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

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



Case Details

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VAERS ID: 1306269 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001653 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Bipolar disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Haemorrhagic stroke; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC STROKE (Haemorrhagic stroke) in an 85-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001653) for COVID-19 vaccination. Concurrent medical conditions included Arterial hypertension and Bipolar disorder. On 15-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criterion death). The patient died on 22-Apr-2021. The reported cause of death was Haemorrhagic stroke. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 in response to the event was not applicable. No concomitant medications and treatment information were 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: Haemorrhagic stroke


VAERS ID: 1306415 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-19
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Heart rate, Loss of consciousness, Pulse absent
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), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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: 2021-04-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Blood pressure high; Treatment noncompliance
Preexisting Conditions: Medical History/Concurrent Conditions: Cranioencephalic trauma; Hernia repair (scrotal hernia surgery); Scrotal hernia; Traumatic brain injury; Comments: art. Hypertonie, OPS bei SHT, Z.n. Skrotalhernie operat. Noncompliance
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Pulse rate; Test Result: Negative ; Result Unstructured Data: Pulse absent
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS and PULSE ABSENT in a 54-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001531) for COVID-19 vaccination. art. Hypertonie, OPS bei SHT, Z.n. Skrotalhernie operat. Noncompliance. The patient''s past medical history included Scrotal hernia, Cranioencephalic trauma, Traumatic brain injury and Hernia repair (scrotal hernia surgery). Concurrent medical conditions included Arterial hypertension, Blood pressure high and Treatment noncompliance. On 12-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (seriousness criterion death) and PULSE ABSENT (seriousness criterion death). The patient died on 19-Apr-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-Apr-2021, Heart rate: pulse absent (Negative) Pulse absent. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Company Comment: This is a case of death in a 54-year-old male subject with unknown medical history of HTN, and Traumatic brain injury, who died 10 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Translation received. On 05-May-2021: Dose 1 added.; Sender''s Comments: This is a case of death in a 54-year-old male subject with unknown medical history of HTN, and Traumatic brain injury, who died 10 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1306420 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH J07BX03 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic renal failure; Chronic renal failure anaemia (anemia (renal)); Coronary artery disease; Insulin-requiring type 2 diabetes mellitus (DM type 2 (insulin dependent)); Peripheral arterial disease; Subclavian steal syndrome (subclavian steal syndrome left)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021512158

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB (Regulatory Authority number AT-BASGAGES-2021-25045). A 94-year-old female patient received the first single dose of BNT162B2 (COMIRNATY; lot/batch J07BX03) intramuscular, on 03Feb2021, for COVID-19 immunisation. Medical history included multiple, severe previous illnesses: ongoing subclavian steal syndrome left, ongoing coronary artery disease, ongoing chronic renal failure, ongoing peripheral artery disease, ongoing anemia renal (chronic renal failure anaemia), ongoing DM type 2 (insulin dependent). Concomitant medications were not reported. The patient died in the presence of nursing staff in the nursing home on 05Feb2021 morning. Due to the pre-existing diseases and the old age, no doctor was consulted. A post-mortem examination was not performed, the exact cause of death was unclear. The patient''s outcome was: fatal for death NOS. Sender Comment: BASGAGES-comment: Follow-up information requested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1306421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Condition aggravated, Cough, Dyspnoea, Ischaemic cardiomyopathy, Pyrexia
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ischaemic cardiomyopathy (Multimorbid patient with ischemic cardiomyopathy.); Multimorbidity (Multimorbid patient with ischemic cardiomyopathy.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021506075

Write-up: Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Dyspnea; Cough; Fever; This is a spontaneous report received from the regulatory authority. The regulatory authority report number is AT-BASGAGES-2021-25098. An 87-year-old male patient received bnt162b2 (COMIRNATY) unknown dose number, intramuscular on 28Apr2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included multimorbid patient with ischemic cardiomyopathy, ongoing. The patient''s concomitant medications were not reported. On 29Apr2021, the patient experienced decompensated ischemic cardiomyopathy with new-onset atrial fibrillation, dyspnea, cough, and fever. The events decompensated ischemic cardiomyopathy with new-onset atrial fibrillation were reported as serious (death); events dyspnea, cough, and fever were reported as serious (medically significant). Clinical course details were reported as follows. On 29Apr2021, the patient had complained of fever, cough, and shortness of breath 24h after vaccination. The patient died 48 h after vaccination due to consequences of decompensated ischemic cardiomyopathy with new onset atrial fibrillation. Outcome of the events fever, cough, and dyspnea were not recovered; while fatal for decompensation myocardial, atrial fibrillation, exacerbation of disease. The patient died on 29Apr2021. It was not reported if an autopsy was performed. Reporter''s comment: A causal relationship with the vaccination seems unlikely to us. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: A causal relationship with the vaccination seems unlikely to us.; Sender''s Comments: Apart from a temporal association, there is not a reasonable possibility that the reported events (decompensated ischemic cardiomyopathy, atrial fibrillation, dyspnea, cough, and fever ) are related to BNT162B2 vaccine. The ongoing ischemic cardiomyopathy may provide a plausible explanation.in this multimorbid patient.; Reported Cause(s) of Death: Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardiomyopathy with new-onset atrial fibrillation; Decompensated ischemic cardi


VAERS ID: 1306453 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001413 / 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: 2021-04-08
   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: PANTOPRAZOL [PANTOPRAZOLE]; SOLIAN; D-CURE; GLUCOPHAGE; APOCARD RETARD; BISOPROLOL [BISOPROLOL FUMARATE]; ZYPREXA VELOTAB; FOLAVIT; L-THYROXINE [LEVOTHYROXINE]; PROTHIADEN
Current Illness: Cardiac failure; Diabetes; Psychiatric disorder NOS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Sudden death; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN DEATH (Sudden death) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001413) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Cardiac failure and Psychiatric disorder NOS. Concomitant products included PANTOPRAZOL [PANTOPRAZOLE], AMISULPRIDE (SOLIAN), COLECALCIFEROL (D-CURE), METFORMIN HYDROCHLORIDE (GLUCOPHAGE), FLECAINIDE ACETATE (APOCARD RETARD), BISOPROLOL FUMARATE (BISOPROLOL [BISOPROLOL FUMARATE]), OLANZAPINE (ZYPREXA VELOTAB), FOLIC ACID (FOLAVIT), L-THYROXINE [LEVOTHYROXINE] and DOSULEPIN HYDROCHLORIDE (PROTHIADEN) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient died on 08-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other concomitant medications included MACROGOL 3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE Description: The patient had not reported any complaints during the day or signs after vaccination. The patient fell down in her room and must have died right away. She was hanging stockings on a heater, the position of the body clearly showed that she had fallen down and had not moved. The patient did not receive any treatment. Action taken with the drug in response to events was not applicable. Company comment:This is a case of death in a 56-year-old female subject with a medical history of Diabetes, Cardiac failure and Psychiatric disorder NOS, who died 7 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Translation received included medical history information.; Sender''s Comments: This is a case of death in a 56-year-old female subject with a medical history of Diabetes, Cardiac failure and Psychiatric disorder NOS, who died 7 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1306499 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Death, Dyspnoea, Oxygen saturation, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   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: Dialysis; Thrombotic microangiopathy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:low
CDC Split Type: DEPFIZER INC2021506083

Write-up: Unknown cause of death; Oxygen saturation low; Acute respiratory distress syndrome; Dyspnoea; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory authority DE-PEI-202100053684. A 69-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Unknown) as UNKNOWN, 0.3ML SINGLE for COVID-19 immunization. Medical history included dialysis from Jun2005 and ongoing , thrombotic microangiopathy from Jun2005 and ongoing. The patient''s concomitant medications were not reported. On 19Apr2021, the patient experienced acute respiratory distress syndrome, dyspnoea, oxygen saturation low. On 23Apr2021, unknown cause of death was reported. The patient died on 23Apr2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. No follow-up attempts possible. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Oxygen saturation low; Acute respiratory distress syndrome; Dyspnoea; Unknown cause of death


VAERS ID: 1306501 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506138

Write-up: Asystolia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100054632. A 78-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 06Apr2021 (Batch/Lot Number: ER9480) as UNKNOWN, 0.3 mL, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 06Apr2021, the patient experienced asystolia. The patient died on 06Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: Asystolia


VAERS ID: 1306502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hypertensive heart disease; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506141

Write-up: Infarct myocardial; This is a spontaneous report from a non-contactable physician reporting for a patient downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100054649. A 90-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EW8904) as UNKNOWN, 0.3 ML SINGLE for covid-19 immunisation, age at vaccination unknown. Medical history included ongoing hypertensive heart disease and ongoing hypothyroidism from an unspecified date. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on 12Apr2021 with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events: Source of assessment: Regulatory Authority Result of Assessment: C. Inconsistent causal association to immunization. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1306503 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   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: Arterial hypertension; COPD; Dementia; Pleuritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506140

Write-up: Sudden cardiac death; This is a spontaneous report from a non-contactable physician downloaded from a regulatory authority-WEB, regulatory authority number is DE-PEI-202100054650. An 86-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 07Jan2021 (Batch/Lot Number: Unknown) as unknown, 0.3 mL single (at the age of 86 years old) for COVID-19 immunisation. Medical history included ongoing pleuritis, arterial hypertension, COPD and dementia. The patient''s concomitant medications were not reported. On 15Jan2021, the patient experienced sudden cardiac death. The patient died on 15Jan2021. Death cause: pathologically-anatomically not ascertainable beyond doubt, conceivably most likely sudden cardiac death in high -grade 3-vessel coronary artery disease, mitral and aortic valve vitium, and chronic obstructive pulmonary disease; no meaningful association between vaccination and death. An autopsy was performed, and results were not provided. Relatedness of drug to reactions/events per PEI was D (Unclassifiable). No follow-up attempts are possible; Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1306504 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Ileus paralytic, Large intestine perforation
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow), Ischaemic colitis (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; General physical condition decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506134

Write-up: Acute heart failure/Toxic-resorptive cardiovascular failure; sigma perforation after massive stooling of the large intestine with suspected paralytic intestine / ileus; sigma perforation after massive stooling of the large intestine with suspected paralytic intestine / ileus; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100054651. An 85-year-old female patient received bnt162b2 (COMIRNATY, lot number was not reported), via an unspecified route of administration on 19Mar2021 (at the age of 85-years-old) as unknown, 0.3 mL single for covid-19 immunisation. The patient medical history included ongoing arterial hypertension, and ongoing general physical condition decreased from Jan2021. The patient''s concomitant medications were not reported. The patient experienced acute heart failure. Also, toxic - resorptive cardiovascular failure with sigma perforation after massive stooling of the large intestine with suspected paralytic intestine/ileus. The outcome of the events was fatal. The cause of death was acute heart failure and also reported as toxic - resorptive cardiovascular failure with sigma perforation after massive stooling of the large intestine with suspected paralytic intestine / ileus. The patient died on 20Mar2021. An autopsy was performed and results were not provided. This report is serious - death. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Acute heart failure/Toxic-resorptive cardiovascular failure; Dead cause: Toxic-resorptive cardiovascular failure with sigma perforation after massive stooling of the large intestine with suspected paralytic intestine / ileus; Dead cause: Toxic-resorp


VAERS ID: 1306505 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated
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: DEPFIZER INC2021506126

Write-up: Condition worsened; This is a spontaneous report from a non-contactable other healthcare professional downloaded from a regulatory authority-WEB, regulatory authority number DE-PEI-202100054652. A female patient of an unspecified age received BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 14Jan2021 as unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced condition worsened with fatal outcome. 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: Condition worsened


VAERS ID: 1306506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-26
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Retching
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-15
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021506136

Write-up: Dyspnoea; Gagging; Condition worsened; Tiredness; This is a spontaneous report from a non-contactable other healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100054653. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14Jan2021 (Batch/Lot Number: Unknown) as UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced condition worsened on 31Jan2021, tiredness on 26Jan2021, dyspnoea and gagging on 06Feb2021. The patient died on 15Feb2021. Outcome of the events was fatal. 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: Tiredness; Dyspnoea; Gagging; Condition worsened


VAERS ID: 1306512 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-31
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   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: Cardiac failure; Coronary heart disease; Dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 30-Apr-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of MYOCARDIAL INFARCTION in a 63-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. Concurrent medical conditions included Dialysis, Cardiac failure and Coronary heart disease. On 24-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced MYOCARDIAL INFARCTION seriousness criterion death). The patient died on 31-Mar-2021. The reported cause of death was Infarct myocardial. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered MYOCARDIAL INFARCTION to be unlikely related. The concomitant medications were not reported. The patient was resuscitated and later died at the hospital. The relationship to the vaccine was considered unlikely because the patient had severe heart disease. The action taken with mRNA 1273 with the event was not applicable. Company comment: This is a case of death in a 63-year-old male subject with a medical history of Dialysis, Cardiac failure and Coronary heart disease, who died 7 days after receiving the first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Translation received. Narrative updated.; Sender''s Comments: This is a case of death in a 63-year-old male subject with a medical history of Dialysis, Cardiac failure and Coronary heart disease, who died 7 days after receiving the first dose of vaccine. Based on reporter''s causality the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1308160 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Confusional state, Investigation, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigations; Result Unstructured Data: Test Result:Apart from the vaccine, no other causes were clear; Comments: identified
CDC Split Type: FIPFIZER INC2021506113

Write-up: Pyrexia; Confusional state; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FI-FIMEA-20212186. A 92-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 14Apr2021 (Batch/Lot Number: UNKNOWN) as 2ND DOSE single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received first dose of the vaccine COMIRNATY on 20Jan2021 for COVID-19 immunization (First vaccine dose). On April 16, 2021 at 1 p.m., a severe fever and confusion began. The patient''s condition collapsed at a rapid pace and he died on 16Apr2021 in the hospital emergency room. Apart from the vaccine, no other causes were clearly identified in the performed investigations. The patient underwent lab tests and procedures which included investigation: apart from the vaccine, no other causes were clear on an unspecified date identified. The patient died on 16Apr2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pyrexia; Confusional state


VAERS ID: 1308162 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congenital heart disease NOS (Congenital heart defect fixed); Obesity; Sleep apnea; Tetralogy of Fallot
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021506764

Write-up: pulmonary embolism; This is a spontaneous report from a contactable consumer. A 43-years-old non-pregnant female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Apr2021 10:00 (Batch/Lot Number: Unknown) as 1st dose, single for COVID-19 immunization. Medical history included congenital heart defect fixed, Tetralogy of Fallot, sleep apnea and obesity. The patient''s concomitant medications were not reported. The patient had no other vaccine in four weeks, and no other medications in two weeks. The patient has no Covid prior vaccination and it was unknown if the patient tested for Covid post vaccination. The patient died within 24 hours from receiving the vaccination, most probably due to pulmonary embolism. The patient died on 23Apr2021. Autopsy was performed, and autopsy investigation results are pending. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1308178 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-13
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Covid-19 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021506254

Write-up: Vaccination failure/COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from contactable physician downloaded from the regulatory authority-WEB regulatory authority or other manufacturer number FR-AFSSAPS-BX20213928, Safety Report Unique Identifier FR-AFSSAPS-2021046483. A 89-years-old female patient received bnt162b2 (COMIRNATY), intramuscular on 23Feb2021 (Batch/Lot Number: EM6950) as 2nd dose, single; via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included dementia (Unlabeled dementia) and Unwanted effect. Patient living in nursing home. The patient''s concomitant medications were not reported. COVID infection with progression towards the death of patient, despite complete diagram bnt162b2. COVID infection at 49 days of the 2nd dose of the vaccine, Positive Covid-19 PCR test on 13Apr2021, progressive asthenia and hypoxia (desaturation) on 23apr2021 with fatal evolution (without more precision). The patient experienced vaccination failure and covid-19 confirmed by positive covid-19 test on 13Apr2021. The patient died on Apr2021. It was not reported if an autopsy was performed. N.B.: Imputation made without prejudice to the elements of investigations which could be carried out in the framework of legal or amicable compensation procedures. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Vaccination failure/COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1308338 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Echocardiogram, 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: 2021-04-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (with left cardiac decompensation (2019)); Basedow''s disease (treated with ATS); Breast cancer (CANCER of the left breast (mastectomy in 2007, prosthesis), treated by FEMARA until 2011.); Cushing''s syndrome ((bilateral nodular hyperplasia of the adrenals with moderate ACTH-independent hypercortisolemia)); Dyslipidaemia; Hypertension arterial; Mastectomy (prosthesis); Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20190531; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:good LV function, moderate mitral leakage with di; Comments: good LV function, moderate mitral leakage with dilated left atrium, moderate aortic leak, dry pericardium, systolic pulmonary artery pressure (sPAP) not evaluable.
CDC Split Type: FRPFIZER INC2021506195

Write-up: Sudden death unexplained/ died the next day at 3:15 p.m. without clinical symptoms; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PB20212451 Safety Report Unique Identifier FR-AFSSAPS-2021044883. An 82-year-old female patient received bnt162b2 (COMIRNATY; Lot Number: EW4815), intramuscular on 23Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included parkinson''s disease, breast cancer treated by FEMARA until 2011, Cushing''s syndrome (bilateral nodular hyperplasia of the adrenals with moderate ACTH-independent hypercortisolemia), atrial fibrillation with left cardiac decompensation (2019), Basedow''s disease from 1980 to an unknown date treated with ATS, dyslipidaemia, hypertension, mastectomy from 2007 to an unknown date prosthesis. The patient''s concomitant medications were not reported. The patient died the next day (24Apr2021) at 3:15 p.m. without clinical symptoms. The patient underwent lab tests and procedures which included echocardiogram on 31May2019 with good LV function, moderate mitral leakage with dilated left atrium, moderate aortic leak, dry pericardium, systolic pulmonary artery pressure (sPAP) not evaluable. The patient died on 24Apr2021. 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: She died the next day at 3:15 p.m. without clinical symptoms


VAERS ID: 1308353 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: Medical History/Concurrent Conditions: AFib (complete arrhythmia due to atrial fibrillation); Arrhythmia; Arterial hypertension (history of high blood pressure); Diabetes; Heart failure; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: computerised tomography scan; Result Unstructured Data: Test Result:no lesion and it was considered to be located in t; Comments: no lesion and it was considered to be located in the brainstem
CDC Split Type: FRPFIZER INC2021506214

Write-up: CVA/stroke; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB FR-AFSSAPS-RN20211134, Safety Report Unique Identifier FR-AFSSAPS-2021042271. This is a report received from the Regulatory Authority. A 79-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 15Mar2021 (Batch/Lot Number: EP9605) as 2nd dose, single (1 injection D2) for covid-19 immunisation. Medical history included diabetes, obesity, heart failure, complete arrhythmia due to atrial fibrillation and arterial hypertension (history of high blood pressure). The patient has no allergies. The patient is treated long term with an anticoagulant (not specified). Living quarters not specified. The patient has no history of COVID-19 and was not tested for COVID-19. The patient''s concomitant medications were not reported. The patient experienced CVA on 26Mar2021. The patient was vaccinated on 15Mar2021 with COMIRNATY with immediate good tolerance. On 26Mar2021, 11 days after the vaccination, he presented with a stroke in a comatose state and with massive left haemiplegia initially, with no lesion on the computerised tomography scan and it was considered to be located in the brainstem. The patient was hospitalized and died on Mar2021. An autopsy was not performed. Subject to further investigations that could be carried out as part of legal or amicable compensation procedures. Reported Cause(s) of Death: CVA/stroke


VAERS ID: 1308370 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral amyloid angiopathy, Computerised tomogram, Haemorrhagic stroke, Investigation
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), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 22
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: OMEPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion (pace maker for sinoatrial rhythm disorder since the age of 45); Cardiovascular disorder (pace maker for sinoatrial rhythm disorder since the age of 45); GERD (treated with omeprazole)
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: CT scan; Result Unstructured Data: Test Result:parenchymal hemorrhage; Comments: this parenchymal hemorrhage presented features consistent with the diagnosis of cerebral amyloid angiopathy; Test Date: 202104; Test Name: Imaging analysis; Result Unstructured Data: Test Result:2-stage frontal cerebral hemorrhage; Test Date: 202103; Test Name: Rhythmology; Result Unstructured Data: Test Result:without anomaly, no hypertension
CDC Split Type: FRPFIZER INC2021506180

Write-up: Hemorrhagic stroke/spontaneous, lobar, left fronto-parietal intracerebral hemorrhage/cerebral hematoma; cerebral amyloid angiopathy; This is as spontaneous report downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-TO20213024 , Safety report unique identifier FR-AFSSAPS-2021045530. A contactable physician reported that a 74-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: ER9470), intramuscular, administered in the left arm on 03Apr2021 as a single dose for COVID-19 vaccination. Medical history included cardiac pacemaker insertion for sinoatrial rhythm disorder from an unspecified date, since the age of 45 and GERD from an unknown date treated with omeprazole. Rhythmology assessment in Mar2021 was without anomaly, no hypertension. Concomitant medication included omeprazole (manufacturer unknown) taken for GERD, start and stop date were not reported. The patient had a hemorrhagic stroke on 20Apr2021, (also reported as 20 days after the first COVID-19 injection with the Pfizer vaccine). The patient underwent Emergency admission on 20Apr2021 then hospitalization in the intensive care of the neurovascular service on 23Apr2021 at 22:00 for a spontaneous, lobar, left fronto-parietal intracerebral hemorrhage, centered on the Rolando. Imaging analysis is consistent with a 2-stage frontal cerebral hemorrhage. On CT scan, this parenchymal hemorrhage presented features consistent with the diagnosis of cerebral amyloid angiopathy. This was the first hemorrhagic event in this patient who until now had perfect cognitive and physical autonomy and had no particular pathology. It was also reported that in retrospect, the patient''s husband reports headaches 10 days before the stroke he There was no PSA monitoring performed. The patient died on 23Apr2021 as a result of this alertness disorder and cerebral hematoma, under analgesic and comfort treatment. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhagic stroke/spontaneous, lobar, left fronto-parietal intracerebral hemorrhage/cerebral hematoma


VAERS ID: 1308386 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-27
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ARICEPT; TOCO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peritoneal fibrosis
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: Nasal Swab - Covid-19 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021518031

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer or other non HCP. An 88-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration at the age of 88-year-old, administered in arm left on 26Feb2021 16:30 (Batch/Lot Number: EP2166) as single dose; dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot Number: Unknown) as single dose; for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included peritoneal fibrosis. Concomitant medications included donepezil hydrochloride (ARICEPT); tocopheryl acetate (TOCO, strength 500 with no unit). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced drug ineffective, covid-19 on 27Apr2021 12:00. On 27Apr2021, nasal swab was positive to Covid-19. The events required emergency room visit, then hospitalization for 6 days. Therapeutic measures included oxygen therapy (60 liters). The patient died on 06May2021 due to Covid-19. An autopsy was not performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Covid-19


VAERS ID: 1308425 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, Fall, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery bypass graft; Ischemic heart disease; Myocardial infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021469012

Write-up: Myocardial infarction; Myocardial infarction; Fall; This is a spontaneous report from a contactable other healthcare professional. This is a report received from a regulatory authority (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202104261015540100-S1XDE, Safety Report Unique Identifier GB-MHRA-ADR 25196416. An 84-year-old male patient received the 1st dose of bnt162b2 (Pfizer-BioNTech COVID-19 VACCINE), via an unspecified route of administration at 1st dose, single on 31Mar2021 for COVID-19 immunization. Medical history included coronary artery bypass graft (CABG), ischemic heart disease (IHD) and myocardial infarction (MI). Unsure if patient has had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date, the patient experienced myocardial infarction; fall on 04Apr2021. The patient died on 13Apr2021 with myocardial infarction. Patient has not tested positive for COVID-19 since having the vaccine.The cause of death was myocardial infarction. The outcome of event fall was recovered on an unspecified date; myocardial infarction was fatal. It was unknown if an autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: myocardial infarction


VAERS ID: 1308588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-03-24
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute aortic syndrome, COVID-19, Chronic obstructive pulmonary disease, Drug ineffective, SARS-CoV-2 test, Wrong product administered
SMQs:, Lack of efficacy/effect (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute aortic syndrome; COPD
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021492612

Write-up: Acute aortic syndrome; exacerbation of COPD; SARS-CoV-2 infection; SARS-CoV-2 infection; first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose COVID-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA; This is a spontaneous report from a contactable Physician. This is a report received from a regulatory authority (RA). Regulatory authority report number is GB-MHRA-WEBCOVID-202104300946529940-PEXZK, Safety Report Unique Identifier is GB-MHRA-ADR 25223208. An 89-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown) via an unspecified route of administration on 13Jan2021 as single dose and second dose of COVID-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA, lot number and expiration date unknown) via an unspecified route of administration on 24Mar2021 as single dose both for COVID-19 immunization. Medical history included acute aortic syndrome and chronic obstructive pulmonary disease (COPD). Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced acute aortic syndrome on an unspecified date and SARS-COV-2 infection on 22Apr2021. The patient was hospitalized for acute aortic syndrome from 21Apr2021 to an unknown date. Positive RT-PCR (Cepheid) on 22Apr2021 was positive. Patient required steroids for exacerbation of COPD (unspecified date). It was reported that the patient died as a consequence of acute aortic syndrome, not COVID-19. The patient underwent lab tests and procedures which included SARS-COV-2 test with yes - positive COVID-19 test result on 22Apr2021. The patient died on an unspecified date. The patient not recovered from SARS-COV-2 infection while the outcome for exacerbation of COPD was unknown. 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: Acute aortic syndrome


VAERS ID: 1308607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diplegia, Dizziness, Laboratory test, Loss of consciousness, Monoplegia, Myocardial infarction, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   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: Medical History/Concurrent Conditions: Cardiac disorder NOS (had to undergo a coronary angioplasty, but she had postponed it for unknown reasons)
Allergies:
Diagnostic Lab Data: Test Name: laboratory examination; Result Unstructured Data: Test Result:nothing shown
CDC Split Type: GRPFIZER INC2021520736

Write-up: fever; loss consciousness/blackout; vomiting; dizziness; paralysis at the arms and legs; paralysis at the arms and legs; unknown cause of death; myocardial infarction/symptoms of myocardial infarction.; This is a spontaneous report from a contactable consumer and from a contactable physician via a sales representative also reported from a non-contactable consumer. A 68-years-old female patient received the second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 04May2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation . Medical history included Cardiac problems from an unknown date and unknown if ongoing (''had to undergo a coronary angioplasty, but she had postponed it for unknown reasons'') The patient''s concomitant medications were not reported. The patient experienced unknown cause of death on an unspecified date , myocardial infarction on 05May2021 , loss consciousness/blackout, vomiting, dizziness, paralysis at the arms and legs on 04May2021, fever on an unspecified date . The patient underwent lab tests and procedures which included laboratory test: nothing shown on an unspecified date. The patient died on 05May2021. It was not reported if an autopsy was performed. ''It was mentioned on the media'': Coronovirus: 68-year-old dies a few hours after second dose of Covid vaccine. Lawsuit against anyone responsible from the children of the unfortunate 68-year-old - She was vaccinated with Pfizer. According to her family, the woman had no underlying disease. According to the lawsuit that has been filed, the 68-year-old received the first dose of the Pfizer vaccine on April 14, while the second was scheduled for May 4. After the second dose, the woman stayed for half an hour at the Health Center where she was vaccinated and left, with her daughter, who had accompanied her. A few hours later, on the night of May 4, the 68-year-old began to feel blackout, dizziness, vomiting and paralysis of her arms and legs. Her children took her to the hospital where she described to the doctor on duty her symptoms. There, they did some tests (details not provided) without finding anything, while according to the patient''s children, the doctors from the hospital said that they were adverse events of the second dose of the vaccine and that it would not happen again, giving the woman discharge. According to the lawsuit of the family of the 68-year-old, a few hours later (according to another article next day) the woman developed fever, while she had the same symptoms with vomiting and paralysis of the limbs. Her children took her to the hospital in their car as there was no free ambulance. Arriving at the hospital, the 68-year-old had lost consciousness, but remained alive with a low pulse. The doctors proceeded to intubation, but after about half an hour, she died. According to her family, the woman had no underlying disease and was in excellent physical condition. The lawyer of the family, [Privacy] filed a lawsuit against anyone responsible to investigate the possibility of committing criminal acts in any way. The family also appointed a medical examiner as a technical consultant and thus blocked the burial. The necropsy will take place on Tuesday and the findings of the forensic examination are awaited.'' It was also reported: The same report was received from a contactable physician through a sales representative. A pediatrician reported that this 68 year old female was administered the 2nd dose of Comirnaty on 04May2021 at the Health Center. After the vaccination, the patient was fine and left the Health Center without any problem. The following day the physician heard that the patient came to the Hospitals Emergency Room with symptoms of myocardial infarction. The physician reported that according to information the patient had cardiac problems and had to undergo a coronary angioplasty, but she had postponed it for unknown reasons. The clinical outcome of the events Vomiting, Dizziness, Monoplegia, Diplegia, Pyrexia, loss consciousness/blackout were unknown., While myocardial infarction and unknown cause of death was fatal.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1308621 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NOACID; THIOGAMMA; FURON [FUROSEMIDE SODIUM]; GLURENORM; TANYDON; KALDYUM; MODUXIN MR; ALFUZOSIN; ASACTAL; NEBILET
Current Illness: Cardiac insufficiency; Cerebral arteriosclerosis; Diabetes mellitus; Hypertension; Myocardial ischaemia; Polyneuropathy; Prostatic hypertrophy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021480830

Write-up: cardiac insufficiency; myocardial infarction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is HU-OGYI-240921. A 95-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: EL0725), intramuscular, administered in left arm on 17Feb2021, at 14:00 as 0.3 mg/m2, single for covid-19 immunisation. Medical history included ongoing hypertension, ongoing polyneuropathy, ongoing diabetes mellitus, ongoing cardiac insufficiency, ongoing prostatic hypertrophy, ongoing myocardial ischaemia, ongoing cerebral arteriosclerosis, all from unspecified dates. Concomitant medications included pantoprazole (NOACID) taken for an unspecified indication, start and stop date were not reported; thioctic acid (THIOGAMMA) taken for an unspecified indication, start and stop date were not reported; furosemide sodium(FURON) taken for an unspecified indication, start and stop date were not reported; gliquidone (GLURENORM) taken for an unspecified indication, start and stop date were not reported; telmisartan (TANYDON) taken for an unspecified indication, start and stop date were not reported; potassium chloride (KALDYUM) taken for an unspecified indication, start and stop date were not reported; trimetazidine hydrochloride (MODUXIN MR) taken for an unspecified indication, start and stop date were not reported; alfuzosin (ALFUZOSIN) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (ASACTAL) taken for an unspecified indication, start and stop date were not reported; nebivolol hydrochloride (NEBILET) taken for an unspecified indication, start and stop date were not reported. On 20Feb2021, the patient experienced cardiac insufficiency, which was serious as it involved hospitalization and lead to death. Details were as follows: On 20Mar2021, the patient was submitted to hospital due to worsening cardiac insufficiency and confusion. The patient died on 22Feb2021. An autopsy was performed and results were not provided. Cause of death was myocardial infarction. The physician does not suppose relationship with vaccination. Sender Comment: Cardiac insufficiency is not expected adverse event of COMIRNATY. It might be resulted by the patient''s cardiovascular diseases. TTO was 3 days. Based on the above, relationship between the event and COMIRNATY is unlikely. The case is serious because the patient died. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1308622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-18
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   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: FURON [FUROSEMIDE]; HUMA-PRONOL; JARDIANCE; KALDYUM; PANTOPRAZOLE; RIVOTRIL; TIAPRIDAL; VEROSPIRON
Current Illness: Hospitalization (for alcohol-induced liver cirrhosis)
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol dependence syndrome; Ascites; Cirrhosis alcoholic (been decompensated parenchymally and vasculrisically); Decubitus; Hydrothorax; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: Chest X-ray; Result Unstructured Data: Test Result:right lung pneumonia infiltrate and right upper lo; Comments: right lung pneumonia infiltrate and right upper lobe atelectasia; Test Date: 20210318; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021506492

Write-up: COVID-19 PCR test positive; COVID-19 PCR test positive/COVID-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-241221. A 69-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, lot: EP2163), intramuscular in left arm on 02Mar2021 as 1 st dose, 0.3 ml single for covid-19 immunisation. Medical history included hydrothorax on 22Jan2021, ascites, hypertension, decubitus, Alcohol dependence syndrome and cirrhosis alcoholic (been decompensated parenchymally and vasculrisically), all not ongoing and permanent hospitalization ongoing from Dec2010 (for alcohol-induced liver cirrhosis). Concomitant medications included furosemide (FURON); propranolol hydrochloride (HUMA-PRONOL); empagliflozin (JARDIANCE); potassium chloride (KALDYUM); pantoprazole; clonazepam (RIVOTRIL); tiapride hydrochloride (TIAPRIDAL) and spironolactone (VEROSPIRON). No side effects were observed after vaccination, the patient''s condition was dominated by alcoholic liver cirrhosis for which he was hospitalized. The patient experienced covid-19 pcr test positive (death, hospitalization) on 18Mar2021 and was placed in the hospital''s COVID department. The patient underwent lab tests and procedures which included chest x-ray on 26Mar2021 right lung pneumonia infiltrate and right upper lobe atelectasia. Despite the applied antiviral, antibiotic, steroid, LMWH therapy, the patient''s condition gradually deteriorated and he died on 05Apr2021. The patient died on 05Apr2021 with cause of death was respiratory and circulatory insufficiency on the ground of hydrothorax in consequence of hepatic cirrhosis due to alcohol dependence, next to COVID-19 pneumonia (drug ineffective) according to the death certificate. An autopsy was not performed. Sender Comment: COVID-19 PCR test became positive 16 days after Comirnaty vaccination, the patient died 34 days after vaccination. Autopsy was not done. Cause of death was respiratory and circulatory insufficiency on the ground of hydrothorax in consequence of hepatic cirrhosis due to alcohol dependence, next to COVID-19 pneumonia. Immunity may not be fully developed 2 weeks after the first dose. The case is serious due to fatal outcome. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: respiratory and circulatory insufficiency on the ground of hydrothorax in consequence of hepatic cirrhosis due to alcohol dependence, next to COVID-19 pneumonia; respiratory and circulatory insufficiency on the ground of hydrothorax in consequence of


VAERS ID: 1308623 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-13
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Drug ineffective, Suspected COVID-19
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign meningioma; Cholecystectomy; Epilepsy; Stomach cancer; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021506497

Write-up: Vaccination failure; possibility of vaccination failure; cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB, regulatory authority number HU-OGYI-254921. An 85-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 26Feb2021 (Batch/Lot Number: EP2166) as 2nd dose, 0.3 ml single for COVID-19 immunization. Medical history included epilepsy, benign meningioma, stomach cancer, stroke and cholecystectomy. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) on 04Feb2021 (batch number: EP0725) for COVID-19 immunization. On 13Mar2021 at 13:45, the patient passed away. The cause of death was cardiac arrest. It was not reported if an autopsy was performed. The patient died 15 days after the booster shot, therefore there''s a possibility of vaccination failure, however the reporter physician assessed the adverse event as related to the patient''s primary diseases. The events were assessed as serious-fatal. Sender Comment: According to the guidelines of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient died 15 days after the booster shot, therefore there''s a possibility of vaccination failure, however the reporter physician assessed the adverse event as related to the patient''s primary diseases. Based on the above, the causal relationship cannot be excluded between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1308624 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis of arteries of the extremities; Hyperlipidaemia; Hypertension; Pulmonary embolism (in chronic anticoagulant program)
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021506499

Write-up: Cardiac insufficiency; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-255121. A 80-years-old female patient received the first dose of BNT162b2 (COMIRNATY), intramuscular, administered in arm left on 25Feb2021 (Lot Number: EP2166) as 0.3 ml single for covid-19 immunisation. Medical history included hyperlipidaemia unknown if ongoing, hypertension unknown if ongoing, peripheral arterial occlusive disease unknown if ongoing, pulmonary embolism from 05Feb2020 to 15Feb2020 (in chronic anticoagulant program). The patient''s concomitant medications were not reported. The patient experienced cardiac insufficiency on 16Mar2021. The patient died on 16Mar2021 at 11:50. The cause of death was cardiac insufficiency. It was not reported if an autopsy was performed. On 16Mar2021 at 11:50 the patient passed away. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event as the reporter physician assessed the adverse event as related to the patient''s primary diseases. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: Based on the information available the event cardiac insufficiency is attributed to patient''s multiple underlying medical conditions and assessed unrelated to BNT162b2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: Cardiac insufficiency


VAERS ID: 1308645 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   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: CARDIRENE; ENALAPRIL IDROCLOROTIAZIDE EG; COLECALCIFEROL; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Comments: No medical history was provided by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Cerebrovascular accident; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021. The most recent information was received on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) in an 83-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. No medical history was provided by the reporter. On 01-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 ml. On 08-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criterion death). The patient died on 10-Apr-2021. The reported cause of death was Stroke. 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 provided. Action taken with mRNA-1273 in response to the event was not applicable. This is a case of death in a 83-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died 10 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible. Senders case reference number is IT-MINISAL02-714401. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Stop date of the event and date of death was updated.; Sender''s Comments: This is a case of death in a 83-year-old female subject with unknown medical history of HTN, PVD, CHF, A fib, MI, DM, COPD, OA and insomnia, who died 10 days after receiving the vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: stroke


VAERS ID: 1308648 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-04-06
   Days after vaccination:53
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725_65_008 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 19
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: Anaemia; Atrial fibrillation; Diabetes; Hypertension; Senile degeneration of brain
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: SARS-CoV-2 molecular test positive; Test Result: Positive
CDC Split Type: ITPFIZER INC2021434348

Write-up: SUSPECTED CLINICAL VACCINE FAILURE AS COVID 19 POSITIVE PATIENT FOLLOWING MOLECULAR SWAB AFTER 2 PFIZER DOSES. ASYMPTOMATIC PATIENT; SUSPECTED CLINICAL VACCINE FAILURE AS COVID 19 POSITIVE PATIENT FOLLOWING MOLECULAR SWAB AFTER 2 PFIZER DOSES. ASYMPTOMATIC PATIENT; This is a spontaneous report from a contactable other hcp downloaded from the regulatory authority, number IT-MINISAL02-716222. An 85-year-old female patient received bnt162b2 (COMIRNATY), first dose (lot number: EJ6797_65_003 ) on 21Jan2021, 1st dose, single, unspecified route of administration; second dose (lot number: EL0725_65_008) , intramuscular on 12Feb2021 12:17as 2nd dose, 0.3 mL, single for covid-19 immunisation. Medical history included , atrial fibrillation, diabetes, hypertension, anaemia, senile degeneration of encephalon, all from an unknown date. The patient''s concomitant medications included eight unspecified medicines for atrial fibrillation, diabetes, hypertension, anaemia, senile degeneration of encephalon. The patient experienced asymptomatic covid-19 on 06Apr2021 considered as non-serious by the reporter who described the event as: ''suspected clinical vaccine failure as covid 19 positive patient following molecular swab after 2 pfizer doses. Asymptomatic patient''. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Apr2021. The events was fatal and the patient died on 25Apr2021. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: Asymptomatic COVID-19; Asymptomatic COVID-19


VAERS ID: 1308656 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Haemoptysis, Loss of consciousness, Oesophageal haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BENTELAN; PALEXIA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nephrectomy (NEPHRECTOMY OF THE LEFT KIDNEY BY ETP); Surgery (hernia operation); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: ch
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: Oesophageal haemorrhage; Unconsciousness; Haemoptysis; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of OESOPHAGEAL HAEMORRHAGE (Oesophageal haemorrhage), LOSS OF CONSCIOUSNESS (Unconsciousness) and HAEMOPTYSIS (Haemoptysis) in a 60-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. Co-suspect products included non-company products CABOZANTINIB S-MALATE (CABOMETYX) for an unknown indication and ENALAPRIL MALEATO (NAPRILENE 20 MG COMPRESSE) for Hypertension. The patient''s past medical history included Surgery (hernia operation) and Nephrectomy (NEPHRECTOMY OF THE LEFT KIDNEY BY ETP). Concomitant products included BETAMETHASONE SODIUM PHOSPHATE (BENTELAN) and TAPENTADOL HYDROCHLORIDE (PALEXIA) for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form in total. On an unknown date, the patient started CABOZANTINIB S-MALATE (CABOMETYX) (unknown route) dosage form On an unknown date, CABOZANTINIB S-MALATE (CABOMETYX) (unknown route) dosage was changed to at an unspecified dose. and ENALAPRIL MALEATO (NAPRILENE 20 MG COMPRESSE) (unknown route) 20 milligram. On 02-Apr-2021, the patient experienced OESOPHAGEAL HAEMORRHAGE (Oesophageal haemorrhage) (seriousness criterion death), LOSS OF CONSCIOUSNESS (Unconsciousness) (seriousness criterion medically significant) and HAEMOPTYSIS (Haemoptysis) (seriousness criterion medically significant). On 02-Apr-2021, LOSS OF CONSCIOUSNESS (Unconsciousness) and HAEMOPTYSIS (Haemoptysis) outcome was unknown. The patient died on 02-Apr-2021. The reported cause of death was Oesophageal haemorrhage. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. At 7:15 PM, the patient started vomiting blood . The blood came from his oesophagus.and shortly afterwards lost consciousness. Treatment provided included resuscitation and medical observation. No additional treatment was provided. The reporter did not provide any causality assessments. This is a case of death in a 60-year-old male subject with a medical history of Surgery (hernia operation) and Nephrectomy (LEFT KIDNEY), who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Translation provided primary source reaction details. On 03-May-2021: No new information; Sender''s Comments: This is a case of death in a 60-year-old male subject with a medical history of Surgery (hernia operation) and Nephrectomy (LEFT KIDNEY), who died one day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Oesophageal haemorrhage


VAERS ID: 1308765 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 2246 / 1 - / -

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? 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: Diabetes (without insulin); Prostate cancer (treated with puncture every 3 months)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021501418

Write-up: Stroke; This is a spontaneous report received from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-723042. A 79-year-old male patient received the first dose of BNT162B2 (COMIRNATY, COVID 19 COMIRNATY VACCINE, lot number: EW 2246), via an unspecified route of administration on 09Apr2021 at single dose for COVID-19 immunisation. Medical history included mild diabetes (without insulin) and prostate cancer treated with puncture every 3 months. The patient''s concomitant medications were not reported. The patient experienced stroke on 10Apr2021. Patient was hospitalized for this event. 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: Stroke


VAERS ID: 1308987 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-06
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: LEUPLIN PRO; BICALUTAMIDE; OLMESARTAN; BISOPROLOL; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic dissection; Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210429; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210507; Test Name: Postmortem CT examination; Result Unstructured Data: Test Result:Thoracic aortic dissection was found
CDC Split Type: JPPFIZER INC2021510386

Write-up: Thoracic aortic dissection; Cardiopulmonary arrest (CPA); Feels poorly; Appetite impaired; This is a spontaneous report from a contactable physician received via a regulatory authority; and then received from a regulatory authority. Regulatory authority report number is v21105134. A 69-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscularly, administered in the right arm on 29Apr2021 at 14:30 (Batch/Lot Number: EP2163; Expiration Date: 31May2021) at 69-years-old as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included aortic dissection from an unknown date and unknown if ongoing, and prostate cancer from an unknown date and unknown if ongoing. Concomitant medications included leuprorelin acetate (LEUPLIN PRO; 22.5mg, injection); bicalutamide (MANUFACTURER UNKNOWN; 80mg); olmesartan (MANUFACTURER UNKNOWN; 20mg, orodispersible tablet); bisoprolol (MANUFACTURER UNKNOWN; 2.5mg); amlodipine (MANUFACTURER UNKNOWN; 5mg, orodispersible tablet); all within two weeks of vaccination, and taken for an unspecified indication, start and stop date were not reported. On 06May2021, 6 days 9 hrs. 30 min, the patient experienced: feels poorly (non-serious) and appetite impaired (non-serious). On 07May2021 at 09:00, 7 days 18 hrs. 30 min after the vaccination, the patient experienced: thoracic aortic dissection (death, medically significant), and cardiopulmonary arrest (CPA) (death, medically significant). The clinical course was reported as follows: "On 06May2021 (6 days after vaccination), feels poorly and appetite impaired were noted. On 07May2021 at 09:00 (7 days after vaccination), the patient got into the bathroom at home. As the patient did not come out for about 20 minutes, his family checked the bathroom and found him there. On 07May2021 at 9:20 (7days after vaccination), the patient was emergently transferred in cardiopulmonary arrest (CPA). At 10:11, resuscitation was performed, but the patient did not respond, and the patient was confirmed dead. Postmortem CT examination on 07May2021 showed thoracic aortic dissection. The outcome of the event cardiopulmonary arrest was fatal without treatment (as reported). On 07May2021 at 10:11 (7 days 19 hours and 41 minutes after the vaccination), the patient died. An autopsy was not performed." The contactable physician reported to a regulatory authority (Regulatory authority report number is v21105134) the clinical course as follows: The 69-year-7-month old male received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EP2163, Expiration date 31May2021) on 29Apr2021 at 14:30 (the day of vaccination) at the age of 69-year-7-month old. Body temperature before vaccination on 29Apr2021 was 36.7 degrees Celsius. The patient was concomitantly taking leuprorelin acetate (LEUPLIN PRO 22.5MG, injection), oral bicalutamide (80MG), oral olmesartan (20MG, orodispersible tablet), oral bisoprolol (2.5MG), and oral amlodipine (5MG, orodispersible tablet). The reporting physician assessed the causality between the event, thoracic aortic dissection, and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases was thoracic aortic dissection (as reported). The patient underwent lab tests and procedures which included body temperature: 36.4 Centigrade on 29Apr2021 (Before vaccination), computerised tomogram (Postmortem CT examination): thoracic aortic dissection was found on 07May2021. Therapeutic measures were taken as a result of cardiopulmonary arrest (CPA). The clinical outcome of the events feels poorly and appetite impaired, was unknown. The clinical outcome of the events: thoracic aortic dissection (death, medically significant), and cardiopulmonary arrest (CPA), was fatal. The patient died on 07May2021 at 10:11 (7 days 19 hours and 41 minutes after the vaccination) due to thoracic aortic dissection and cardiopulmonary arrest (CPA). An autopsy was not performed.; Reported Cause(s) of Death: Thoracic aortic dissection; cardiopulmonary arrest (CPA)


VAERS ID: 1308993 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cerebral infarction, Coma scale, Computerised tomogram, Computerised tomogram head, Diarrhoea, Heart rate, Oxygen saturation
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   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: ASPARA POTASSIUM; LANSOPRAZOLE; MOSAPRIDE CITRATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deaf mutism; Nutritional supplement; Rehabilitation therapy
Allergies:
Diagnostic Lab Data: Test Date: 20210507; Test Name: Blood pressure; Result Unstructured Data: Test Result:128/73 mmHg; Test Date: 20210428; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210507; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Date: 20210507; Test Name: JCS; Result Unstructured Data: Test Result:200; Test Date: 20210506; Test Name: Abdominal CT; Result Unstructured Data: Test Result:revealed no clear abnormality; Test Date: 20210507; Test Name: Head CT; Result Unstructured Data: Test Result:no haemorrhage intracranial was found; Test Date: 20210507; Test Name: Pulse; Result Unstructured Data: Test Result:58/min; Test Date: 20210507; Test Name: Peripheral oxygen saturation; Test Result: 97 %
CDC Split Type: JPPFIZER INC2021511530

Write-up: Cerebral infarction (vomiting and consciousness disturbed); Diarrhoea; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. The regulatory authority report number is v21105068. A 76-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: EW4811, Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 28Apr2021, at 12:00 as single dose for covid-19 immunization. Medical history included deaf mutism, rehabilitation therapy, and nutritional supplementation from an unknown date and unknown if ongoing. Concomitant medications included potassium aspartate (ASPARA POTASSIUM) taken for an unspecified indication, start and stop date were not reported; lansoprazole (MANUFACTURER UNKNOWN), taken for an unspecified indication, start and stop date were not reported; mosapride citrate (MANUFACTURER UNKNOWN) taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebral infarction (vomiting and consciousness disturbed) on 02May2021, at 10:30, which was serious as it lead to death and diarrhoea on 02May2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure: 128/73 mmhg on 07May2021, body temperature: 36.3 Centigrade on 28Apr2021 before vaccination, body temperature: 35.7 Centigrade on 07May2021 Coma Scale: 200 on 07May2021, abdominal computerised tomogram: revealed no clear abnormality on 06May2021, computerised tomogram head: no haemorrhage intracranial was found on 07May2021, pulse: 58/min on 07May2021, Peripheral oxygen saturation: 97 % on 07May2021. Therapeutic measures were taken as a result of cerebral infarction (vomiting and consciousness disturbed). Details were as follows: The patient was a 76-year and 2-month-old female. Body temperature before vaccination was 36.3 degrees centigrade. Family was nothing noteworthy (no alive relatives other than the older brother and younger sister who have adult guardians and are receiving a residential care for intellectual disability). Medical history included deaf mutism, rehabilitation therapy, and nutritional therapy (although the patient was hospitalized over the last 1 month, she mainly received treatments like rehabilitation therapy and nutritional therapy and underwent no medical interventions other than oral drug treatment). On 02May2021 at 10:30 (4 days after the vaccination), the patient experienced cerebral infarction (vomiting and consciousness disturbed). On an unknown date, after the vaccination, the patient''s hospitalization was prolonged, no otherwise specified. On 07May2021 (9 days after the vaccination), the patient was discharged, and the outcome of the event was fatal. The event course of the event was as follows: On 02May2021 (4 days after the vaccination), the patient had several episodes of vomiting and diarrhoea, due to which she received intravenous therapy while fasting temporarily. On 06May2021, abdominal computerised tomography (CT) revealed no clear abnormality, and aggravation of general condition was confirmed to be absent; the patient restarted eating. On the same day, the patient experienced no changes in the consciousness level, had full meals, and felt asleep. On 07May2021 at 5:45, the patient was found to have a sudden onset of consciousness disturbed (200 on coma scale) in the hospital room. Inner downward deviation of both eyes was noted, and the response of the upper extremities to pain stimuli was observed to be different bilaterally. When found, the patient had peripheral oxygen saturation of 97%, blood pressure of 128/73 mmHg, pulse of 58/min, and body temperature of 35.7 degrees Centigrade. Intracranial disease (especially cerebral infarction due to basilar artery occlusion) was suspected; on 07May2021 at 8:45, head CT was performed. No haemorrhage intracranial was found, and a definite diagnosis of cerebral infarction could not be made because of the short time gap from the onset. However, considering that no haemorrhagic lesion was revealed from the symptom''s clinical course and head CT, a disease called cerebral infarction (cerebral infarction due to basilar artery occlusion) was diagnosed. The patient died on 07May2021. An autopsy was not performed. The reporting physician classified the event, Cerebral infarction (vomiting and consciousness disturbed) as serious per death, and assessed the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented that as pathological anatomy and other methods could not be suggested considering the familial and social backgrounds, the diagnosis this time was made based on head CT ad the symptoms'' course. The causal relationship between vomiting (4 days after the vaccination) and the symptoms strongly suspected of cerebral infarction (9 days after the vaccination) was unclear. As a Pfizer vaccine was used, considered that the causal relationship between the vaccination and the ensuing cerebral infarction-like symptoms after 9 days was also unclear.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1308996 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Cardio-respiratory arrest, Chest discomfort, Cyanosis, Death, Myocardial ischaemia, Nausea, Oxygen saturation, Pallor, Peripheral vascular disorder
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (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 (narrow), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: cT (AI) blood test; Result Unstructured Data: Test Result:was conducted; Test Date: 20210426; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210426; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: at 18:15; Test Date: 20210426; Test Name: SpO2; Result Unstructured Data: Test Result:85-91 %
CDC Split Type: JPPFIZER INC2021511627

Write-up: Respiratory and cardiac arrest; Circulatory disorder peripheral; Queasy; Cyanosis; pallor facial; Chest tightness; Unknown cause of death; ischaemic heart disease; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21105072. An 82-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Apr2021 at 14:45 (Batch/Lot Number: ER7449; Expiration Date: 30Jun2021) at 82-years-old as a single dose for COVID-19 immunisation. The patient''s medical history included Heart disorder from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient previously took influenza vaccine for influenza immunisation and experienced pyrexia on an unspecified date. On 26Apr2021 at 18:15, the patient experienced: cyanosis (hospitalization, life threatening), pallor facial (hospitalization, life threatening), chest tightness (hospitalization, life threatening). On 26Apr2021 at 19:30, the patient experienced: queasy (hospitalization, life threatening). On 27Apr2021 at 08:30, the patient experienced: circulatory disorder peripheral (hospitalization, life threatening). On 27Apr2021 at 08:30, the patient experienced: respiratory and cardiac arrest (hospitalization, medically significant, life threatening). On 27Apr2021 at 11:41, the patient experienced: unknown cause of death and ischaemic heart disease (death, medically significant). The patient was hospitalized for cyanosis, pallor facial, chest tightness, queasy, circulatory disorder peripheral, and cardio-respiratory arrest from 27Apr2021 to 27Apr2021. The clinical course was reported as follows: The patient was an 82-year and 8-month-old male. Body temperature before vaccination was 36.6 degrees Centigrade. Family history was not reported. Medical history included heart disorder. Historical vaccine included influenza vaccine for influenza immunization and reaction included pyrexia. On 26Apr2021 at 14:45 (the day of vaccination), the patient received?the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 26Apr2021 at 18:15 (3 hours 30 minutes after the vaccination), the patient experienced circulatory disorder peripheral, cyanosis, respiratory and cardiac arrest, chest tightness, and queasy (as reported). On 27Apr2021 (1 day after the vaccination), the patient was admitted to the hospital. On 27Apr2021 (1 day after the vaccination), the outcome of the events was fatal. The course of the events was as follows: On 26Apr2021 (Monday) at 14:45, the patient was vaccinated. At 18:15, the patient developed pallor facial and cyanosis of lip. Body temperature was 37.5 degrees Centigrade and the patient''s chief complaint was "chest tightness". At 19:30, the patient developed queasy. From 23:00 to 04:00 on the following day, SpO2 was 85-91% and the patient had breathing shallow, and mild hyperpnoea. The patient repeatedly had normal breathing and respiratory distress. On 27Apr2021 (Tuesday) at 08:30, the patient had circulatory disorder peripheral, feeling cold, and cyanosis of distal extremities. At 10:30, respiratory and cardiac arrest was confirmed. At 11:05, the patient was transferred to a depressurized room of an emergency room of another hospital. At 11:41, death was confirmed. Due to investigate a cause, cT (AI) blood test was conducted. At 13:35, cause of death could not be identified, and autopsy was initiated (the result of autopsy was not reported). The patient was admitted to the hospital from 27Apr2021 to 27Apr2021. The reporting physician classified the events of circulatory disorder peripheral, cyanosis, respiratory and cardiac arrest, chest tightness, and queasy as serious (life-threatening and hospitalization) and assessed that the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was ischaemic heart disease. The reporting physician commented as follows: Physician of the medical institution where the patient was transferred reported that cause of death could not be identified in postmortem examination; however, ischaemic heart disease was suspected. Causality between the vaccination and the events were unknown. The patient underwent lab tests and procedures which included body temperature: 36.6 Centigrade on 26Apr2021 before vaccination, body temperature: 37.5 Centigrade on 26Apr2021 at 18:15, oxygen saturation (SpO2): 85-91 % on 26Apr2021, cT (AI) blood test: was conducted on 27Apr2021. The clinical outcome of the events: cyanosis, pallor facial, chest tightness, queasy, circulatory disorder peripheral, and cardio-respiratory arrest, was unknown. The clinical outcome of the event, unknown cause of death, was fatal. The patient died on 27Apr2021 due to an unknown cause of death; and the other possible cause of the event such as any other diseases was ischaemic heart disease. An autopsy was performed, and results were not provided. ; Reported Cause(s) of Death: ischaemic heart disease; ischaemic heart disease; Unknown cause of death


VAERS ID: 1309001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Body temperature, Cardiac arrest, Choking, Hypophagia, Irregular breathing, Nausea, Oedema, Pneumonia aspiration, Pyrexia, Respiration abnormal, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (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), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BASSAMIN
Current Illness: Hypertension; Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hemiplegia
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: Test Result:around 37 Centigrade; Test Date: 20210421; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210422; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Comments: at 00:45 (one day after vaccination); Test Date: 20210423; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: at 19:00 (two days after vaccination)
CDC Split Type: JPPFIZER INC2021513004

Write-up: cardiac arrest; Pneumonia aspiration; Choked on sputum; irregular breathing; respiratory like blew; Vomiting; queasy; Abdominal distension; could no longer be taken orally; Oedema; Pyrexia; This is a spontaneous report from a contactable consumer (patient''s daughter) via medical information team and from a contactable physician received from a regulatory authority(v21105245). An 88-year and 8-month-old male patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 21Apr2021 at 13:30 (Lot Number: ER9480; Expiration Date: 31Jul2021) (at the age of 88-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing living in nursing home, non-ongoing cerebral infarction on an unspecified date, hemiplegia, and ongoing hypertension. The patient had no noteworthy family history. Concomitant medication included acetylsalicylic acid, aluminium glycinate, magnesium carbonate (BASSAMIN) taken as antiplatelet agent. The patient experienced pyrexia on 22Apr2021 00:45; could no longer be taken orally and odema on 24Apr2021 12:00; vomiting, queasy, and abdominal distension on 27Apr2021; respiratory like blew on 29Apr2021; irregular breathing on 30Apr2021 at 19:30; choked on sputum, pneumonia aspiration, and cardiac arrest on 01May2021 02:40. All of the events were reported as fatal. The clinical course was reported as follows: On 21Apr2021 at 13:30, the patient received BNT162B2 with a body temperature before vaccination of 36.3 degrees Centigrade on 21Apr2021. On 22Apr2021 at 00:45, pyrexia with body temperature of 38.4 degrees Centigrade (one day after vaccination) was noted and oral acetaminophen (CALONAL) was administered. On 23Apr2021 at 19:00, pyrexia with body temperature of 38.3 degrees Centigrade (two days after vaccination) was noted. On 24Apr2021 at noon, the patient could no longer be taken orally, so unspecified transfusion was initiated, and oedema of extremities developed (as reported). After that, oedema persisted but the body temperature remained around 37 degrees Centigrade in Apr2021. On 27Apr2021, vomiting and queasy were noted. On 28Apr2021, no vomiting and queasy were noted, so oral ingestion was initiated but was discontinued due to queasy. Oedema extremities and abdominal distension were recovering. After that, the amount of oral ingestion was small and queasy sometimes occurred, so oral unspecified injection was repeatedly interrupted. On 29Apr2021, respiratory like blew was noted and there was no pneumonic bruit. On 30Apr2021 at 19:30, the patient had vomiting and irregular breathing. On 01May2021 at 01:30, the patient had jaw breathing and then cardiac arrest. Although cardiac massage was performed, it was not improved. On the same date at 02:40, the patient''s death was confirmed. A diagnosis of pneumonia aspiration was made by a physician. The reporter reported that no pyrexia was evidently noted until 20Apr2021 based on the data (blood pressure, pulse and body temperature) but pyrexia and vomiting were noted after the vaccination, on 20Apr2021. The reporter was told by the physician that although he/she recognized that the patient had febrile symptom, he/she could not state confidently that the death cause was pneumonia aspiration due to the vaccine. Therapeutic measures were taken as a result of all of the events as aforementioned. The patient died on 01May2021. The cause of death was reported as pneumonia aspiration. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the events and BNT162B2 as unassessable. Other possible causes of the events, such as any other diseases, were reported as pneumonia aspiration and suffocation due to sputum. The reporting physician commented as follows: the causal relationship with the vaccine was unknown and it was considered that the association was low. However, the family strongly claimed about the association with the vaccine and requested a report to the country. Therefore, this case was reported.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1309017 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-28
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NITROFURANTOINE; RISPERIDON; AZITHROMYCIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200420; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: SARS-CoV-2 test positive
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Fever; Death; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 20-Apr-2020. Concomitant products included NITROFURANTOINE, RISPERIDONE (RISPERIDON) and AZITHROMYCIN for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant). The patient died on 28-Feb-2021. The reported cause of death was Fever. It is unknown if an autopsy was performed. At the time of death, PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2020, SARS-CoV-2 test: positive (Positive) SARS-CoV-2 test positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not confirmed; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not confirmed; Reported Cause(s) of Death: Fever


VAERS ID: 1309029 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-14
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, SARS-CoV-2 test
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; FAMOTIDINE ACID REDUCER; TRAMADOL; CLONAZEPAM; ALFACALCIDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident ("5 months ago"); COVID-19; Dialysis; Renal insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20200402; Test Name: Corona, bevestigd met test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: Cardiac arrest; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest) in an 83-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Renal insufficiency, Dialysis, Cerebrovascular accident ("5 months ago") in December 2020, Renal insufficiency, Dialysis and COVID-19 on 02-Apr-2020. Concomitant products included ALLOPURINOL, FAMOTIDINE (FAMOTIDINE ACID REDUCER), TRAMADOL, CLONAZEPAM and ALFACALCIDOL for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death). The patient died on 14-Apr-2021. The reported cause of death was Cardiac arrest. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2020, SARS-CoV-2 test positive: positive (Positive) Positive. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. Company comment: This case concerns death of a 83-year-old male patient 1 day after the administration of the mRNA-1273 vaccine. Patient is reported to have known risk factors such as Renal insufficiency, Dialysis, Cerebrovascular accident4 months prior and COVID-19, 12 days prior to vaccine administration. Although a temporal association exist, based on the current available information a causal relationship between the reported events and mRNA-1273 use is assessed as unlikely. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: The follow-up received has NNI.; Sender''s Comments: This case concerns death of a 83-year-old male patient 1 day after the administration of the mRNA-1273 vaccine. Patient is reported to have known risk factors such as Renal insufficiency, Dialysis, Cerebrovascular accident4 months prior and COVID-19, 12 days prior to vaccine administration. Although a temporal association exist, based on the current available information a causal relationship between the reported events and mRNA-1273 use is assessed as unlikely.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1309030 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: pulmonary embolism; The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 29-Apr-2021. This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis) and PULMONARY EMBOLISM (pulmonary embolism) in a 70-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced THROMBOSIS (The day of the vaccine, the ankle was very swollen (photo material as evidence); leg / ankle thrombosis) (seriousness criterion death). On 07-Apr-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria death and medically significant). The patient died on 07-Apr-2021. The reported cause of death was pulmonary embolism presumably from thrombotic. It is unknown if an autopsy was performed. No concomitant medication reported. No treatment information was provided. Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities, further information required. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Translation received; The event verbatim changed for both the events and the stop date for the event thrombosis leg updated; Sender''s Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient''s comorbidities, further information required.; Reported Cause(s) of Death: Pulmonary embolism presumably from thrombotic


VAERS ID: 1309035 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac tamponade, Electrocardiogram, Myocardial infarction, Ventricular fibrillation, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Myocardial infarction (narrow), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL SUCCINATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: ECG; Result Unstructured Data: Test Result:first ventricular fibrillation followed by; Comments: first ventricular fibrillation followed by ventricular tachycardia. Later ventricular fibrillation again after which asystolic.
CDC Split Type: NLPFIZER INC2021506309

Write-up: Myocardial infarction; Tamponade cardiac; Ventricular fibrillation; Ventricular tachycardia; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number NL-LRB-00525909. An 80-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 30Apr2021 as second dose, 0.3 mL, single for COVID-19 immunization. Medical history was not reported. The patient has no previous COVID-19 infection. Concomitant medications included metoprolol succinate taken for an unspecified indication. The patient previously received BNT162B2 (COMIRNATY) on 26Mar2021, as first dose, 0.3 mL, for COVID-19 immunization. On 30Apr2021, the patient experienced myocardial infarction and tamponade cardiac. An ECG by ambulance nurses showed first ventricular fibrillation, followed by ventricular tachycardia, and later ventricular fibrillation again after which the patient was asystolic. The patient died on 30Apr2021. 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: Ventricular fibrillation; Ventricular tachycardia; Myocardial infarction with cardiac tamponade; Myocardial infarction with cardiac tamponade


VAERS ID: 1309036 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021506274

Write-up: himself not feeling well; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [NL-LRB-00526430], received from Regulatory Authority. An 82-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Lot number and expiry date were unknown), via an unspecified route of administration on 29Apr2021 as 0.3 mL, single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on unspecified date as a single dose for COVID-19 immunization; there were no side effects were reported. The patient experienced not feeling well/ malaise on 30Apr2021. The patient was found deceased the day after vaccination on 30Apr2021. As a differential diagnosis HA been examined in the patient unexpected death (sudden death) on 30Apr2021. Two (2) hours before death he had indicated that he did not feel well but was walking around. Afterwards found dead. Unclear relation with vaccine. The outcome of malaise was fatal. The patient died on 30Apr2021. Cause of death was not feeling well/ malaise. It was unknown if an autopsy was performed. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: not feeling well/ malaise; unexpected death (sudden death)


VAERS ID: 1309041 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-28
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Oxygen saturation decreased, 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 (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy (Sequelae: paresis); Chronic renal failure (Age-related mild renal failure); Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: B.1.351 lineage
CDC Split Type: NOPFIZER INC2021506306

Write-up: Pulmonary failure; Oxygen saturation decreased; Lack of drug effect; COVID-19 disease/Vaccination failure; COVID-19 pneumonia; This is a spontaneous report from a contactable physician, downloaded from the Regulatory Authority (RA)-WEB, Regulatory authority report number: NO-NOMAADVRE-FHI-2021-U2m1wr, Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00026412. An 87-years-old male patient received BNT162b2 (COMIRNATY), intramuscular on 26Jan2021 14:11 (Batch/Lot Number: EJ6134) as 2ND DOSE, SINGLE, and intramuscular on 06Jan2021 08:20 (Batch/Lot Number: EJ6795) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included living in a nursing home in 2014, chronic renal failure (age-related mild renal failure), and apoplexy with paresis sequelae in 2014. The patient''s concomitant medications were not reported. On 28Mar2021, the patient had vaccination failure, lack of drug effect, due to confirmed COVID-19 pneumonia, and oxygen saturation decreased continuously, despite increasing amounts of medical oxygen. On 03Apr2021, the patient died due to COVID-19 pneumonia/pulmonary failure since Apr2021. Relevant laboratory findings and investigations included in the report (SARS-COV-2 PCR TEST on 28Mar2021, Positive, B.1.351 lineage. Cycle threshold not known at the time of the report.). The patient died on 03Apr2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. The Center assessed the causal relationship between BNT162b2 (COMIRNATY) and all the reported events as Possible. The case was considered to be Serious. Sender comment: Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. Your message is therefore important to expand knowledge about adverse reactions that were not discovered in the studies, and it is an important contribution to international cooperation to maintain safe vaccination worldwide.; Reporter''s Comments: Reporters qualification: Physician.; Reported Cause(s) of Death: COVID-19 pneumonia; Pulmonary failure


VAERS ID: 1309043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Incomplete course of vaccination, Infection, Oxygen saturation, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (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), Medication errors (narrow), Infective pneumonia (narrow), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LIPITOR [ATORVASTATIN]; SOMAC; DEXAMETASON ABCUR; TARGINIQ; AFIPRAN; METOPROLOL MYLAN [METOPROLOL SUCCINATE]; ATACAND; LIXIANA; IMOVANE; HALOPERIDOL; LYRICA; AKYNZEO
Current Illness: Exposure to COVID-19
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac arrest (Date of event not specified by the reporter.); Chemotherapy induced peripheral neuropathy; Hypertension; Implantable defibrillator user (Since cardiac arrest.); Living in residential institution; Metastatic gastric cancer (Cancer ventriculi with metastases to liver, brain and skeleton.); Overweight
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Oxygen saturation (p02); Result Unstructured Data: Test Result:around 90 %; Test Date: 20210402; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Comments: Result: Positive.
CDC Split Type: NOPFIZER INC2021506321

Write-up: Covid 19 lung failure/ COVID-19 PNEUMONIA; Covid 19 lung failure/ PULMONARY FAILURE; Covid 19 lung failure/ INCOMPLETE COURSE OF VACCINATION; Covid 19 lung failure/ BREAKTHROUGH INFECTION; This is a spontaneous report from a contactable physician, downloaded from a regulatory authority-WEB. The regulatory authority number is NO-NOMAADVRE-FHI-2021-U4n1jd with Safety Report Unique Identifier: NO-NOMAADVRE-E2B_00026430. A 71-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscularly, administered in the arm on 24Mar2021 (batch/lot number: ET3674, expiration date: unknown) as the 1st dose, single for COVID-19 immunization. Relevant medical history included cardiac arrest in 2014 (date of event not specified by the reporter); implantable defibrillator user from 2014 since cardiac arrest; and exposure to COVID-19 in 31Mar2021; and overweight, hypertension, living in residential institution, chemotherapy induced peripheral neuropathy, metastatic gastric cancer (cancer ventriculi with metastases to liver, brain and skeleton), and atrial fibrillation; all from an unknown date. Concomitant medications included atorvastatin (LIPITOR, strength: 20 mg); pantoprazole sodium sesquihydrate (SOMAC, strength: 40 mg); dexamethasone (DEXAMETASON ABCUR, strength: 4 mg); naloxone hydrochloride, oxycodone hydrochloride (TARGINIQ, Tablet, strength: naloxone hydrochloride 10 mg, oxycodone hydrochloride 20 mg); metoclopramide hydrochloride (AFIPRAN, strength: 10 mg); metoprolol succinate (METOPROLOL MYLAN, strength: 100 mg); candesartan cilexetil (ATACAND, strength: 32 mg); edoxaban tosilate (LIXIANA, strength: 60 mg); zopiclone (IMOVANE, Tablet, strength: 7.5 mg); haloperidol (strength: 0.5 mg); pregabalin (LYRICA, strength: 150 mg); and netupitant, palonosetron hydrochloride (AKYNZEO, strength: netupitant 300 mg, palonosetron hydrochloride 0.5 mg), all taken for an unspecified indication, start and stop date were not reported. On 02Apr2021, the patient experienced Covid 19 lung failure, further described as COVID-19 pneumonia, pulmonary failure, incomplete course of vaccination, and breakthrough infection, which all led to hospitalization and death. The patient was hospitalized for Covid 19 lung failure/COVID-19 pneumonia, pulmonary failure, incomplete course of vaccination, and breakthrough infection from 07Apr2021 to an unknown date. It was further reported that the patient gradually developed COVID-19 lung disease with increasing oxygen demand and decreasing oxygen saturation with oxygen saturation (p02) around 90 % with 2 L on nasal catheter (date of measurement not specified)] in Apr2021. The patient underwent further lab tests and procedures, which included SARS-CoV-2 PCR test: positive on 02Apr2021 as part of infection tracing. The patient died at the hospital in the evening of 10Apr2021. It was not reported if an autopsy was performed. A regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. Reporters comments: 22Apr2021: Telephone contact with the reporter to obtain additional information regarding the case. Following fields have been updated according to this conversation: Person (Disease), Product, Event. This is a final report. Sender comment: Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 22-Apr-2021: Telephone contact with the reporter to obtain additional information regarding the case. Following fields have been updated according to this conversation: Person (Disease), Product, Event. This is a final report.; Reported Cause(s) of Death: Covid 19 lung failure/ COVID-19 PNEUMONIA; Covid 19 lung failure/ PULMONARY FAILURE; Covid 19 lung failure/ INCOMPLETE COURSE OF VACCINATION; Covid 19 lung failure/ BREAKTHROUGH INFECTION


VAERS ID: 1309053 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021510917

Write-up: death; This is a spontaneous report from a contactable other HCP forwarded by company representative. A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) 2nd dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient died (death) two days after receiving the first dose of Comirnaty. Information obtained from an acquaintance related to the patient that the patient did not suffer from any serious medical conditions. The patient died on an unspecified date. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1309055 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-14
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac failure, Haemorrhagic diathesis, Respiratory tract haemorrhage, Thrombocytopenia
SMQs:, Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLMODERNATX, INC.MOD20211

Write-up: Diathesis skin-mucosal; Respiratory tract bleeding; Failure heart; Acute thrombocytopenia; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGIC DIATHESIS (Diathesis skin-mucosal), RESPIRATORY TRACT HAEMORRHAGE (Respiratory tract bleeding), THROMBOCYTOPENIA (Acute thrombocytopenia) and CARDIAC FAILURE (Failure heart) in an 86-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Mar-2021, the patient experienced THROMBOCYTOPENIA (Acute thrombocytopenia) (seriousness criterion death). On 18-Mar-2021, the patient experienced HAEMORRHAGIC DIATHESIS (Diathesis skin-mucosal) (seriousness criterion death), RESPIRATORY TRACT HAEMORRHAGE (Respiratory tract bleeding) (seriousness criterion death) and CARDIAC FAILURE (Failure heart) (seriousness criterion death). The patient died on 18-Mar-2021. The reported cause of death was Respiratory tract bleeding, Heart failure, acute thrombocytopenia and diathesis skin-mucosal. An autopsy was not performed. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Cardiac failure, thrombocytopaenia (both immune and toxic thrombocytopaenia) and the associated dermatomucosal diathesis and respiratory tract bleeding are unexpected adverse reactions which are not listed in section 4.8 of the COVID-19 Vaccine Moderna Summary ofProduct Characteristics. A causal relationship between the administration of the Moderna vaccine and the occurrence of immune thrombocytopaenia cannot be ruled out or confirmed at the current stage of development. Based on the information in the report, although acute immune thrombocytopaenia was reported as an adverse reaction, the type of thrombocytopaenia has not been confirmed (immune thrombocytopaenia or toxic thrombocytopaenia was merely suspected). There is a temporal relationship between vaccine administration and the onset of thrombocytopaenia, but due to the reasons listed above, a causal relationship has not been established. No information is available on whether cardiac failure existed before the vaccination (an attempt to obtain information was unsuccessful); therefore, no temporal or causal relationships can be established. The reporting physician assessed the adverse reactions as severe (death). The regulatory authority classified the report as severe. This is a case of death in a 86-year-old female subject with unknown medical history, who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Translation received. Sender''s comments added.; Sender''s Comments: This is a case of death in a 86-year-old female subject with unknown medical history, who died 16 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Respiratory tract bleeding; Heart failure; Acute thrombocytopenia; Diathesis skin-mucosal


VAERS ID: 1309107 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: NYSTATIN ORIFARM; FOLACIN [FOLIC ACID]; MIRTAZAPIN ACTAVIS; BEHEPAN [CYANOCOBALAMIN]; DUROFERON; CANDESARTAN SANDOZ; SPIRONOLACTONE ACCORD; AMLODIPIN ACCORD; LEVAXIN; IMPUGAN [FUROSEMIDE SODIUM]; ALVEDON; RISPERIDON ACTAVIS
Current Illness: Cardiac failure; Dementia NOS; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021506346

Write-up: CEREBROVASCULAR DISEASE; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is [SE-MPA-2021-032319 ]. A 92-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Feb2021 (Batch/Lot Number: EJ6136) 2ND DOSE, single for COVID-19 immunisation. Medical history included ongoing hypertension, cardiac failure, and dementia NOS. Concomitant medications included nystatin (NYSTATIN ORIFARM); folacin [folic acid] (FOLACIN [FOLIC ACID]); mirtazapine (MIRTAZAPIN ACTAVIS); cyanocobalamin (BEHEPAN); ferrous sulfate (DUROFERON); candesartan cilexetil (CANDESARTAN SANDOZ); spironolactone (SPIRONOLACTONE ACCORD); amlodipine besilate (AMLODIPIN ACCORD); levothyroxine sodium (LEVAXIN); furosemide sodium (IMPUGAN); paracetamol (ALVEDON); risperidone (RISPERIDON ACTAVIS); all taken for an unspecified indication, start and stop date were not reported. The patient experienced cerebrovascular disease in Mar2021. Time to onset was reported as 28 days. The patient died on an unspecified date. Cause of death: Unspecified cerebrovascular disease. No autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CEREBROVASCULAR DISEASE


VAERS ID: 1309108 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cardiac failure acute, Cerebrovascular disorder, Decreased appetite, Fatigue
SMQs:, Cardiac failure (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OXASCAND; XARELTO; NYSTATIN ORIFARM; FOLACIN [FOLIC ACID]; ATORBIR; ALVEDON; BEHEPAN [CYANOCOBALAMIN]
Current Illness: Cognitive disturbance; Hypertension; Late effects of cerebral infarction
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021506340

Write-up: CVS (cerebrovascular disease); Acute cardiac failure due to arteriosclerosis; Acute cardiac failure due to arteriosclerosis; tired; stopped eating; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB SE-MPA-2021-032398, other case identifier is SE-VISMA-1619541691170. An 88-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot Number: EJ6136) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included ongoing hypertension, ongoing late effects of cerebral infarction, and ongoing cognitive disturbance. Concomitant medications included oxazepam (OXASCAND; strength: 5 mg); rivaroxaban (XARELTO; strength: 20 mg); nystatin (NYSTATIN ORIFARM; strength: 100000 IU/ml); folacin [folic acid] (FOLACIN [FOLIC ACID]; strength: 1 mg); atorvastatin calcium (ATORBIR; strength: 20 mg); paracetamol (ALVEDON; strength: 500 mg); cyanocobalamin (BEHEPAN [CYANOCOBALAMIN]; strength: 1 mg). On an unspecified date in Feb2021, the patient was tired and stopped eating. The patient had CVS (cerebrovascular disease) and acute cardiac failure due to arteriosclerosis on an unspecified date in Feb2021. The patient died on an unspecified date. An autopsy was performed and results were not provided. The outcome of CVS (cerebrovascular disease), and acute cardiac failure due to arteriosclerosis was fatal while the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute cardiac failure due to arteriosclerosis; Acute cardiac failure due to arteriosclerosis; CVS (cerebrovascular disease)


VAERS ID: 1309109 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
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: 2021-04-01
   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: ENALAPRIL COMP; ATENOLOL ACCORD; ATORVASTATIN KRKA; AMLODIPIN SANDOZ [AMLODIPINE MESILATE]; SPIRONOLACTONE ACCORD; ACETYLSALICYLSYRA TEVA; ATENOLOL ORIFARM; BETMIGA; DERMOVATE; FELODIPIN; FINASTERID SANDOZ; KETOCONAZOL ACTAVIS; LACROFARM; L
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021506349

Write-up: saddle embolus pulmonary embolism in lung at autopsy; This is a spontaneous report from a contactable physician downloaded from the regulatory authority SE-MPA-2021-032855. A 69-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on Apr2021 (Batch/Lot Number: Unknown) as UNKNOWN, SINGLE for covid-19 immunisation (Age at vaccination: 69 years). Medical history included ongoing hypertension. Concomitant medications included enalapril maleate, hydrochlorothiazide (ENALAPRIL COMP); atenolol (ATENOLOL ACCORD); atorvastatin calcium (ATORVASTATIN KRKA); amlodipine mesilate (AMLODIPIN SANDOZ [AMLODIPINE MESILATE]); spironolactone (SPIRONOLACTONE ACCORD); acetylsalicylic acid (ACETYLSALICYLSYRA TEVA); atenolol (ATENOLOL ORIFARM); mirabegron (BETMIGA); clobetasol propionate (DERMOVATE); felodipin; finasteride; ketoconazole; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LACROFARM); levocabastine hydrochloride (LIVOSTIN); omeprazole (OMEPRAZOL SANDOZ [OMEPRAZOLE]); oxycodone hydrochloride (OXIKODON ACTAVIS); paracetamol (PARACETAMOL ORIFARM); ramipril (RAMIPRIL HEXAL); simvastatin (SIMVASTATIN SANDOZ); diclofenac sodium (VOLTARENE). The patient experienced saddle embolus pulmonary embolism in lung at autopsy on Apr2021. Outcome of the event was fatal. The patient died on Apr2021. An autopsy was performed that revealed pulmonary embolism . Information on the lot/batch number has been requested.; Autopsy-determined Cause(s) of Death: pulmonary embolism


VAERS ID: 1309784 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular insufficiency, Coronary artery occlusion
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIAMICRON; SIMVASTATIN; JANUMET; FORXIGA
Current Illness: Hyperlipidaemia (Hyperlipid?mie); NIDDM (NIDDM)
Preexisting Conditions: Comments: No medical history was reported by the reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CARDIOVASCULAR INSUFFICIENCY and CORONARY ARTERY OCCLUSION in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No medical history was reported by the reporter. Concurrent medical conditions included NIDDM (NIDDM) and Hyperlipidaemia (Hyperlipid?mie). Concomitant products included GLICLAZIDE (DIAMICRON), SIMVASTATIN, METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET) and DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FORXIGA) for an unknown indication. On 16-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced CARDIOVASCULAR INSUFFICIENCY (seriousness criterion death) and CORONARY ARTERY OCCLUSION (seriousness criterion death). The patient died on 18-Apr-2021. The reported cause of death was Occlusion coronary. An autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. Treatment medications were not reported. Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) in response to the event was not applicable. Company comment:This is a case of death in a 81-year-old male subject with a medical history of NIDDM and Hyperlipidaemia, who died 2 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient autopsy info, Medical History, and Concomitant medication info added; Sender''s Comments: This is a case of death in a 81-year-old male subject with a medical history of NIDDM and Hyperlipidaemia, who died 2 days after receiving the second dose of vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible.; Reported Cause(s) of Death: Occlusion coronary


VAERS ID: 1309786 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Asthenia, Cardiac failure, Dyspnoea, Pleural effusion
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-03
   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: Anemia (Myelodysplastic syndrome (anemia, thrombocytopenia)); Atrial fibrillation (permanent atrial fibrillation); Chronic renal failure (chronic renal failure KDOQI III); COPD (COPD III); Coronary artery disease (coronary heart disease (condition after 4-fold aortocoronary bypass)); Myelodysplastic syndrome NOS (Myelodysplastic syndrome (anemia, thrombocytopenia)); Thrombocytopenia (Myelodysplastic syndrome (anemia, thrombocytopenia))
Preexisting Conditions: Medical History/Concurrent Conditions: Aortocoronary bypass (coronary heart disease (condition after 4-fold aortocoronary bypass))
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021512163

Write-up: anemia was worsened; increasing shortness of breath; Weakness; bilateral pleural effusions; Global cardiac decompensation; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-25042. A 91-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 18Mar2021 (Lot Number: ET1831) at unknown, single for covid-19 immunisation. Medical history included ongoing coronary heart disease (condition after 4-fold aortocoronary bypass - not ongoing), ongoing Myelodysplastic syndrome (anemia, thrombocytopenia), ongoing permanent atrial fibrillation, ongoing chronic obstructive pulmonary disease (COPD) III, and ongoing chronic renal failure KDOQI III. The patient''s concomitant medications were not reported. The patient experienced global cardiac decompensation on 03Apr2021, bilateral pleural effusions on 21Mar2021, and consequently increasing shortness of breath and weakness and blood count deterioration (anemia was worsened and thrombocytopenia was stable, in the presence of a known myelodysplastic syndrome) on unknown date. Outcome of the events increasing shortness of breath, weakness and anemia was worsened was not recovered while unknown for bilateral pleural effusions. The patient died on 03Apr2021. It was not reported if an autopsy was performed. The event global cardiac decompensation was reported as serious, fatal and other events were serious, causing hospitalization from 21Mar2021. Health Authority Comment: Regulatory Authority-comment: Follow-up information requested. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Global cardiac decompensation


VAERS ID: 1309787 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: Chronic renal insufficiency (chronic kidney failure); Epilepsy; Hypertension arterial; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Transient ischaemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: blood pressure; Result Unstructured Data: Test Result:Drop
CDC Split Type: ATPFIZER INC2021512151

Write-up: Unresponsive to stimuli/Patient no longer responsive; acute deterioration in general condition; Drop in blood pressure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority WEB with regulatory authority number AT-BASGAGES-2021-25044. An 88-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 12Feb2021 (Lot Number: EJ6790) as second dose, single for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing hypertension arterial, ongoing chronic renal insufficiency/chronic kidney failure, ongoing epilepsy and transient ischaemic attack from 2014 to an unknown date (not ongoing). The patient''s concomitant medications were not reported. On 15Feb2021, the patient experienced general physical condition decreased death, drop of blood pressure and unresponsive to stimuli (patient no longer responsive). The outcome of the events was fatal. The patient died on 19Feb2021. It was not reported if an autopsy was performed. Sender''s comments: regulatory authority -comment: Follow-up information requested. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Unresponsive to stimuli/Patient no longer responsive; acute deterioration in general condition; Drop of blood pressure


VAERS ID: 1309827 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Death, General physical health deterioration, Inflammation, Liver function test, Renal function test, Thyroid function test, Urine analysis, White blood cell count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LANOXIN; DONEPEZIL; D-CURE; CALCIUM CITRATE; BISOPROLOL; MAGNESIUM; QUETIAPINE; LIXIANA; HALDOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Breast cancer (Vinorelbine with Gemcitabine (VG) for breast cancer); Hypercholesterolemia
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: CRP; Test Result: 20.6 mg/dl; Test Date: 20210121; Test Name: Liver; Result Unstructured Data: Test Result:Normal; Test Date: 20210121; Test Name: kidney; Result Unstructured Data: Test Result:Normal; Test Date: 20210121; Test Name: Thyroid; Result Unstructured Data: Test Result:Normal; Test Date: 20210121; Test Name: Urine; Test Result: Negative ; Test Date: 20210121; Test Name: white blood cell count; Result Unstructured Data: Test Result:Normal
CDC Split Type: BEPFIZER INC2021512193

Write-up: inflammatory picture with rapidly progressive deterioration and death; inflammatory picture with rapidly progressive deterioration and death; inflammatory picture with rapidly progressive deterioration and death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-89935. An 83-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: EJ6796) as 1st dose, single for covid-19 immunisation. Medical history included dementia Alzheimer, atrial fibrillation, hypercholesterolaemia, and breast cancer (Vinorelbine with Gemcitabine (VG) for breast cancer). Concomitant medications included digoxin (LANOXIN), donepezil, colecalciferol (D-CURE), calcium citrate, bisoprolol, magnesium, quetiapine, edoxaban tosilate (LIXIANA), haloperidol (HALDOL); all taken for an unspecified indication, start and stop date were not reported. The patient experienced inflammatory picture with rapidly progressive deterioration on 21Jan2021 which resulted in death. No treatment was given for the events. The patient underwent lab tests and procedures which included c-reactive protein: 20.6 mg/dl on 21Jan2021, liver: normal on 21Jan2021,kidney: normal on 21Jan2021, thyroid: normal on 21Jan2021, urine analysis: negative on 21Jan2021, white blood cell count: normal on 21Jan2021. The patient died on 04Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death; inflammatory picture with rapidly progressive deterioration; inflammatory picture with rapidly progressive deterioration


VAERS ID: 1309828 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Vaccination site reaction
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: NOBIRETIC; CARDIOASPIRINE; COVERAM; VEINOFYTOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021512210

Write-up: Death; Pain in the chest; Reaction at the injection site; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB BE-FAMHP-DHH-N2021-90559. An elderly male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot Number: ET9096) as 1st dose, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, nebivolol hydrochloride (NOBIRETIC); acetylsalicylic acid (CARDIOASPIRINE); amlodipine besilate, perindopril arginine (COVERAM) and aesculus hippocastanum extract (VEINOFYTOL) all taken for an unspecified indication, start and stop date were not reported. It was reported that the patient experienced death, pain in the chest and reaction at the injection site on 16Apr2021. The patient died on 19Apr2021 (as reported- pending clarification). It was unknown if an autopsy was performed. Reporter''s comments: Treatment - No Evolution of the ADR - Death; Reporter''s Comments: Treatment - No Evolution of the ADR - Death; Reported Cause(s) of Death: Death


VAERS ID: 1309841 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-13
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acquired haemophilia, Gallbladder rupture, Haemobilia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Gallbladder related disorders (narrow), Biliary tract disorders (narrow), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-10
   Days after onset: 27
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: ACETYLSALICYLIC ACID; ATORVASTATIN; SPIRONOLACTONE; BISOPROLOL FUMARATE; EZETIMIBE; Aldactone; CONCOR; Fludex; Triatec; ZANIDIP; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute blood loss anemia; Acute on chronic renal failure; Acute renal failure; Chronic renal failure; Coronary artery disease; Coronary artery disorder; Thrombopenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Acquired haemophilia A with anti factor VIII; gall bladder hemorrhage; gallbladder perforation; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII), HAEMOBILIA (gall bladder hemorrhage) and GALLBLADDER RUPTURE (gallbladder perforation) in an 85-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3000496 and 300042460) for COVID-19 vaccination. The patient''s past medical history included Acute renal failure on 14-Mar-2021, Chronic renal failure, Acute blood loss anemia, Coronary artery disease, Acute on chronic renal failure on 14-Mar-2021, Thrombopenia and Coronary artery disorder. Concomitant products included ACETYLSALICYLIC ACID, ATORVASTATIN, SPIRONOLACTONE, BISOPROLOL FUMARATE, EZETIMIBE, Spironolactone (Aldactone), BISOPROLOL FUMARATE (CONCOR), Indapamide (Fludex), Ramipril (Triatec), LERCANIDIPINE HYDROCHLORIDE (ZANIDIP) and ALLOPURINOL (ZYLORIC) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced HAEMOBILIA (gall bladder hemorrhage) (seriousness criterion death) and GALLBLADDER RUPTURE (gallbladder perforation) (seriousness criterion death). The patient died on 10-Apr-2021. The reported cause of death was gallbladder rupture and Gallbladder hemorrhage. It is unknown if an autopsy was performed. At the time of death, ACQUIRED HAEMOPHILIA (Acquired haemophilia A with anti factor VIII) had not resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Based on the current available information and the temporal association between product use and the start date of the event a causal relationship cannot be excluded. This is a case of death in a 85-year-old male subject with a medical history of Chronic renal failure, Acute blood loss anemia, Thrombopenia and Coronary artery disorder., who died 29 days after receiving the second dose of vaccine. Based on information received, death was due to gallbladder hemorrhage and perforation, hence the events and death are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Translated document received on 08 May 2021.Updated event death, death date and concomitant drug details.; Sender''s Comments: This is a case of death in a 85-year-old male subject with a medical history of Chronic renal failure, Acute blood loss anemia, Thrombopenia and Coronary artery disorder., who died 29 days after receiving the second dose of vaccine. Based on information received, death was due to gallbladder hemorrhage and perforation, hence the events and death are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Gallbladder rupture; Gallbladder hemorrhage


VAERS ID: 1309868 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-18
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial sepsis, Body temperature, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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: TIAPRIDAL; KALNORMIN; HALOPERIDOL
Current Illness: Hypertension; Ischemic heart disease; Right bundle branch block
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: Body temperature; Result Unstructured Data: Test Result:$g40 Centigrade; Test Date: 20210414; Test Name: COVID-19 antigen test; Test Result: Negative
CDC Split Type: CZPFIZER INC2021512359

Write-up: Gram-negative sepsis; Fever over 40 degree Celsius; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority number is CZ-CZSUKL-21004614. An 82-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Unknown) as 1st dose, single dose for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing ischemic heart disease and ongoing right bundle branch block. Concomitant medications included tiapride hydrochloride (TIAPRIDAL); potassium chloride (KALNORMIN); and haloperidol. On 18Apr2021, the patient experienced gram-negative sepsis and fever. The patient experienced a fever over 40 degree Celsius (C) after the vaccination with COMIRNATY the first dose was on 16Apr2021. The patient was transferred to the hospital on 18Apr2021 and died in the hospital on 22Apr2021. The cause of death was sepsis by other G negative organisms. On 29Apr2021, the nurse of home for the elderly stated that the patient was in normal health condition before and after the vaccination. The fever occurred on 18Apr2021, then was transferred to the hospital. The patient had an antigen test COVID-19 test on 14Apr2021 that provided a negative result. An autopsy was not performed. The outcome of fever was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Gram-negative sepsis


VAERS ID: 1309874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Dyspnoea, Hypotonia, Myocarditis, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512315

Write-up: Floppy; Stomach discomfort; Vomiting; Nausea; Myocarditis; Dyspnea; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100054953. An 80-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: Unknown), via an unspecified route of administration on 07Apr2021 as UNKNOWN, 0.3ML SINGLE for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced floppy, stomach discomfort, vomiting and nausea on an unspecified date, myocarditis and dyspnea on 12Apr2021. Outcome of the events was fatal. The patient died on 22Apr2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Floppy; Stomach discomfort; Vomiting; Myocarditis; Dyspnea; Nausea


VAERS ID: 1309875 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-02-09
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL7491 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   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 INC2021512281

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-202100054955. A 93-year-old female patient received the second dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL7491), via an unspecified route of administration on 24Jan2021 (at the age of 93-year-old) as 0.3 mL, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previous received first dose of BNT162B2 on 08Jan2021 for COVID-19 immunization. The patient experienced unknown cause of death on 09Feb2021. The patient died on 09Feb2021 due to unknown cause of death. An autopsy was not performed. Relatedness of Comirnaty to event Unknown cause of death was assessed as inconsistent causal association to immunization. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309876 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-25
Onset:2021-04-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall, 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), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512300

Write-up: Unconsciousness; Fall; Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, company number DE-PEI-202100054957. An 86-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 25Apr2021 (Lot Number: ET3045) at 2nd dose, 0.3 mL single for covid-19 immunisation. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 01Apr2021 for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On unknown date (also reported as 26Mar2021, pending clarification), the patient experienced unconsciousness and fall, both considered as serious (medically significant). On 30Apr2021, the patient experienced unknown cause of death. The outcome of event unconsciousness was recovered, while unknown for event fall. It was not reported if an autopsy was performed. Relatedness of drug to reactions from regulatory authority was D. Unclassifiable.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309878 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512311

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100055000. An 81-year-old male patient received second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 29Apr2021 (at age of 81 years old) (Lot Number: ET3045) as 0.3 ml single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received the first dose of Comirnaty on 18Mar2021 also at age of 81 years old as 0.3 ml single for covid-19 immunization. On 30Apr2021, the patient experienced unknown cause of death. The event outcome was fatal. It was not reported if an autopsy was performed. Relatedness of Comirnaty to event unknown cause of death was unclassifiable by Regulatory Authority. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309880 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-20
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021512337

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100055066. An 86-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 08Apr2021 (Lot Number: ER9480) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 20Apr2021. The patient died on 20Apr2021. It was not reported if an autopsy was performed. The reporter''s assessment on the causal relationship between the suspect product Comirnaty and the event death was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309881 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: AMLODIPINE; CANDESARTAN; ELIQUIS
Current Illness: Asthma bronchial; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Lung embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522053

Write-up: Unknown cause of death; This is a spontaneous report received from a non-contactable physician downloaded from the Medicine Agency (EMA) -WEB DE-PEI-202100056654. A 61-years-old female patient received BNT162B2 (Pfizer vaccine), via an unspecified route of administration at the age of 61-years-old on 07Apr2021 (Lot Number: EW8904) as 0.3mL single for covid-19 immunisation. Medical history included ongoing hypertension, lung embolism, ongoing asthma bronchial. Concomitant medications included amlodipine; candesartan; apixaban (ELIQUIS). The patient experienced unknown cause of death on 30Apr2021. The patient died on 30Apr2021. It was not reported if an autopsy was performed. The reporter''s assessment on the causal relationship between the suspect product Pfizer vaccine and the event death was unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1309928 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Hyperhidrosis, Oxygen saturation decreased, Pyrexia, Tremor
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (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: 2021-01-21
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NOVORAPID; DILIBAN; ADIRO; URSOBILANE; DISTRANEURINE [CLOMETHIAZOLE EDISILATE]; HALOPERIDOL ESTEVE; AMLODIPINE; LEXATIN [BROMAZEPAM]; ORFIDAL; ABASAGLAR; TRAVATAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021506158

Write-up: Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; Fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation.; This is a spontaneous report from a contactable healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-725200. An 87-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 20Jan2021 (lot number: EK9788) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included hypertension arterial, alzheimer''s disease, and type 2 diabetes mellitus. Concomitant medications included insulin aspart (NOVORAPID); paracetamol, tramadol hydrochloride (DILIBAN); acetylsalicylic acid (ADIRO); ursodeoxycholic acid (URSOBILANE); clomethiazole edisilate (DISTRANEURINE); haloperidol (HALOPERIDOL ESTEVE); amlodipine; bromazepam (LEXATIN); lorazepam (ORFIDAL); insulin glargine (ABASAGLAR); and travoprost (TRAVATAN); all taken for an unspecified indication, start and stop date were not reported. Historical vaccination included first dose of bnt162b2 (COMIRNATY) on 30Dec2020 (Batch/lot number: EJ6796) for COVID-19 immunisation. The patient experienced fever, tremors, fatigue, low saturation, sweating, dyspnea and constant decompensation (unspecified) on 20Jan2021. The patient died on 21Jan2021. An autopsy was not performed. Clinical course: the patient was referred to the hospital the day after administration of the vaccine with death in emergency triage. The family did not wish to perform an autopsy although it was offered. It was unknown if the patient had COVID-19. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: SECOND DOSE. Reasons for patient vaccination: Over 65 years of age Has she passed COVID-19?: Unknown Additional information on ADRs: Resident in residence xxx referred to the hospital the day after administration of the vaccine with death in emergency triage. The family did not wish to perform an autopsy although it was offered.; Reported Cause(s) of Death: Fever; Tremors; Fatigue; low saturation; sweating; dyspnea


VAERS ID: 1310317 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Death, Decreased appetite, Fatigue, Gait inability, Migraine, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   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: Diabetes
Preexisting Conditions: Depression, arthritis, diabetes
Allergies:
Diagnostic Lab Data: Awaiting autopsy
CDC Split Type:

Write-up: Fatigue, nausea, inability to walk and eat, migraines and death.


VAERS ID: 1311538 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Acute aortic syndrome, Amylase, Auscultation, Blood creatinine, Blood glucose, Blood glucose increased, Blood lactate dehydrogenase, Blood pressure decreased, Blood pressure increased, Blood pressure measurement, C-reactive protein, C-reactive protein increased, Cardio-respiratory arrest, Dyspepsia, Dyspnoea, Electrocardiogram, Haemodynamic instability, Haemoglobin, Lipase, Malaise, Nausea, Neutrophil percentage, Neutrophil percentage increased, Oxygen saturation, Oxygen saturation decreased, Physical examination, Platelet count, White blood cell count, White blood cell count increased
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: amylase; Result Unstructured Data: Test Result:42; Test Date: 20210430; Test Name: Cardiopulmonary auscultation; Result Unstructured Data: Test Result:rhythmic at good frequency, without audible murmur; Test Date: 20210501; Test Name: Cardiopulmonary auscultation; Result Unstructured Data: Test Result:rhythmic heart tones without murmurs, Good ventila; Comments: rhythmic heart tones without murmurs, Good ventilatory mechanics without pathological sounds; Test Date: 20210430; Test Name: creatinin; Result Unstructured Data: Test Result:0.72; Test Date: 20210430; Test Name: blood glucose; Result Unstructured Data: Test Result:161; Test Date: 20210430; Test Name: LDH; Result Unstructured Data: Test Result:262; Test Date: 20210430; Test Name: blood pressure; Result Unstructured Data: Test Result:168/108 mmHg; Test Date: 20210501; Test Name: blood pressure; Result Unstructured Data: Test Result:140/12 mmHg; Comments: upper right limb; Test Date: 20210501; Test Name: blood pressure; Result Unstructured Data: Test Result:40/20 mmHg; Comments: upper left limb; Test Date: 20210430; Test Name: C-reactive protein; Result Unstructured Data: Test Result:26.3; Test Date: 20210430; Test Name: ecg; Result Unstructured Data: Test Result:SR at 75bpm, without acute repolarization disorder; Test Date: 20210430; Test Name: hemoglobin; Result Unstructured Data: Test Result:14.2; Test Date: 20210430; Test Name: lipase; Result Unstructured Data: Test Result:41.7; Test Date: 20210430; Test Name: Neutrophil percentage; Test Result: 82 %; Test Date: 20210501; Test Name: oxygen saturation; Result Unstructured Data: Test Result:significant desaturation; Test Date: 20210430; Test Name: examination; Result Unstructured Data: Test Result:Good general condition; nauseous in consultation,; Comments: Good general condition, nauseous in consultation, conscious, oriented and collaborative. Well hydrated and perfused. Abdomen: soft and depressible, not painful on palpation, no masses or megalies are palpable, no signs of peritoneal irritation.; Test Date: 20210501; Test Name: examination; Result Unstructured Data: Test Result:Badly perfused. with cyanosis in lips and extremit; Comments: Badly perfused. with cyanosis in lips and extremities.; Test Date: 20210430; Test Name: platelet count; Result Unstructured Data: Test Result:150000; Test Date: 20210430; Test Name: leucocyte count; Result Unstructured Data: Test Result:12200
CDC Split Type: ESPFIZER INC2021512291

Write-up: blood pressure: 140/12mmHg (upper right limb)/40/20mmHg (upper left limb); hemodynamic instability with significant desaturation; hemodynamic instability with significant desaturation; dyspnea; abdominal pain; general malaise; heartburn; suspected acute aortic syndrome; cardiorespiratory arrest; blood pressure: 168/108mmHg; nauseous/nausea; blood glucose: 161; c-reactive protein:26.3; neutrophil percentage: 82%; white blood cell count: 12200; This is a spontaneous report received from a contactable physician and other health professional downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is ES-AEMPS-849394. A 70-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Apr2021 as 1st dose, single for COVID-19 immunisation. Medical history included hypertension arterial. The patient''s concomitant medications were not reported. It was reported that upon examination on 30Apr2021, patient was in good general condition, nauseous in consultation, conscious, oriented and collaborative. Well hydrated and perfused. Abdomen: soft and depressible, not painful on palpation, no masses or megalies are palpable, no signs of peritoneal irritation. The patient had lab tests which includes (30Apr2021): Cardiopulmonary auscultation : rhythmic at good frequency, without audible murmurs, Amylase: 42, Blood creatinine: 0.72, Blood glucose: 161, Blood lactate dehydrogenase: 262, Blood pressure measurement: 168/108 mmHg, C-reactive protein: 26.3, Electrocardiogram: SR at 75bpm, without acute repolarization disorder, Haemoglobin: 14.2, Lipase: 41.7, Neutrophil percentage: 82 %, Platelet count: 150000 and White blood cell count: 12200. On 01May2021, patient experienced dyspnea, abdominal pain, general malaise, heartburn and nausea and was brought to the emergency room. Upon examination on 01May2021, patient was badly perfused with cyanosis in lips and extremities. Cardiopulmonary auscultation rhythmic heart tones without murmurs, Good ventilatory mechanics without pathological sounds, Blood pressure measurement: from upper right limb 140/12 mmHg and upper left limb 40/20 mmHg. The patient then presented hemodynamic instability with significant desaturation and was transferred to observation for intubation. The patient presented the first cardiorespiratory arrest, CPR maneuvers were started with a good response. Later, she presented a second cardiorespiratory arrest, starting resuscitation maneuvers again for 20 minutes without success. It was reported that the patient had suspected acute aortic syndrome. The patient died on 01May2021 at 12:30 PM. It was not reported if an autopsy was performed. The medical assessment was reported as abdominal pain, suspected SAO and death. Outcome of all other events was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: suspected acute aortic syndrome; cardiorespiratory arrest


VAERS ID: 1311539 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-18
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure (heart failure); Cardiac hypertrophy; Chronic renal failure (chronic kidney failure); COPD; Flutter atrial; Hypertension arterial; Hypertriglyceridaemia; Obesity; Pulmonary thrombosis (pulmonary thromboembolism); Thyroid tumour; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021512674

Write-up: Faint; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB ES-AEMPS-850124. A 76-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Lot Number: EW4815, expiry date not reported), intramuscular on 15Apr2021 as first dose, 0.3 mL, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus type 2, cardiac failure/heart failure, chronic renal failure/chronic kidney failure, hypertension arterial, thyroid tumor, hypertriglyceridemia, flutter atrial, obesity, COPD, and cardiac hypertrophy, all from an unknown date and unknown if ongoing; and pulmonary thrombosis/pulmonary thromboembolism from 2013 to an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 15Apr2021, patient received the first dose of Comirnaty vaccine (batch EW4815). The same night, he got out of bed to go to the bathroom and fainted described as fell unconscious to the floor. His relatives have notified the emergency room and an ambulance has come. The patient had COVID-19 PCR test on an unspecified date in 2021 and the result was negative. The patient died on 18Apr2021 (as reported). The event faint was fatal. It was reported that CPR maneuvers were performed, being able only to certify his death without being able to specify the specific cause. An autopsy was performed the Institute of Legal Medicine and results were not provided (pending report). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Faint


VAERS ID: 1311540 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardio-respiratory arrest, Chest pain, Headache, Heart rate, Malaise, Neck pain, Oxygen saturation, SARS-CoV-2 test
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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOL CINFAMED; SINEMET PLUS; FUROSEMIDA CINFA; TAMSULOSINA STADA; ALDACTONE [SPIRONOLACTONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankle arthrodesis (right); Anxiodepressive syndrome; Cholecystectomy; Clumsiness; Dyslipidemia; Echocardiogram (Left ventricle not dilated, with slight concentric hypertrophy and proximal septal knee....); Fall; Gilbert''s syndrome; Hip prosthesis insertion; Hypertension arterial; Inguinal hernia (Hernia right groin in 2014); Kidney calculus; Knee arthrodesis (right, reoperated in 2014 for rearthrodesis); Lumbar vertebral fracture L2 (after fall); Memory deficit; Parkinsonism; Prostate cancer (radiotherapy ending in Apr2018); Radiotherapy
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Pulse; Result Unstructured Data: Test Result:62 bpm; Test Date: 20210411; Test Name: Oxygen saturation; Test Result: 93 %; Comments: constans; Test Date: 20210412; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ESPFIZER INC2021512714

Write-up: Acute myocardial infarction; oppressive chest pain; neck pain; headache along with general malaise; headache along with general malaise; cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number ES-AEMPS-850370. An 80-year-old male patient received bnt162b2 (COMIRNATY) (at 80 years of age), intramuscular on 10Apr2021 (Batch/Lot Number: EW2246) as UNKNOWN, 0.3ML SINGLE for COVID-19 immunisation. Medical history included HTA in 2004, dyslipidemia in 1999, Gilbert''s syndrome in 2015, calculi in the right kidney in 2015, adenocarcinoma of the prostate in Mar2017, radiotherapy ending in Apr2018; memory deficits and motor clumsiness; was diagnosed with parkinsonian syndrome; had anxious-depressive syndrome, L2 fracture after fall in Jun2019. Surgical Background included cholecystectomy, left hip prosthesis; right knee and right ankle arthrodesis in 2013, re-operated in 2014 for rearthrodesis; and inguinal hernia (hernia right groin) in 2014. She had an echocardiogram on 07Oct2020: Left ventricle not dilated, with slight concentric hypertrophy and proximal septal knee. Preserved global systolic function. Asynchrony of visu due to BRIHH (Left bundle branch block of Hiss). No other alterations of contractility. Poor visualization of the ascending aorta. Normally functioning sclerocalcified aortic valve. Concomitant medications included omeprazole (OMEPRAZOL CINFAMED) from 03Sep2020 to 12Apr2021; carbidopa monohydrate, levodopa (SINEMET PLUS) from 25Jan2019 to 12Apr2021; furosemide (FUROSEMIDA CINFA) from 05Feb2021 to 12Apr2021; tamsulosin hydrochloride (TAMSULOSINA STADA) from 19Mar2018 to 12Apr2021; spironolactone (ALDACTONE [SPIRONOLACTONE]) from 09Mar2021 to an unspecified stop date, all taken for an unspecified indication. The patient experienced acute myocardial infarction on 12Apr2021. Further ADR description: it was reported that yesterday, 10Apr2021, the patient was administered a covid vaccine (Pfizer). This afternoon, 11Apr2021, he presented picture of oppressive chest pain, neck pain and headache along with general malaise. No dyspnea or sickness. A doctor came to the home, patient was presenting O2 constants 93%, Fc62bpm (pulse) and afebrile. Conscious oriented and eupneic. During the transfer (in Apr2021), he had cardiorespiratory arrest, oxygen therapy is started, guedel and cardiopulmonary resuscitation maneuvers are started. Upon arrival at emergency department started maneuvers resuscitation for 20 minutes, requiring 6mg of adrenaline, staying in asystole throughout moment. The patient underwent lab tests and procedures which included heart rate: 62 bpm on 11Apr2021, oxygen saturation: 93 % (constans) on 11Apr2021, and COVID-19 PCR test was negative on 12Apr2021. Therapeutic measures were also taken as a result of acute myocardial infarction. The patient died on 12Apr2021. An autopsy was done: Natural death. Intermediate cause of death: Cardiac tamponade. Final cause: AMI. The outcome of acute myocardial infarction was fatal while unknown for other events. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Acute myocardial infarction; Autopsy-determined Cause(s) of Death: Autopsy: Natural death. Intermediate cause of death: Cardiac tamponade. Final cause: AMI.


VAERS ID: 1311562 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypotension, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Bardet-Biedl syndrome; End stage renal disease (ESRD); Renal dialysis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Shock circulatory; Arterial hypotension; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOTENSION (Arterial hypotension) and SHOCK (Shock circulatory) in a 66-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000493) for COVID-19 vaccination. The patient''s past medical history included Renal dialysis since an unknown date. Concurrent medical conditions included End stage renal disease (ESRD) and Bardet-Biedl syndrome. On 16-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Mar-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced HYPOTENSION (Arterial hypotension) (seriousness criteria death and hospitalization). On 21-Mar-2021, the patient experienced SHOCK (Shock circulatory) (seriousness criteria death and hospitalization). The patient died on 21-Mar-2021. The reported cause of death was ?tat de choc avec hypoperfusion globale. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication reported. No treatment information was provided. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021040371. This is a case of death in a 66-year-old male subject with a medical history of End stage renal disease (ESRD) and Bardet-Biedl syndrome, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: No new information On 04-May-2021: Follow up received on 04MAY2021 included an updated date of death (21MAR2021), no autopsy completed, and an updated start date of the event, shock, to 21MAR2021.; Sender''s Comments: This is a case of death in a 66-year-old male subject with a medical history of End stage renal disease (ESRD) and Bardet-Biedl syndrome, who died 5 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: ?tat de choc avec hypoperfusion globale


VAERS ID: 1311563 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdomen scan, Blood pressure measurement, Body temperature, Cardiovascular function test, Chest pain, Deep vein thrombosis, Electrocardiogram, Gastrointestinal examination, Heart rate, Intestinal ischaemia, Neurological examination, Oxygen saturation, Pulmonary function test, Septic shock, Subileus
SMQs:, Toxic-septic shock conditions (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal obstruction (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Ischaemic colitis (narrow), Cardiomyopathy (broad), Sepsis (narrow), Opportunistic infections (broad)

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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ABILIFY; HALDOL; LEPTICUR; FLUOXETINE [FLUOXETINE HYDROCHLORIDE]; SPAGULAX; SERESTA; CALCIUM + VITAMIN D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer; Breast operation; Colon prolapse; Gastrointestinal edema; Hernial eventration; Hip fracture; Hyperthyroidism (Under simple surveillance); Ileocolostomy; Intestinal resection (Emergency surgical management); Intestinal resection (By supra-aponeurotic plate); Manic depressive illness; Radiotherapy; Rectal prolapse repair; Stoma hernia repair (Emergency surgical management); Vertiginous syndrome (Under neuroleptic)
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: Abdominal CT; Result Unstructured Data: Test Result:Hellic occlusive syndrome upstream; Comments: Hellic occlusive syndrome upstream of the left flank stoma with significant signs of digestive distress. Major esophageal and gastric distension, parietal pneumatosis, airway and major aeromesenteria with low abundance intraperitoneal effusion.; Test Date: 20210326; Test Name: BP; Result Unstructured Data: Test Result:141/75; Test Date: 20210326; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210326; Test Name: CV level; Result Unstructured Data: Test Result:Regular BDC, tachycardia, no breath; Comments: Regular BDC, tachycardia, no breath, no sign of heart failure, no sign of DVT, no mottling.; Test Date: 20210326; Test Name: ECG; Result Unstructured Data: Test Result:Regular sinus tachycardia; Comments: Regular sinus tachycardia, no conduction disturbance or repolarization.; Test Date: 20210326; Test Name: Abdominal level; Result Unstructured Data: Test Result:No defense or contracture, BHA abolished, ostomy; Comments: Reducible prolapse; Test Date: 20210326; Test Name: Heart rate; Result Unstructured Data: Test Result:132 per minute; Test Date: 20210326; Test Name: Neurological level; Result Unstructured Data: Test Result:G15, no temporo-spatial disorientation; Test Date: 20210326; Test Name: Oxygen saturation; Test Result: 92 %; Test Date: 20210326; Test Name: Pulmonary level; Result Unstructured Data: Test Result:MV +/+, eupneic in ambient air, some crackling; Comments: MV +/+, eupneic in ambient air, some crackling at the bases, no sign of struggle.
CDC Split Type: FRPFIZER INC2021512214

Write-up: Septic shock; Right mid-sternal or parasternal chest pain; Non-occlusive bilateral iliac and femoral deep vein thrombosis; Mesenteric ischaemia; Subocclusive syndrome; This is a spontaneous report downloaded from the regulatory authority (Regulatory Authority Report Numbers: FR-AFSSAPS-BR20211432 and FR-AFSSAPS-2021045862). A contactable consumer reported that a 78-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: ER9470), intramuscular, on 19Mar2021, as second dose, single, for COVID-19 immunization. The patient''s medical history included rectal prolapse operated in 2015 then resumed surgery in front of a recurrence and left iliac colostomy in 2017; occlusive table on peristomal eventration in May2020; segmental colonic resection (by supra-aponeurotic plate) in Jun2020; significant sigmoid prolapse with edematous mucosa with emergency surgical management with segmental colonic resection and repair of the stoma on 25Jul2020; manic depressive illness from Mar2019; vertiginous syndrome under neuroleptic; frustrated hyperthyroidism under simple surveillance from May2020; new right breast operated then radiotherapy in 2004 due to breast cancer (unspecified date); and fracture of the right obturator frame in Mar2019.The patient''s concomitant medications included aripiprazole (ABILIFY), haloperidol (HALDOL), tropatepine hydrochloride (LEPTICUR), fluoxetine hydrochloride (FLUOXETINE), Plantago ovata (SPAGULAX), oxazepam (SERESTA), and calcium/ colecalciferol (CALCIUM + VITAMIN D3); and an unspecified enema. The patient previously took the first dose of BNT162B2 (COMIRNATY; Lot Number: EP9598) on 19Feb2021 for COVID-19 immunization. On the morning of 26Mar2021, the patient was referred to the emergency department by the attending physician for subocclusive syndrome despite an enema through the stoma since the day before (25Mar2021). The patient complained of abdominal pain and right mid-sternal or parasternal chest pain on 26Mar2021. On arrival, temperature was up to 38 degrees Centigrade, heart rate (HR) at 132 per minute, blood pressure (BP) at 141/75, and SpO2 at 92%. At the cardiovascular (CV) level, there was regular BDC (heartbeat), tachycardia, no breath, no sign of heart failure, no sign of DVT (deep vein thrombosis), and no mottling. Per ECG, there was regular sinus tachycardia, no conduction disturbance or repolarization. At the pulmonary level, MV + / +, eupneic in ambient air, some crackling at the bases, no sign of struggle. At the abdominal level, there was no defense or contracture, BHA hydroaeric noises abolished, ostomy; reducible prolapse. At the neurological level, G15, no temporo-spatial disorientation. An abdominal computerized tomography (CT) scan is performed on 26Mar2021 in front of the occlusive syndrome and showed context of sigmoid stoma, suspicion of pulmonary embolism and infectious disease with COVID-19. Full abdominal CT scan showed hellic occlusive syndrome upstream of the left flank stoma with significant signs of digestive distress. Major esophageal and gastric distension, parietal pneumatosis, airway and major aeromesenteria with low abundance intraperitoneal effusion. Also, on 26Mar2021, there was non-occlusive bilateral iliac and femoral deep vein thrombosis; no argument for pulmonary embolism up to the distal segmental level; and no argument for infectious infection with COVID-19 within the limits of the examination. Per evolution, the patient was in septic shock (fever, tachycardia, hypertension, and mottling of the lower limbs) on mesenteric ischemia. Given the precarious general condition and the advanced stage of ischemia, the patient refused surgery. The patient was hospitalized from 26Mar2021. Implementation of palliative care, initiation of midazolam (HYPNOVEL) 1 mg/h and morphine 2 mg/h. Death was noted at 8 PM on 26Mar2021. In conclusion, this is a death from septic shock. Initial picture of subocclusive syndrome in a context of heavy digestive history (recurrent rectal prolapse, colostomy, occlusive picture on peristomal eventration, and sigmoid prolapse). Fortuitous discovery of iliac and femoral deep vein thrombosis. Demonstration of a mesenteric ischemia without the possibility of establishing a causal link with the subocclusive syndrome or de novo ischemia. The outcome of septic shock was fatal while the patient had not recovered from the other events. 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: Septic shock


VAERS ID: 1311564 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-27
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Hyperthermia, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Accidents and injuries (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 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: Anxiodepressive syndrome; Coxarthrosis; Diverticulosis; Esophagitis; Hypothyroidism; Permanent cardiac pacemaker insertion; Uterine fibroid
Allergies:
Diagnostic Lab Data: Test Date: 20210427; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade
CDC Split Type: FRPFIZER INC2021512208

Write-up: death; Pyrexia; Hyperthermia at 40 deg C; This is a spontaneous report from a contactable physician reporting for a patient downloaded from a regulatory authority-WEB FR-AFSSAPS-BR20211440, Safety Report Unique Identifier FR-AFSSAPS-2021046193 . A 91-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 22Apr2021 (Batch/Lot Number: ET6956) as 1ST DOSE, SINGLE for covid-19 immunisation, age at vaccination 91 years old. Medical history included Coxarthrosis, Diverticulosis, Anxiodepressive syndrome, Uterine fibroid, Permanent cardiac pacemaker insertion, Hypothyroidism, Esophagitis from unspecified dates and unknown if ongoing. The patient''s concomitant medications were not reported. On 27Apr2021, hyperthermia at 40 deg C for 24 hours with sudden death (reported as death unexplained) in the suites. Conclusion: 5 days after vaccination, appearance of a high fever leading to death within 24 hours. Onset latency/ Time Interval between Beginning of Drug Administration and Start of Reaction was 5 days (also reported as 6 days by reporter). Awaiting contact with the reporting physician. The patient died on 27Apr2021 due to death, hyperthermia and fever. It was not reported if an autopsy was performed. Pyrexia/Hyperthermia was considered serious, medically significant. No follow-up attempts possible. No further information expected. Information on lot number has been received.; Reported Cause(s) of Death: death; pyrexia; Hyperthermia at 40 deg C


VAERS ID: 1311565 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest discomfort, Chest pain, Discomfort, 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), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial; Overweight
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021512202

Write-up: chest pain; cardiopulmonary arrest; chest tightness radiating to her back and legs; feeling of discomfort; slight difficulty in breathing; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-BR20211467 ; Safety Report Unique Identifier: FR-AFSSAPS-2021047131. A 63-year-old female patient received bnt162b2 (COMIRNATY; Lot number was not reported), intramuscular on 28Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included hypertension and overweight; both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. In the immediate aftermath, the patient presented with a feeling of discomfort with slight difficulty in breathing. Taking of normal constants, and favorable evolution with return home. On 30Apr2021, the patient presented with severe chest pain with chest tightness radiating to her back and legs. Then unrecovered cardiopulmonary arrest and death of the patient. According to the emergency physician, no thromboembolic risk factors in this patient, and the picture could correspond to a probable aortic dissection. The patient died on 30Apr2021. An autopsy was not performed. The outcome of the events discomfort and dyspnea was unknown while other events were fatal. Batch/Lot# and expiry date not provided and not possible to obtain. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The causal association between the reported events chest pain, cardiopulmonary arrest and chest discomfort which led to a fatal outcome in this 63-year old female patient 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: Death unexplained


VAERS ID: 1311576 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-04-06
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

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

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: Ischemic stroke (significant aftereffects, poor overall condition)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021512237

Write-up: Diarrhoea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-GR20211446, Safety Report Unique Identifier FR-AFSSAPS-2021046576. An 89-year-old male patient received BNT162B2 (COMIRNATY; lot number: ER9470) intramuscular on 29Mar2021 as 1st dose, 30 ug single for COVID-19 immunisation. Medical history included ischemic stroke from 2019 (significant aftereffects, poor overall condition). The patient had no COVID-19 Infection. The patient''s concomitant medications were not reported. On 06Apr2021, onset of diarrhoea episodes. In total, the patient had episodes of diarrhea that led to his death. The patient died on 07Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Diarrhoea


VAERS ID: 1311602 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-15
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood fibrinogen, C-reactive protein, Death, Haemoglobin, Petechiae, Platelet count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-18
   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: MIANSERIN; ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia (with behavioral disturbances); Heart failure (due to rhythmic heart disease); Hypertension; PTH abnormal; Ulcer (of the lower limbs); Venous insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210316; Test Name: fibrinogen; Result Unstructured Data: Test Result:4.22 g/l; Test Date: 20210316; Test Name: CRP; Result Unstructured Data: Test Result:11 mg/l; Test Date: 20210316; Test Name: Hb; Result Unstructured Data: Test Result:136 g/l; Test Date: 20210316; Test Name: plq; Result Unstructured Data: Test Result:258 x10 9/l
CDC Split Type: FRPFIZER INC2021512144

Write-up: Unexpected death; Petechiae; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20211785. A 90-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EJ6788) at 2ND DOSE, SINGLE for covid-19 immunisation; apixaban (ELIQUIS), oral from an unspecified date (Batch/Lot Number: Unknown) to 18Mar2021, at 2.5 mg, twice a day (1-0-1) for an unspecified indication. Medical history included atrial fibrillation, heart failure due to rhythmic heart disease, venous insufficiency, hypertension, dementia with behavioral disorders, left PTH, venous ulcers of the lower limbs. The patient previously received COMIRNATY on 27Jan2021 for COVID-19 immunisation (1st dose, batch/lot number: EJ6788, left arm). Concomitant medications included mianserin taken for an unspecified indication, start and stop date were not reported. On 15Mar2021, occurrence of petechiae of the left hemiface that does not disappear with vitropression. On 16Mar2021, normal biological assessment with in particular Hb 136 g / L, plq 258 G / L, fibrinogen 4.22 g / L, CRP 11 mg / L. On 18Mar2021, death of the patient. No known etiology. Unexpected death but patient described as end of life. The link to vaccination or petechiae is not clear. The patient underwent lab tests and procedures which included blood fibrinogen: 4.22 g/l on 16Mar2021, c-reactive protein: 11 mg/l on 16Mar2021, haemoglobin: 136 g/l on 16Mar2021, platelet count: 258 x10 9/l on 16Mar2021. The patient died on 18Mar2021. It was not reported if an autopsy was performed. The outcome of the event petechiae was unknown. The pharmacovigilant notes: Accountability score (s) established without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures, Official Bulletin of the Minister in charge of Health. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unexpected death


VAERS ID: 1311605 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Malignant peritoneal neoplasm, Ovarian cancer, Pleural effusion, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Ovarian malignant tumours (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 61
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: Myelodysplastic syndrome; RAEB; Rendu-Osler-Weber syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021478367

Write-up: respiratory distress; Dyspnea; ovarian cancer with peritoneal carcinosis and tumour pleural effusion; ovarian cancer with peritoneal carcinosis and tumour pleural effusion; ovarian cancer with peritoneal carcinosis and tumour pleural effusion; died; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number FR-AFSSAPS-NT20211224 A 56-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 03Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included Rendu-Osler-Weber syndrome from an unknown date and unknown if ongoing, refractory anaemia with an excess of blasts (RAEB) from an unknown date and unknown if ongoing, Type 2 Myelodysplastic syndrome (MDS-EB2) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced dyspnea (hospitalization, medically significant) on 06Feb2021 with outcome of unknown. Her condition worsened and on 16Feb2021 she was hospitalised with respiratory distress. During hospitalisation, diagnosis of ovarian cancer with peritoneal carcinosis and tumour pleural effusion. The patient died on 09Apr2021. Case Summary and Reporter Comments Text :NT2101218. Patient: Female, 56 years old. History: Osler-Weber-Rendu disease (OWRD). Type 2 Myelodysplastic syndrome (MDS-EB2). COVID-19 history: The patient has not had COVID-19. Usual treatment: Not specified. Suspected medicine(s): Commercial name of the vaccine: COMIRNATY. Lot number: unknown. Injection date: 03Feb2021. Injection in Question: 1st dose. Route of administration: Intramuscular. Injection site: not specified. Description of the adverse effect(s): First dose of COMIRNATY given on 03Feb2021. At Day+3, the patient presented with rapid onset of dyspnoea. Her condition worsened and on 16Feb2021 she was hospitalised with respiratory distress. During hospitalisation, diagnosis of ovarian cancer with peritoneal carcinosis and tumour pleural effusion. Progress: The patient died on 09Apr2021. The reporter wonders about the role of the vaccine in the worsening of the clinical condition in this precarious and vulnerable patient. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment: First dose of COMIRNATY given on 03Feb2021. At Day+3, the patient presented with rapid onset of dyspnoea. Her condition worsened and on 16Feb2021 she was hospitalised with respiratory distress. During hospitalisation, diagnosis of ovarian cancer with peritoneal carcinosis and tumour pleural effusion. Progress: The patient died on 09Apr2021. The reporter wonders about the role of the vaccine in the worsening of the clinical condition in this precarious and vulnerable patient.; Reported Cause(s) of Death: died


VAERS ID: 1311613 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-04-01
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Abdominal wall haematoma, Blood fibrinogen, Computerised tomogram, Echocardiogram, Gamma-glutamyltransferase, Haemoglobin, Heparin-induced thrombocytopenia test, Hepatic infarction, Investigation, Lipoprotein (a), Magnetic resonance imaging, Platelet count, Portal vein thrombosis, Scan, Shock haemorrhagic, Thrombocytopenia
SMQs:, Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Hypovolaemic shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 20
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: CHOLECALCIFEROL; FUROSEMIDE; RENAGEL [SEVELAMER HYDROCHLORIDE]; SIMVASTATIN
Current Illness: Arterial hypertension; Arthritis rheumatoid (treated with sarilumab (KEVZARA)); Haemodialysis; Kidney failure
Preexisting Conditions: Medical History/Concurrent Conditions: Fistula arteriovenous; Nephroangiosclerosis (treated with haemodialysis (anticoagulation with CALCIPARINE)); Pyelonephritis, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: fibrinogen; Result Unstructured Data: Test Result:normal; Test Date: 20210413; Test Name: injected computerised tomography; Result Unstructured Data: Test Result:large hypodense area regarding the middle segment; Comments: large hypodense area regarding the middle segment of the liver (hepatocellular carcinoma? cholangiocarcinoma? steatosis?).; Test Date: 20210420; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:Left ventricle not dilated, contractility is satis; Comments: Left ventricle not dilated, contractility is satisfactory and homogeneous, no valvular calcification, no significant detectable regurgitation, undilated right cavities not collapsed, inferior vena cava of normal calibre depressible on inhalation, no pericardial effusion.; Test Date: 20210413; Test Name: GGT; Result Unstructured Data: Test Result:337 IU/l; Comments: inflammatory syndrome with cholestasis; Test Date: 20210413; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.9 g/dl; Test Date: 20210414; Test Name: anti-FP4 antibodies; Test Result: Negative ; Test Date: 20210414; Test Name: Coagulation assessment; Result Unstructured Data: Test Result:normal; Test Date: 20210421; Test Name: Investigation; Result Unstructured Data: Test Result:large haematoma of the rectus abdominis with haemo; Comments: large haematoma of the rectus abdominis with haemorrhagic shock and liver failure (significant increase in liver enzymes, significant glycaemic disorders, collapsed Quick time, etc.) on probable portal rethrombosis in a context of suspension of anticoagulation.; Test Date: 20210413; Test Name: lipoprotein level; Result Unstructured Data: Test Result:112 IU/l; Comments: lipasaemia; Test Date: 20210414; Test Name: hepatic magnetic resonance imaging; Result Unstructured Data: Test Result:ischemia of the right liver with thrombosis of the; Comments: ischemia of the right liver with thrombosis of the right branch of the trunk probably of cruoric origin. Positron emission tomography scan scheduled remotely.; Test Date: 20210413; Test Name: Platelet count; Result Unstructured Data: Test Result:40 x10 9/l; Test Date: 20210419; Test Name: Platelet count; Result Unstructured Data: Test Result:133 x10 9/l; Test Date: 20210419; Test Name: Emergency thoraco-abdomino-pelvic scan; Result Unstructured Data: Test Result:scan large haematoma beginning in the rectus muscl; Comments: scan large haematoma beginning in the rectus muscle of the abdomen lateralized to the right, extending towards the pelvis (198 mm long axis). No active bleeding.
CDC Split Type: FRPFIZER INC2021506206

Write-up: pain in the right hypochondrium; Abdominal wall haematoma/haemorrhagic shock on haematoma of the rectus abdominis; Abdominal wall haematoma/haemorrhagic shock on haematoma of the rectus abdominis; hepatic infarction; atypical thrombosis of the portal vein; Thrombocytopenia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB FR-AFSSAPS-NY20210787, Safety Report Unique Identifier FR-AFSSAPS-2021040417. A 68-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, lot: EP9605), intramuscular on 18Mar2021 as 2 nd dose, single for covid-19 immunisation. Medical history included ongoing kidney failure; ongoing arthritis rheumatoid (treated with sarilumab (KEVZARA)); ongoing arterial hypertension; Nephroangiosclerosis (treated with haemodialysis (anticoagulation with heparin calcium (CALCIPARINE)/suspension of heparin calcium switched with danaparoid sodium (ORGARAN)); Pyelonephritis, unspecified (not ongoing); fistula arteriovenous and ongoing haemodialysis. Concomitant medications included cholecalciferol; furosemide; sevelamer hydrochloride (RENAGEL) and simvastatin. The patient previously took sarilumab (KEVZARA) for arthritis rheumatoid from an unspecified date to Jan2021 and experienced severe neutropenia on 18Feb2021 (suspended), heparin calcium (CALCIPARINE) for nephroangiosclerosis. On 10Apr2021, highlighting of atypical thrombosis of the portal vein with hepatic infarction. It was associated with a thrombocytopaenia. On 13Apr2021, patient hospitalized for pain in the right hypochondrium (in Apr2021) evolving for a week. In the biological evaluation, inflammatory syndrome with cholestasis (GGT 337 U/L), hepatic cytolysis (not documented), lipasaemia 112 U/L, Haemoglobin 11.9 g/dL and platelet count of 40 x10 9/l. On injected computerised tomography, large hypodense area regarding the middle segment of the liver (hepatocellular carcinoma? cholangiocarcinoma? steatosis?). On 14Apr2021, hepatic magnetic resonance imaging: ischemia of the right liver with thrombosis of the right branch of the trunk probably of cruoric origin. Positron emission tomography scan scheduled remotely. Switching the unfractionated heparin for danaparoid sodium (ORGARAN). Coagulation assessment normal, fibrinogen normal. Thrombophilia assessment has been initiated. Negative anti-FP4 antibodies (heparin-induced thrombocytopaenia considered unlikely by the biologist, a platelet aggregation test was not performed). Resumption of unfractionated heparin. On 19Apr2021, haemorragic shock, pain in the right hypochondrium and abdominal wall haematoma. Emergency thoraco-abdomino-pelvic scan large haematoma beginning in the rectus muscle of the abdomen lateralized to the right, extending towards the pelvis (198 mm long axis). No active bleeding. Surgical advice, no indication of urgent surgery. Increase in analgesic treatment and biological monitoring of the complete blood count. Transfusion 2 units of packed red cells and 2 units fresh frozen plasma. Platelets 133 G/L. Transfusion 2 units of packed red cells and 2 units fresh frozen plasma. On 20Apr2021, cardiac ultrasound (subcostal route): Left ventricle not dilated, contractility is satisfactory and homogeneous, no valvular calcification, no significant detectable regurgitation, undilated right cavities not collapsed, inferior vena cava of normal calibre depressible on inhalation, no pericardial effusion. On 21Apr2021, large haematoma of the rectus abdominis with haemorrhagic shock and liver failure (significant increase in liver enzymes, significant glycaemic disorders, collapsed Quick time, etc.) on probable portal rethrombosis in a context of suspension of anticoagulation. Unfavorable evolution leading to the death of the patient. The outcome of thrombocytopenia was recovering and for abdominal pain upper was unknown. The patient died on 21Apr2021 due to abdominal wall haematoma, shock haemorrhagic, hepatic infarction and portal vein thrombosis. It was unknown if autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Abdominal wall haematoma/haemorrhagic shock on haematoma of the rectus abdominis; Abdominal wall haematoma/haemorrhagic shock on haematoma of the rectus abdominis; hepatic infarction; atypical thrombosis of the portal vein


VAERS ID: 1311623 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 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: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021512404

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number is FR-AFSSAPS-PO20212041. An 84-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 intramuscular, administered on right arm on 23Apr2021 (Batch/Lot Number: ET6956) as 2nd dose, 0.3 mL, single (at the age of 84 years old) for COVID-19 immunisation. Medical history included arterial hypertension and dementia. The patient''s concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, solution for injection), dose for COVID-19 immunisation. On 23Apr2021, the same evening, 12 hours later, the patient died from sudden death. (Mobile Emergency and Resuscitation Structures) was contacted but attempts at resuscitation were unsuccessful. The patient died on 23Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1311625 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-04-11
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   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; Cancer of prostate; Cessation of smoking (history of weaning tobacco since 2020); COVID-19 (COVID-19 history: yes with hospitalization); Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Covid test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021512392

Write-up: SARS-CoV-2 pneumonia; vaccination failure; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-RN20211191, Safety Report Unique Identifier FR-AFSSAPS-2021045712. A 93-year-old male patient received BNT62B2 (COMIRNATY), dose 1 intramuscular on 03Feb2021 (Batch/Lot Number: EJ6788) as 1st dose, single and dose 2 intramuscular on 24Feb2021 (Batch/Lot Number: EJ6788) as 2nd dose, single for covid-19 immunization. Medical history included Ischemic stroke from 2015, Arrhythmia, Cancer of prostate from 1990, weaning tobacco since 2020 (history of weaning tobacco since 2020), COVID-19 history: yes with hospitalization. The patient''s concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 pneumonia on 11Apr2021. The patient was hospitalized for sars-cov-2 pneumonia. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021. Therapeutic measures were taken as a result of sars-cov-2 pneumonia. The patient died on 24Apr2021. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts possible. No further information expected. Lot/Batch number already obtained.; Reported Cause(s) of Death: Pneumonia SARS COV2 (unknown variant)


VAERS ID: 1311641 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-20
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pH, Blood potassium, Blood pressure measurement, Cardiogenic shock, Chest injury, Coma scale, Computerised tomogram, Computerised tomogram head, Fall, Heart rate, Oxygen saturation, PCO2
SMQs:, Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   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: Tabaquism (between 10 and 20 pack years)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute coronary syndrome (treated by angioplasty); AFib; Angioplasty; Appendectomy; Cholecystectomy; Dementia; GDU; Heart failure (on an external electric shock); Hypertensive heart disease NOS; Ischaemic heart disease (ischemic with acute coronary syndrome in 1997 treated by angioplasty); Left anterior descending coronary artery stenosis (50% proximal LAD (Left anterior descending artery) stenosis and 75-80% distal LAD in 2011); Microalbuminuria; Obesity; Tonsillectomy; Type 2 diabetes mellitus (Non-insulin-dependent type 2 diabetes, sugar-free diet at home); Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: pH blood; Result Unstructured Data: Test Result:6.95; Test Date: 20210424; Test Name: potassium; Result Unstructured Data: Test Result:6.3 mM; Test Date: 20210424; Test Name: blood pressure; Result Unstructured Data: Test Result:70/30 mmHg; Test Date: 20210424; Test Name: blood pressure; Result Unstructured Data: Test Result:40/20 mmHg; Test Date: 20210424; Test Name: GCS; Result Unstructured Data: Test Result:12 at best; Test Date: 20210424; Test Name: GCS; Result Unstructured Data: Test Result:5; Test Date: 20210424; Test Name: Thoracic-abdomino-pelvic CT scan; Result Unstructured Data: Test Result:cardiac decompensation; Comments: appearance compatible with a picture of cardiac decompensation, with in particular bilateral pleural effusion of moderate abundance. Focus of associated right lower lobar pneumonitis, of probable infectious origin.; Test Date: 20210424; Test Name: CT brain scan; Result Unstructured Data: Test Result:no significant acute abnormality; Comments: no intracranial hemorrhage; Test Date: 20210424; Test Name: heart rate; Result Unstructured Data: Test Result:110; Test Date: 20210424; Test Name: oxygen saturation; Result Unstructured Data: Test Result:84; Test Date: 20210424; Test Name: pCO2; Result Unstructured Data: Test Result:$g110
CDC Split Type: FRPFIZER INC2021506184

Write-up: Cardiogenic shock; fall with rib trauma; fall with rib trauma; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB FR-AFSSAPS-ST20211733, Safety Report Unique Identifier FR-AFSSAPS-2021046286. An 86-year-old female patient received second dose of BNT162B2 (Pfizer vaccine) intramuscular, administered in Arm Left on 17Apr2021 (Batch/Lot Number: EW9127) as 0.3 mL, single for covid-19 immunization and atorvastatin calcium (ATORVASTATIN CALCIUM), ramipril (RAMIPRIL), potassium chloride (DIFFU K), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]), morphine sulfate (SKENAN), furosemide (FUROSEMIDE), gliclazide (GLICLAZIDE), atenolol (ATENOLOL), fluindione (PREVISCAN [FLUINDIONE]), mianserin (MIANSERIN), acarbose (ACARBOSE), paracetamol (PARACETAMOL), morphine sulfate (ACTISKENAN) all via unspecified routes of administration from unspecified dates (Batch/Lot Number: Unknown) at unspecified doses for unspecified indications. Medical history included Type 2 diabetes mellitus (Non-insulin-dependent type 2 diabetes, sugar-free diet at home), GDU (gastroduodenal ulcer), microalbuminuria from 2010 to an unknown date, Ischaemic heart disease (ischemic with acute coronary syndrome in 1997 treated by angioplasty), hypertensive heart disease, obesity, AFib (atrial fibrillation), severe dementia, angioplasty, Left anterior descending artery stenosis (50% proximal LAD (Left anterior descending artery) stenosis and 75-80% distal LAD in 2011), tabaquism (between 10 and 20 pack years), heart failure on 2011 (on an external electric shock), varicectomy, cholecystectomy, appendectomy, tonsillectomy and acute coronary syndrome since 1997 (treated by angioplasty). The patient''s concomitant medications were not reported. The patient experienced cardiogenic shock on 24Apr2021 and fall with rib trauma on 20Apr2021. The patient underwent lab tests and procedures which included pH blood: 6.95 on 24Apr2021, potassium (blood potassium): 6.3 mm on 24Apr2021, blood pressure (blood pressure measurement): 70/30 mmhg and 40/20 mmhg on 24Apr2021, GCS (coma scale): 12 at best and 5 on 24Apr2021, Thoracic-abdomino-pelvic CT scan (computerised tomogram): cardiac decompensation on 24Apr2021 (appearance compatible with a picture of cardiac decompensation, with in particular bilateral pleural effusion of moderate abundance. Focus of associated right lower lobar pneumonitis, of probable infectious origin), CT brain scan (computerised tomogram head): no significant acute abnormality on 24Apr2021 (no intracranial hemorrhage), heart rate: 110 on 24Apr2021, oxygen saturation: 84 on 24Apr2021 and pco2: $g110 on 24Apr2021. Therapeutic measures were taken as a result of cardiogenic shock. The outcome of Cardiogenic shock was fatal and unknown for fall with rib trauma. The patient died on 24Apr2021. An autopsy was not performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1311645 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Communication disorder, Depressed level of consciousness, Feeding disorder, Heart rate, Hemiplegia, SARS-CoV-2 test
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: LASILIX [FUROSEMIDE]; RISPERDAL; LOXAPAC [LOXAPINE]; DIFFU K; ZYMAD; DUPHALAC [LACTULOSE]; SERESTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriopathic disease; Atrial fibrillation; Dementia (Severe); Heart failure; Hypokalaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: heart rate; Result Unstructured Data: Test Result:100 bpm; Test Date: 20210114; Test Name: COVID test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021512362

Write-up: Obtundation/disorders of consciousness; Suspicion of stroke; Left hemiplegia; Any food intake turns out to be impossible; No longer communicates at all; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FR-AFSSAPS-TO20213073. An 84-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in right arm on 14Apr2021 (Batch/Lot Number: EW2246) as first dose, single, for COVID-19 immunisation. Medical history included hypokalaemia, heart failure, atrial fibrillation, severe dementia, and arteriopathic disease, all from an unknown date and unknown if ongoing. Concomitant medication(s) included furosemide (LASILIX); risperidone (RISPERDAL); loxapine (LOXAPAC); potassium chloride (DIFFU K); colecalciferol (ZYMAD); lactulose (DUPHALAC); and oxazepam (SERESTA) taken for an unspecified indication, start and stop date were not reported. The patient presented disorders of consciousness and tachycardia at 100 bpm on 14Apr2021 at around 4 p.m. (16:00), a start of a left hemiplegia was also reported. There has been a suspicion of stroke, with no further investigations. Any food intake turns out to be impossible and the patient no longer communicates at all. Death of the patient on the night of 20Apr2021 was reported. The patient underwent lab tests and procedures which included heart rate: 100 bpm on 14Jan2021, and COVID test: negative on 14Jan2021. The patient died on 20Apr2021. An autopsy was not performed. The outcome of the events aside from obtundation/ disorders of consciousness was not recovered. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Obtundation


VAERS ID: 1311647 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-04-08
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ARANESP; NOVOMIX; LANSOPRAZOLE; CLOPIDOGREL; LERCANIDIPINE; AMIODARONE; FUROSEMIDE; ZYMAD
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Cardiac failure; Cardiac valvulopathy; Carotid artery stenosis; Chronic renal failure; Diabetes mellitus insulin-dependent; Disease coronary artery; Glaucoma; Hernia hiatal; Hypertension arterial; Peripheral obliterative arteriopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210408; Test Name: DESATURATION; Result Unstructured Data: Test Result:DESATURATION; Test Date: 20210408; Test Name: PCR; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021512344

Write-up: Vaccination failure; Symptomatic Covid sets in with desaturation.; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20213133, Safety Report Unique Identifier FR-AFSSAPS-2021047051. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Lot Number: EK9788) as single dose, dose 1 intramuscular on 14Jan2021 (Lot Number: EM0477) as single dose for COVID-19 immunisation. Medical history included disease coronary artery, diabetes mellitus insulin-dependent, cardiac valvulopathy, cardiac failure, peripheral obliterative arteriopathy, chronic renal failure, glaucoma, atrial fibrillation paroxysmal, hypertension arterial, hernia hiatal, and carotid artery stenosis; all from an unknown date and unknown if ongoing. Concomitant medications included darbepoetin alfa (ARANESP); insulin aspart, insulin aspart protamine (crystalline) (NOVOMIX); lansoprazole; clopidogrel; lercanidipine; amiodarone; furosemide; and colecalciferol (ZYMAD); all taken for an unspecified indication, start and stop date were not reported. The patient experienced vaccination failure and symptomatic covid sets in with desaturation on 08Apr2021. Support: monitoring and putting on oxygen. The patient underwent lab tests and procedures which included PCR: positive (variant) and oxygen saturation: desaturation on 08Apr2021. The patient died due to events on 22Apr2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; Symptomatic Covid sets in with desaturation.


VAERS ID: 1312090 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 10359267100013 / 2 - / OT

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: 2021-04-08
   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: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Anticoagulant therapy; Atrial fibrillation; Cardiac dysfunction; Drug-eluting stent placement; Hypertension; Ischemic heart disease; Myocardial necrosis; Percutaneous coronary intervention
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021506491

Write-up: pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HU-OGYI-235821. A 77-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 08Apr2021 (Batch/Lot Number: 10359267100013) at the age of 77 years old, as 2ND DOSE, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included myocardial necrosis, ischemic heart disease from 2018 to an unknown date, atrial fibrillation from 2018 to an unknown date, Drug-eluting stent placement from 2018 to an unknown date, alcohol use, hypertension, cardiac dysfunction from 2018 to an unknown date, percutaneous coronary intervention from 2018 to an unknown date, anticoagulant therapy from 2018 to an unknown date. The patient''s concomitant medication included apixaban (ELIQUIS) from 24Oct2019 for unspecified indication. The patient experienced pulmonary embolism on 08Apr2021. On the same day of COVID vaccination (08Apr2021), the patient died. Neighbors talked to her at 1 p.m., her son could not reach her on the phone in the evening, the neighbors found the patient dead. Forensic autopsy was ordered due to sudden death, pulmonary embolism was considered as the cause of death, and its association with the vaccine was reported unlikely. According to the physician, the patient has been at home for the last year; walked a lot and travelled by buses on the way to the vaccine center, which may also have played a role. Combination of anticoagulants was started in 2018, and from 24Oct2019, only Eliquis (apixaban) was recommended, the patient had been taking it regularly. The patient died on 08Apr2021. An autopsy was performed that revealed pulmonary embolism. Sender Comment: The 77-year-old patient died within a day after Comirnaty vaccination. Autopsy was done, cause of death was pulmonary embolism. The causal relationship between the event and Comirnaty is considered unlikely. The case is serious due to fatal outcome. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1312091 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-04-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Drug ineffective, Dyspnoea, Left ventricular failure, Oxygen saturation, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Hypertension; Ischemic heart disease; Myocardial infarction acute
Allergies:
Diagnostic Lab Data: Test Name: oxygen saturation; Test Result: 85 %; Test Date: 20210408; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Positive
CDC Split Type: HUPFIZER INC2021506502

Write-up: Dyspnea; Coughing; Cardiac failure left; Drug ineffective; COVID-19/COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number HU-OGYI-254821 reported on 19Apr2021. An 81-year-old male patient received bnt162b2 (COMIRNATY, tozinameran, concentrate for dispersion for injection, COVID-19 mRNA Vaccine embedded in lipid nanoparticles), dose 1 intramuscular, administered in left arm on 19Mar2021 (Batch/Lot Number: EP2166) as first dose, 0.3 mL single, for COVID-19 immunization/for active immunization to prevent COVID-19. Relevant medical history includes myocardial infarction acute, ischemic heart disease, COVID-19 and hypertension from unspecified dates and unknown if ongoing. The patient''s concomitant medications were not reported. On 08Apr2021, the patient''s COVID PCR test was positive. On 15Apr2021 the patient was admitted in the hospital because of coughing and dyspnea which started the day before (14Apr2021). The patient received oxygen therapy as his oxygen saturation was 85% and had severe dyspnea. On 17Apr2021 at 17:45 the patient died. The cause of death were COVID-19 infection and cardiac failure left. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 08Apr2021, and oxygen saturation: 85 % on an unspecified date. The patient died on 17Apr2021. It was not reported if an autopsy was performed. Case was reported as serious, medically confirmed. Sender Comment: According to the SmPC of Comirnaty, immunity usually develops 14 days after the second dose of the vaccine. The patient received the first dose of Comirnaty on 19Mar2021 and got infected with the virus 20 days after, therefore immunity may not have developed yet without the second dose. Based on the above, the causal relationship is unlikely between the suspected drug and the adverse events. The case is considered serious because the outcome was fatal. Further information is not expected.; Reported Cause(s) of Death: Drug ineffective; Dyspnea; Coughing; COVID-19/COVID-19 PCR test positive; Cardiac failure left


VAERS ID: 1312092 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Decompensation cardiac; Hypertension; Ischemic heart disease; Mitral stenosis with insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021506501

Write-up: Death/ died due to her long persisting heart disease; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HU-OGYI-255021. A 76-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 20Mar2021 (Batch/Lot Number: EP2166) as 1st dose, 0.3 ml single for COVID-19 immunization. Medical history included mitral stenosis with insufficiency, ischemic heart disease, hypertension, decompensation cardiac and atrial fibrillation. The patient''s concomitant medications were not reported. On 13Apr2021 at 13:35 the patient passed away. The cause of death was due to her long persisting heart disease. It was not reported if an autopsy was performed. Sender Comment: The causal relationship is unlikely between the suspected drug and the adverse event as the reporter physician assessed the adverse event as related to the patient''s primary diseases. The case is considered serious because the outcome was fatal. Further information is not expected. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: cause of death was due to her long persisting heart disease


VAERS ID: 1312098 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-28
Onset:2021-03-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 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? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bowel cancer; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021473696

Write-up: MASSIVE STROKE; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. This is a report received from the Health Products Regulatory Authority Regulatory authority report number IE-HPRA-2021-071026. A 90-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 28Feb2021 (Batch/Lot Number: EP2163) as UNKNOWN, SINGLE for COVID-19 immunization. Medical history included atrial fibrillation, Bowel cancer, and ischaemic heart disease. The patient''s concomitant medications were not reported. On 05mar2021, the patient experienced massive stroke. The patient died on 05Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: MASSIVE STROKE


VAERS ID: 1312099 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN8904 / 1 - / -

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

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: RAMIPRIL; GLUCOPHAGE [METFORMIN]; SIMVASTATIN; XARELTO; LOW CENTYL K
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Family history of cardiovascular disorder (father died from myocardial infarction (MI) at age of 54; brother died from MI at age of 49); Hypertension; NIDDM; Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021501421

Write-up: cause of death was unknown; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IE-HPRA-2021-071676. A 75-year-old male patient received bnt162b2 (Pfizer vaccine; Lot Number: EN8904), via an unspecified route of administration on 13Apr2021 15:30 (at the age of 75-years) at first dose, single dose for COVID-19 immunisation. Medical history included hypertension, family history of cardiovascular disorder (it was reported that the patient''s father died from myocardial infarction at the age of 54 and the patients brother died from myocardial infarction at the age of 49), prostate cancer from 2019, non-insulin-dependent diabetes mellitus (NIDDM) from 2014, and atrial fibrillation from 2016. Concomitant medications included ramipril, metformin (GLUCOPHAGE) taken for diabetes, simvastatin, rivaroxaban (XARELTO) taken for atrial fibrillation, and bendroflumethiazide, potassium chloride (LOW CENTYL K) taken for hypertension. On 13Apr2021, approximately 2-3 hours post-vaccination, the patient died. He was found by his daughter at 18:00. The reporter stated the cause of death was unknown. 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: cause of death was unknown


VAERS ID: 1312100 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Brain injury, Cardio-respiratory arrest, Malaise
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ULTIBRO BREEZHALER; IPRAMOL; LISINOPRIL; ATORVASTATIN; ALDACTONE [SPIRONOLACTONE]; SALBUTAMOL; WARFARIN; AMOXICILLIN; CARDICOR; CALCICHEW-D3 FORTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Atrial fibrillation; Chronic obstructive pulmonary disease; Fractured neck of femur; Hyperlipidaemia; Hypertension; Osteoporosis; Rheumatic heart disease (in childhood); Upper respiratory tract infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021473647

Write-up: WORKING DIAGNOSIS OF DELAYED ANAPHYLACTIC REACTION TO THE PFIZER BIONTECH VACCINE; CARDIOPULMONARY ARREST; EXTENSIVE HYPOXIC BRAIN INJURY; unwell; This is a spontaneous from a contactable physician downloaded from the regulatory authority-WEB. This is a report received from Healthcare Products Regulatory Authority Regulatory authority report number IE-HPRA-2021-072045 with Safety Report Unique Identifier IE-HPRA-2021-072045. An 82-year-old female patient received bnt162b2 (COMIRNATY, lot number: EW8904), via an unspecified route of administration on 15Apr2021 14:15 as 2ND DOSE, 0.3 mL, SINGLE for COVID-19 immunisation. Medical history included atrial fibrillation, chronic obstructive pulmonary disease, hyperlipidaemia, fractured neck of femur from 2009, osteoporosis, rheumatic heart disease (in childhood), aortic valve replacement from 1999, hypertension, and upper respiratory tract infection. Concomitant medications included glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER) taken for chronic obstructive pulmonary disease (COPD); ipratropium bromide, salbutamol sulfate (IPRAMOL) taken for COPD; lisinopril taken for hypertension; atorvastatin taken for hyperlipidaemia; spironolactone (ALDACTONE [SPIRONOLACTONE]) taken for hypertension; salbutamol taken for COPD; warfarin taken for atrial fibrillation; amoxicillin taken for upper respiratory tract infection; bisoprolol fumarate (CARDICOR) taken for hypertension; and calcium carbonate, colecalciferol (CALCICHEW-D3 FORTE). Historical vaccine includes first dose of bnt162b2 (COMIRNATY, batch/lot: unknown) on 18Mar2021 at a dose of 0.3 ml for COVID-19 immunization. On 15Apr2021 at approximately 21:30, the patient became unwell and was reported to have experienced cardiopulmonary arrest at home. The patient''s relative called an ambulance. The paramedics resuscitated, ventilated and transferred the patient to hospital. It was reported that the patient suffered an extensive hypoxic brain injury and passed away. The consultant contacted the reporter on 20Apr2021 21 to advise that working diagnosis and cause for cardiopulmonary arrest was a delayed anaphylactic reaction to the Pfizer/BioNTech vaccine received earlier that day. The outcome of the event unwell was unknown. Therapeutic measures were taken as a result of all events. The events working diagnosis of delayed anaphylactic reaction to the Pfizer Biontech vaccine, cardiopulmonary arrest, and extensive hypoxic brain injury resulted to fatal outcome. The patient died on 15Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: EXTENSIVE HYPOXIC BRAIN INJURY; CARDIOPULMONARY ARREST; WORKING DIAGNOSIS OF DELAYED ANAPHYLACTIC REACTION TO THE PFIZER BIONTECH VACCINE


VAERS ID: 1312112 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-06
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725_65_008 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test, Vaccination failure, Viral test
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cerebral hemorrhage (Patient in polytherapy with 4 drugs for hypertension and celebral hemorragia); Hypertension (Patient in polytherapy with 4 drugs for hypertension and celebral hemorragia)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210406; Test Name: SARS-CoV-2 molecular test; Result Unstructured Data: Test Result:positive; Test Date: 20210406; Test Name: Molecular swab; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC2021428638

Write-up: Clinical vaccinal failure suspected as a positive patient in covid 19 following molecular swab at a distance of second dose pfizer. asymptomatic patient/ sars-cov-2 test: positive on 06Apr2021; Clinical vaccinal failure suspected as a positive patient in covid 19 following molecular swab at a distance of second dose pfizer. asymptomatic patient/ sars-cov-2 test: positive on 06Apr2021; This is a spontaneous report downloaded from the Regulatory Authority-WEB IT-MINISAL02-715747. A contactable other healthcare professional reported a 88-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EL0725_65_008), intramuscular on 11Feb2021 10:00 as single dose, first dose (Lot Number: EJ6797_65-003), via an unspecified route of administration on 21Jan2021 as single dose for covid-19 immunization. Medical history included hypertension, cerebral haemorrhage (both ongoing) (patient in polytherapy with 4 drugs for hypertension and celebral hemorragia). The patient''s concomitant medications were not reported. On 06Apr2021, the patient experienced clinical vaccinal failure suspected as a positive patient in covid 19 following molecular swab at a distance of second dose pfizer. asymptomatic patient/ sars-cov-2 test: positive on 06apr2021. Actions taken (MOLECULAR SWAB ON 06Apr2021) COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (left shoulder) Booster dose number (2) Time of administration (10: 00) 28Apr2021 follow up: modification of the severity and outcome field. The patient died of unknown cause on 28Apr2021, it was unknown if autopsy was done. The patient did not receive any treatment for the events. The clinical outcomes of the clinical vaccinal failure suspected as a positive patient in covid 19 following molecular swab at a distance of second dose pfizer. asymptomatic patient/ sars-cov-2 test: positive on 06apr2021 were fatal.; Reporter''s Comments: INTERCOSED TIME BETWEEN FIRST AND SECOND DOSE: 21Jan2021 12Feb2021. Time elapsed between the administration of the second dose and the detection of the infection 12Feb2021 - 06Apr2021. Lot and expiration physiological solution not available; vaccine reconstitution not available now; first dose vaccine batch EJ6797_65_003 administered on 21Jan2021, no adverse reactions. PATIENT in polytherapy with 4 drugs for HYPERTENSION, CELEBRAL HEMORRAGIA.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1312135 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6326 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Chest pain
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: 2021-04-30
   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: Abnormal glucose tolerance (Impaired glucose tolerance currently not treated with drugs); Heavy smoker (Strong smoker)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021512335

Write-up: cardiac respiratory arrest; chest pain/Thoracic pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority IT-MINISAL02-722990. A 69-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EW6326), intramuscular, administered in deltoid left on 27Apr2021 as 1st dose, 0.3 ml single for COVID-19 immunisation. Medical history included abnormal glucose tolerance (impaired glucose tolerance currently not treated with drugs) and a heavy smoker (strong smoke) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. From the morning of the 29Apri2021 chest pain/thoracic pain, around the hours of the 30th, found in ACR (cardiac respiratory arrest). Therapeutic measures were taken as a result of cardiac respiratory arrest, none for chest pain/thoracic pain. The patient died on 30Apr2021. It was unknown if an autopsy was performed. Sender Comment: Spontaneous report form inserted in the regional vaccination register received following access by the Local Pharmacovigilance Center 30Apr: clinical report request 30Apr: clinical report and module form attached No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: thoracic pain; cardiac respiratory arrest


VAERS ID: 1312397 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-09
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: JPPFIZER INC2021524510

Write-up: Death due to subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from a Pfizer sales representative. A 61-year and 6-month-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration, administered on 02May2021(at the age of 61 years old) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 09May2021 (7 days after the vaccination), the patient experienced subarachnoid haemorrhage, and the outcome of the event was fatal. It was not reported if an autopsy was performed. The course of the event was as follows: On 02May2021 (the day of vaccination), the patient, a working staff at the reporting hospital, received a COMIRNATY vaccination (first dose) at the group vaccination venue. On 09May2021 (7 days after the vaccination), the patient died of subarachnoid haemorrhage. The reporting physician assessed the causality between the event and BNT162b2 as unknown. The seriousness was not reported. The outcome of the events was fatal. Comments: It was unknown who gave the vaccination. The reporting hospital director himself did not perform the vaccination. ; Sender''s Comments: There is limited information in the case provided, the causal association between the event subarachnoid hemorrhage and the suspect drug Comirnaty cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death due to subarachnoid haemorrhage


VAERS ID: 1312402 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Malaise, Pallor
SMQs:, Guillain-Barre syndrome (broad), Hypotonic-hyporesponsive episode (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: Medical History/Concurrent Conditions: Adverse event NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTMODERNATX, INC.MOD20211

Write-up: Death; Pale; Weakness; Feeling unwell; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-May-2021 and was forwarded to Moderna on 04-May-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH (Death), PALLOR (Pale), ASTHENIA (Weakness) and MALAISE (Feeling unwell) in a 78-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001650) for COVID-19 vaccination. The patient''s past medical history included Adverse event NOS in 2005. On 13-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 13-Apr-2021, the patient experienced DEATH (Death) (seriousness criterion death), PALLOR (Pale) (seriousness criterion medically significant), ASTHENIA (Weakness) (seriousness criterion medically significant) and MALAISE (Feeling unwell) (seriousness criterion medically significant). The patient died on 13-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PALLOR (Pale), ASTHENIA (Weakness) and MALAISE (Feeling unwell) outcome was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported. Events of pale, weakness and feeling unwell conservatively retained as serious as reported with outcome of fatal by Authority and unclear of their connection to patient''s death.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Cause of death not reported. Events of pale, weakness and feeling unwell conservatively retained as serious as reported with outcome of fatal by Authority and unclear of their connection to patient''s death; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1312437 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-25
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PREGABALINE; PANTOPRAZOLE; OXYCODONE; CLOZAPINE; SINEMET
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20211

Write-up: asystolie; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (asystole) in a 70-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concomitant products included PREGABALINE, PANTOPRAZOLE, OXYCODONE, CLOZAPINE and CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) for an unknown indication. On 10-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced CARDIAC ARREST (asystole) (seriousness criterion death). The patient died on 25-Apr-2021. The reported cause of death was sudden death, asystole. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not reported. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: Limited information regarding the event or the patient''s medical history has been provided at this time and a causal relationship cannot be excluded; Sender''s Comments: Limited information regarding the event or the patient''s medical history has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: sudden death, asystole.


VAERS ID: 1312465 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Diarrhoea, Fall, Malaise, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: LISINOPRIL; HYDROCHLOROTHIAZIDE; METOPROLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021506276

Write-up: Possibly died from dehydration, possibly died because of this.; Nausea; Puke; Diarrhoea; Not feeling well, malaise; Fell three times; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00526003. An 86-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: Unknown) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included lisinopril 10mg tablet; hydrochlorothiazide 25mg tablet and metoprolol 200mg modified release tablet; all taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunization and no side effect was reported. The patient experienced dehydration, nausea, malaise, vomiting, falling, diarrhoea on 25Apr2021, 1 day following administration of covid-19 vaccine. The patient complained immediately after vaccination, she fell three times, she was previously healthy. She vomited several times, had diarrhea and nausea, and was found dead in the toilet on 30Apr2021. It was not reported if an autopsy was performed. The patient had no previous COVID-19 infection and no other diagnostic procedures. All the events were assessed as fatal. Dehydration was also assessed as life-threatening. Reporter''s comments: Nausea, puke, malaise, possibly died from dehydration, possibly died because of this. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: dehydration; nausea; puke/vomiting; diarrhea; malaise; fell three times


VAERS ID: 1312494 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-18
Onset:2021-04-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disease risk factor; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021512162

Write-up: Fatigue; Myalgia; Generalized joint pain; COVID-19 LIM This is non-interventional study report received from a contactable other health professional via regulatory authority downloaded from the regulatory authority-WEB NL-LRB-COVID-00529988. A 68-year-old female subject received bnt162b2 (COMIRNATY), via an unspecified route of administration on 18Apr2021 (Lot Number: EW9127) as 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension and disease risk factor. The subject''s concomitant medications were not reported. The subject did not previous get COVID-19 infection. The subject experienced myalgia, generalized joint pain, fatigue (death) following administration of vaccination on 19Apr2021 (1 days after start). It was also reported that Date of end of reaction/event for Fatigue: 20Apr2021. The event fatigue was death, events myalgia, generalized joint pain were non-serious. The subject did not receive any treatment for events. The subject died on an unspecified date. It was not reported if an autopsy was performed. The outcome of events myalgia and generalized joint pain was recovered on 20Apr2021. The outcome of event fatigue was fatal. The reporter''s assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported fatigue resulting in a fatality and the use of BNT162B2 cannot be fully excluded while the causal relationship between the reported myalgia and generalized joint pain and the use of BNT162B2 is possible. There is limited information available to make a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.; Reported Cause(s) of Death: Fatigue


VAERS ID: 1312514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, General physical health deterioration, Myalgia, Nausea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   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: ELIQUIS; SOMAC; NIFEREX [FERROGLYCINE SULFATE COMPLEX]; LERKANIDIPIN ACTAVIS; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure (Slight cardiac failure); Hypertension; Iron deficiency; Kidney failure (Slight kidney failure); Ulcer duodenal (ULCER DUODENAL (has underwent surgery))
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: Autopsy; Result Unstructured Data: Test Result:the results have not been received yet; Comments: the results have not been received yet.
CDC Split Type: NOPFIZER INC2021512229

Write-up: nausea, muscle pain, felt nauseous and had muscle aches; nausea, muscle pain, felt nauseous and had muscle aches; Felt then generally bad.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority [NO-NOMAADVRE-FHI-2021-Up2mpa], Safety Report Unique Identifier [NO-NOMAADVRE-E2B_00027522]. A 71-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EX2405), intramuscular in left arm on 14Apr2021 09:00 as 1st dose, single for COVID-19 immunisation. The patient''s medical history included ulcer duodenal (has underwent surgery), kidney failure (slight kidney failure), iron deficiency, atrial fibrillation, cardiac failure (slight cardiac failure), and hypertension. Concomitant medications included apixaban (ELIQUIS), pantoprazole sodium sesquihydrate (SOMAC), ferroglycine sulfate complex (NIFEREX), lercanidipine hydrochloride (LERKANIDIPIN ACTAVIS), and metoprolol. On 15Apr2021, the patient developed nausea, muscle pain, felt nauseous and had muscle aches. The patient also felt generally bad on 15Apr2021. He was found dead on the evening of 20Apr2021 in his own home (lived alone). Probably hit his head against the wall in the fall. The patient''s outcome was fatal, at the time of the report. The patient underwent lab tests and procedures which included autopsy on 26Apr2021: the results have not been received yet. An autopsy was performed and results were not provided. The case was considered to be serious. Reporters comments: 27Apr2021 NIPH: requested additional information. If new medical information is received, report will be updated. Sender Comment: Since the report describes a suspected side effect that is serious and in order to better assess the incident that was reported, we have requested additional information from the relevant hospital. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: 27-april-2021 NIPH: requested additional information. If new medical information is received, report will be updated.; Reported Cause(s) of Death: nausea, muscle pain, felt nauseous and had muscle aches; nausea, muscle pain, felt nauseous and had muscle aches; felt then generally bad


VAERS ID: 1312568 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-01
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Computerised tomogram, Fall, Fibrin D dimer, Hypoaesthesia, Malaise, Muscular weakness, Pain in extremity, Pulmonary embolism, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BETASERC; GINKGO BILOBA; EUTIROX; LOSARTAN + HIDROCLOROTIAZIDA; IDECORTEX; HYDROXYCARBAMIDE; ACETYLSALICYLIC ACID; PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Hypertension arterial; Hypothyroidism; JAK-2 mutation; Thrombocytosis
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: CT-CE; Result Unstructured Data: Test Result:without acute changes; Test Date: 20210415; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:more than 23000 iU
CDC Split Type: PTPFIZER INC2021512280

Write-up: Pulmonary thromboembolism; decreased strength and pain in the lower limbs; decreased strength and pain in the lower limbs; imbalances / vertigo; imbalances / vertigo; numbness in the right lower limb; several falls; a sudden episode of malaise; This is a spontaneous report from a contactable physician downloaded from the regulatory authority PT-INFARMED-T202104-1819. An 85-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: ER9470), intramuscular on 26Mar2021 (at the age of 85-years-old) as 1st dose, 0.3 ml single for COVID-19 immunisation. Medical history included janus kinase 2 (JAK-2) mutation, thrombocytosis, hypertension arterial, anaemia and hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included betahistine hydrochloride (BETASERC), ginkgo biloba, levothyroxine sodium (EUTIROX), hydrochlorothiazide, losartan potassium (LOSARTAN + HIDROCLOROTIAZIDA), idebenone (IDECORTEX), hydroxycarbamide, acetylsalicylic acid and pantoprazole, all taken for an unspecified indication, start and stop dates were not reported. The patient presented with a picture of pulmonary thromboembolism associated with the use of COMIRNATY. Previous history of arterial hypertension, hypothyroidism, anemia and thrombocytosis (JaCK2V617f - POSITIVE). Cognitively integrated patient, previously autonomous, lived alone at home. The adverse reaction (ADR) appeared 6 days after the first dose of the suspected drug was administered (01Apr2021), with the patient initially presenting decreased strength and pain in the lower limbs, 5 days later she went to the emergency department with complaints of pain in the lower limbs and imbalances / vertigo. After 20 days of inoculation of the vaccine, she resorts again to the emergency department due to decreased muscle strength in the lower limb, numbness in the right lower limb, with several falls, with about 3 weeks of evolution. She denies trauma. She reports episodes of vertigo, without other neurological complaints. She would be in a good mood when, suddenly, she develops a sudden episode of malaise being referred to the emergency service, in gasping, assisted with ambu + guedel, with evident signs of poor perfusion. Rapid progression to PCR in pulseless electrical activity. ADR led to the patient''s death. There was no reduction in dosage, suspension or reintroduction of the suspected drug, due to its single dose character. There is no suspicion of interaction between drugs. There is no history of previous reactions to other drugs. Specific treatment of the reaction was carried out with VAS (advanced life support) and in the face of the suspicion of PTE (asthenia, MId edema with functional impotence) underwent alteplase. ADR did not improve with treatment. Additional data: Analysis with elevation D-Dimers 23463 ?g / L, without other relevant changes. CT-CE without acute changes. Analyzes with elevation of DD 23000 - without other relevant changes. CT-CE without acute changes. The patient underwent lab tests and procedures which included computerised tomogram: without acute changes and fibrin d dimer: more than 23000 iu on 15Apr2021. Therapeutic measures were taken as a result of pulmonary thromboembolism. The patient died on 15Apr2021. An autopsy was performed, and results were not provided. Reporter Comment: Concomitant Medication-AAS, Eutirox, Losartan / HCTZ, Hydrocarbamide, Pantoprazole, Idecortex, Betaserc, Gigkobiloba Did Medication Error Occur? -No Other information-Medical History: HTA, JAK2V617f Thrombocytosis. Vaccine COVID19 on 26Mar. 4/1: decreased strength and pain in limbs inf. 06Apr - Emergency Department - pain in lower limbs and imbalance. 15Apr she returns to the emergency department due to generalized pain and numbness of the right lower limb, with several falls. right lower limb stuffing. DDimer$g 23 000. PCR in AEsP, SAV and Alteplase. Deceased. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Summary: Concomitant Medication-AAS, Eutirox, Losartan / HCTZ, Hydrocarbamide, Pantoprazole, Idecortex, Betaserc, Gigkobiloba. Medical History: HTA, JAK2V617f Thrombocytosis. Vaccine COVID19 on 26/03. 4/1: decreased strength and pain in limbs inf. 04/06 - Emergency Department - pain in lower limbs, and imbalance. 04/15 he returns to the emergency department due to generalized pain and numbness of the right lower limb, with several falls. right lower limb stuffing. DDimer$g 23 000. PCR in AEsP, SAV and Alteplase. Deceased.; Reported Cause(s) of Death: Pulmonary thromboembolism


VAERS ID: 1313354 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Septic shock; Urosepsis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021522161

Write-up: Death; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is AT-BASGAGES-2021-25598. A 78-year-old male patient received first dose of BNT162B2 (COMIRNATY) intramuscularly on 24Apr2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunization. Medical history included urosepsis and septic shock from an unknown date and not ongoing. Concomitant drugs were unknown. The patient experienced death on 01May2021 after first vaccination on 24Apr2021. The patient died on 01May2021. It was unknown if an autopsy was performed. Comment: Follow-up information has been requested. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1313386 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Fall, Influenza like illness, Malaise, Myalgia, Pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021519966

Write-up: he had a malaise and fell from the stairs; he had a malaise and fell from the stairs; body aches; muscle pain; bone pain; flu-like symptoms; feeling unwell; heavy pain at arm; This is a spontaneous report from a contactable consumer or other non hcp (spouse of the patient). A 49-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation (Age at vaccination: 49 years). The patient medical history and concomitant medications were not reported. The patient had a malaise and fell from the stairs on 07May2021 10:15 causing the patient death on the same day. The patient experienced heavy pain at arm on 01May2021 with outcome of unknown , feeling unwell on 02May2021 with outcome of unknown; body aches, muscle pain and bone pain, flu-like symptoms; all on 03May2021 with outcome of unknown. Therapeutic measures were taken as a result of body aches, muscle pain, bone pain, flu-like symptoms: dafalgan. Course of the event: the husband of the reporter was vaccinated on Sunday 01May2021 and began to feel bad on the following day. He already presented severe pain in arm the day of the injection. He suffered from body aches, muscle pain, bone pain, flu-like symptoms from Monday to Friday and took Dafalgan as advised by the treating physician. At 10h15 on Friday he had a malaise and fell from the stairs at home. Help came but after 1 hour of reanimation, they declared the death of the patient. The patient died on 07May2021. It was not reported if an autopsy was performed. Lot number information has been requested.; Reported Cause(s) of Death: Fall


VAERS ID: 1313396 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042450 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: Artificial cardiac pacemaker user; Cardiomyopathy (Coronary and chronic valvular cardiomyopathy); Dementia (Severe dementia since 2014 Moderate dementia since 2011)
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block second degree
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: Death; convulsions; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) and SEIZURE (convulsions) in a 96-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 300042450) for COVID-19 vaccination. The patient''s past medical history included Atrioventricular block second degree in 1995. Concurrent medical conditions included Cardiomyopathy (Coronary and chronic valvular cardiomyopathy), Dementia (Severe dementia since 2014 Moderate dementia since 2011) since 2011 and Artificial cardiac pacemaker user since 04-Oct-1995. On 21-Jan-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 23-Jan-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced SEIZURE (convulsions) (seriousness criterion medically significant). The patient died on 24-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, SEIZURE (convulsions) outcome was unknown. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment medication was provided. Company Comment: This is a case of death in a 96-year-old female subject with unknown medical history of Atrioventricular block second degree with cardiac pacemaker, Coronary and chronic valvular cardiomyopathy and Severe dementia, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Translation received. NNI; Sender''s Comments: This is a case of death in a 96-year-old female subject with unknown medical history of Atrioventricular block second degree with cardiac pacemaker, Coronary and chronic valvular cardiomyopathy and Severe dementia, who died 3 days after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1313406 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001653 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMIODARONE; BISOPROLOL MEPHA; ELIQUIS; Fentanyl transdermal system; PREGABALINUM; TORASEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Atrial fibrillation; Blood pressure high; Hypertension; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: This case was received via a regulatory authority (Reference number: 14776) on 04-May-2021 and was forwarded to Moderna on 04-May-2021. This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of DEATH in an 85-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3001653) for COVID-19 vaccination. The patient''s past medical history included Blood pressure high, Atrial fibrillation, Stroke, Aortic valve insufficiency and Hypertension. Concomitant products included AMIODARONE, BISOPROLOL FUMARATE (BISOPROLOL MEPHA), APIXABAN (ELIQUIS), Fentanyl (Fentanyl transdermal system), PREGABALIN (PREGABALINUM) and TORASEMIDE for an unknown indication. On 19-Apr-2021 at 8:20 AM, 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) (Intramuscular) 1 dosage form. Death occurred on 20-Apr-2021 The patient died on 20-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered DEATH (Tod) to be unlikely related. No treatment information was reported by the reporter. Action taken with mRNA-1273 in response to the events was not Applicable. This is a case of death in a 85-year-old female subject with a medical history of Hypertension, Atrial fibrillation, Aortic valve insufficiency and Stroke, who died next day after receiving the second dose of vaccine. Based on reporter''s causality, the patient''s age and comorbid risk factors the event is assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Significant Translated information regarding case narrative, reporter''s and sender''s comments, medical history, suspect and concomitant medication dosing, causality. Sender''s Comments: This is a case of death in a 85-year-old female subject with a medical history of Hypertension, Atrial fibrillation, Aortic valve insufficiency and Stroke, who died next day after receiving the second dose of vaccine. Based on reporter''s causality, the patient''s age and comorbid risk factors the event is assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1313425 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522073

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100056274. A 57-years-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 21Apr2021 at the age of 57-years-old (Batch/Lot Number: EX3510) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 23Apr2021 the patient experienced unknown cause of death. It was not reported if an autopsy was performed. The causality assessment for suspect drug to event was reported as follows: Source of assessment Regulatory Authority; Result of Assessment D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1313426 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3599 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac insufficiency; Coronary heart disease; Hypertension; Renal insufficiency; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522047

Write-up: Unknown cause of death; This spontaneous report was received from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100056650. An 84-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 27Apr2021 (Lot Number: EL3599) as single dose for covid-19 immunisation (vaccination age was 84-year-old). Ongoing medical history included coronary heart disease, type ii diabetes mellitus, cardiac insufficiency, renal insufficiency and hypertension. The patient''s concomitant medications were not reported. The patient died on 29Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1313427 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021522109

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-202100056652. A 77-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: EX3599), via an unspecified route of administration on 30Apr2021 at age of 77 years old as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced unknown cause of death on 01May2021. This report was reported as serious due to death. It was not reported if an autopsy was performed. The causality assessment for suspect drug to event was reported as D. unclassifiable by regulatory authority. No follow-up attempts possible. No further information expected.; Autopsy-determined Cause(s) of Death: Unknown cause of death


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