred to the hospital where he died. It was unknown if an autopsy was performed. Actions taken included oxygen, hospital transport. Impact on quality of life was 10/10. The outcome of events was fatal. Reporter comments: From a previous malignancy the deceased had been subjected to the removal of a lung. A control visit was carried out in December and the patient was in good condition. He used to go for walks and take care of the garden, the day of the vaccination he was fine and after the administration he only reported a weight in the stomach. A few hours later he began to feel ill with a fever at 39.5 controlled by tachipirina, then diarrhea. On day 8 only tenths and wheezing, saturation 76-80 on 05Mar2021. Sender comments: 08Apr2021 Contact with the reporter: patient positive with molecular swab for SARS CoV 2 performed on March 16; all family members were positive except the niece with a positive serologic for IgG Regional PV Center: a request for a clinical report is sent to the PRIVACY. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Reporter comments: From a previous malignancy the deceased had been subjected to the removal of a lung. A control visit was carried out in December and the patient was in good condition. He used to go for walks and take care of the garden, the day of the vaccination he was fine and after the administration he only reported a weight in the stomach. A few hours later he began to feel ill with a fever at 39.5 controlled by tachipirina, then diarrhea. On day 8 only tenths and wheezing, saturation 76-80 on 05Mar2021.; Reported Cause(s) of Death: Fever; respiratory crisis; diarrhea


VAERS ID: 1235026 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-05
   Days after vaccination:7
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: 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: 2021-04-05
   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: SINTROM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409006

Write-up: Cardiocirculatory arrest at home. Rescued by the Emergency 112 with helicopter, Cardiopulmonary resuscitation with return of spontaneous circulation (ROSC). Later received in the intensive care unit and died.; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-711663. An 86-years-old female patient received bnt162b2 (COMIRNATY; COVID 19 COMIRNATY VACCINE (PFIZER)), dose 1 intramuscular on 29Mar2021 (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as 0.3 mL, single for covid-19 immunisation. Medical history included atrial fibrillation and dementia, both from an unknown date and unknown if ongoing. Concomitant medication included acenocoumarol (SINTROM) taken for atrial fibrillation and anticoagulant therapy, start and stop date were not reported. The patient experienced cardiocirculatory arrest at home. rescued by the emergency 112 with helicopter, cardiopulmonary resuscitation with return of spontaneous circulation (rosc). later received in the intensive care unit and died on 05Apr2021. Therapeutic measures were taken as a result of event included: Cardiopulmonary resuscitation [CPR] Orotracheal intubation infusion of Adrenaline. The patient died on 05Apr2021. An autopsy was not performed. Reporter''s comments: Irreversible cardiac arrest occurred on 05Apr2021 in a patient aged 86 with a history of dementia and atrial fibrillation, anticoagulated with Sintrom. The Patient was a subject to vaccination with Comirnaty on 29Mar2021 (the 1 dose) Sender''s comments: Regional Pharmacist: autopsy not performed (not requested). No follow-up attempts possible. No information expected.; Reporter''s Comments: Irreversible cardiac arrest occurred on 05Apr2021 in a patient aged 86 with a history of dementia and atrial fibrillation, anticoagulated with Sintrom. The Patient was a subject to vaccination with Comirnaty on 29Mar2021 (the 1 dose); Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1235028 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-20
   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 ET1831 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORAL; PLAVIX; BISOPROLOL FUMARATE
Current Illness: Diabetes
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: Echocardiogram; Result Unstructured Data: Test Result:unknown results
CDC Split Type: ITPFIZER INC2021409246

Write-up: pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number IT-MINISAL02-712070. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY) intramuscularly administered in left arm on 16Mar2021 (Lot Number: ET1831; Expiration Date: 30Jun2021) at single dose for COVID-19 immunisation. Medical history included diabetes from 01Jan2010 to 20Mar2021. Concomitant medications included metformin hydrochloride (METFORAL) taken for diabetes mellitus; clopidogrel bisulfate (PLAVIX) taken for secondary prevention; bisoprolol fumarate taken for cardiac failure chronic. The patient previously received the first dose of bnt162b2 on 23Feb2021 for COVID-19 immunisation. The patient experienced pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea (death) on 20Mar2021. Clinical course: Indicative of massive pulmonary embolism. The patient underwent lab tests and procedures which included Echocardiogram with unknown results on 21Mar2021. Therapeutic measures were taken as a result of pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea which included treatment with resuscitation and thrombolysis. The patient died on 21Mar2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. Reporters comments: Administered first dose on 23Feb and second dose on 16Mar2021 Health Authority Comment: no autopsy examination was required.; Reporter''s Comments: Administered first dose on 23Feb and second dose on 16Mar2021; Reported Cause(s) of Death: pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea; pulmonary embolism, subsequently respiratory failure and cardiac arrest in pea


VAERS ID: 1235030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Dizziness, Dysphagia, Muscular weakness, Nervous system disorder, Pleural effusion, Speech disorder, Visual impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021398779

Write-up: autoimmune neurological syndrome; pulmonary effusions; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow/weakness; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. The regulatory authority number is IT-MINISAL02-712445. A 91-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: EJ6790), via an unspecified route of administration, on 16Mar2021, as single dose, for COVID-19 immunisation. Medical history included mild hypertension. The patient''s concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (COMIRNATY, lot number: EJ6790), via an unspecified route of administration, on an unspecified date, for COVID-19 immunisation. It was reported that on 17Mar2021 "from the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow". It was also reported that the patient was admitted (unspecified date) where the doctors suspected an autoimmune neurological syndrome (onset date unspecified) and was treated with cortisone and immunosuppressant therapy. On an unspecified date, pulmonary effusions followed and then death. The reporter had no information about the hospitalization and death. The outcome of "from the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow" was fatal; and the outcome of the remaining events was unknown. The patient died on an unspecified date. It was unknown if an autopsy was performed. The health authority assessed the event "from the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow" as serious (fatal). Health authority Comment: On 07Apr2021 additional information is requested from the reporter: Lot number; clinical report on it or other available documentation; concomitant therapies, possibility of contacting a healthcare professional. No follow-up attempts possible. No further information expected.; Reporter''s Comments: mild hypertension; Reported Cause(s) of Death: From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vision problems, dizziness, then inability to hold up, speak, swallow.; From the day after the II dose of covid19 vaccine Pfizer; accused weakness in the legs, vi


VAERS ID: 1235033 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-02
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / UNK - / -

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021408960

Write-up: died from natural causes; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB manufacturer report number IT-MINISAL02-712914. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: ET7205) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient died from natural causes on 02Apr2021. The patient arrived in cardio-respiratory arrest, cardiopulmonary resuscitation maneuvers were performed without success (death) 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: death from natural causes


VAERS ID: 1235034 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-07
   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 ET7205 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409121

Write-up: access to the emergency room for dyspnea, died to suspect pulmonary embolism; access to the emergency room for dyspnea, died to suspect pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-713004. A 94-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 07Apr2021 14:45 (Lot Number: ET7205; Expiration Date: 31Jul2021) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced dyspnea and pulmonary embolism both on 07Apr2021, with outcome fatal. It is reported vaccination 1st dose with COMIRNATY mRNA vaccine against covid-19 on 07Apr2021 care of the home at 2:45 pm, in the evening, access to the emergency room for dyspnea, died to suspect pulmonary embolism. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender Comment: On 08Apr2021 request clinical report and if an autopsy examination was performed.; Reported Cause(s) of Death: died to suspect pulmonary embolism; dyspnea


VAERS ID: 1235037 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   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 ET7205 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409141

Write-up: Patient arrived in the emergency room at 15:55 and died at 16:40 from cardiovascular arrest. Absence of signs and symptoms attributable to anaphylactic shock.; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-713425. An 88-years-old male patient received BNT162B2 (COMIRNATY), intramuscular on 08Apr2021 15:36 (Lot Number: ET7205; Expiration Date: 31Jul2021) as 0.5 mL, single for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. Patient arrived in the emergency room at 15:55 and died at 16:40 from cardiovascular arrest on 08Apr2021. Absence of signs and symptoms attributable to anaphylactic shock. The patient died on 08Apr2021. It was not reported if an autopsy was performed. Event outcome was fatal.; Reported Cause(s) of Death: cardiovascular arrest


VAERS ID: 1235038 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021409130

Write-up: sudden death; This is as spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority report number IT-MINISAL02-713690. A 74-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: ET7205) intramuscularly in right deltoid on 06Apr2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension and benign prostatic hypertrophy. The patient''s concomitant medications were not reported. The patient experienced sudden death on 07Apr2021. It was not reported if an autopsy was performed. Reporter Comment: Request for death report and additional information to the reporting doctor, waiting for answer. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Request for death report and additional information to the reporting doctor, waiting for answer; Reported Cause(s) of Death: sudden death


VAERS ID: 1235039 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-07
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-20
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: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Solid tumour
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021414221

Write-up: sudden death; This is a spontaneous report received from a contactable pysician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-713945. A 57-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left shoulder on 29Mar2021 08:46 (Batch/Lot Number: ET7205; Expiration Date: 31Jul2021) as 30 ug, single (at the age of 57-year-old) for covid-19 immunisation. Medical history included solid tumour. The patient''s concomitant medications were not reported. The patient experienced sudden death on 07Apr2021. 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: 1235098 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2020-04-05
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Infective spondylitis, Magnetic resonance imaging, Pyrexia, Sepsis, White blood cell count
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 373
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Catheter placement; Haemodialysis; Renal failure chronic; Shunt occlusion
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: CRP; Test Result: 28.3 mg/dl; Test Date: 202104; Test Name: MRI; Result Unstructured Data: Test Result:Pyogenic spondylitis (L2/3) noted; Test Date: 20210403; Test Name: Pyrexia; Result Unstructured Data: Test Result:38.0 Centigrade; Comments: In the evening; Test Date: 20210405; Test Name: Pyrexia; Result Unstructured Data: Test Result:38.4 Centigrade; Comments: In the evening; Test Date: 20210406; Test Name: White blood cells; Result Unstructured Data: Test Result:22100 /mm3
CDC Split Type: JPPFIZER INC2021417806

Write-up: Pyrexia; pyogenic spondylitis due to long-term placed catheter infection; Sepsis; This is an initial spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number v21101813. A 73-year-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number-ER2659; Expiration Date: 30Jun2021) via an unspecified route of administration on 05Apr2021 at 15:00 as a single dose and was previously administered the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as single dose for covid-19 immunization. The patient was 73-years-old at the time of vaccination. The patient had a medical history of renal failure chronic, haemodialysis (from 20Oct2020), shunt occlusion, and insertion of long term catheter (on 18Jan2021). The patient''s concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection). It was reported that, on an unspecified date, the patient experienced pyogenic spondylitis due to long-term placed catheter infection, on 05Apr2021 (the day of the vaccination), the patient experienced pyrexia and on an unspecified date in Apr2021 sepsis. The patient underwent lab tests and procedures which included c-reactive protein: 28.3 mg/dl on 06Apr2021, magnetic resonance imaging: pyogenic spondylitis (l2/3) noted on Apr2021. On 03Apr2021 in the evening, pyrexia: 38.4 centigrade on 05Apr2021 in the evening 38.0 centigrade. On 06Apr2021 (1 day after the vaccination), the patient visited fever outpatient of the hospital. At the visit, white blood cell count: 22100 /mm3 on 06Apr2021. On 06Apr2021 (1 day after the vaccination), the patient was admitted to the hospital. Patient was receiving conservative treatment with antibiotics. On 13Apr2021 (8 days after the vaccination), the patient died and was discharged. It was not reported if an autopsy was performed. The reporting physician classified the event, pyrexia as serious (hospitalized, medically significant). The reporting physician commented as follows; It was unknown as to whether the event was related to BNT162b2. Regarding other possible cause of the event such as any other diseases, the reporting physician commented as follows: The patient was being in haemodialysis due to renal failure chronic and experienced pyogenic spondylitis due to long-term placed catheter infection. The outcome of the events sepsis and pyogenic spondilytis was fatal and for pyrexia was unknown.; Reported Cause(s) of Death: Sepsis; pyogenic spondylitis due to long-term placed catheter infection


VAERS ID: 1235105 (history)  
Form: Version 2.0  
Age: 102.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Blood pressure measurement, Body temperature, Computerised tomogram, Oxygen saturation
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MINEBASE; THEOLONG; AMLODIPINE; TELMISARTAN
Current Illness: Pneumonia aspiration (Treatment with clarithromycin)
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve incompetence; Aortic valve stenosis; Cardiac failure chronic; Hospitalization NOS; Tricuspid valve incompetence
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210402; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Comments: pyrexia; Test Date: 20210412; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210402; Test Name: CT; Result Unstructured Data: Test Result:Pneumonia aspiration; Test Date: 20210414; Test Name: SpO2; Test Result: 75 %
CDC Split Type: JPPFIZER INC2021425503

Write-up: Asthmatic attack; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21102060. A 102-year and 4-month-old female patient received the first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot number ER9480, Expiration date 31Jul2021), via an unspecified route of administration on 12Apr2021 14:40 (at the age of 102-years and 4-months) as a single dose for COVID-19 immunization. Medical history included: ongoing pneumonia aspiration from 02Apr2021, cardiac failure chronic (aortic valve stenosis, aortic valve incompetence, tricuspid valve incompetence). On 24Mar2021, the patient was admitted to the hospital (hospitalization reason not specified). On 02Apr2021, the patient had pyrexia of 37.3 degrees Centigrade. Pneumonia aspiration was diagnosed based on the image of computed tomography (CT). Treatment with antibacterial drug of clarithromycin was started. The patient''s body temperature was 37.3 Centigrade on 02Apr2021, and before vaccination was 36.6 degree Centigrade on 12Apr2021. Concomitant medications included: clarithromycin (MINEBASE) from 02Apr2021, theophylline (THEOLONG), amlodipine, and telmisartan for an unspecified indication. On 12Apr2021 at 14:40 (the day of vaccination), the patient received the first dose of COMIRNATY. On 13Ap2021 around 21:00 (1 day after the vaccination), the patient experienced asthmatic attack. On 16Apr2021 (4 days after the vaccination) at 6:51, the patient died. The course of the event was as follows: On 13Apr2021 around 21:00 (1 day after the vaccination), intraoral sputum accumulation developed, and large volume of sputum was vacuumed. Moaning was noted but no wheezing was seen. On 14Apr2021 (2 days after the vaccination), the patient made reaction to verbal contact. At 18:40, labored respiration, moaning, and wheezing were noted. SpO2 decreased to 75%. Drugs including bronchodilator, steroid, and catecholamine were administered, but they were ineffective. Until 14Apr2021, the patient had no pyrexia. On 15Apr2021 (3 days after the vaccination), blood pressure decreased, and bradycardia developed. On 16Apr2021 at 6:51, the patient''s death was confirmed, and the patient left hospital mortality. The outcome of the event asthmatic attack was fatal. The reporting physician classified the event as serious (Death) and the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were bronchial asthma and cardiac failure.; Reported Cause(s) of Death: Asthmatic attack


VAERS ID: 1235238 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract; Eczema; Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021409092

Write-up: The patient died suddenly the day after the injection. I don''t know if it was a side effect, patient probably died of a myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00483548, Safety Reportu Unique Identifier NL-LRB-00485690. A 79-years-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 11Mar2021 (Lot Number: EP9605) as single dose for Covid-19 immunisation. Medical history included cataract, smoker, eczema. The patient''s concomitant medications were not reported. The patient died suddenly the day after the injection on 12Mar2021. The reporter did not know if it was a side effect, patient probably died of a myocardial infarction. The death is unlikely to be due to the vaccination. only report because it was close to the vaccination and it was an unexpected death. Patient lived independently, single. Not a clear picture of health, but went for a weekly walk with a group of friends. No medication. No home care. The reporter did not know if it is a side effect. Myocardial infarction is the most likely cause of death. No previous COVID-19 infection. No diagnostic procedures. The patient died on 12Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: I don''t know if it was a side effect, patient probably died of a myocardial infarction


VAERS ID: 1235253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-13
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Chromaturia, Confusional state, Fatigue, Heart rate, Hypophagia, Malaise, Oxygen saturation, Renal failure, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVODOPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210321; Test Name: blood pressure; Test Result: Inconclusive; Result Unstructured Data: 155/135 mmhg; Test Date: 20210321; Test Name: body temperature; Test Result: Inconclusive; Result Unstructured Data: 36.3/min; Test Date: 20210321; Test Name: heartbeat; Test Result: Inconclusive; Result Unstructured Data: 68-90/min; Test Date: 20210322; Test Name: pulse; Test Result: Inconclusive; Result Unstructured Data: 90/min; Test Date: 20210321; Test Name: Saturation; Test Result: Inconclusive; Result Unstructured Data: variable 60-90%,; Test Date: 20210321; Test Name: urine stick; Test Result: Inconclusive; Result Unstructured Data: no increased leukocytes
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 an other health care professional and describes the occurrence of RENAL FAILURE (not tested but looks like kidney failure), MALAISE (not feeling well), CHROMATURIA (dark urine), CONFUSIONAL STATE (some confusion), HYPOPHAGIA (drank with difficulty or not, 3 bites of bread) and FATIGUE (fatigue) in a 98-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 300042721) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No reported medical history). Concomitant products included LEVODOPA for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MALAISE (not feeling well) (seriousness criterion death), CONFUSIONAL STATE (some confusion) (seriousness criterion death) and FATIGUE (fatigue) (seriousness criterion death). On 20-Mar-2021, the patient experienced RENAL FAILURE (not tested but looks like kidney failure) (seriousness criterion death) and CHROMATURIA (dark urine) (seriousness criterion death). On 21-Mar-2021, the patient experienced HYPOPHAGIA (drank with difficulty or not, 3 bites of bread) (seriousness criterion death). The patient died on 22-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 21-Mar-2021, Blood pressure measurement: 155/135 mmhg (Inconclusive) 155/135 mmhg. On 21-Mar-2021, Body temperature: 36.3/min (Inconclusive) 36.3/min. On 21-Mar-2021, Heart rate: 68-90/min (Inconclusive) 68-90/min. On 21-Mar-2021, Oxygen saturation: 60-90% (Inconclusive) wisselend 60-90%. On 21-Mar-2021, Urine analysis: no increases leukocytes (Inconclusive) no increased leucocytes. On 22-Mar-2021, Heart rate: 90 (Inconclusive) 90/min. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications also included non specified anticoagulants. Treatment of these events were not reported. Reporter did not allow further contact; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1235260 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-09-01
Onset:2021-03-11
   Days after vaccination:2748
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Magnetic resonance imaging, Myelopathy, Quadriplegia, Spinal cord compression, Spinal epidural haemorrhage, Spinal meningeal cyst
SMQs:, Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: MOVICOLON; PANTOPRAZOL [PANTOPRAZOLE]; FERROUS FUMARATE; MADOPAR; METOPROLOL SUCCINATE; ATORVASTATINE [ATORVASTATIN]; LEVODOPA/CARBIDOPA; APROVEL; RIVAROXABAN; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Non STEMI
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:meningeal cyst at the level of vertebrae C5 and C6; Comments: Conclusion: meningeal cyst at the level of vertebrae C5 and C6 right dorsolateral with myelum compression and myelopathy herd over vertebrae C4-C7 (during surgery they found it was due to haemorrhage)
CDC Split Type: NLPFIZER INC2021399184

Write-up: epidural bleeding at C4-C6 with spinal cord injury/quadriplegia; epidural bleeding at C4-C6 with spinal cord injury; meningeal cyst at the level of vertebrae C5 and C6 right dorsolateral; myelum compression; myelopathy herd over vertebrae C4-C7; This is a spontaneous report from a contactable physician downloaded from the regulatory authority Regulatory Authority number NL-LRB-00493370. An 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation; rivaroxaban, via an unspecified route of administration from Sep2013 (Batch/Lot Number: Unknown) to 12Mar2021, at 15 mg, once daily for atrial fibrillation; and clopidogrel, via an unspecified route of administration from Jun2020 (Batch/Lot Number: Unknown) to 12Mar2021, at 75 mg, once daily for non STEMI. Medical history included non STEMI and atrial fibrillation. The patient has no previous COVID-19 infection. Concomitant medications included macrogol, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOLON), pantoprazol [pantoprazole], ferrous fumarate, benserazide hydrochloride, levodopa (MADOPAR), metoprolol succinate, atorvastatine [atorvastatin], carbidopa, levodopa (LEVODOPA/CARBIDOPA) and irbesartan (APROVEL). The patient experienced epidural bleeding at c4-c6 with spinal cord injury on 11Mar2021. The events were assessed as medically significant and require hospitalization. The patient had spinal epidural bleeding and quadriplegia following administration of Pfizer covid-19 vaccine. Spinal epidural bleeding and quadriplegia are treated with hospital admission and operation which had no effect. The spinal epidural bleeding was at C4-C6 and led to spinal cord injury: quadriplegia. The operation was not effective, and patient died 3 weeks later. Latency of events spinal epidural bleeding and quadriplegia was 5 days after of Pfizer Covid-19 vaccine, within 8 years after start of rivaroxaban tablet 15 mg and within 9 months after start of clopidogrel tablet 75mg. MRI showed a meningeal cyst at the level of vertebrae C5 and C6 right dorsolateral with myelum compression and myelopathy herd over vertebrae C4-C7 (during surgery they found it was due to haemorrhage). The action taken in response to the events for rivaroxaban and clopidogrel was permanently withdrawn on 12Mar2021. The outcome of the events "meningeal cyst at the level of vertebrae C5 and C6 right dorsolateral", "myelum compression" and "myelopathy herd over vertebrae C4-C7" were unknown. The patient died on an unspecified date due to epidural bleeding at C4-C6 with spinal cord injury/quadriplegia. It was unknown if an autopsy was performed. Reporter Comment: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Epidural haemorrhage at C4-C6 with spinal cord injury. Information council other or disabling information: deterioration in general condition with completely dependent and bedbound. High aspiration risk. Hospitalization information: Spinal cord injury and surgery,. Additional information ADR: Admission and operation in hospital, no improvement on spinal cord injury. Death 3 weeks later. BSN available: yes. COVID19 Previous COVID-19 infection: No. Other diagnostic procedures: MRI - Conclusion: Meningeal cyst at the level of vertebral body C5 and C6 right dorsolateral with myelum compression and myelopathy over a longer range of vertebral body C4-C7. (appears to be due to bleeding during surgery). No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment: Information council other or disabling information: deterioration in general condition with completely dependent and bedbound. High aspiration risk. Admission and operation in hospital, no improvement on spinal cord injury. Death 3 weeks later. MRI - Conclusion: Meningeal cyst at the level of vertebral body C5 and C6 right dorsolateral with myelum compression and myelopathy over a longer range of vertebral body C4-C7. (appears to be due to bleeding during surgery).; Reported Cause(s) of Death: epidural bleeding at C4-C6 with spinal cord injury/quadriplegia; epidural bleeding at C4-C6 with spinal cord injury


VAERS ID: 1235263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Epistaxis, Malaise
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; NITRAZEPAM; NORTRIPTYLINE; CALCIUM + D3 [CALCIUM CARBONATE;CHOLECALCIFEROL]; BUSPIRONUM; IBANDRONINEZUUR ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Inguinal hernia repair; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021398902

Write-up: nosebleed; Malaise; Abdominal pain; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB manufacturer report number NL-LRB-00501806. A 93-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05Feb2021, single dose for covid-19 immunisation. Medical history included suspected covid-19 from 08Feb2021, inguinal hernia repair from Feb2021 to an unknown date. Concomitant medications included pantoprazolum; nitrazepam; nortriptyline; calcium carbonate, colecalciferol (CALCIUM + D3); buspironum; ibandronate sodium (IBANDRONINEZUUR ACTAVIS). The patient experienced nosebleed, malaise, abdominal pain, all on 08Feb2021, all outcome was fatal. 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: nosebleed; Malaise; Abdominal pain


VAERS ID: 1235264 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-16
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021409108

Write-up: Fatigue; Nausea; Not feeling well; This is a spontaneous report from a contactable consumer downloaded from a regulatory authority-WEB, regulatory authority number NL-LRB-00502722. An 87-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 12Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 16Mar2021, the patient experienced fatigue (death), nausea (death) and not feeling well (death). The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. No Past drug therapy Comirnaty. "BSN" was available. No Previous COVID-19 infection and no Other diagnostic procedures. The outcome of the events was fatal. Information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: fatigue; nausea; not feeling well


VAERS ID: 1235265 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: ACTRAPID; ATORVASTATIN; METOPROLOL
Current Illness: Coronary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Name: lab; Result Unstructured Data: Test Result:unknown results
CDC Split Type: NLPFIZER INC2021409162

Write-up: Myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number NL-LRB-00502948. A 74-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly on 06Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included ongoing Coronary disease. Concomitant medications included insulin (ACTRAPID), atorvastatin and metoprolol. The patient experienced myocardial infarction on 07Apr2021. The event was reported as serious with serious criteria death. The patient underwent lab tests and procedures which included electrocardiogram (ECG): unknown results on unknown date, laboratory test: unknown results on unknown date. Therapeutic measures were taken as a result of myocardial infarction included treated with medications according to a protocol. The patient died on Apr2021. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. BSN available: yes. Confounding factors: Coronary suffering. Previous COVID-19 infection: No. Other diagnostic procedures: ECG, lab. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. BSN available: yes. Confounding factors: Coronary suffering. Previous COVID-19 infection: No. Other diagnostic procedures: ECG, lab.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1235266 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   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 ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Ecchymosis, Fatigue, Headache, Magnetic resonance imaging, Magnetic resonance imaging head, Malaise, Myalgia, Nausea, Pneumonia, Ventilation/perfusion scan
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: OXAZEPAM; COTRIMOXAZOL; ACENOCOUMAROL
Current Illness: Bladder infection; Cardiac failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI scan abdomen; Result Unstructured Data: Test Result:full or faeces; Test Name: MRI head; Result Unstructured Data: Test Result:MRI because of suspected meningitis: negative; Test Name: lung scan; Result Unstructured Data: Test Result:Pneumonia
CDC Split Type: NLPFIZER INC2021409178

Write-up: pneumonia, which was fatal; extensive hematomas; Headache; Pain in the joints; Fatigue; Nausea; Not feeling well, became deathly ill; Muscle pain; This is a spontaneous report from a contactable other HCP downloaded from a regulatory authority-WEB manufacturer report number NL-LRB-00503249. This is the first case of two reports for the second dose. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 02Apr2021 (Lot Number: ET3674) at age of 83 years old as single dose for covid-19 immunisation. Medical history included ongoing cardiac failure, ongoing bladder infection. Concomitant medications included oxazepam; sulfamethoxazole, trimethoprim (COTRIMOXAZOL); acenocoumarol. The patient previously took bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 25Feb2021 at single dose for covid-19 immunisation and experienced malaise, sudden deafness, and nausea. On 02Apr2021, the patient experienced malaise, myalgia, fatigue, nausea, pneumonia, generalized joint pain. On 03Apr2021, the patient experienced headache. On an unknown date, the patient experienced ecchymosis. All events were fatal and life threatening. Nausea was treated with acetylcysteine (FLUIMICIL). The outcome of all events was fatal. The patient died in Apr2021. 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: Nausea and sudden deafness, and just not feeling well Date: 25Feb2021. Incredible deafness after first Pfizer vaccine. Additional information ADR: Mothers has become critically ill. Her complaints were only heart failure, but for the rest still up to date. Already a deterioration in hearing after the first vaccination. Last week cystitis, she asked the doctor if she could have a vaccination. No problem. Admitted to hospital with pneumonia on Saturday 03April which was fatal. Thanks vaccination. COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: MRI scan abdomen - full of faeces - MRI head due to meningitis (was not) - Lung photo - Pneumonia. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: Nausea and sudden deafness, and just not feeling well Date: 25Feb2021 Incredible deafness after first Pfizer vaccine ; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-2021415031 same patient, different vaccine dose and events; Reported Cause(s) of Death: Malaise; myalgia; ecchymosis; fatigue; nausea; generalized joint pain; headache; pneumonia


VAERS ID: 1235268 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-12
   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 - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021403560

Write-up: Collapsed and was reanimated/Man died shortly after administration Pfizer vaccine; This is a spontaneous report from a non-contactable consumer. A 77-years-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 (at 77-years-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. After the vaccination the patient waited for 15 minutes under supervision, before he went outside. Outside the patient collapsed and was reanimated before the emergency services came, the man was brought to the hospital by ambulance and died shortly after administration of Pfizer vaccine on the same day in the hospital on 12Apr2021. 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: Collapsed and was reanimated/Man died shortly after administration Pfizer vaccine


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


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