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

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



Case Details

This is page 119 out of 172

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VAERS ID: 1342835 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-27
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (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:
Current Illness: Atrial fibrillation; Hypertension; Insufficiency cerebrovascular; Renal insufficiency; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021579689

Write-up: Infarct myocardial; Death sudden; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-202100069973. An 81-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 27Apr2021 (Batch/Lot Number: EX3599) as 0.3ML single dose for covid-19 immunisation (vaccination age was 81-year-old). Medical history included ongoing hypertension, apoplexy from an unknown date and not ongoing, ongoing renal insufficiency, ongoing type II diabetes mellitus, ongoing insufficiency cerebrovascular and ongoing atrial fibrillation. The patient''s concomitant medications were not reported. The patient experienced infarct myocardial on an unspecified date in 2021. The patient was death sudden on an unspecified date in 2021. 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: Infarct myocardial; Death sudden


VAERS ID: 1342839 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Fatigue, Malaise, Nausea, Sudden death, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (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: Schizo-affective type of psychosis
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561224

Write-up: sudden death; weakness on the 2nd day after the vaccination; Injection site pain; Fatigue; Nausea; malaise; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021061549, Safety Report Unique Identifier DE-PEI-202100053957. A 74-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Apr2021 10:30 (at age of 74 years old) as single dose for COVID-19 immunisation. Medical history included Parkinson''s disease NOS from 2011, ongoing Schizo-affective type of psychosis. The patient''s concomitant medications were not reported. On 30Apr2021 the patient experienced sudden death. 28Apr2021, malaise. On 29Apr2021 the patient experienced Injection site pain, Fatigue, Nausea. On 30Apr2021, weakness on the 2nd day after the vaccination. An autopsy was not performed. The outcome was the not recovered/not resolved for Injection site pain, fatigue, Nausea. The outcome of the non-fatal event was not recovered. Senders comments: Information on risk factors or previous illnesses Schizo-affective psychosis for about 40 years; Parkinson''s diagnosis since 2011/malaise on the evening of the vaccination (28Apr2021; 10.30h vaccination appointment) and the days after, pain in the whole left arm on the day after the vaccination, fatigue; sudden death on the 2nd night after vaccination. The Pharmacovigilance Center assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sudden death


VAERS ID: 1342840 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Cardiac arrest, Cardiac procedure complication, Cough, Dyspnoea, Malaise, Myocardial infarction, Nausea, Vaccination site pain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (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), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021561172

Write-up: Nausea, shortness of breath, cough, cardiac arrest with fatal consequences; Myocardial infarction due to a suddenly occluded blood vessel in the coronary artery; Myocardial infarction due to a suddenly occluded blood vessel in the coronary artery; Nausea, shortness of breath, cough, cardiac arrest with fatal consequences; Nausea, shortness of breath, cough, cardiac arrest with fatal consequences; Nausea, shortness of breath, cough, cardiac arrest with fatal consequences; Nausea, shortness of breath, cough, cardiac arrest with fatal consequences; Injection site pain; unwell; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB DE-PEI-CADR2021065554, Safety Report Unique Identifier DE-PEI-202100058213. A 56-year-old male patient received first dose of bnt162b2 (COMIRNATY, reported as mRNA TOZINAMERAN, solution for injection, strength: 0.3mL, Batch/Lot Number: EX3510), via an unspecified route of administration on 20Apr2021 (at the age of 56-year-old) at single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included COVID-19 from 2020 to an unknown date, not ongoing. The patient''s concomitant medications were not reported. The patient experienced myocardial infarction due to a suddenly occluded blood vessel in the coronary artery, nausea, shortness of breath, cough, cardiac arrest with fatal consequences, all on 27Apr2021; injection site pain and unwell on 20Apr2021. It was reported that on 27Apr2021 the patient experienced Arrhythmia. On 20Apr2021 the patient experienced Malaise, Injection site pain. On 27Apr2021 the patient experienced Infarct myocardial, Nausea, Dyspnoea, Coughing, Arrest cardiac. The outcome of events ''myocardial infarction due to a suddenly occluded blood vessel in the coronary artery'' and cardiac arrest was fatal, outcome of injection site pain was recovered on 22Apr2021, outcome of the other events was not recovered. The patient died on 27Apr2021. An autopsy was not performed. This report is serious - death, hospitalization. A regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest; a suddenly occluded blood vessel in the coronary artery; Infarct myocardial


VAERS ID: 1342854 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021559012

Write-up: acute anterior wall infarction; one-vessel coronary heart disease with death; This is a spontaneous report from a non-contactable physician based on information received by Pfizer from Biontech [manufacturer control number: 55177], license party for Comirnaty. A patient of unspecified age and gender received first dose bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) at singe dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. 4 days after 1st Corminaty the patient experienced vaccination acute anterior wall infarction, one-vessel coronary heart disease with death. 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 number cannot be obtained.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the events of anterior wall myocardial infarction and one-vessel coronary heart disease. The reported events likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: acute anterior wall infarction; one-vessel coronary heart disease with death


VAERS ID: 1342855 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-14
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Myocardial infarction, Pulmonary embolism, Renal failure, Rib fracture
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Osteoporosis/osteopenia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac arrhythmia; Pacemaker insertion (cardiac)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021572369

Write-up: Renal failure; Lung embolism; Heart attack, cardiac arrest, restored vital functions with resuscitation resulting in broken ribs; Heart attack, cardiac arrest, restored vital functions with resuscitation resulting in broken ribs; Heart attack, cardiac arrest, restored vital functions with resuscitation resulting in broken ribs; This is a spontaneous report from a non-contactable consumer. This is the second of two reports. The first report is a report downloaded from a regulatory authority [DE-PEI-CADR2021068279], Safety Report Unique Identifier [DE-PEI-202100060854]. A 91-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. Medical history included ongoing Cardiac arrhythmia, ongoing pacemaker. No known allergies. The patient''s concomitant medications were not reported. This report is serious-death. On 14Apr2021 the patient experienced Heart attack, cardiac arrest, restored vital functions with resuscitation resulting in broken ribs and was died on 14May2021 due to all above events. Also experienced Lung embolism and Renal failure on 14Apr2021 and was hospitalized on unknown date. The patient deceased in intensive care unit, cardiovascular support discontinued according to patient''s instructions and will. All events lead to emergency room visit. It was unknown if an autopsy was performed. The outcome for Heart attack, Arrest cardiac, Rib fracture was fatal, for other events was not recovered. A regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as D. Unclassifiable. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : DE-PFIZER INC-2021561204 Same reporter, same patient, different doses, different events; Reported Cause(s) of Death: Heart attack, cardiac arrest, restored vital functions with resuscitation resulting in broken ribs; Heart attack, cardiac arrest, restored vital functions with resuscitation resulting in broken ribs; Heart attack, cardiac arrest, restored vital funct


VAERS ID: 1342856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021574483

Write-up: died; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 55578, license party for COMIRNATY. A contactable consumer reported that a male patient of an unspecified age received BNT162B2 (COMIRNATY, Solution for injection, lot/batch number not provided), via an unspecified route of administration (at unknown age) on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date. It was unknown if an autopsy was performed. information on the lot/batch number has been requested. ; Reported Cause(s) of Death: died


VAERS ID: 1344443 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Confusional state, Nasopharyngitis, Renal failure, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
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: FIMODERNATX, INC.MOD20211

Write-up: Confusional state; Renal failure; Urinary tract infection; Cold symptoms; This regulatory authority case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusional state), RENAL FAILURE (Renal failure), URINARY TRACT INFECTION (Urinary tract infection) and NASOPHARYNGITIS (Cold symptoms) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusional state) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criteria death and medically significant), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion death) and NASOPHARYNGITIS (Cold symptoms) (seriousness criterion death). The patient died on 21-Apr-2021. The reported cause of death was Confusional state, Renal failure, Urinary tract infection and Cold symptoms. It is unknown if an autopsy was performed. No concomitant medications were reported. No treatment information was reported. Action taken with mRNA-1273 in response to the drug was not applicable. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. All events conservatively retained as resulting in death as this is how they are assessed by the Authority although it is unknown if an autopsy was performed and events such as confusional state and cold symptoms are unlikely to be fatal in and of themselves; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. All events conservatively retained as resulting in death as this is how they are assessed by the Authority although it is unknown if an autopsy was performed and events such as confusional state and cold symptoms are unlikely to be fatal in and of themselves; Reported Cause(s) of Death: Confusional state; Renal failure; Urinary tract infection; Cold symptoms


VAERS ID: 1344568 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-18
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Intestinal ischaemia
SMQs:, Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: Retardation mental; Sleep apnea
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholic gastritis; Anxiety; Enlarged prostate; Esophagitis; Volvulus of bowel
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20211

Write-up: Mesenteric ischemia; This regulatory authority case was reported by a pharmacist and describes the occurrence of INTESTINAL ISCHAEMIA (Mesenteric ischemia) in a 69-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Co-suspect products included non-company products TROPATEPINE HYDROCHLORIDE (LEPTICUR) for Parkinson''s syndrome and CYAMEMAZINE (TERCIAN [CYAMEMAZINE]) for Agitation. The patient''s past medical history included Alcoholic gastritis, Volvulus of bowel, Anxiety, Enlarged prostate and Esophagitis. Concurrent medical conditions included Retardation mental and Sleep apnea. On 18-Feb-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient started TROPATEPINE HYDROCHLORIDE (LEPTICUR) (unknown route) 10 milligram once a day. On an unknown date, the patient started CYAMEMAZINE (TERCIAN [CYAMEMAZINE]) (Oral) 1 dosage form. On 18-Apr-2021, the patient experienced INTESTINAL ISCHAEMIA (Mesenteric ischemia) (seriousness criteria death and medically significant). The patient died on 21-Apr-2021. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. There is no treatment medication reported. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Intestinal ischemia captured as cause of death as per Authority assessment of event in SD although it is unknown if an autopsy occurred.; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Intestinal ischemia captured as cause of death as per Authority assessment of event in SD although it is unknown if an autopsy occurred.


VAERS ID: 1344738 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021566366

Write-up: death; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The medical history was not reported. The concomitant medications were not reported. It was unknown if the patient was pregnant at the time of report. The patient died 8 days after receiving bnt162b2. Death cause was not provided; it was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The information provided is too limited for a reasonable medical assessment. There was no information provided regarding the specific cause of death, detailed medical history and counteractive treatment measures. As per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified and re-assessed based on additional data. Queries are in place for the missing information. This case will be updated once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1344969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-28
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory arrest, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arteriosclerosis obliterans; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:neagtive; Test Date: 20210211; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:neagtive; Test Date: 20210223; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:neagtive; Test Date: 20210308; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:neagtive
CDC Split Type: HUPFIZER INC2021560192

Write-up: respiratory arrest; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is HU-OGYI-287121. A 90-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via intramuscular, administered in left arm on 02Mar2021 (Lot Number: EJ6790) as 0.3 ml single for covid-19 immunization. Medical history included ongoing arteriosclerosis obliterans, ongoing hypothyroidism. The patient''s concomitant medications were not reported. The patient was under in-patient care at the time of the vaccinations, the hospitalization started on 08Feb2021. The Covid-19 PCR test was negative. The occurrence of respiratory arrest after the administration of Comirnaty on 28Mar2021. On 28Mar2021, the patient died. Autopsy was not performed. According to the patient''s death certificate, the direct cause of death was respiratory arrest, indirect causes were general atherosclerosis. The patient''s hospitalization was prolonged as a result of respiratory arrest. In the reporter physician''s opinion, the patient''s death was related to his underlying diseases. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 09Feb2021, on 11Feb2021, on 23Feb2021 and on 08Mar2021. The outcome of the event was fatal. Sender Comment: The 90-year-old patient died 26 days after Comirnaty vaccination. The cause of death was respiratory arrest. The causal relationship between the reported death and the vaccine is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of respiratory arrest. The reported event likely appears associated with intercurrent medical conditions in this elderly 90 year old patent. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: direct cause of death was respiratory arrest, indirect causes were general atherosclerosis.; direct cause of death was respiratory arrest, indirect causes were general atherosclerosis.


VAERS ID: 1344970 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-05-03
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021572835

Write-up: sudden death (died suddenly, died 4 days after Comirnaty vaccination); This is a spontaneous report from a contactable physician downloaded from the regulatory authority HU-OGYI-319321. A 79-years-old male patient received BNT162B2 (COMIRNATY), first dose intramuscularly administered in left arm on 29Apr2021 (Batch/Lot Number: EX6537) as 0.3 mL single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and was not ongoing. The patient''s concomitant medications were not reported. The patient experienced sudden death (died suddenly, died 4 days after Comirnaty vaccination) on 03May2021. There was no information about the cause of death and about the autopsy results. The patient died on 03May2021. It was not reported if an autopsy was performed. The causal relationship between the reported death and Comirnaty was unassessable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1344987 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Angiopathy
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Atrial fibrillation; Chronic kidney disease stage 3; Diverticular disease; IHD; Prostate cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021553710

Write-up: ABDOMINAL PAIN; LIKELY VASCULAR EVENT; This is a spontaneous report from contactable Physician downloaded from a regulatory authority-WEB IE-HPRA-2021-072610. A 77-year-old male patient received second dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Apr2021 (Batch/Lot Number: EX2405) at 0.3 ml, single for COVID-19 immunisation. The patient''s medical history included chronic kidney disease (CKD3), prostate cancer, atrial fibrillation, ischemic heart disease (IHD), and diverticular disease. The patient''s concomitant medications were not reported. The patient previously received first dose bnt162b2 (COMIRNATY) via an unspecified route of administration on 25Mar2021 (Batch/Lot Number: Unknown) at 0.3 mL, single for COVID-19 immunisation. On 23Apr2021, the patient experienced abdominal pain and died 12 hours post-vaccination. The reporter outlined that the cause of death was likely a vascular event, which they were awaiting post-mortem results to confirm. The patient died on an unspecified date in 23Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ABDOMINAL PAIN; LIKELY VASCULAR EVENT


VAERS ID: 1345166 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLYCOPYRRONIUM BROMIDE; CLOPIDOGREL; TORVAST; PERINDOPRIL; LASIX [FUROSEMIDE]; OXYGEN; TAMSULOSIN; LUCEN [ESOMEPRAZOLE MAGNESIUM]; TENORMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579711

Write-up: Unexpected death; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is IT-MINISAL02-729029. A 73-years-old male patient received BNT162b2 (COMIRNATY, solution for injection, Lot Number: FA5831), via an unspecified route of administration on 12May2021 (at the age of 73-years-old) as 2ND DOSE, SINGLE for covid-19 immunization. The patient''s medical history was not reported. The patient''s concomitant medications included GLYCOPYRRONIUM BROMIDE, CLOPIDOGREL, atorvastatin calcium (TORVAST), PERINDOPRIL, furosemide (LASIX ), OXYGEN, TAMSULOSIN, esomeprazole magnesium (LUCEN ), atenolol (TENORMIN). The patient previously took first dose of BNT162b2 (COMIRNATY, solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration as 1ST DOSE, SINGLE for covid-19 immunization. On 12May2021, the patient experienced unexpected death. The patient died on 12May2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. Case narrative: 2nd dose. On 13May2021 contacted reporter for information on reaction, clinical report and autopsy examination. On 13May2021 the reporter sent the attached report. No follow-up attempts possible. No further information expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unexpected death


VAERS ID: 1345167 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Decreased appetite, Pyrexia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-08
   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: HEXOPRENALINE SULFATE; LEVOXACIN; CARDICOR; REVINTY ELLIPTA; FORTOVASE [SAQUINAVIR]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure (Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis); Non-Hodgkin''s lymphoma (Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis); Pulmonary fibrosis (Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579667

Write-up: cardiac arrest occurred; lack of appetite; weakness; Fever after first dose of Pfizer; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-729249. A 71-year-old male patient received first dose of BNT162B2 (COMIRNATY, lot number: EX7389, expiration date: 31Aug2021), via intramuscular route on 01May2021 at 15:48 as 1ST DOSE, SINGLE for COVID-19 immunisation. Medical history of the patient included: Non-Hodgkin''s lymphoma, Chronic respiratory failure, pulmonary fibrosis [Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis]. Concomitant medications included: hexoprenaline sulfate, levoxacin (levofloxacin) at a dose of 500 ug/kg, Cardicor (bisoprolol fumarate) at a dose of 2.5mg, Revinty Ellipta (fluticasone furoate, vilanterol trifenatate) at a dose of 92 ug, Fortovase (saquinavir). On 02May2021, one day after first dose of vaccine, the patient experienced fever. On 06May2021, five days after vaccination, patient experienced lack of appetite and had weakness. Reportedly, impact on quality of life was 6/10. On 08May2021, seven days after receiving vaccination, patient died due to cardiac arrest. Cause of death was reported as cardiac arrest. It was unknown if the autopsy was performed or not. Corrective treatment included Tachipirin intake. Outcome for the event fever was resolved on 05May2021 (three days after onset), and for other events was fatal. Reporter''s comments: Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis Sender''s comments: a regulatory authority comment: The form has been modified according to the information requested from the reporter by email. The clinical report has been requested from the treating physician and will be attached to the clinical case as soon as he responds. FU of 17May2021: the clinical report received from the treating physician is attached.; Reporter''s Comments: Non-Hodgkin''s lymphoma Dlbcl. Rcomp 6 Chronic respiratory failure in pulmonary fibrosis; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1345168 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery stenosis (Bilateral carotid stenosis since 2008, performed TEA left, right at last sten control); Multiple myeloma (Multiple myeloma since 2013, now in relapse phase with indication to restart chemo treatment); Parkinson''s disease (Parkinson''s disease since 2008)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579844

Write-up: DEATH BY SUDDEN DEATH; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is IT-MINISAL02-729634. A 69-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EX7389, Expiration Date: 05May2021), via intramuscular on 05May2021 at 10:39 as a 2nd dose, single for COVID-19 immunisation. The patient''s medical history included parkinson''s disease since 2008 and unknown if ongoing, bilateral carotid stenosis since 2008, performed TEA left, right at last sten control and unknown if ongoing, multiple myeloma since (plasma cell myeloma) 2013, now in relapse phase with indication to restart chemo treatment and unknown if ongoing. The patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EW2246, Expiration Date: 31Jul2021), via intramuscular in left deltoid on 14Apr2021 at 13:13 as a 1st dose, single for COVID-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced death by sudden death on 12May2021. It was not reported if an autopsy was performed. Therapeutic measures were taken as a result of death by sudden death. The outcome of the event was fatal. Description: Actions taken (INTERVENTION 112 WITH ACTIVATION OF REANIMATION PROCEDURES) No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: DEATH BY SUDDEN DEATH


VAERS ID: 1345169 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-15
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX 7389 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579760

Write-up: death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-730129. A 92-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EX 7389, Expiration date not reported), via an unspecified route of administration on 04May2021 as a single dose for COVID-19 immunization. The patient past medical history and concomitant medication was not reported. It was reported that, the patient died on15May2021 but not due to the vaccine. Reporter assessed the causality of event as unrelated. The cause of death and autopsy was Unknown. Outcome of the event was was Fatal. Reporter''s comments: In my opinion this is an adverse event not related to the vaccine, with occasional concomitance only of a temporal and not causal type, i.e., not an adverse reaction but an adverse event not due to the vaccine. Sender''s comments: we asked the reporter for a clinical report. No follow-up attempts possible. No further information expected.; Reporter''s Comments: In my opinion this is an adverse event not related to the vaccine, with occasional concomitance only of a temporal and not causal type, i.e. not an adverse reaction but an adverse event not due to the vaccine.; Reported Cause(s) of Death: death


VAERS ID: 1345171 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-05-02
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage (with resentment of the left hemisoma but with discrete autonomy); Diabetes; Hypertension; Lymphoma (at the age of 80); Venous thrombosis (Previous venous or nail thrombosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021579546

Write-up: Sudden death/instant death; Severe headache appeared, followed by almost instant death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-730302. A 93-year-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: ET7205, expiration date not reported) intramuscularly administered on right arm on 02Apr2021 as a 2nd dose, 0.3 ml single for COVID-19 immunisation. The patient medical history included diabetes, hypertension, previous venous or nail thrombosis, previous cerebral haemorrhage (2018) with resentment of the left hemisoma but with discrete autonomy, lymphoma at the age of 80. The patient concomitant medications were not reported. On an unknown date, the patient previously received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number: not reported) via unspecified route of administration as 1st dose, single for COVID-19 immunisation. The patient had no adverse reaction during 1st dose of Comirnaty vaccine. On 02May2021(one month after the 2nd dose), the patient experienced severe headache, followed by almost instant death. After consulting the attending physician, he reported the symptoms as the cause of death given the symptoms: sudden death from cerebral haemorrhage, probable recurrence of cerebral haemorrhage which occurred in 2018 in an elderly patient with multiple pathologies-COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (right shoulder) Booster dose number (2). It was unknown if autopsy was performed or not. The outcome of the events was fatal. Reporter Comment: Diabetes, hypertension, previous venous or nail thrombosis, previous cerebral haemorrhage (2018) with resentment of the left hemisoma but with discrete autonomy, lymphoma at the age of 80. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1345215 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cerebral ventricular rupture, Coma scale, Computerised tomogram head, Syncope, Thalamus haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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: INSULIN
Current Illness: Diabetes mellitus (receiving insulin self-injection)
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Pancreatitis acute
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210514; Test Name: GCS; Result Unstructured Data: Test Result:E1V1M2; Test Date: 20210514; Test Name: JCS; Result Unstructured Data: Test Result:III-200; Test Date: 20210514; Test Name: Head CT; Result Unstructured Data: Test Result:thalamus haemorrhage and cerebral ventricular; Comments: rupture
CDC Split Type: JPPFIZER INC2021572308

Write-up: Thalamus haemorrhage; Cerebral ventricular rupture; Swooning; This is a spontaneous report from two contactable physicians received from a regulatory authority. The regulatory authority report number is v21107553 and v21107462. A 63-year and 10-month-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot Number: ER7449; Expiration Date: 30Jun2021), via an unspecified route of administration, on 11May2021 at 14:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus (receiving insulin self-injection), hypertension, and pancreatitis acute. Concomitant medications included insulin (MANUFACTURER UNKNOWN) taken for diabetes mellitus from an unspecified date and ongoing. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 20Apr2021 for COVID-19 immunisation and experienced no adverse event. The patient experienced thalamus haemorrhage, cerebral ventricular rupture, and swooning on 14May2021 at 05:10, which required hospitalization from 14May2021 to 15May2021 and were reported as fatal. The clinical course was reported as follows: The patient received the first vaccination on 20Apr2021 and the second vaccination on 11May2021 at another hospital. The body temperature before vaccination was 36.2 degrees Centigrade on 11May2021. Subsequently, the patient had no adverse reaction post-vaccination. On 14May2021 (3 days after the vaccination) in the morning hours, the patient complained of dysphoria at home and at 05:10 (2 days 15 hours 10 minutes after the vaccination), when the patient was going to a toilet, the patient swooned, which was seen by the patient''s wife and the patient was taken to the reporting hospital by ambulance. At consultation, Coma Scale (JCS) was III-200 and Glasgow Coma Scale (GCS) was E1V1M2 on 14May2021. Head computerized tomogram (CT) revealed thalamus haemorrhage and cerebral ventricular rupture on 14May2021. There was no operability and the patient was admitted to intensive care unit (ICU). The patient was intubated and placed under mechanical ventilation; however, the condition did not improve. On 15May2021 at 11:45, the patient died and was discharged from the hospital. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 15May2021. The cause of death was reported as thalamus haemorrhage. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the events and BNT162B2 as unassessable. The reporting physician commented as follows: Hypertension may be a contributory factor in the onset of cerebral haemorrhage.; Reported Cause(s) of Death: Thalamus haemorrhage


VAERS ID: 1345216 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-17
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia (historical condition); Dyslipidaemia (historical condition); Ischaemic heart disease (historical condition)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021576514

Write-up: Myocardial infarction; This is a spontaneous report from a contactable physician via a Company representative. An 85-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unknown route, on 13May2021 (at the age of 85-year-old) at single dose for COVID-19 immunisation. Relevant medical history dementia, dyslipidaemia, and ischaemic heart disease. No relevant concomitant medications were provided. On 17May2021 at unknown time (4 days after the vaccination), the patient experienced myocardial infarction and died. It was unknown whether autopsy was done. Information about Batch/Lot number has been requested.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event myocardial infarction cannot be excluded. The medical history of dyslipidaemia and ischaemic heart disease may provide plausible alternative explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1345482 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-04-29
   Days after vaccination:63
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: ACENOCOUMAROL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021561320

Write-up: Death from acute heart failure; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority report number: NL-LRB-00540450. An 82 years old female patient received the second dose of BNT162B2 (COMIRNATY) at 0.3 ml, single dose, on 25Feb2021, for COVID-19 immunisation. Relevant medical history was unknown. Patient had no physical complaints before and had not had cardiac complaints. The patient had not experienced Covid-19 prior vaccination. The patient previously, on 28Jan2021, received the first dose of BNT162B2 (COMIRNATY) at single dose, for COVID-19 immunisation. Concomitant medication included oral acenocoumarol, tablet, 1 mg, from an unspecified date, for an unknown indication. On 29Apr2021, the patient experienced acute heart failure. The patient died on 29Apr2021 due to acute heart failure. No diagnostic procedures were reported. It was unknown if autopsy was done. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Acute heart failure


VAERS ID: 1345486 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-05-03
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body temperature, Computerised tomogram thorax, Oxygen saturation, 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: 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: PERINDOPRIL; PANTOPRAZOLE; SIMVASTATIN; PRADAXA; COMBODART; METFORMIN; ASCORBIC ACID; COLECALCIFEROL; METOPROLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder; Diabetes; Hypertension; Lung disorder; Urinary retention; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood culture; Result Unstructured Data: Test Result:no result; Test Date: 20210504; Test Name: body temperature; Result Unstructured Data: Test Result:38.0-40.4 Centigrade; Test Date: 2021; Test Name: CT lungs; Result Unstructured Data: Test Result:Lots of fluid; Comments: No cause found for fever; Test Date: 2021; Test Name: oxygen saturation; Test Result: 89 %; Test Date: 2021; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative
CDC Split Type: NLPFIZER INC2021560953

Write-up: fever / 38.0-40.4 centigrade; COVID-19 LIM This is a non-interventional study report from a contactable consumer or downloaded from the regulatory authority-WEB NL-LRB-COVID-00541380. An 82-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26Apr2021 (Lot Number: EX0893) as 0.3 mL single for COVID-19 immunisation. Medical history included lung disorder, hypertension, cardiovascular disorder, diabetes, vascular dementia, urinary retention. Concomitant medications included perindopril taken for an unspecified indication from 01Oct2003 to an unspecified stop date; pantoprazole taken for an unspecified indication from 01Sep2003 to an unspecified stop date; simvastatin taken for an unspecified indication from 01Sep2003 to an unspecified stop date; dabigatran etexilate mesilate (PRADAXA) taken for an unspecified indication from 01Oct2019 to an unspecified stop date; dutasteride, tamsulosin hydrochloride (COMBODART) taken for an unspecified indication from 01Mar2009 to an unspecified stop date; metformin taken for an unspecified indication from 01Sep2003 to an unspecified stop date; ascorbic acid taken for an unspecified indication, start and stop date were not reported; colecalciferol taken for an unspecified indication from 01Jan2003 to an unspecified stop date; metoprolol taken for an unspecified indication from 01Oct2013 to an unspecified stop date and lim - herbal, vitamine, homeopathic, other non registered. The patient experienced fever / 38.0-40.4 centigrade on 03May2021 (as reported) with fatal outcome. The patient underwent lab tests and procedures which included blood culture: no result in 2021, body temperature: 38.0-40.4 centigrade on 04May2021 (as reported), computerised tomogram thorax: lots of fluid in 2021 (No cause found for fever), oxygen saturation: 89% in 2021, sars-cov-2 test: negative in 2021. Pyrexia was treated with Amoxicilline clavulanic acid./and additional antibiotics to achieve an even broader spectrum. Low Saturation Oxygen (89). The patient died on an unspecified date. It was not reported if an autopsy was performed. Reporter''s Comments: Fever -New Reaction.Treatment: Yes, with: Amoxicillin clavulanic acid and additional iv antibiotics to reach even broader spectrum. Oxygen through low Saturation (89). lth: Impact qualify of life: Very much. Other diagnostic procedures: Computed tomography lung scan. No cause found for fever. Lots of fluid, though. Blood on culture: no result . A test for Covid-19 and broader respiratory infections. Results negative (nothing found COVID-19). The reporter''s assessment of the causal relationship of the event 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 are possible, no information is expected.; Reporter''s Comments: Fever -New Reaction.Treatment: Yes, with: Amoxicillin clavulanic acid and additional iv antibiotics to reach even broader spectrum. Oxygen through low Saturation (89). lth: Impact qualify of life: Very much. Other diagnostic procedures: Computed tomography lung scan. No cause found for fever. Lots of fluid, though. Blood on culture: no result . A test for Covid-19 and broader respiratory infections. Results negative (nothing found COVID-19).; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Pyrexia cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: fever / 38.0-40.4 centigrade


VAERS ID: 1345548 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-04-21
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Uterine neoplasm (active)
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: PTPFIZER INC2021560652

Write-up: Vaccine failure - covid-19 pneumonia; Vaccine failure - covid-19 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PT-INFARMED-T202104-3099. A 93-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), via intramuscular route on 25Feb2021 (Batch/Lot number was not reported) at 0.3 ml single, and the second dose via intramuscular route on 18Mar2021 (Batch/Lot number was not reported) at 0.3 ml single for COVID-19 immunization. Medical history included bronchitis chronic from an unknown date and unknown if ongoing and ongoing uterine neoplasm active. COVID-19 infection prior to vaccination was not known. The patient''s concomitant medications were not reported. On 21Apr2021 the patient experienced vaccine failure - COVID-19 pneumonia which led to the patient''s hospitalization and finally to her death. The patient was hospitalized from 24Apr2021. The adverse drug reaction (ADR) manifested, after high-risk contact with a positive family member, 5 weeks after the administration of the 2nd dose of the suspected drug and led to the patient''s hospitalization 3 days later with confirmed pneumonia COVID-19 (unknown test). Unspecified ADR treatment was instituted. The patient underwent SARS-CoV-2 test on 24Apr2021, which was positive. The patient died on 24Apr2021, on the same day of hospitalization. It was not reported if an autopsy was performed. According to the reporter''s opinion, the relatedness of vaccine to reaction is probable. There is no suspicion of interaction between medications or medication errors. Reporter''s comment: Other information: 93-year-old patient, with a history of uterine neoplasia (active) and chronic bronchitis - complete vaccination schedule according to records on the vaccine platform. High-risk contact with a positive family member. Admitted on 24Apr2021 with confirmation of COVID-19 pneumonia. Died the same day. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reporter''s Comments: Other information: 93-year-old patient, with a history of uterine neoplasia (active) and chronic bronchitis - complete vaccination schedule according to records on the vaccine platform. High-risk contact with a positive family member. Admitted on 24Apr2021 with confirmation of COVID-19 pneumonia. Died the same day; Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure


VAERS ID: 1345599 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002531 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Eusaprim forte 160 mg/800 mg; Movicol; AZOPT 10 mg/ml; Oxascand 5 mg; Mirtazapin Actavis 15 mg; Alvedon 500 mg; Dexametason Abcur 4 mg; Kalcipos-D 500 mg/400 IE; Alphagan 0,2 % (2 mg/ml); Innohep 4500 anti-Xa IE; Revlimid 25 mg; xalcom 50 m
Current Illness: Multiple myeloma; Plasmacytoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of ILLNESS and DECREASED APPETITE in a 77-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002531) for COVID-19 vaccination. The patient''s past medical history included Plasmacytoma since an unknown date and Multiple myeloma since an unknown date. Concomitant products included sulfamethoxazole, trimethoprim (Eusaprim forte 160 mg/800 mg), macrogol, potassium chloride, sodium hydrogen carbonate, sodium chloride (Movicol), brinzolamide (AZOPT 10 mg/ml), oxazepam (Oxascand 5 mg), mirtazapine (Mirtazapin Actavis 15 mg), paracetamol (Alvedon 500 mg), dexamethasone (Dexametason Abcur 4 mg), calcium carbonate, cholecalciferol, calcium, Dry Vitamin D3 100 SD/S (Kalcipos-D 500 mg/400 IE), brimonidine tartrate, brimonidine (Alphagan 0,2 % (2 mg/ml), tinzaparin, tinzaparin sodium (Innohep 4500 anti-Xa IE), lenalidomide (Revlimid 25 mg), Timolol, combinations (xalcom 50 mikrogram/ml + 5 mg/ml) and codeine phosphate hemihydrate, codeine anhydrous, Paracetamol DC (PVP) 284N, paracetamol (Citodon 500 mg/30 mg) for an unknown indication. In April 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. In April 2021, the patient experienced ILLNESS (seriousness criterion death) and DECREASED APPETITE (seriousness criterion death). The patient died in April 2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events were not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear what the cause of death was and events of illness and decreased appetite conservatively retained as resulting in death as they were captured as doing so by the Authority; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unclear what the cause of death was and events of illness and decreased appetite conservatively retained as resulting in death as they were captured as doing so by the Authority; Reported Cause(s) of Death: unknown cause of death; Unknown cause of death


VAERS ID: 1345915 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210541514

Write-up: SUSPICIOUS DEATH; This spontaneous report received from a company representative who reported seeing tweets and news articles concerning a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, therapy start date were not reported, at frequency of one total administered for prophylactic vaccination. The batch number was not reported. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. It was reported in news articles that on unspecified date in MAY-2021, there was suspicious death (cause unknown) of the patient. However, the first forensic investigation did not reveal obvious connection with vaccine. The patient died from unknown cause. It was unknown whether the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210533585.; Sender''s Comments: V0 -20210541514-covid-19 vaccine ad26.cov2.s-Suspicious death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1346247 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEMODERNATX, INC.MOD20211

Write-up: Cardiac failure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021. This regulatory authority case was reported by an other (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Cardiac failure) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Parkinson''s disease and Decompensation cardiac. On 13-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced CARDIAC FAILURE (Cardiac failure) (seriousness criteria death and medically significant). The patient died on 14-Apr-2021. The reported cause of death was Cardiac failure. It is unknown if an autopsy was performed. No relevant concomitant medication information provided. Treatment was none. Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1346270 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Laboratory test
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASPIRIN CARDIO; CALPEROS [CALCIUM CARBONATE]; SIRDALUD; FENTANYL ACTAVIS [FENTANYL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic bi-femoral bypass; Arteriopathy (lower limb arteriopathy, diagnosis date unknown); Chronic renal failure (severe chronic renal failure , diagnosis date unknown, CL= 13ml/min on 28Dec2020); General physical health deterioration (poor general condition); Lumbar radicular pain (diagnosis date unknown); Malnutrition (treated with Aspirin cardio, Calperos, Sirdalud 4 mg and Fentanyl patch 25mcg/h); Osteoporosis with fracture (diagnosis date unknown); Radicular syndrome (lumbar-radicular syndrome); Tobacco user
Allergies:
Diagnostic Lab Data: Test Date: 20201228; Test Name: Renal clearance; Result Unstructured Data: Test Result:13 ml/min
CDC Split Type: CHPFIZER INC2021574687

Write-up: heart problem; This is a spontaneous report received from a contactable physician via a regulatory authority. Regulatory authority report number CH-SM-2021-15636. A 77-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 04May2021 morning (Batch/Lot number was not reported) as single dose, for covid-19 immunisation. Medical history included smoker, no known allergies, in very poor general condition, Aortic bi-femoral bypass from 2009, known for lower limb arteriopathy, severe chronic renal failure (CL= 13ml/min on 28Dec2020), fracturing osteoporosis, lumbar-radicular syndrome, Lumbar radicular pain, malnutrition, treated with Aspirin cardio, Calperos, Sirdalud 4 mg and Fentanyl patch 25mcg/h. Historical vaccine included first dose of COMIRNATY intramuscular in 2021 for covid-19 immunisation. Concomitant medications included acetylsalicylic acid (ASPIRIN CARDIO); calcium carbonate (CALPEROS [CALCIUM CARBONATE]); tizanidine hydrochloride (SIRDALUD); fentanyl (FENTANYL ACTAVIS [FENTANYL]). The patient was found dead at 3 PM on 05May2021, indicating that there was probably a heart problem (autopsy not performed). The patient was seen alive on 04May2021 at 2 pm. Renal clearance on 28Dec2020 was 13 ml/min. A causal relationship between Comirnaty and Death was assessed as being unlikely. Sender''s comment: Death of a 77-year-old polymorbid patient in poor general condition on the day after administration of the second dose of Comirnaty. The monograph of Comirnaty does not report any cases of death (1). On the basis of the data available to us and following a telephone conversation with the patient''s attending physician (PRIVACY, 12May2021), who considered the patient''s general condition to be very poor, and in the absence of further information (autopsy not performed), we consider the correlation between death and Comirnaty to be unlikely. This judgement of causality cannot, however, totally rule out the role of the vaccine. Information about batch/lot number will be requested.; Reporter''s Comments: Death of a 77-year-old polymorbid patient in poor general condition on the day following administration of the second dose of Comirnaty.; Reported Cause(s) of Death: heart problem


VAERS ID: 1346303 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001659 / 1 - / OT

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

Life Threatening? Yes
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: WARFARIN
Current Illness: Atrial fibrillation (Warfarin); Cardiomyopathy (Ischemic, ejection fraction of left ventricle under 25 %); Cerebral atrophy (Advanced, diffuse); Chronic ischemic heart disease, unspecified; Internal carotid artery stenosis (Severe, lateris sinistri)
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensated heart failure (Fluidothorax, chest drainage); Inferior myocardial infarction (Thrombolysis, coronarographically occlusion of ramus interventricularis anterior and arteria coronaria dextra); Subdural hematoma removal
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZMODERNATX, INC.MOD20211

Write-up: Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Death) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001659) for COVID-19 vaccination. The patient''s past medical history included Inferior myocardial infarction (Thrombolysis, coronarographically occlusion of ramus interventricularis anterior and arteria coronaria dextra) in 1999, Decompensated heart failure (Fluidothorax, chest drainage) in 2019 and Subdural hematoma removal on 30-Jan-2017. Concurrent medical conditions included Atrial fibrillation (Warfarin), Internal carotid artery stenosis (Severe, lateris sinistri), Cardiomyopathy (Ischemic, ejection fraction of left ventricle under 25 %), Cerebral atrophy (Advanced, diffuse) and Chronic ischemic heart disease, unspecified. Concomitant products included WARFARIN for Anticoagulant therapy. On 29-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. Death occurred on 30-Apr-2021 The patient died on 30-Apr-2021. The reported cause of death was found dead in the morning. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the patient being found dead, a causal relationship cannot be excluded. Patient''s medical history suggests underlying pathophysiology likely played a role in their death and autopsy results not provided; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the patient being found dead, a causal relationship cannot be excluded. Patient''s medical history suggests underlying pathophysiology likely played a role in their death and autopsy results not provided; Reported Cause(s) of Death: Found dead in the morning


VAERS ID: 1346347 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-26
Onset:2021-04-09
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 21 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021579484

Write-up: Pneumonia; Deceased; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB DE-PEI-CADR2021072929. A 97-year-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via an unspecified route of administration, on mar2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided) administered on unknown date for COVID-19 immunisation. On unknown date, the patient was hospitalized for 3 weeks due to pneumonia. Then, she died at home 1 week later on 09Apr2021. The cause of death was not provided. No autopsy was performed. The patient had not recovered from pneumonia at the time of death. Regulatory Authority/ Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Deceased


VAERS ID: 1347943 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021566827

Write-up: died after vaccination; This is a spontaneous report from a contactable consumer (patient''s children) based on information received by Pfizer from Biontech [manufacturer control number: 55859], license party for bnt162b2 (COMIRNATY). A male patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient (father) had died after being vaccinated on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: died after vaccination


VAERS ID: 1347944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder
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 INC2021571448

Write-up: cardiac disorder; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 55711], license party for COMIRNATY. This is a spontaneous report from a contactable other healthcare professional (HCP). A male patient of an unspecified age received first dose of BNT162B2 (COMIRNATY) via unspecified route single dose for COVID-19 immunisation on unspecified date. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced cardiac disorder on an unspecified date. The patient died on an unspecified date. It was reported the patient died after 1. dose (not vaccine related, he had cardiac problems). It was unknown if an autopsy was performed. Outcome of the event was fatal. Lot/batch number has been requested.; Sender''s Comments: Based on the current available information, the event cardiac disorder is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: cardiac disorder


VAERS ID: 1347946 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-30
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Platelet count, SARS-CoV-2 test, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 26
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMID; SODIUM PICOSULFATE; CANDESARTAN; BISOPROLOL; APIXABAN; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia absoluta; Arterial hypertension; Chronic renal insufficiency; Heart failure; Rectal carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: thrombocytopenia; Result Unstructured Data: Test Result:2; Comments: /nl; Test Date: 20210325; Test Name: SARS-CoV 2 test; Test Result: Negative
CDC Split Type: DEPFIZER INC2021574601

Write-up: suspicion on intracerebral bleeding; Thrombocytopenia until 2/nl; This is a spontaneous report from a non-contactable physician. A 85-year-old female patient received second dose of bnt162b2 (COMIRNATY) intramuscular on 15Mar2021 (Batch/Lot Number: Unknown) as 2nd dose, single for covid-19 immunisation. Medical history included arterial hypertension, state after rectum carcinoma from 2008, heart failure from 2008, chronic renal insufficiency from 2008, absolute arrhythmia from 2008. Historical vaccine included first dose of bnt162b2 (COMIRNATY) intramuscular on 16Feb2021 (Batch/Lot Number: Unknown) for covid-19 immunisation. Concomitant medications included furosemide (FUROSEMID); sodium picosulfate; candesartan; bisoprolol; apixaban; amlodipine; all taken for an unspecified indication, start and stop date were not reported. The patient experienced thrombocytopenia until 2/nl on 30Mar2021. Event seriousness criteria was death. Treatment received for the adverse event included imungglobulines and romiplostim. The lab test included sars-cov-2 test: negative on 25Mar2021. The patient died on 25Apr2021. Cause of death was reported as suspicion on intracerebral bleeding. An autopsy was not performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on chronological connection to the vaccine, a causal relationship between events thrombocytopenia and intracerebral bleeding and BNT162B2 (COMIRNATY) vaccine 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: suspicion on intracerebral bleeding; Thrombocytopenia until 2/nl


VAERS ID: 1347948 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-26
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Antibody test, Auscultation, Autoantibody positive, Autopsy, Biopsy lung, Blood creatinine, Blood lactate dehydrogenase, Blood pressure measurement, Blood sodium, Body temperature, C-reactive protein, COVID-19, Chest X-ray, Colonoscopy, Diarrhoea, Drug ineffective, Endoscopy upper gastrointestinal tract, Haemoglobin, Hypernatraemia, Laboratory test, Oxygen saturation, Platelet count, Renal failure, Respiratory failure, SARS-CoV-2 test, Ultrasound abdomen, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Chronic venous insufficiency; Dementia; Prostate carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210202; Test Name: (nucleocapsid) NCP- IgG/IgM; Result Unstructured Data: Test Result:not elicited (<0.1 U/ml); Comments: not elicited (<0.1 U/ml, reference value $g1.0 U/ml; Roche ECLIATM); Test Date: 20210126; Test Name: Antigen test; Result Unstructured Data: Test Result:were negative; Test Date: 20210202; Test Name: lung auscultation; Result Unstructured Data: Test Result:displayed crackles; Test Date: 20210202; Test Name: antibody response; Result Unstructured Data: Test Result:8.7; Comments: 8.7 U/ml, reference value <0.8-1.2 U/ml; Roche ECLIATM; Test Date: 2021; Test Name: Postmortem study; Result Unstructured Data: Test Result:revealed acute bilateral bronchopneumonia with abs; Comments: revealed acute bilateral bronchopneumonia with abscesses, sometimes being surrounded by bacterial cocci (Figure 1). There were no findings of commonly described manifestations of COVID-19-associated pneumonitis. In the heart, we found biventricular hypertrophy (weight 580 g) and histologically, we diagnosed ischemic cardiomyopathy. We detected amyloidosis of the transthyretin type in the heart and to a lesser extent in the lungs. The kidneys revealed both chronic damage with arteriolosclerosis and interstitial fibrosis, and acute renal failure with hydropic tubular degeneration. The examination of the brain revealed a left parietal pseudocystic tissue necrosis, which was diagnosed as an old infarction area.; Test Date: 20210131; Test Name: Lung uscultation; Result Unstructured Data: Test Result:Lung uscultation with any pathological signs, hype; Comments: Lung uscultation with any pathological signs, hypernatremia.; Test Date: 20210126; Test Name: Creatinine; Test Result: 1.91 mg/dl; Comments: day 18; Test Date: 20210127; Test Name: Creatinine; Test Result: 1.78 mg/dl; Comments: day 19; Test Date: 20210131; Test Name: Creatinine; Test Result: 2.04 mg/dl; Comments: day 23; Test Date: 20210202; Test Name: Creatinine; Test Result: 2.17 mg/dl; Comments: day 25; Test Date: 20210203; Test Name: Creatinine; Test Result: 3.23 mg/dl; Comments: day 26; Test Date: 2021; Test Name: creatinine serum levels; Result Unstructured Data: Test Result:increased; Test Date: 20210126; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:179 IU/l; Comments: day 18; Test Date: 20210127; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:165 IU/l; Comments: day 19; Test Date: 20210203; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:439 IU/l; Comments: day 26; Test Date: 20210123; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/70 mmHg; Comments: day 15; Test Date: 20210126; Test Name: Blood pressure; Result Unstructured Data: Test Result:187/83 mmHg; Comments: day 18; Test Date: 20210131; Test Name: Blood pressure; Result Unstructured Data: Test Result:180/80 mmHg; Comments: day 23; Test Date: 20210201; Test Name: Blood pressure; Result Unstructured Data: Test Result:166/73 mmHg; Comments: day 24; Test Date: 20210202; Test Name: Blood pressure; Result Unstructured Data: Test Result:160/80 mmHg; Comments: day 25; Test Date: 20210126; Test Name: Sodium; Result Unstructured Data: Test Result:138 mmol/L; Comments: day 18; Test Date: 20210127; Test Name: Sodium; Result Unstructured Data: Test Result:138 mmol/L; Comments: day 19; Test Date: 20210131; Test Name: Sodium; Result Unstructured Data: Test Result:154 mmol/L; Comments: day 23; Test Date: 20210201; Test Name: Sodium; Result Unstructured Data: Test Result:155 mmol/L; Comments: day 24; Test Date: 20210203; Test Name: Sodium; Result Unstructured Data: Test Result:156 mmol/L; Comments: day 26; Test Date: 20210126; Test Name: Temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: day 18; Test Date: 20210131; Test Name: Temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: day 23; Test Date: 20210201; Test Name: Temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: day 24; Test Date: 20210202; Test Name: Temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: day 25; Test Date: 20210202; Test Name: chest radiograph; Result Unstructured Data: Test Result:minimal infiltrates; Comments: minimal infiltrates. Dehydration, lung auscultation with crackles.; Test Date: 20210126; Test Name: colonoscopy; Result Unstructured Data: Test Result:demonstrated ulcerative lesion of the left colonic; Comments: were performed to investigate the cause of diarrhea further, demonstrated an ulcerative lesion of the left colonic flexure, which was histologically diagnosed as ischemic colitis; Test Date: 20210128; Test Name: colonoscopy; Result Unstructured Data: Test Result:ischemic colitis; Test Date: 20210126; Test Name: C-reactive protein; Test Result: 1.0 mg/dl; Comments: day 18; Test Date: 20210127; Test Name: C-reactive protein; Test Result: 0.8 mg/dl; Comments: day 19; Test Date: 20210131; Test Name: C-reactive protein; Test Result: 2.0 mg/dl; Comments: day 23; Test Date: 20210203; Test Name: C-reactive protein; Test Result: 8.8 mg/dl; Comments: day 26; Test Date: 20210126; Test Name: Gastroscopy; Result Unstructured Data: Test Result:mild gastritis; Comments: (mild gastritis), were performed to investigate the cause of diarrhea further; Test Date: 20210126; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.4 g/dl; Comments: day 18; Test Date: 20210127; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.1 g/dl; Comments: day 19; Test Date: 20210128; Test Name: Hemoglobin; Result Unstructured Data: Test Result:7.2 g/dl; Comments: day 20; Test Date: 20210131; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.0 g/dl; Comments: day 23; Test Date: 20210202; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.6 g/dl; Comments: day 25; Test Date: 20210203; Test Name: Hemoglobin; Result Unstructured Data: Test Result:9.3 g/dl; Comments: day 26; Test Date: 20210126; Test Name: Laboratory testing; Result Unstructured Data: Test Result:revealed hypochromic anemia and increased creatini; Comments: revealed hypochromic anemia and increased creatinine serum levels; Test Date: 20210126; Test Name: Oxygen saturation; Test Result: 97 %; Comments: day 18; Test Date: 20210202; Test Name: Oxygen saturation; Test Result: 97 %; Comments: day 25 97%+2l Q2; Test Date: 20210126; Test Name: Platelet count; Result Unstructured Data: Test Result:267; Comments: /nl, day18; Test Date: 20210127; Test Name: Platelet count; Result Unstructured Data: Test Result:263; Comments: day 19; Test Date: 20210128; Test Name: Platelet count; Result Unstructured Data: Test Result:262; Comments: day 20; Test Date: 20210131; Test Name: Platelet count; Result Unstructured Data: Test Result:254; Comments: day 23; Test Date: 20210202; Test Name: Platelet count; Result Unstructured Data: Test Result:204; Comments: day 25; Test Date: 20210203; Test Name: Platelet count; Result Unstructured Data: Test Result:196; Comments: day 26; Test Date: 20210126; Test Name: biopsy/SARS-CoV-2/polymerase chain reaction PCR; Result Unstructured Data: Test Result:was negative for SARS-CoV-2; Test Date: 20210126; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Antigen-test: negative PCR-test: negative; Comments: day 18; Test Date: 20210128; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:PCR-test: negative; Comments: day 20; Test Date: 20210201; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: positive SARS-CoV-2 RT-PCR test (Ct,15); Test Date: 20210202; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:RT-PCR-test: positive (Ct, 20); Comments: day 25; Test Date: 20210127; Test Name: abdominal ultrasound; Result Unstructured Data: Test Result:unknown result; Test Date: 20210126; Test Name: White-cell count; Result Unstructured Data: Test Result:6.6; Comments: /nl, day 18; Test Date: 20210127; Test Name: White-cell count; Result Unstructured Data: Test Result:7.1; Comments: day 19; Test Date: 20210128; Test Name: White-cell count; Result Unstructured Data: Test Result:12.1; Comments: day 20; Test Date: 20210131; Test Name: White-cell count; Result Unstructured Data: Test Result:13.5; Comments: day 23; Test Date: 20210202; Test Name: White-cell count; Result Unstructured Data: Test Result:9.2; Comments: day 25; Test Date: 20210203; Test Name: White-cell count; Result Unstructured Data: Test Result:15.2; Comments: day 26
CDC Split Type: DEPFIZER INC2021577668

Write-up: received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later /tested SARS-CoV-2 positive; received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later /tested SARS-CoV-2 positive; the patient died from acute renal and respiratory failure on the following day; the patient died from acute renal and respiratory failure on the following day; hypernatremia; Anemia; worsening diarrhea; This is a literature report from a publication. We report on an 86-year-old male resident of a retirement home who received vaccine against SARS-CoV-2. Past medical history included systemic arterial hypertension, chronic venous insufficiency, dementia and prostate carcinoma. On January 9, 2021, the man received lipid nanoparticle-formulated, nucleosidemodified RNA vaccine BNT162b2 in a 30 mg dose. On that day and in the following 2 weeks, he presented with no clinical symptoms (Table 1). On day 18 (26Jan2021), he was admitted to hospital for worsening diarrhea. Since he did not present with any clinical signs of COVID- 19, isolation in a specific setting did not occur. Laboratory testing revealed hypochromic anemia and increased creatinine serum levels. Antigen test and polymerase chain reaction (PCR) for SARSCoV-2 were negative. Gastroscopy and colonoscopy were performed to investigate the cause of diarrhea further. Colonoscopy, in particular, demonstrated an ulcerative lesion of the left colonic flexure, which was histologically diagnosed as ischemic colitis. PCR-analysis on biopsy specimens, following a previously reported method, was negative for SARS-CoV-2. Treatment was supportive with mesalazine and intravenous iron substitution. Subsequently, the patient''s condition deteriorated under the development of renal insufficiency. On day 24 (01Feb2021), a patient in the same hospital room as our case tested positive for SARS-CoV-2. On day 25 (02Feb2021), our patient tested SARS-CoV-2 positive by real-time PCR (RT-PCR), with a low cycle threshold (Ct) value indicating high virus load. On further analysis of the swab sample, there was no evidence for mutant SARS-CoV-2 variants B.1.1.7, B.1.351 or B.1.1.28.1. Taken together, it appears the patient became infected from the patient in his hospital room. Our patient now presented with fever and respiratory discomfort, and lung auscultation displayed crackles. Despite starting supplemental oxygen (2L per minute) and antibiotic therapy by ceftriaxone, the patient died from acute renal and respiratory failure on the following day. Immunogenicity assessment by measuring spike protein (S1) antigen-binding immunoglobulin (Ig) G in the serum samples obtained at day 25 (02Feb2021) showed antibody response (8.7 U/ml, reference value <0.8-1.2 U/ml; Roche ECLIATM), while (nucleocapsid) NCP- IgG/IgM was not elicited (<0.1 U/ml, reference value $g1.0 U/ml; Roche ECLIATM). These results indicate that the patient had already developed relevant immunogenicity through vaccination. Postmortem study revealed acute bilateral bronchopneumonia with abscesses, sometimes being surrounded by bacterial cocci (Figure 1). There were no findings of commonly described manifestations of COVID-19-associated pneumonitis. In the heart, we found biventricular hypertrophy (weight 580 g) and histologically, we diagnosed ischemic cardiomyopathy. We detected amyloidosis of the transthyretin type in the heart and to a lesser extent in the lungs. The kidneys revealed both chronic damage with arteriolosclerosis and interstitial fibrosis, and acute renal failure with hydropic tubular degeneration. The examination of the brain revealed a left parietal pseudocystic tissue necrosis, which was diagnosed as an old infarction area. Figure 1 showed that synopsis of the relevant histological findings and the results of molecular mapping is presented. The histomorphology is obtained by standard hematoxylin and eosin reaction, except for the myocardium on the right side (Congo red staining). The magnification is shown by bars. Note that in the lungs, we also observed colonies of cocci (arrow) in granulocytic areas. In addition, the results of molecular mapping are given as evaluated cycle threshold values of the real-time polymerase chain reaction for SARSCoV- 2. Note that only in the olfactory bulb and the liver SARS-CoV-2 could not be detected. Table 1 showed Summary of major features of the patient''s history, clinical symptoms and laboratory findings, including SARS-CoV-2 testing (reference values given in brackets). On day1 (09Jan2021), the patient vaccination, No relevant symptoms recorded. On day 15 (23Jan2021), the patient collapse during breakfast and no further relevant symptoms recorded, blood pressure (mmHg) 130/70. On day 18 (26Jan2021), the patient admission to hospital; gastroscopy (mild gastritis) and diarrhea. The temperature (C) was 36.4, blood pressure (mmHg) 187/83, Oxygen saturation (SpO2) 97%, SARS-CoV-2 test: Antigen-test: negative PCR-test: negative. White-cell count (4-9/nl): 6.6. Platelet count (140-400/nl): 267. Hemoglobin (14.0-8.0 g/dl): 7.4. Lactate dehydrogenase (135-250 U/L): 179. Creatinine (0.7-1.2 mg/dl): 1.91. C-reactive protein (<0.5 mg/dl): 1.0. Sodium (135-145 mmol/l): 138. On day 19 (27Jan2021), the patient had abdominal ultrasound, initiating intravenous iron application. The patient had anemia. White-cell count (4-9/nl): 7.1. Platelet count (140-400/nl): 263. Hemoglobin (14.0-8.0 g/dl): 7.1. Lactate dehydrogenase (135-250 U/L): 165. Creatinine (0.7-1.2 mg/dl): 1.78. C-reactive protein (<0.5 mg/dl): 0.8. Sodium (135-145 mmol/l): 138. On day 20 (28Jan2021): the patient had colonoscopy (ischemic colitis), initiating mesalazine. Still had anemia. SARS-CoV-2 test: PCR-test: negative. White-cell count (4-9/nl): 12.1. Platelet count (140-400/nl): 262. Hemoglobin (14.0-8.0 g/dl): 7.2. On day 23 (31Jan2021): the patient had acute renal insufficiency, initiating intravenous glucose application. Lung uscultation with any pathological signs, hypernatremia. The temperature (C) was 36.8. Blood pressure (mmHg) 180/80. White-cell count (4-9/nl): 13.5. Platelet count (140-400/nl): 254. Hemoglobin (14.0-8.0 g/dl): 8.0. Creatinine (0.7-1.2 mg/dl): 2.04. C-reactive protein (<0.5 mg/dl): 2.0. Sodium (135-145 mmol/l): 154. On day 24 (01Feb2021): Patient in same hospital room has positive SARS-CoV-2 RT-PCR test (Ct,15) and hypernatremia. The temperature (C) was 36.2. Blood pressure (mmHg) 166/73. Sodium (135-145 mmol/l): 155. On day 25 (02Feb2021): Patient somnolent, initiating antibiotic therapy, chest radiograph with minimal infiltrates. Dehydration, lung auscultation with crackles. The temperature (C) was 38.8, blood pressure (mmHg) 160/80, Oxygen saturation (SpO2) 97% + 2l O2, SARS-CoV-2 test: RT-PCR-test: positive (Ct, 20). White-cell count (4-9/nl): 9.2. Platelet count (140-400/nl): 204. Hemoglobin (14.0-8.0 g/dl): 8.6. Creatinine (0.7-1.2 mg/dl): 2.17. On day 26 (03Feb2021): the patient death at 14:30 due to acute renal and respiratory failure. White-cell count (4-9/nl): 15.2. Platelet count (140-400/nl): 196. Hemoglobin (14.0-8.0 g/dl): 9.3. Lactate dehydrogenase (135-250 U/L): 439. Creatinine (0.7-1.2 mg/dl): 3.23. C-reactive protein (<0.5 mg/dl): 8.8. Sodium (135-145 mmol/l): 156. We conducted molecular mapping of 9 different anatomical parts of formalin-fixed paraffin-embedded tissue as previously described. RNA was extracted from paraffin sections using the specific method. Multiplex RT-PCR analysis targeted 2 independent genes of the SARS-CoV-2-genome (Fluorotype SARS-CoV-2 plus Kit): RNA-dependent RNA polymerase (Target 1) and nucleopeptide (Target 2). The negative cut-off value was Ct $g45. We examined 9 different tissue samples for known and relevant pathways of virus spreading in the human body (Figure 1). To prevent cross-contamination, each specimen was directly embedded in separate tissue cassettes and separately fixed in 4% phosphate-buffered saline-buffered formalin. We demonstrated viral RNA in nearly all organs examined except for the liver and the olfactory bulb (Figure 1). A detailed autopsy study including molecular virus mapping of a patient vaccinated against SARS-CoV-2 with a positive SARS-CoV-2 test post-vaccination has not previously been reported, to the authors'' knowledge. We suggest that a single treatment with BNT162b2 RNA vaccine elicited significant immunogenicity, as reflected in the reported spike proteinbased neutralizing IgG serum values. From the weeks before vaccination, through vaccination (day 1), to shortly before death (day 24), the patient was free of any clinical symptoms typically ascribed to COVID-19. Furthermore, blood work did not show an IgM titer that is generally observed 7-14 days after symptom onset (Kim et al., 2020). However, the patient tested SARS-CoV-2 positive. Both the Ct value measured in nasopharyngeal swab and values measured in formalin-fixed paraffinembedded autopsy specimens indicate viral load and suggest transmissibility. Because our patient died approximately 2 days after his first positive SARS-CoV-2 test result, we suppose that the molecular mapping data reflects an early stage of viral infection. An early stage of infection might also explain why different regions such as the olfactory bulb and liver were not (yet) affected by systemic viral spread. We did not observe any characteristic morphological features of COVID-19 reported in comprehensive morphological autopsy studies so far. We did not find any typical signs of diffuse alveolar damage in the lungs, but we identified extensive acute bronchopneumonia, possibly of bacterial origin. We concluded that the In summary, the results of our autopsy case study in a patient with mRNA vaccine confirm the view that by first dose of vaccination against SARS-CoV-2 immunogenicity can already be induced, while sterile immunity is not adequately developed.; Sender''s Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of BNT162B2 to the reported drug ineffective and COVID-19 cannot be ruled out. There is a reasonable possibility that the event diarrhea is related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the events "renal failure, respiratory failure, hypernatremia, and anemia" with BNT162b2 cannot be completely excluded. Possible contribution from patient''s advanced age and underlying medical conditions are assessed as possible. 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: the patient died from acute renal and respiratory failure on the following day; the patient died from acute renal and respiratory failure on the following day; COVID-19; received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks l


VAERS ID: 1347959 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   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: ESPFIZER INC2021566035

Write-up: Cardio-respiratory arrest; This is a spontaneous report received from a contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority report number is ES-AEMPS-736198. A male patient of an unspecified age received BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died of cardio-respiratory arrest in Jan2021 within 24 hours of having the vaccine administered. The patient died in Jan2021. It was unknown if an autopsy was performed. The reporter wanted to know why the reporter was not able to see in the report from the agency on adverse reactions reported in the area from 27Dec2020 to 12Jan2021, those who died after having the vaccine administered. The health center to which the reporter''s deceased uncle belonged informed reporter that they would notify the agency and, consulting the report, the reporter did not find any deaths, when the reporter''s uncle died of cardio-respiratory arrest within 24 hours of having the vaccine administered. Any explanation why the case was not included in the report, please. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1347998 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Breath sounds abnormal, Cardiac death, Dyspnoea
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 (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; FURESIS; CITALOPRAM; LYRICA; MONTELUKAST; PANADOL FORTE [PARACETAMOL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Atrial fibrillation; Coronary artery disease; Disability; Leg amputation; Loss of personal independence in daily activities; Lower limb ischaemia; Shortness of breath (Episodes of shortness of breath, swelling in the past while living in an assisted living facility); Swelling (Episodes of shortness of breath, swelling in the past while living in an assisted living facility)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021572963

Write-up: Cardiac death; Coarse breath sounds; Dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB FI-FIMEA-20212550. An 89-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number: EW4815 and expiration date not provided), via intramuscular, on 29Apr2021 (at the age of 89-year-old), at single dose, for COVID-19 immunization. Medical history included patient was multi-disabled, had been in 24-hour care for over a year, advanced Alzheimer''s disease, coronary artery disease, atrial fibrilation, acute lower limb ischaemia from Nov2019, left thigh amputation, restricted to hospital transfers. Patient had episodes of shortness of breath, swelling in the past while living in an assisted living facility. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL); furosemide (FURESIS); citalopram; pregabalin (LYRICA); montelukast; and paracetamol (PANADOL FORTE). Patient previously took first dose of BNT162B2 (COMIRNATY, lot number: EJ6134 and expiration date not provided), via unknown route of administration, on unknown date, at single dose, for COVID-19 immunization. The patient received vaccine on 29Apr2021, and later that day patient experienced cardiac death (death), coarse breath sounds (death), and dyspnoea (death). Patient had an increase in breathlessness, which was treated symptomatically (ventoline oral solution) and the dose of furosemide (FURESIS) was increased. The following day, as the symptoms persisted, an additional oral cortisone course was started, as there had been intermittent episodes of obstruction in the past, although the patient had no previous diagnosis of lung disease, but was no longer in a good enough overall health to warrant further investigation. With changes in medication, the patient''s condition improved and on 03May2021 the patient was already back to normal. On 05May2021 evening developed shortness of breath and wheezing, during the night patient received symptomatic medication, on 06May2021 morning patient exitus. The death was thought to be cardiac-related and a death certificate was issued. The situation has not yet been discussed with the infectious disease doctor, the coronary vaccine and death have a time link but no causal link was established, filing an incident report was nevertheless recommended. It was reported that it can''t be directly concluded that the drug harm was fatal, and on the other hand, the recovery from the possible harm remains a question mark. Therapeutic measures were taken as a result of events coarse breath sounds and dyspnoea. The outcome of the events were fatal. The patient died on 06May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac death; coarse breath sounds; dyspnoea


VAERS ID: 1347999 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-01-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Echocardiogram, Fatigue, Insomnia, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUODART; DICLOMEX [DICLOFENAC POTASSIUM]; METFORMIN; MAREVAN; JARDIANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (compensated diabetes); Echocardiogram; Obesity (There was a family obesity problem, and due to diet he lost 10 kg since the beginning of January.); Repeated surgical procedure (undergone 12 operations in one leg); Traffic accident (In his youth, he suffered a car accident and had a severe post-traumatic injury.); Traumatic injury (severe post-traumatic injury); Venous thrombosis (It was also treated and his general condition was pretty normal for a long time.); Venous thrombosis limb (had been diagnosed with lower limb venous stoppages)
Allergies:
Diagnostic Lab Data: Test Name: echocardiogram; Result Unstructured Data: Test Result:There was no heart failure
CDC Split Type: FIPFIZER INC2021572962

Write-up: Death; Thrombosis; Fatigue; Insomnia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number FI-FIMEA-20212565. A 64-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 26Jan2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included in his youth, he suffered a car accident and had a severe post-traumatic injury, obesity (there was a family obesity problem, and due to diet he lost 10 kg since the beginning of January), It was taken care of. For a long time everything was fine. Before coming to work in this country, he had a venous thrombosis recurred. It was also treated and his general condition was pretty normal for a long time. He had undergone 12 operations in one leg and had been diagnosed with lower limb venous stoppages. It was taken care of. For a long time everything was fine. There was compensated diabetes, there was no heart failure (he was examined in another country in autumn, had an echocardiogram, lab test) and no changes were found, just well compensated diabetes. Concomitant medications included dutasteride, tamsulosin hydrochloride (DUODART) taken for an unspecified indication, start and stop date were not reported; diclofenac potassium (DICLOMEX) taken for an unspecified indication, start and stop date were not reported; metformin taken for an unspecified indication, start and stop date were not reported; warfarin sodium (MAREVAN) taken for an unspecified indication from Jan2021 to an unspecified stop date; empagliflozin (JARDIANCE) taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 for COVID-19 vaccination on 05Jan2021. The patient experienced thrombosis (death) on 29Jan2021, fatigue (death) on 29Jan2021, insomnia (death) on 29Jan2021. The reporter stated that: My husband, specialist physician, died suddenly at home on 06Apr2021. He received Covid-19 vaccine twice in Jan2021, and the vaccine resulted in death. The whole face became blue. Was not sore. He came to his home country on holiday to get his health in order. He arrived by car himself at one. And he lived at home for another 3 days and suddenly died. Clinically it was a thrombus. He was monitoring his health. Had a lot of plans in life. After the vaccine started new symptoms in the same leg, he started using marevan (marevan was at home) and the symptoms got better, but did not completely go away. There was a lot of fatigue. The onset of insomnia. There was no reason why he could die, only COVID19 vaccine and thrombosis in the background. He always feared thrombosis. No one has said that after the vaccine there can be thrombosis. The patient died on 06Apr2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The event Death occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death; Insomnia; Fatigue; Thrombosis


VAERS ID: 1348004 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-26
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, COVID-19, Computerised tomogram, SARS-CoV-2 test positive, 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: 2021-05-06
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: AFib; Ischaemic heart disease (Stented ischemic heart disease)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Arrhythmia (complete arrhythmia by atrial fibrillation anticoagulated and treated with amiodarone); BPH (benign prostatic hyperplasia with 2 transurethral resection of the prostate); Cataract (left); Cholecystectomy; Defibrillation; Glaucoma; Hypotension (Syncope due to severe hypotension, hospitalized in 2014 with malaise); Knee meniscectomy; Malaise (Syncope due to severe hypotension, hospitalized in 2014 with malaise); Pacemaker insertion (cardiac); Parkinson''s disease; Right inguinal hernia; Syncope (Syncope due to severe hypotension, hospitalized in 2014 with malaise); Transurethral prostatectomy
Allergies:
Diagnostic Lab Data: Test Name: blood culture; Test Result: Negative ; Test Name: Computerised tomography chest scan; Result Unstructured Data: Test Result:in favour; Test Date: 20210426; Test Name: COVID-19 virus test positive; Test Result: Positive
CDC Split Type: FRPFIZER INC2021572956

Write-up: Vaccination failure; covid-19/respiratory distress; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021053331. A 93-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 31Mar2021 (Batch/Lot Number: ER9470) as single dose; dose 1 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included ongoing stented ischemic heart disease, ongoing atrial fibrillation, Syncope due to severe hypotension and hospitalized in 2014 with malaise, complete arrhythmia by atrial fibrillation anticoagulated and treated with amiodarone (defibrillation on 10Sep2014), pacemaker in 2015, benign prostatic hypertrophy (2 transurethral resections of the prostate), glaucoma, cataract left eye, cholecystectomy, appendicectomy, Right inguinal hernia cure, Meniscectomy right knee and Parkinson''s (as reported). The patient had no allergy. The patient''s concomitant medications were not reported. Patient who completed his complete vaccination schedule with Comirnaty with administration of the 2nd dose on 31Mar2021. The patient had COVID on 26Apr2021 (26 days after the 2nd dose). Computerized tomography chest scan in favour. Negative blood culture. The patient was however placed on antibiotics. Death of the patient from respiratory distress on 06May2021. Overall, vaccine failure with COVID-19 infection 26 days after the 2nd dose of Comirnaty. The patient was hospitalized due to the event. The patient underwent lab tests and procedures which included COVID-19 virus test positive on 26Apr2021. The patient died on 06May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.; Reported Cause(s) of Death: COVID-19; Distress respiratory/COVID-19


VAERS ID: 1348137 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Apnoea, Arrhythmia, Atrial fibrillation, Blood potassium, Blood sodium, Body temperature, C-reactive protein, Cardio-respiratory arrest, Computerised tomogram, Computerised tomogram head, Depressed level of consciousness, Hypernatraemia, Hypoxia, Infection, Ischaemic stroke, Lower respiratory tract congestion, Magnetic resonance imaging head, Oxygen saturation, Oxygen saturation decreased, Pyelonephritis acute, Pyrexia, SARS-CoV-2 test, Ultrasound Doppler, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-04
   Days after onset: 33
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: CANDESARTAN CILEXETIL; NORSET; RILMENIDINE; ESCITALOPRAM
Current Illness: Depression; Hip prosthesis insertion; Hypertension arterial; Knee prosthesis insertion; Shoulder tendinitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210327; Test Name: K+; Result Unstructured Data: Test Result:3.2 mmol/L; Test Date: 202103; Test Name: Hypernatraemia; Result Unstructured Data: Test Result:151 mmol/L; Test Date: 20210327; Test Name: body temperature; Result Unstructured Data: Test Result:febrile; Test Date: 202103; Test Name: CT thorax; Result Unstructured Data: Test Result:absence of pneumonia; Comments: absence of pneumonia; Test Date: 202103; Test Name: CT cerebral; Result Unstructured Data: Test Result:absence of hemorrhagic transformation; Comments: absence of hemorrhagic transformation; Test Date: 20210327; Test Name: CRP; Result Unstructured Data: Test Result:17 mg/l; Test Date: 20210327; Test Name: mri cerebral; Result Unstructured Data: Test Result:Semi-recent ischemic stroke; Comments: Semi-recent ischemic stroke of the right anterior cerebral territory with a long-standing ischemic history of the right posterior cerebral territory, multiple intracranial stenoses. ruled out a haemorrhagic transformation; Test Date: 20210327; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:desaturation; Test Date: 20210327; Test Name: PCR COVID; Test Result: Negative ; Test Date: 20210327; Test Name: Doppler of the neck vessels; Result Unstructured Data: Test Result:Multiple bilateral intracranial stenosis; Comments: Multiple bilateral intracranial stenosis predominantly on the right middle cerebral artery, basilar trunk not recorded.; Test Date: 20210327; Test Name: trans-thoracic echocardiography; Result Unstructured Data: Test Result:undilated left ventricle; Comments: undilated left ventricle, LVEF 65%, homogeneous hypertrophic cardiomyopathy, left atrium moderately dilated
CDC Split Type: FRPFIZER INC2021572959

Write-up: Cardio-respiratory arrest; Ischemic stroke; ARDS; Obnubilation/clouding of consciousness; Hypoxaemia; AFib; febrile; arrhythmia; infectious syndrome; desaturation; bronchial congestion; respiratory pauses; Hypernatraemia at 151 mmol/L; suspected acute pyelonephritis; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is FR-AFSSAPS-NY20210892. Safety report unique identifier FR-AFSSAPS-2021047876. A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 03Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. Medical history included ongoing knee prosthesis insertion, hypertension arterial, hip prosthesis insertion, shoulder tendinitis, depression. Concomitant medications included candesartan cilexetil taken for hypertension, start and stop date were not reported; mirtazapine (NORSET) taken for depression, start and stop date were not reported; rilmenidine taken for hypertension, start and stop date were not reported; escitalopram taken for depression, start and stop date were not reported. On 27Mar2021, the patient was hospitalised for ischemic stroke. On admission, atrial fibrillation, febrile, COVID-19 polymerase chain reaction negative. Patient also experienced complete arrhythmia by atrial fibrillation, respiratory distress syndrome, hypoxemia, clouding, acute pyelonephritis and died from cardiorespiratory arrest on 04Apr2021. On 27Mar2021, brain magnetic resonance imaging showed somewhat recent ischemic stroke. Doppler ultrasound showed multiple intracranial stenosis. Echography showed left ventricular ejection fraction 65%, hypertrophic cardiomyopathy homogenous potassium was 3.2 mmol/L, C-reactive protein was 17 mg/L and Covid-19 polymerase chain reaction test was negative. During hospital stay, brain scan did not evidence hemorrahgic transformation of stroke and chest scanner did not evidence pneumopathy. Acute pyelonephritis was suspected. The patient was intubated and ventilated. The patient died from cardiorespiratory arrest on 04Apr2021. Cerebral magnetic resonance imaging: Somewhat recent ischemic stroke of the right anterior cerebral region with a long-standing ischemic history of the right posterior cerebral region, multiple intracranial stenoses. Ultrasound of the neck vessels: bilateral multiple intracranial stenosis predominantly on the right middle cerebral artery, basilar trunk not recorded. Transthoracic ultrasound: left ventricle not dilated, left ventricular ejection fraction 65%, homogeneous hypertrophic cardiomyopathy, left atrium moderately dilated. Hypokalaemia at 3.2 mmol/L. C-reactive protein 17 mg/L. Due to complete arrhythmia by atrial fibrillation, implementation of ELIQUIS, but replaced immediately by curative CALCIPARINE 12,500 IU 3/day in view of the impossibility of taking medication orally. Evolution marked by the onset of an infectious syndrome with respiratory distress, desaturation and clouding of consciousness. Hypernatraemia at 151 mmol/L. The computerised tomography brain scan ruled out a haemorrhagic transformation. A computerised tomography chest scan did not reveal pneumonia. Unfavourable evolution with sudden degradation, bronchial congestion, respiratory pauses. Initiation of a double antibiotic therapy (ceftriaxone aminoglycoside) in view of the suspicion of severe pyelonephritis. Orotracheal intubation and ventilation implemented. Cardiorespiratory arrest and death on 04Apr2021. The serious criteria of events Cardio-respiratory arrest, Ischemic stroke, ARDS, Obnubilation/clouding of consciousness, Hypoxaemia was reported as Death and Hoapitalization, event suspected acute pyelonephritis was death, event AFib was Hoapitalization. The outcome of event AFib was not recovered, events Cardio-respiratory arrest, Ischemic stroke, ARDS, Obnubilation/clouding of consciousness, Hypoxaemia was fatal, other events was unknown. The patient died on 04Apr2021. It was not reported if an autopsy was performed. Conclusion: 75-year-old woman, treated for high blood pressure and depression, vaccinated with a first dose of COMIRNATY (batch not specified), who 25 days later was hospitalised for a somewhat recent ischemic stroke with multiple (prior) intracranial stenosis. Context of complete arrhythmia by atrial fibrillation unknown previously. Unfavourable evolution with onset of an infectious syndrome, respiratory distress, desaturation and clouding. Suspicion of acute pyelonephritis. Death 8 days after admission to hospital due to cardiorespiratory arrest. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: cardiorespiratory arrest; Ischemic stroke; ARDS; Obnubilation/clouding of consciousness; Hypoxaemia; suspected acute pyelonephritis


VAERS ID: 1348163 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Circulatory collapse, Fatigue, Headache, Monoplegia, Pyrexia, Somnolence, Vertigo
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), 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 (broad), Vestibular disorders (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-15
   Days after onset: 44
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lasilacton 20/100 mg; Kalioral; Pantoloc 40 mg; Folsan 5 mg; Hepamerz; Buronil 50 mg
Current Illness: Alcoholic steatohepatitis; Ascites; Depression; Disorder sleep; Gastritis (Gastritis); Hepatic encephalopathy (hepat.); Hypercholesteraemia; Hypertension arterial; Hypokalaemia; Lumbago (Lumbago)
Preexisting Conditions: Medical History/Concurrent Conditions: Bariatric surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20211

Write-up: massive; This regulatory authority case was reported by a physician and describes the occurrence of CIRCULATORY COLLAPSE, the first episode of MONOPLEGIA and the second episode of MONOPLEGIA in a 54-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001531 and 300042721) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Depression since an unknown date, Gastritis (Gastritis) since an unknown date, Hepatic encephalopathy (hepat.) since an unknown date, Bariatric surgery, Ascites since an unknown date, Lumbago (Lumbago) since an unknown date, Disorder sleep since an unknown date, Hypertension arterial since an unknown date, Alcoholic steatohepatitis since an unknown date, Hypokalaemia since an unknown date and Hypercholesteraemia since an unknown date. Concomitant products included Lasilacton 20/100 mg for Ascites, Pantoloc 40 mg for Bariatric surgery and Gastritis, Buronil 50 mg for Disorder sleep, Kalioral for Hypokalaemia, Folsan 5 mg and Hepamerz 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. In March 2021, the patient experienced the first episode of MONOPLEGIA (seriousness criterion medically significant), the second episode of MONOPLEGIA (seriousness criterion medically significant), SOMNOLENCE, the first episode of VERTIGO, HEADACHE, FATIGUE and the first episode of PYREXIA. On 15-Apr-2021, the patient experienced the second episode of VERTIGO and the second episode of PYREXIA. 15-Apr-2021, the patient experienced HEADACHE (massive) and FATIGUE. On 15-Apr-2021 at 7:00 PM, the patient experienced CIRCULATORY COLLAPSE (seriousness criteria death and medically significant). The patient died on 15-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, last episode of MONOPLEGIA, SOMNOLENCE, HEADACHE and FATIGUE had resolved and last episode of VERTIGO, HEADACHE (massive), FATIGUE and the last episode of PYREXIA had not resolved. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered CIRCULATORY COLLAPSE, MONOPLEGIA, MONOPLEGIA, SOMNOLENCE, VERTIGO, VERTIGO, HEADACHE, HEADACHE (massive), FATIGUE, FATIGUE, PYREXIA and PYREXIA to be probably related. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to AT-BASGAGES-2021-25397, AT-BASGAGES-2021-24979 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13-MAY-2021 contains non-significant information. On 13-May-2021: Translation received on 19-MAY-2021 and does not contain any new information.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. AT-BASGAGES-2021-25397: AT-BASGAGES-2021-24979:; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1348183 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000493 / 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: 2021-04-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Peripheral arterial occlusive disease
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 a 79-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 Peripheral arterial occlusive disease. On 30-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced HAEMORRHAGIC STROKE (Haemorrhagic stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 18-Apr-2021. The reported cause of death was accident. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not reported. Treatment information was not reported. Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-2021048327; 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: Accident


VAERS ID: 1348453 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-24
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Multiple organ dysfunction syndrome, SARS-CoV-2 test, Sepsis syndrome, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HRPFIZER INC2021573863

Write-up: Vaccination failure; COVID-19 infection; Multiorgan failure; Sepsis syndrome; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HR-HALMED-300047493. An 81-years-old female patient received second dose of bnt162b2 (COMIRNATY), intramuscular on 10Feb2021 (Lot Number: EL0725) as single dose, first dose intramuscular on 19Jan2021 (Lot Number: EJ6134) as single dose both for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure, COVID-19 infection, multiorgan failure, sepsis syndrome on 24Apr2021. On 24Apr2021, she was admitted to the Hospital, a rapid antigen test was found positive. On 01May2021 she passed away - the conclusion of the discharge letter stated that the cause of death of the patient with comorbidities was COVID-19 infection, consequent sepsis syndrome, and multiorgan failure. Epidemiologically she came from a foster care where the owner and her son were positive for the SARS CoV-2 virus. The outcome of the events was fatal. The report was considered as serious with the criteria of medically significant and death. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: multiorgan failure; COVID-19 infection; consequent sepsis syndrome; Vaccination failure


VAERS ID: 1348457 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure, Circulatory collapse, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), 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: ASA PROTECT PHARMAVIT; FRONTIN; TIAPRIDAL; TRITACE HCT
Current Illness: Cerebellar ataxia; Cerebral atherosclerosis; Cognitive disturbance; Dementia NOS; Heart failure; Hospitalization; Hyperlipidaemia; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to SARS-CoV-2
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Test Result: Negative ; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021572831

Write-up: Cardio-respiratory failure; circulatory failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, the Regulatory Authority number is HU-OGYI-253621. This physician reported events for the same patient after the 1st and 2nd vaccine dose. This is the first of two reports, for the 2nd dose. A 71-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 06Apr2021 (Lot Number: EW2239) as 2nd dose, 0.3mL, single for covid-19 immunisation. Medical history included ongoing cerebellar ataxia, ongoing cerebral atherosclerosis, ongoing cognitive disturbance, ongoing dementia NOS, ongoing heart failure, ongoing hypertension and ongoing hyperlipidaemia, exposure to sars-cov-2 on 09Mar2021, hospitalization from 23Jan2021 and ongoing (due to her mental state (dementia NOS). The patient''s primary conditions worsened during her stay at the hospital. In the hospital, there were two COVID-19 PCR tests initiated, both were negative). Concomitant medications included acetylsalicylic acid (ASA PROTECT PHARMAVIT) taken for arteriosclerosis from 06Feb2021; alprazolam (FRONTIN) taken for dementia from 15Feb2021; tiapride hydrochloride (TIAPRIDAL) taken for dementia from 24Jan2021; hydrochlorothiazide, ramipril (TRITACE HCT) taken for hypertension from 26Jan2021. The patient previously received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 03Mar2021 (Lot Number: EJ6790) as 1st dose, 0.3mL, single for covid-19 immunisation and experienced diarrhea on 21Mar2021. On 14Apr2021, the patient experienced cardio-respiratory failure and circulatory failure and died. According to the patient''s death certificate, the direct cause of death was a circulatory failure, indirect causes were dementia NOS, cerebral atherosclerosis and hypertension. The outcome of the events was fatal. The patient died on 14Apr2021 due to events. It was not reported if an autopsy was performed. Sender Comment: Death after vaccination with Comirnaty concentrate for dispersion for injection is not expected. TTO is 8 days after the second dose of the vaccine. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the event is considered unlikely. The case is considered serious due to fatal outcome. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : HU-PFIZER INC-2021578972 same patient, same vaccine, different dose and events; Reported Cause(s) of Death: circulatory failure; dementia NOS; cerebral atherosclerosis; hypertension; Cardio-respiratory failure


VAERS ID: 1348459 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 42
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: NITRODERM; DIGOXIN; DETRALEX; ASA PROTECT PHARMAVIT; CONCOR; ADIMET; ROSUVASTATIN; ELIQUIS; KALIUM-R; FUROSEMIDE; PANTACID FLUX; MILURIT; COVERCARD PLUS; COVERCARD
Current Illness: Brain stem stroke; Deep venous thrombosis prophylaxis; Hypertension; Obesity; Paroxysmal atrial fibrillation; Type II diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210404; Test Name: COVID-19 rapid POC test; Result Unstructured Data: Test Result:positive
CDC Split Type: HUPFIZER INC2021572834

Write-up: COVID-19 pneumonia; COVID-19; COVID-19/COVID-19 pneumonia; heart failure; septicaemia; respiratory failure; fever; cough; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, the Regulatory Authority number is HU-OGYI-288621. A 66-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscularly on 27Mar2021 (lot number: ET7205) in the right arm at 0.3 ml single dose for COVID-19 immunization. Ongoing medical history included hypertension, Type II diabetes mellitus, paroxysmal atrial fibrillation, deep vein thrombosis prophylaxis, brain stem stoke and obesity. Concomitant medications included glyceryl trinitrate (NITRODERM), digoxin, diosmin, hesperidin (DETRALEX), acetylsalicylic acid (ASA PROTECT PHARMAVIT), bisoprolol fumarate (CONCOR), metformin hydrochloride (ADIMET), rosuvastatin, apixaban (ELIQUIS), potassium chloride (KALIUM-R), furosemide, pantoprazole sodium sesquihydrate (PANTACID FLUX), allopurinol (MILURIT), amlodipine besilate, indapamide, perindopril arginine (COVERCARD PLUS), amlodipine besilate, perindopril arginine (COVERCARD). After the vaccination in Mar2021, the patient experienced fever and cough. One week later, the patient''s condition worsened. On 04Apr2021, the patient was hospitalized. The COVID-19 rapid POC test was positive. The patient was diagnosed with COVID-19 and COVID-19 pneumonia on 04Apr2021. COVID-19 treatment was initiated, the patient''s condition worsened with time. On 13Apr2021, the patient died. According to the death certificate, direct cause of death was heart failure. The patient''s primary disease was COVID-19, which escalated to COVID-19 pneumonia, septicaemia and respiratory failure. It was unknown if autopsy was done. The outcome of events fever and cough were unknown while outcome of other events were fatal. Sender Comment: COVID-19 and COVID-19 pneumonia is not expected after Comirnaty vaccination. TTO is 8 days until COVID-19 diagnosis. Dechallenge and rechallenge were not applicable. According to the SmPC, individuals may not be fully protected until 7 days after their second dose of vaccine. The causal relationship between the suspected drug and the event is considered unlikely. The case is considered serious due to hospitalization and fatal outcome.; Reported Cause(s) of Death: heart failure; COVID-19; COVID-19 pneumonia; septicaemia; respiratory failure


VAERS ID: 1348517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-15
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210533585

Write-up: DEATH; CARDIAC ARREST; This spontaneous report received from a company representatives who reported seeing tweets and news articles concerning a 61 year old male, race and ethnicity unspecified. Initial information was processed with additional information received on 17-MAY-2021 and 18-MAY-2021. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced cardiac arrest. On 15-MAY-2021, the patient died after receiving the vaccine (date of vaccination discrepant; as some tweets note the vaccine was inoculated on the morning of death and others state the vaccine was inoculated four days before he died (11-MAY-2021)). The magistrate on duty was informed, who then arranged for his body to be taken to the morgue pending autopsy. The local health unit informed the Regional Crisis Unit of the episode. No other details on the identity of the man were communicated. In recent weeks, there were two other suspicious deaths, in which autopsy ruled out as being related to the vaccination. As the prosecutor opened an investigation into this man''s death, the investigators arranged an autopsy to establish a possible link with the vaccine. It was noted that he did not suffer from particular pathology and as ordered by the prosecutor, the body was currently in the morgue at the hospital awaiting examination. The doctors would have hypothesized a cardiac arrest. The magistrate asked for the seizure of the entire batch of vials, however, had already been almost entirely inoculated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on 15-MAY-2021. This report was serious (Death). This case, from the same reporter is linked to 20210541514 and 20210541498.; Sender''s Comments: V0: 20210533585- Covid-19 vaccine ad26.cov2.s-Death, Cardiac arrest. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DEATH; CARDIAC ARREST


VAERS ID: 1348571 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001940 / 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: 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: Obstruction bowel
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: Arresto cardiaco da causa indeterminato naturale.; This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Arresto cardiaco da causa indeterminato naturale.) in a 73-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001940) for COVID-19 immunisation. The patient''s past medical history included Obstruction bowel. On 01-May-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 01-May-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIAC ARREST (Arresto cardiaco da causa indeterminato naturale.) (seriousness criteria death and medically significant). The reported cause of death was Standstill cardiac. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medicines were reported. No treatment information were reported. Based on the current available information and temporal association between the use of the product and the cardiac arrest, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: NNI; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the cardiac arrest, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Standstill cardiac


VAERS ID: 1348575 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001442 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute pulmonary oedema, Cardiac failure, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   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: TIKLID; LETROZOLO AHCL; TOTALIP; GLURENOR; KARVEA; TILDIEM; NORVASC; LASIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20211

Write-up: Acute pulmonary edema; Consciousness loss; Decompensation cardiac; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ACUTE PULMONARY OEDEMA (Acute pulmonary edema), LOSS OF CONSCIOUSNESS (Consciousness loss) and CARDIAC FAILURE (Decompensation cardiac) in a 92-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001442) for COVID-19 vaccination. The patient''s past medical history included Aortic stenosis, Hypertension arterial and Type 2 diabetes mellitus. Concomitant products included TICLOPIDINE HYDROCHLORIDE (TIKLID), LETROZOLE (LETROZOLO AHCL), ATORVASTATIN CALCIUM (TOTALIP), GLIQUIDONE (GLURENOR), IRBESARTAN (KARVEA), DILTIAZEM HYDROCHLORIDE (TILDIEM), AMLODIPINE BESILATE (NORVASC) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication. On 31-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 01-Apr-2021, the patient experienced ACUTE PULMONARY OEDEMA (Acute pulmonary edema) (seriousness criteria death and medically significant), LOSS OF CONSCIOUSNESS (Consciousness loss) (seriousness criteria death and medically significant) and CARDIAC FAILURE (Decompensation cardiac) (seriousness criteria death and medically significant). The patient died on 01-Apr-2021. The reported cause of death was Acute pulmonary edema, Consciousness loss and Decompensation cardiac. 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 information regarding treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Live follow up received on 18-May-2021: Added Medical history and concomitant medication.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. All events retained as being cause of death with fatal outcome per assessment / reporting by Authority in SD although it is not known if cause of death has been confirmed; Reported Cause(s) of Death: Acute pulmonary edema; Consciousness loss; Decompensation cardiac


VAERS ID: 1348611 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDICOR; COUMADIN; EPLERENONE; TRIATEC [RAMIPRIL]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Extrasystole ventricular; Thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021566206

Write-up: Unexpected death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-727863. A 55-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in deltoid left on 07May2021 09:42 (Batch/Lot Number: EX7389) as 1st dose, single for covid-19 immunisation. Medical history included extrasystole ventricular and thrombosis. Concomitant medications included bisoprolol fumarate (CARDICOR) taken for ventricular extrasystoles, start and stop date were not reported; warfarin sodium (COUMADIN) taken for thrombosis, start and stop date were not reported; eplerenone taken for an unspecified indication, start and stop date were not reported; ramipril (TRIATEC) taken for an unspecified indication, start and stop date were not reported. The use of other plant-based medical products, dietary supplements is not known. The patient experienced unexpected death on 10May2021. On 12May2021 a clinical report was requested and whether an autopsy was performed. Follow up information 12May2021: The reporter referred that the patient had no history of covid and submitted the attached clinical report. The patient died on 10May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unexpected death


VAERS ID: 1348738 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Cardio-respiratory arrest, Loss of consciousness, Myocardial rupture, Pericardial effusion, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   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: Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021572908

Write-up: Ventricular fibrillation/Refractory ventricular fibrillation; Cardio-respiratory arrest; collapsed; pericardial effusion; Acute antero septal myocardial infarction; Cardiac rupture; This is a spontaneous report from a contactable pharmacist received via a regulatory authority. A 73-year-old male patient received BNT162B2 (COMIRNATY, lot number not reported), intramuscular, on 11May2021, as 1st dose, single, for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension both from unknown dates. The patient''s concomitant medications were not reported. On 14May2021 at 16:00, 3 days after the first vaccination, the patient was found collapsed by his friends while playing golf, the patient had ventricular fibrillation and cardio-respiratory arrest (VCPA). An ambulance was requested. The events resulted to emergency room visit. The events required emergency catheter treatment and resuscitation. After resuscitation, ventricular fibrillation persisted. The patient also experienced pericardial effusion, acute antero septal myocardial infarction and cardiac rupture. Because of pericardial effusion, blood transfusion and "transfusion" (as reported) were performed. However, circulation could not be controlled, and the patient died on 15May2021. The outcome of the events was fatal. The cause of death was reported as refractory ventricular fibrillation, acute antero septal myocardial infarction and cardiac rupture. Autopsy was not performed.; Sender''s Comments: Based on the available information, known drug safety profile and disease pathophysiology, the serious events are most likely related to the underlying conditions diabetes mellitus and hypertension hence unrelated to the suspect drug.; Reported Cause(s) of Death: Acute antero septal myocardial infarction; Cardiac rupture; cardio-respiratory arrest; Ventricular fibrillation/Refractory ventricular fibrillation; collapsed; pericardial effusion


VAERS ID: 1348739 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure acute, Cardio-respiratory arrest, Decreased appetite, Investigation, Malaise, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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; ROSUVASTATIN; EDIROL; ZOLPIDEM; BILANOA; AMITIZA; ALENDRONATE; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Gonarthrosis; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:37.0-37.9 Centigrade; Comments: after vaccination; Test Name: Body temperature; Result Unstructured Data: Test Result:declined to 37 Centigrade; Test Date: 20210423; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 21:00; Test Date: 20210428; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Comments: at 13:00; Test Date: 20210428; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210428; Test Name: level of consciousness; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC2021576685

Write-up: Inappetence; Cardiac failure acute; Cardio-respiratory arrest; slight vomiting; malaise; pyrexia; This is a spontaneous report from a contactable physician received via a regulatory authority. An 80-year-old female patient received the first dose of the bnt162b2 (COMIRNATY), intramuscular administered in the left arm on 23Apr2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included dementia, osteoporosis, gonarthrosis, and atrial fibrillation. The patient had no allergies to medications, food, or other products. Concomitant medications included apixaban (ELIQUIS); rosuvastatin (MANUFACTURER UNKNOWN); eldecalcitol (EDIROL); zolpidem (MANUFACTURER UNKNOWN); bilastine (BILANOA); lubiprostone (AMITIZA); alendronate sodium (MANUFACTURER UNKNOWN); lansoprazole (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced cardiac failure acute on 28Apr2021 05:00, cardio-respiratory arrest on 28Apr2021 at 3:30, pyrexia on 23Apr2021 21:00, slight vomiting on 25Apr2021 01:30, malaise on 25Apr2021 01:30, inappetence on an unspecified date. The events were, cardiac failure acute and cardio-respiratory arrest, were serious for death. The clinical course was as follows: although the patient received BNT162b2 in the afternoon of 23Apr2021, pyrexia of 37.9 degrees Centigrade was observed at 21:00 on the same date (the day of vaccination). The patient was prescribed with acetaminophen and pyrexia declined to 37 degrees Centigrade. But slight vomiting and malaise were present on 25Apr2021 at 01:30 (2 days after the vaccination). Because inappetence and malaise still continued on 26Apr2021 (3 days after the vaccination), the patient visited the hospital. Side effects by a vaccine were considered and intravenous drip at 500 ml was administered. Low grade fever and malaise were observed still thereafter, but her general condition was relatively maintained. On 28Apr2021 at 13:00 (5 days after the vaccination), although pyrexia of 38 degrees Centigrade was observed at the time of temperature check while the patient was in the bed at the facility, her blood pressure and level of consciousness were normal. Therefore, the patient was being continuously observed. On 28Apr2021 at 03:30 (5 days after the vaccination), the patient in the bed was found to be in cardio-respiratory arrest when a medical staff was patrolling. On 28Apr2021 at 05:02 (5 days after the vaccination), the patient was confirmed to be dead by the physician. Although the cause was not clear, cardiac failure acute was diagnosed as the cause of death. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of all events with treatment including intravenous drip. The outcome of the events, cardiac failure acute and cardio-respiratory arrest, was fatal. The clinical outcome of the event, pyrexia, was not recovered. The clinical outcome of the events, slight vomiting, malaise, and inappetence, was unknown. The patient died on 28Apr2021 due to cardiac failure acute and cardio-respiratory arrest. An autopsy was not performed. The batch/lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information provided, the reported cardiac failure acute and cardio-respiratory arrest are likely due to patient''s underlying atrial fibrillation and are deemed unrelated to the suspect drug. A possible contributory role of BNT162B2 cannot be excluded for the reported vomiting, malaise, decreased appetite and pyrexia considering the temporal association and known safety profile of the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure acute; Cardio-respiratory arrest


VAERS ID: 1348741 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-28
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 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: 2021-05-10
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021578608

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A 54-year-old female patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: ER7449; Expiration Date: 30Jun2021), via an unspecified route of administration, on 24Apr2021 at 15:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced subarachnoid haemorrhage on 28Apr2021 (4 days after the vaccination), which was reported as fatal. The clinical course was reported as follows: A family member reported that on 28Apr2021, the patient was taken to a hospital by ambulance due to subarachnoid haemorrhage. The patient died on 10May2021 (16 days after the vaccination). The cause of death was reported as subarachnoid haemorrhage. It was not reported if an autopsy was performed.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event subarachnoid haemorrhage cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1348742 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood chloride, Blood potassium, Blood sodium, Body temperature, Oxygen saturation
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder; Cardiac failure chronic; Cardiac failure congestive; Cerebral infarction; Choked on food; Disturbance in attention; Dysphagia; Femur fracture; Hypertension; Hypokalaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: chloride; Result Unstructured Data: Test Result:126; Test Date: 20210518; Test Name: potassium; Result Unstructured Data: Test Result:2.4; Test Date: 20210518; Test Name: sodium; Result Unstructured Data: Test Result:171; Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210520; Test Name: Body temperature; Result Unstructured Data: Test Result:in the range of 39s Centigrade; Test Date: 20210519; Test Name: SpO2; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC2021579172

Write-up: Consciousness disturbed; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21108093. An 87-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 13May2021 at 13:05 at a single dose for covid-19 immunisation. Medical history included cardiac disease, right femur fracture on 13Apr2021, dysphagia, cerebral infarction in Jan2017, mild disturbance in attention, hypertension from Aug2017 to an unknown date, cardiac failure chronic accompanied by congestive cardiac failure from Aug2017 to an unknown date, choked on food on 22Apr2021, and hypokalaemia. Concomitant medications included apixaban (ELIQUIS) taken for cardiac disease. On 18May2021 at 08:00, the patient experienced consciousness disturbed, which was serious for death. The clinical course was as follows: on 13May2021 at 13:05 (the day of vaccination), the patient received the first dose of BNT162b2. On 18May2021 at 08:00 (5 days after the vaccination), the patient experienced consciousness disturbed. On 21May2021 at 01:29 (8 days after the vaccination), the patient died of consciousness disturbed. This was further described as: after receiving the vaccination on 13May2021, no problems were noted and she was able to have meals with assistance. On 18May2021 (5 days after the vaccination), the patient did not open her eyes much even when her name was called. The blood test showed: sodium was 171, potassium was 2.4, and chloride was 126, indicating levels of hypernatraemia and hypokalaemia at which disturbed consciousness could occur. In order to correct her electrolytes quickly and distinguish among other diseases such as recurrence of cerebral infarction, admission to a medical facility was recommended. But consent to her hospitalization could not be obtained for reasons including coronavirus pandemic not allowing her family to be by the patient''s bedside in hospital at the final moment. On 19May2021, wheezing started to be noted on auscultation and this was considered to be due to worsening cardiac failure caused by cessation of oral drug treatment and start of fluid infusion. SpO2 (oxygen saturation percutaneous) decreased and oxygen at 2 L/minute was started to be nasally administered. On 20May2021, she developed pyrexia in the range of 39s degrees centigrade which was considered due to aspiration pneumonitis caused by saliva etc. On 21May2021 at 01:29 (8 days after the vaccination), the patient''s death was confirmed. The patient underwent lab tests and procedures which included body temperature: 36.6 degrees Centigrade on 13May2021 before vaccination. Therapeutic measures were taken as a result of consciousness disturbed. The clinical outcome of the event was fatal. The patient died on 21May2021 due to consciousness disturbed. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event was reported as follows: In Jan2017, the patient developed cerebral infarction, and mild disturbance in attention remained as an after effect. In Aug2017, the patient was receiving oral treatment for hypertension and cardiac failure chronic accompanied by congestive cardiac failure. On 13Apr2021, the patient was admitted to a general hospital in the city for right femur fracture. Surgery was not carried out because of her advanced age, and then she was discharged from the hospital on 20Apr2021. On 22Apr2021, she chocked on food, and at a medical university hospital resuscitation was performed. On the next day, swallowing function was evaluated and the patient was referred to the department of otolaryngology at a general hospital in the city, where no significant changes were noted in her swallowing function, and she was discharged from the hospital on 30Apr2021. At the time of discharge, hypokalaemia was pointed out. Potassium excretion by diuretics etc. used for the treatment of cardiac failure caused the occurrence of disturbed consciousness, which could be considered as another cause of the event. REPORTER COMMENT: It was assumed that either hypokalaemia which occurred under the treatment of cardiac failure or recurrence of previous cerebral infarction caused disturbed consciousness, which progressed to death. The possibility of BNT162b2 being the cause was considered extremely low; however, as there was no definite differential diagnosis owing to her family''s request not to have the patient receive active medical service and since the patient died 8 days after the vaccination, this case was reported by consent of her family. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Consciousness disturbed


VAERS ID: 1348743 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body temperature, C-reactive protein, Enterobacter sepsis, Oxygen saturation, Urinary tract infection, Urine analysis, White blood cell count
SMQs:, Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; AMBROXOL; EQUMET; CYMBALTA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cervical vertebra injury (the patient was bedridden); Chronic UTI; Colostomy; Diabetes mellitus; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210514; Test Name: Blood culture test; Result Unstructured Data: Test Result:detected Enterobacter; Test Date: 20210513; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination; Test Date: 20210514; Test Name: Body temperature; Result Unstructured Data: Test Result:39.2 Centigrade; Test Date: 20210514; Test Name: CRP; Result Unstructured Data: Test Result:9.1; Test Date: 20210514; Test Name: SpO2; Test Result: 88 %; Test Date: 20210514; Test Name: Urinalysis; Result Unstructured Data: Test Result:revealed leukocytosis; Test Date: 20210514; Test Name: WBC; Result Unstructured Data: Test Result:52200
CDC Split Type: JPPFIZER INC2021579330

Write-up: Sepsis/Blood culture test conducted at another hospital at this time detected Enterobacter; Urinary tract infection; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number is v21107820. A 71-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EY2173; Expiration Date: 31Aug2021), via an unspecified route of administration on 13May2021 at 11:04 at a single dose for covid-19 immunisation. Medical history included cervical vertebra injury in 1990 (patient was bedridden), colostomy in 2002, diabetes mellitus, chronic urinary tract infection, and repeated episodes of pneumonia aspiration. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN); ambroxol (MANUFACTURER UNKNOWN); metformin hydrochloride/vildagliptin (EQUMET); duloxetine hydrochloride (CYMBALTA). On 14May2021 08:00, the patient experienced sepsis and urinary tract infection, which were serious for death and required emergency room visit. The course of the event was as follows: Body temperature was 36.5 degrees Centigrade on 13May2021 before vaccination. on 13May2021 at 11:04 (the day of vaccination), the patient received?the first dose of BNT162b2. On 14May2021 at 08:00 (20 hours 56 minutes after the vaccination), the patient experienced sepsis and urinary tract infection. On 14May2021 at 08:00, the patient developed complexion ill and laboured respiration. SpO2 was 88% and body temperature was 39.2 degrees Centigrade. Oxygen administration and infusion were initiated. Blood test showed WBC 52200 and CRP 9.1. Urinalysis revealed leukocytosis. The patient was taken to another hospital by ambulance for further examination. The patient was diagnosed with urinary tract infection and returned to the reporting hospital on the same day. Blood culture test conducted at another hospital at this time detected Enterobacter. The patient was treated with antibiotic. On 17May2021, pyrexia tended to resolve; however, on 19May2021 at 09:00, the patient died. Therapeutic measures were taken as a result of sepsis and urinary tract infection. On 19May2021 (6 days after the vaccination), the outcome of the events was fatal. The patient died on 19May2021 due to sepsis and urinary tract infection. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible causes of the event such as any other diseases were urinary tract infection and sepsis. REPORTER COMMENT: There was a finding of urinary tract infection; thus, causality between the events and COMIRNATY was considered as unrelated. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on information provided, the events of sepsis and urinary tract infection were more likely related to underlying disease of diabetes mellitus, chronic urinary tract but unrelated to bnt162b2 (COMIRNATY) in concurred with the assessment of reporting physician.; Reported Cause(s) of Death: Urinary tract infection; Sepsis


VAERS ID: 1348744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral artery embolism, Cerebral infarction, Malaise
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: ACETAMINOPHEN; FERROUS CITRATE SODIUM; AMLODIPINE
Current Illness: Anaemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021580543

Write-up: became unwell; Cerebral infarction; Cerebral embolism; This is a spontaneous report from a contactable pharmacist. A 91-year-old female patient received the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 28Apr2021 (Lot Number: ET9096; Expiration Date: 31Jul2021) as a single dose for COVID-19 immunisation. Medical history included ongoing hypertension and ongoing anaemia. Concomitant medications included acetaminophen (MANUFACTURER UNKNOWN), ferrous citrate sodium (MANUFACTURER UNKNOWN), and amlodipine (MANUFACTURER UNKNOWN). The patient experienced cerebral infarction and cerebral embolism in May2021, which were reported as fatal. The patient also became unwell on 21May2021. The clinical course was reported as follows: On 21May2021 (23 days after vaccination), when the patient was going to receive the second dose of BNT162b2, the patient became unwell and was transported to the reporting hospital. The patient developed cerebral embolism and cerebral infarction. After that, the patient died without recovery. The clinical outcome of cerebral infarction and cerebral embolism was fatal and of became unwell was unknown. The patient died in May2021. The causes of death were reported as cerebral infarction and cerebral embolism. It was not reported if an autopsy was performed. The causality of the event was not provided, and the pharmacist commented that BNT162B2 could not be excluded from the cause of the events.; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events cerebral embolism and cerebral infarction cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cerebral embolism; Cerebral infarction


VAERS ID: 1348746 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Appetite impaired; Dehydration; Mitral valve incompetence; Myocardial infarction old; Renal failure chronic
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Body temperature; Result Unstructured Data: Test Result:35.9 Centigrade; Comments: before vaccination; Test Date: 20210516; Test Name: CT of the head, chest and abdomen; Result Unstructured Data: Test Result:revealing marked calcification; Comments: but showing no abnormalities that could be the cause of death
CDC Split Type: JPPFIZER INC2021585056

Write-up: Cardiac failure acute; Unconscious; CPR; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number is v21108130. A 92-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 15May2021 at 09:30 at a single dose for covid-19 immunisation. Medical history included myocardial infarction old, mitral valve incompetence, renal failure chronic, tended to be dehydrated, and had declining appetite. Family history was not reported. The patient''s concomitant medications were not reported. On 16May2021 at 20:00, the patient experienced cardiac failure acute, unconscious, and CPR (cardio-respiratory arrest), which were serious for death and required emergency room visit. The course of the events was as follows: on 15May2021 around 09:30 (the day of vaccination), the patient received the first dose of BNT162b2. On 16May2021 around 20:00 (1 day after the vaccination), the patient experienced cardiac failure acute. On 16May2021 (1 day after the vaccination) until around 19:40, the patient had remained unchanged, having his dinner (rice porridge) with the assistance of his son. On the same day around 20:00, the patient was found unconscious on the bed by his family. Ambulance crews arrived and confirmed cardiopulmonary arrest (CPA). Because do not attempt resuscitation (DNAR) was not requested, cardiopulmonary resuscitation (CPR) and adrenaline treatment were performed at the physician''s order. Around 20:46, the ambulance arrived at the hospital. CPA state and dilated pupils were noted. Thereafter, CPR was continued but could not restore spontaneous circulation; the patient was confirmed dead at 20:54. Computerised tomography (CT) of the head, chest and abdomen was performed, revealing marked calcification but showing no abnormalities that could be the cause of death on 16May2021. The direct cause of death was cardiac failure acute. The affecting diseases were myocardial infarction old, mitral valve incompetence, and renal failure chronic. Hospital visit records: The patient was regularly visiting a cardiologist and was receiving home nursing care (tended to be dehydrated and had declining appetite). The patient underwent lab tests and procedures which included body temperature: 35.9 degrees Centigrade on 15May2021 before vaccination. Therapeutic measures were taken as a result of cardiac failure acute, unconscious, and CPR (cardio-respiratory arrest). On 16May2021 around 20:54 (1 day after the vaccination), the patient died, and the outcome of the events was fatal. The patient died on 16May2021 due to cardiac failure acute, unconscious, CPR (cardio-respiratory arrest). It was not reported if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the events were unrelated to BNT162b2. Other possible cause(s) of the events such as any other diseases were myocardial infarction old, mitral valve incompetence, and renal failure chronic. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information provided, the reported events are likely due to patient''s underlying history of myocardial infarction old, mitral valve incompetence, and renal failure chronic and were unrelated to the suspect drug.; Reported Cause(s) of Death: Cardiac failure acute; unconscious; CPR


VAERS ID: 1348807 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder (decreased heart function); Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021573248

Write-up: Death; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB NL-LRB-00542864. A 74-year-old male patient received the first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 15Apr2021 (Lot Number: unknown) as 0.3ml single for COVID-19 immunisation. Medical history included lung cancer, heart disorder (decreased heart function). Patient had no previous COVID-19 infection. Concomitant medications included unspecified various medications. The patient experienced death (death) on 16Apr2021. Time interval between beginning of drug administration and start of reaction was 15 hours. It was not reported if an autopsy was performed. Outcome of the event was fatal. Reporter''s comments: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. Adverse Event: Approx. 15 hours after first vaccination. Previous COVID-19 infection: No. Notifier''s note: The person in question indicated to the injection site that he was taking various medications to treat his conditions and whether there were any risks involved. That was not the case according to the person who made the injection. No follow-up attempts possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Adverse Event: Approx. 15 hours after first vaccination. Previous COVID-19 infection: No. Notifier''s note: The person in question indicated to the injection site that he was taking various medications to treat his conditions and whether there were any risks involved. That was not the case according to the person who made the injection.; Reported Cause(s) of Death: Death


VAERS ID: 1348825 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Laboratory 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Test; Result Unstructured Data: Test Result:Positive contamination
CDC Split Type: NLPFIZER INC2021580078

Write-up: Corona after full vaccination, 1.5 week after positive contamination; Corona after full vaccination, 1.5 week after positive contamination; This is a spontaneous report from a contactable consumer. An 89-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history was not reported. There were no concomitant medications. The patient experienced corona after full vaccination, 1.5 week after positive contamination, on an unspecified date, with fatal outcome. The patient died on an unspecified date and it was unknown if an autopsy was performed. It was specified that the patient was fully vaccinated (no details provided) and he was fully healthy, had never been in a hospital and was working in his garden daily. The patient underwent lab tests and procedures which included laboratory test: positive contamination on an unspecified date. The information on the batch number has been requested.; Reported Cause(s) of Death: Corona


VAERS ID: 1348900 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021574656

Write-up: COVID-19; COVID-19; This is a spontaneous report from a contactable consumer received from a female patient of an unspecified age received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Reporter called, he didin''t want to give details, he didn''t want to complain, but said he wouldn''t get vaccinated himself after what happened. He just wanted to convey that his wife died a month after she was vaccinated with the first dose of the vaccine, he did not provide the date of the patient''s vaccination (no specific dates). In the hospital, she was under a ventilator. He mentioned that it would soon be a month after his wife died. The spouse did not suffer from anything before vaccination. He does not consent to contact. The patient died on an unspecified date. Cause of death was COVID-19. 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: COVID-19


VAERS ID: 1348918 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021579780

Write-up: brain clot; This is a spontaneous report from a contactable nurse downloaded from the Agency Regulatory Authority-WEB, PT-INFARMED-R202105-1467. A 79-year-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EY2172), via intramuscular, on 30Apr2021 at 0.3 mL single for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 at dose of 0.3 mL single administered on 03Apr2021 for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient did not experience any adverse reaction. No history of clots or thrombus, being autonomous and independent. On 12May2021, the patient developed brain clot. On 14May2021, the patient died due to the event. It was unknown if an autopsy was performed. Reporter''s comments: Other information-2nd dose of the vaccine on the indicated date. No history of cloth or thrombus. Autonomous and independent. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: brain clot


VAERS ID: 1348948 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-04-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Interstitial lung disease, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (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), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALFUZOSIN STADA; CANDESARTAN SANDOZ; AMLODIPIN BLUEFISH; BISOPROLOL SANDOZ; ATORVASTATIN TEVA; ELIQUIS
Current Illness: Cough; Hypertension; Paroxysmal atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: negative
CDC Split Type: SEMODERNATX, INC.MOD20211

Write-up: Respiratory failure; ; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-May-2021 and was forwarded to Moderna on 17-May-2021. This regulatory authority case was reported by a physician and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure) and INTERSTITIAL LUNG DISEASE in a 90-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. Concurrent medical conditions included Paroxysmal atrial fibrillation, Hypertension and Cough. Concomitant products included ALFUZOSIN HYDROCHLORIDE (ALFUZOSIN STADA), CANDESARTAN CILEXETIL (CANDESARTAN SANDOZ), AMLODIPINE BESILATE (AMLODIPIN BLUEFISH), BISOPROLOL FUMARATE (BISOPROLOL SANDOZ), ATORVASTATIN CALCIUM (ATORVASTATIN TEVA) and APIXABAN (ELIQUIS) for an unknown indication. In March 2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria death and medically significant) and INTERSTITIAL LUNG DISEASE (seriousness criteria death and medically significant). The reported cause of death was Respiratory failure and Interstitial lung disease. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 test: negative (Negative) negative. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unknown if an autopsy was performed to confirm cause of death.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. It is unknown if an autopsy was performed to confirm cause of death.; Reported Cause(s) of Death: Respiratory failure; Interstitial lung disease


VAERS ID: 1348959 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021572965

Write-up: pulmonary embolism from suspected DVT (Deep Vein Thrombosis); pulmonary embolism from suspected DVT (Deep Vein Thrombosis); This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-038674. A 67-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 2021 (Batch/Lot Number: REQUESTED) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pulmonary embolism from suspected deep vein thrombosis in 2021. Reported as: According to the reporter the woman was healthy. The woman died in her home 2-3 days after the vaccination with dose 1 of Comirnaty. Reported suspect adverse event was pulmonary embolism from suspected DVT (Deep Vein Thrombosis). The cause of death was pulmonary embolism from suspected DVT (Deep Vein Thrombosis), according to the reporter. Report assessed as serious, death. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: pulmonary embolism from suspected DVT (Deep Vein Thrombosis); pulmonary embolism from suspected DVT (Deep Vein Thrombosis)


VAERS ID: 1348968 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Condition aggravated, 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: Medical History/Concurrent Conditions: Chronic disease (unspecified)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKMODERNATX, INC.MOD20211

Write-up: Death; vaccination may have contributed to the overall deterioration in health; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) and CONDITION AGGRAVATED (vaccination may have contributed to the overall deterioration in health) in an elderly patient of an unknown gender who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Chronic disease (unspecified). On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage form. On an unknown date, the patient experienced DEATH (Death) (seriousness criteria death and medically significant) and CONDITION AGGRAVATED (vaccination may have contributed to the overall deterioration in health) (seriousness criterion death). The reported cause of death was chronical diseases. An autopsy was performed. Not Provided The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. No treatment or concomitant products reported Reporter did not allow further contact; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: chronical diseases


VAERS ID: 1348972 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Body temperature increased, COVID-19 pneumonia, Cough, Drug ineffective, Dyspnoea, Fatigue, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 46
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: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: body temperature; Result Unstructured Data: Test Result:increased; Test Date: 20210401; Test Name: Oxygen saturation; Test Result: 68 %; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Test Result:positive; Test Name: SARS-CoV-2 IgM antibody test; Result Unstructured Data: Test Result:positive; Test Date: 20210401; Test Name: COVID-19 antigen test; Result Unstructured Data: Test Result:negative; Test Date: 20210401; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210403; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative
CDC Split Type: SKPFIZER INC2021572701

Write-up: Oxygen saturation decreased; COVID-19 pneumonia; COVID-19 pneumonia; Body temperature increased; Cough; Fatigue; Breathing difficult; This is a spontaneous report received from a contactable consumer and a physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is SK-SUKLSK-20214482. A 73-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly at the age of 73 years old on 23Mar2021 at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus. Concomitant medications were not reported. In the evening after the vaccine administration on 23Mar2021, the patient experienced body temperature increased. In the following days in Mar2021, the patient experienced cough, fatigue and breathing difficult. Due to the deteriorating condition, on 29Mar2021 a general practitioner prescribed antibiotics (unspecified). On 01Apr2021, the oxygen saturation was 68 % and the patient was admitted to hospital. COVID-19 antigen test with a negative result was performed in an ambulance, then COVID-19 PCR test with a negative result was performed in the hospital on 01Apr2021 and another COVID-19 PCR test with a negative result was performed on 03Apr2021. On 17Apr2021, the patient died. A contacted physician (pathologist) added: the autopsy was not performed. The causality was assessed as not related to vaccination (unlikely). The patient was according to COVID-19 PCR test negative, but SARS-CoV-2 IgG and IgM antibody tests were positive. The cause of death was reported as COVID-19 pneumonia on 17Apr2021. The outcome of event COVID-19 pneumonia was fatal, outcome of other events were unknown. Sender Comment: This case was verified by the physician (pathologist) and the causality was assessed as not related to vaccination (unlikely). Information on the lot/batch number has been requested.; Reported Cause(s) of Death: COVID-19 pneumonia


VAERS ID: 1349719 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-24
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210545674

Write-up: DEATH; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 22-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. The patient died two days after receiving vaccination cause of death is unknown. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210545674-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1350128 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiomegaly, Pulmonary embolism
SMQs:, Cardiac failure (broad), Embolic and thrombotic events, venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RILUZOL; VENLAFAXIN; RIVOTRIL
Current Illness: Frontotemporal dementia (Primary lateral sclerosis with dementia of the frontotemporal type); Primary lateral sclerosis (Primary lateral sclerosis with dementia of the frontotemporal type)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021579517

Write-up: Cardiac dilatation bilateral; Central pulmonary artery embolism bilateral + peripheral pulmonary artery embolism right; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB-2021-27657. This serious spontaneous report. A 65 years old female patient received the first dose of BNT162B2 (COMIRNATY, batch/lot number: EX0893) via unspecified route of administration on 01May2021 at single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: frontotemporal dementia (continuing), primary lateral sclerosis (continuing). Concomitant medications included riluzol oral 50 mg for primary lateral sclerosis (PLS), venlafaxine hydrochloride (VENLAFAXINE), clonazepam (RIVOTRIL). 04May2021 at 20:20 to exitus: central pulmonary artery embolism bilaterally + peripheral pulmonary artery embolism right, cardiac dilatation bilateral. Resuscitation on 04May2021. On 04May2021 20:20 the patient experienced pulmonary embolism death, cardiac dilatation. The patient''s outcome was fatal for pulmonary embolism, fatal for cardiac dilatation on 04May2021. It is unknown if autopsy was done. Sender Comment: Follow-up information has been requested. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Central pulmonary artery embolism bilateral + peripheral pulmonary artery embolism right; Cardiac dilatation bilateral


VAERS ID: 1350263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-25
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Dyspnoea, Heart rate, Palpitations, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease pulmonary (severe heart disease with pulmonary circulation restriction); Morbid obesity; Pulmonary vascular disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Embolism
Allergies:
Diagnostic Lab Data: Test Date: 20210425; Test Name: Blood pressure; Result Unstructured Data: Test Result:112/90 mmHg; Test Date: 20210425; Test Name: Heart rate; Result Unstructured Data: Test Result:102; Comments: 102/min
CDC Split Type: CZPFIZER INC2021579621

Write-up: heart palpitations; breathlessness; pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number CZ-CZSUKL-21005489. A 44-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 08Apr2021 (Batch/Lot Number: ET1831) as 1st dose, single for covid-19 immunisation. Medical history included embolism in 2017, ongoing severe heart disease with pulmonary circulation restriction, ongoing morbid obesity. The patient''s concomitant medications were not reported. Patient was complicated by breathlessness, heart palpitations, both on 25Apr2021 and she was transported to an intensive care unit by ambulance. She was operated at a cardiovascular and transplant surgery center. The patient died due to pulmonary embolism on 27Apr2021. Lab test on 25Apr2021 included blood pressure 112/90 mmHg, heart rate 102/min. The patient died on 27Apr2021. An autopsy was not performed. Outcome of heart palpitations and breathlessness was unknown. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1351732 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-11
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Haemorrhagic diathesis, Pulmonary haemorrhage, Sepsis, Vaccination site abscess
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Chronic kidney disease (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021579499

Write-up: Sepsis, hemorrhagic diateses with pulmonary bleeding, soft tissue phlegmon at the injection site; Sepsis, hemorrhagic diateses with pulmonary bleeding, soft tissue phlegmon at the injection site; Sepsis, hemorrhagic diateses with pulmonary bleeding, soft tissue phlegmon at the injection site; Sepsis, hemorrhagic diateses with pulmonary bleeding, soft tissue phlegmon at the injection site; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB. The regulatory authority report number is [DE-PEI-CADR2021072436] and Safety Report Unique Identifier [DE-PEI-202100065804]. A 67-year-old male patient received BNT162B2 (COMIRNATY) (Batch/Lot Number: ER9480) via an unspecified route of administration on 08Apr2021 as 2nd dose, single for covid-19 immunisation. No relevant medical history nor concomitant medications reported. On 11Apr2021, the patient experienced sepsis, hemorrhagic diathesis with with pulmonary bleeding, soft tissue phlegmon at the injection site. Patient was hospitalized on an unspecified date. The patient died on 11Apr2021 due to sepsis. The reported cause of death was sepsis. An autopsy was not performed. Outcome of sepsis was fatal, outcome of other events was not recovered. Sender comments: The causality assessment for suspect drug to events was reported as follows: Source of assessment PEI, Result of Assessment D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sepsis


VAERS ID: 1351733 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-29
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021579511

Write-up: death from myocardial infarction; chest pain/ thoracic pain; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB DE-PEI-CADR2021072464. A 90-year-old female patient received BNT162B2 (COMIRNATY, Lot Number: EW8904) via unspecified route 0.3 mL single for COVID-19 immunisation on 09Apr2021. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced death from myocardial infarction on 29Apr2021, chest pain/ thoracic pain on 29Apr2021. The patient died on 29Apr2021. An autopsy was not performed. Outcome of the event myocardial infarction was fatal, outcome of the event chest pain/ thoracic pain was not resolved. Sender Comment: No information on risk factors or previous illnesses / death from myocardial infarction No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: death from myocardial infarction


VAERS ID: 1351734 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-26
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3045 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Diarrhoea, Haematochezia, Malaise, Somnolence
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021579504

Write-up: death; Blood in stool; Diarrhea; Malaise; Groggy; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-CADR2021072538. A 77-year-old female patient received BNT162B2 (COMIRNATY, Batch/lot number: ET3045) at single dose for COVID-19 immunisation on 15Apr2021. The patient''s medical history and concomitant drug was not reported. On 26Apr2021 the patient experienced malaise, diarrhea, groggy, blood in stool. The outcome of events malaise, diarrhea, groggy, blood in stool was resolving, while the patient died due to unknown cause of death on 30Apr2021. No autopsy was performed. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses none / Sudden malaise with severe diarrhea ..... later blood in the stool. After the above symptoms had largely recovered, she died suddenly overnight. All events/ Unclassifiable. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1351735 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Dyspnoea, Hyperhidrosis, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus (adjusted with metformin, other medications: Forxiga); Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Lung embolism; Obesity; Prosthesis user
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021579491

Write-up: Lung embolism; Shortness of breath; Shortness of breath, sweating without exertion; pain right lower abdomen; This is a spontaneous report from a non-contactable consumer downloaded from a regulatory authority-WEB DE-PEI-CADR2021072571. Other case identifier number DE-PEI-202100065926. A 48 years old male patient received 1st dose of BNT162B2 (COMIRNATY, lot#EX3510) on 27Apr2021 at single dose for COVID-19 immunisation. The patient''s medical history included Obesity, Lung embolism from 2013, ongoing Diabetes mellitus (adjusted with metformin, other medications: Forxiga), ongoing Hypertension (family history). No concomitant medication reported. On 03May2021 the patient experienced Short of breath, sweating without exertion/ Sweating attack. On 07May2021 the patient experienced Lung embolism. This report is serious - hospitalization. No autopsy was done. The patient''s outcome was not recovered/not resolved for Short of breath, not recovered/not resolved for Sweating attack, fatal for Lung embolism on 07May2021. Outcome of other events was unknown. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No Information on risk factors or previous illnesses see above / previous illness (obesity, condition after pulmonary embolism in 2013, taking falithrom until 2019, diabetes mellitus - adjusted with metformin, other medications: Forxiga, high blood pressure in family history) indisposition on vaccination day (pain right lower abdomen - treatment from vaccination day after medical consultation with Novaminsulfon 500 mg from ratiopharm). On 07May2021 within 1 1/2 hours from emergency call in the hospital deceased, suspicion of renewed pulmonary embolism (sugar derailment, Covid 19 excluded by test of the paramedics), 20-minute resuscitation unsuccessful. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1351736 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure measurement, Myocardial infarction, Neck pain, Seizure
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Retroperitoneal fibrosis (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Arthritis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrhythmia; Drop in blood pressure; Head pain; Nausea; Neck pain
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:drop
CDC Split Type: DEPFIZER INC2021579700

Write-up: Heart attack; Seizure; Back pain; Neck pain; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-CADR2021074232. Other case identifier number DE-PEI-202100067437. A 63-year-old male patient received second dose of BNT162B2 (COMIRNATY, strength: 0.3ml), via an unspecified route of administration on 06Feb2021 (Lot Number: EK9788) as single dose for covid-19 immunisation. Medical history included cardiac arrhythmia, head and neck pain, nausea, drop in blood pressure. Patient was no known allergies. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. On 14Feb2021, the patient experienced seizure, neck pain, back pain, heart attack. Patient died due to heart attack. The outcome of the event heart attack was fatal. The outcome of events seizure, neck pain, back pain was not recovered. The patient died on 14Feb2021. An autopsy was not performed. Sender Comment: Information on risk factors or previous illnesses: Cardiac arrhythmias/Sudden generalized seizure with previously head and neck pain, nausea, drop in blood pressure, Cardiac symptoms in the sense of heart attack No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1351776 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-30
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure systolic, Cardiac arrest, Heart rate, Intracardiac thrombus
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: HJERTEMAGNYL [ACETYLSALICYLIC ACID]; PEGASYS; FOLIMET; HYDROXYUREA MEDAC; METHOTREXATE
Current Illness: Polycythaemia vera; Rheumatoid arthritis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: rhythm check; Result Unstructured Data: Test Result:asystolia; Comments: at 1.; Test Date: 20210430; Test Name: rhythm check; Result Unstructured Data: Test Result:asystolia; Comments: at 2; Test Date: 20210430; Test Name: systolic pressure; Result Unstructured Data: Test Result:91
CDC Split Type: DKPFIZER INC2021579729

Write-up: Cardiac thrombosis; Cardiac arrest; This is a spontaneous report from two contactable physicians downloaded from the a regulatory authority-WEB DK-DKMA-WBS-0064525. Safety Report Unique Identifier DK-DKMA-ADR 25232424. A 66-year-old female patient received bnt162b2 (COMIRNATY) intramuscular on 15Apr2021 (Batch/Lot Number: EW4811; Expiration Date: 31Jul2021) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing polycythaemia vera, ongoing rheumatoid arthritis. Concomitant medications included acetylsalicylic acid (HJERTEMAGNYL) taken for polycythaemia vera from 26Sep2013; peginterferon alfa-2a (PEGASYS) taken for immunomodulatory therapy from 11Apr2014; folic acid (FOLIMET) taken for folic acid supplementation from 12Dec2020; hydroxycarbamide (HYDROXYUREA MEDAC) taken for polycythaemia vera from 03May2019; methotrexate taken for rheumatoid arthritis from 23Apr2015. The patient experienced cardiac thrombosis (death, life threatening) on 30Apr2021, cardiac arrest (death, life threatening) on 30Apr2021. On 30Apr2021 the patient developed cardiac arrest propably due to Cardiac thrombosis. The Cardiac thrombosis were by the reporter reported as being Fatal. The patient was treated with: Adrenalin, Cordarone (AMIODARONE) and Atropin. The patient died on 30Apr2021. An autopsy was not performed. Clinical course: After being found in the home, an ambulance was called and defibrillator was mounted but died not have a rhythm to give shock. At 1. rhythm check asystole, administered adrenalin, afterward asystole at 2. Rhythm check following pulseless electrical activity. Adrenalin is again administered and at 4. Rhythm check a fast paced pulseless electrical activity occur, and next rhythm check return of spontaneous circulation. Time to first ROSC(return of spontaneous circulation) is 14 minutes. The patient is transported to the emergency room, but on the way develops ventricular tachycardia going to ventricular fibrillation, and there is administered additional 3 times adrenalin and shocked 3 times. Afterwards Cordarone (AMIODARONE) 300 mg is administered. Return of spontaneous circulation is achieved and afterwards administered Atropin 1 mg due to bradycardia to 30. Upon arrival the systolic pressure is 91. Prehospital an intraosseous IV(intravenous) is applied. At 11:38 in arrival the pupils are light stiff, the patient is not in touch. Not sedated. Have laryngeal mask airway. There is spontaneous respiration. Cardiac inspection is called with an eye to the cause, but before arrival the patient develops bradycardia and the cardiac arrest team decides to call of the treatment. In a few minutes the bradycardia quickly develops to asystolia and the patient is declared death at 11:45. Reported causes of death: Cardiac thrombosis and Cardiac arrest. No autopsy will be performed. There is no information regarding test results. Causality: The reporting physician states the cardiac arrest probably is due to the cardiac thrombosis. Furthermore, the reporting physician states that he cannot rule out a connection between the death and the vaccine due to the time frame. Another physician from a regulatory authority informs that at request the cause of death was stated to be due to natural causes and therefore no autophsy will be performed. Outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardiac arrest; Cardiac thrombosis


VAERS ID: 1351780 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-22
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-26
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Atherosclerosis of arteries of the extremities; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC2021579798

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is [EE-SAM-36762105059]. An 83-years-old female patient received BNT162B2 (COMIRNATY), first dose intramuscular on 21Jan2021 (Batch/Lot Number: EL1491) as 0.3 ml single, second dose intramuscular on 11Feb2021 (Batch/Lot Number: EJ6789) as 0.3 ml single for covid-19 immunisation. Medical history included ongoing hypertension, ongoing atherosclerosis of arteries of the extremities. The patient''s concomitant medications were not reported. Patient experienced vaccination failure after vaccination with COVID-19 mRNA vaccine. The patient became ill on 22Mar2021. SARS-Cov-2 PCR test was positive on 23Mar2021. The patient was in hospital between 23 and 26Mar2021. She died on 26Mar2021, the cause of death: acute respiratory failure, Covid-19 pneumonia. Possible causes of ineffectiveness: co-morbidities - hypertension, atherosclerosis of arteries of the lower extremities. It was not reported if an autopsy was performed. Outcome for events was fatal. Sender Comment: Serious, fatal vaccine ineffectiveness report. The causal link is considered possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; Acute respiratory failure


VAERS ID: 1351781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-17
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia due to other general medical condition; Immunodeficiency; Non-insulin-dependent diabetes mellitus; Unspecified hypertensive heart disease without congestive heart failure
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: EEPFIZER INC2021579192

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is EE-SAM-36882105068. An 87-year-old female patient received BNT162B2 (COMIRNATY) 1st dose (lot number EM0477) on 12Jan2021, 2nd dose (lot number EL1491) on 02Feb2021, both at 0.3 ml single dose intramuscular for COVID-19 immunisation. Medical history included hypertension with cardiac damage without (congestive) heart failure; non-insulin dependent diabetes mellitus with unspecified complications; dementia from other diseases, and age-related immunodeficiency. Concomitant drug was not provided. Patient experienced vaccination failure after vaccination with COVID-19 mRNA vaccine. The clinical course was reported as follows: The patient was in hospital due to another medical condition and on 17Feb2021 became ill with COVID-19. On 20Feb2021, SARS-CoV-2 PCR test was positive. The patient died on 28Feb2021 due to another illness. The course of COVID-19 was not severe; according to the physician, age-related immunodeficiency may have been the reason for the low efficacy. Outcome of the event was fatal. Sender Comment: Serious vaccine ineffectiveness report. The causal link is considered possible. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1351784 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-04-23
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001532 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   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: Hypertension arterial; Thrombosis venous superficial
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: Angiogram cerebral; Result Unstructured Data
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of ISCHAEMIC STROKE in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001532) for COVID-19 vaccination. The patient''s past medical history included Hypertension arterial and Thrombosis venous superficial. On 22-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ISCHAEMIC STROKE (seriousness criteria death, hospitalization and medically significant). The patient died on 24-Apr-2021. The reported cause of death was Ischaemic stroke. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Angiogram cerebral: abnormal (abnormal) For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment details were provided. Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: ischaemic stroke


VAERS ID: 1351807 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-04
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Aspartate aminotransferase, Asymptomatic bacteriuria, Axillary vein thrombosis, Blood albumin, Blood creatine phosphokinase, Blood creatinine, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood test, Blood urea, Body temperature, Chest X-ray, Coagulation test, Deep vein thrombosis, Echocardiogram, Electrocardiogram, Fibrin D dimer, Investigation, Jugular vein thrombosis, Laboratory test, Platelet count, Prothrombin level, Prothrombin time, Red blood cell count, Scan brain, Seizure, Subclavian vein thrombosis, Transient ischaemic attack, Ultrasound Doppler, Venous thrombosis limb, White blood cell count
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), 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: 2021-05-14
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block (NOS); Cardiovascular disease, unspecified (Cardiovascular disease (excluding Hypertension)); CVA (LEFT ACM TACI STROKE in 2014, with dysphagia, mixed aphasia and right hemiparesis); Dyslipidemia; Epileptic seizure; Hypertension arterial; Ischemic stroke; Right hemiplegia
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: aPTT; Result Unstructured Data: Test Result:28.6; Test Date: 20210511; Test Name: Glutamic pyruvic transaminas; Result Unstructured Data: Test Result:27; Test Date: 20210511; Test Name: Glutamic oxaloacetic transaminase; Result Unstructured Data: Test Result:47; Test Date: 20210511; Test Name: Albumin; Result Unstructured Data: Test Result:2.2; Test Date: 20210511; Test Name: Creatin kinase; Result Unstructured Data: Test Result:17; Test Date: 20210511; Test Name: Creatinine; Result Unstructured Data: Test Result:0.59; Test Date: 20210511; Test Name: fibrinogen; Result Unstructured Data: Test Result:796; Test Date: 20210511; Test Name: Fibrinogen; Result Unstructured Data: Test Result:94; Test Date: 20210511; Test Name: glucose; Result Unstructured Data: Test Result:126; Test Date: 20210511; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:173; Test Date: 20210511; Test Name: Potassium; Result Unstructured Data: Test Result:4.9; Test Date: 20210511; Test Name: Blood pressure; Result Unstructured Data: Test Result:84/44; Test Date: 20210511; Test Name: Sodium; Result Unstructured Data: Test Result:143; Test Date: 20210511; Test Name: Blood test; Result Unstructured Data: Test Result:Hemogram: 14 MCV81 Leukocytes 16600 (S83 L7 M9); Comments: Hemogram: 14 MCV81 Leukocytes 16600 (S83 L7 M9) platelets 287000.; Test Date: 20210511; Test Name: Urea; Result Unstructured Data: Test Result:87; Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210511; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:Badly positioned, no masses, no condensations; Comments: Badly positioned, no masses, no condensations. X-ray of the abdomen without significant findings, normal psoas line.; Test Date: 20210511; Test Name: Coagulation; Result Unstructured Data: Test Result:TP 83% (13.2sg) aPTT 28.6 fibrinogen 796; Comments: TP 83% (13.2sg) aPTT 28.6 fibrinogen 796, D-dimer 2031; Test Date: 20210511; Test Name: ECODOPPLER DEL MSI; Result Unstructured Data: Test Result:Jugular, subclavian, axillary; Comments: Jugular, subclavian, axillary, left humeral non-compressible veins, with the presence of hyperechogenic material and absence of flow inside. Findings related to deep vein thrombosis. Compressible and permeable right jugular vein.; Test Date: 20210511; Test Name: ECG; Result Unstructured Data: Test Result:FA at 120 l / m; Comments: FA at 120 l / m; Test Date: 20210511; Test Name: D-dimer; Result Unstructured Data: Test Result:2031; Test Date: 20210511; Test Name: pA; Result Unstructured Data: Test Result:130 l/m; Test Date: 20210511; Test Name: Biochemistry; Result Unstructured Data: Test Result:Systemic negative nitrites, normal rest; Test Date: 20210511; Test Name: Platelet count; Result Unstructured Data: Test Result:287000; Test Date: 20210511; Test Name: Prothrombin; Result Unstructured Data: Test Result:5.8; Test Date: 20210511; Test Name: Prothrombin time; Test Result: 83 %; Test Date: 20210511; Test Name: Red blood cell count; Result Unstructured Data: Test Result:50-100; Test Date: 20210511; Test Name: CRANIAL TAC WITHOUT CONTRAST; Result Unstructured Data: Test Result:Normal; Comments: There are no signs of intra- or extra-axial bleeding. Hypodense image with cortico-subcortical dedifferentiation that affects the territory of the left middle cerebral artery in relation to chronic ischemic injury, already present in the previous study and without notable changes. Another hypodense image of smaller size and similar characteristics is observed in the right parietal lobe, also in relation to a chronic ischemic lesion. Signs of leukoaraiosis. Ventricular system and subarachnoid space of increased size in relation to cortico-subcortical atrophy. Undisplaced midline. Posterior fossa without notable findings; Test Date: 20210511; Test Name: Ecodoppler; Result Unstructured Data: Test Result:Abnormal; Comments: Signs suggestive of deep vein thrombosis in the common femoral vein up to the superficial femoral vein of the Lower right limb; Test Date: 20210511; Test Name: Leukocytes; Result Unstructured Data: Test Result:16600; Comments: 100 leukocytes
CDC Split Type: ESPFIZER INC2021579841

Write-up: deep vein thrombosis in the common femoral vein up to the superficial femoral vein of the Lower right limb; transient recurrent stroke; Doubtful seizure; Asymptomatic bacteriuria; Axillary vein thrombosis; Subclavian vein thrombosis; Deep vein thrombosis of Left jugular; Deep vein thrombosis of humeral vein; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-864602. An 81-years-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration in Arm Left on 20Apr2021 (Lot Number: EW4815) as single dose for covid-19 immunisation. Medical history included Epileptic seizure from 2015, Epilepsy (probably vascular, dyslipidemia), Hypertension arterial, atrioventricular block, CVA (cerebrovascular accident) from 2014, left ACM TACI stroke in 2014, with dysphagia, mixed aphasia and right hemiparesis, cardiovascular disease (excluding hypertension), ischemic stroke 7 years ago with residual right hemiplegia. The patient''s concomitant medications were not reported. The patient previously took carbamazepine (TEGRETOL), rosuvastatin calcium (PROVISACOR), ferrous glycine sulfate (FERBISOL), atenolol, fluoxetine hydrochloride (DEPRAX), omeprazole and amlodipine besilate,valsartan (AREMIS). Historical vaccine included first dose of COMIRNATY in Arm Left on 30Mar2021 (Lot Number: EW2239) as single dose for covid-19 immunisation. The patient experienced axillary vein thrombosis on 04May2021, subclavian vein thrombosis on 04May2021, deep vein thrombosis of left jugular on 04May2021, deep vein thrombosis of humeral vein on 04May2021, deep vein thrombosis in the common femoral vein up to the superficial femoral vein of the lower right limb on an unspecified date, transient recurrent stroke on an unspecified date, doubtful seizure on an unspecified date , asymptomatic bacteriuria on an unspecified date. The patient with a history of ischemic stroke 7 years ago, with residual right hemiplegia. Epilepsy (probably vascular, dyslipidemia). Frequent episodes of disconnection from the environment at his home, self-limited. The patient was vaccinated 7 days ago on 20Apr2021 for COVID 19 (Pfizer). From the afternoon of his admission, disconnection from the environment, without any collaboration, or response to oral or painful stimuli, of longer duration than the previous ones. In the last days, greater difficulty in oral feeding. No fever. Physical examination on 11May2021: TA (blood pressure): 84/44. pA: 130 l/m temperature: 36. Upon admission, non-cooperative, eyes closed, reactive pupils. No response to stimuli. Spastic right hemiplegia. Loss of withdrawal reflex. On the floor: Isocoria. Septic mouth, with food debris and probable lesion at the distal end of the tongue (bite?). THORAX AC normal AP no noises added in the anterior plane. ABDOMEN soft, no sore spots, no organomegaly, noises present. EXTREMITIES Spastic right hemiplegia. Spontaneous motility of the left hemibody, although slow. Indurated edema of the right lower limb. Peripheral pulses are palpable well and symmetrically. Collateral circulation of the left upper limb (which had already been present at his home for months), no pain due to muscle kneading, no phlebitic tracts. Other Ecodoppler examinations of the right MI on 11May2021: Abnormal. Signs suggestive of deep vein thrombosis in the common femoral vein up to the superficial femoral vein of the Lower right limb. With the diagnoses of transient recurrent stroke Doubtful seizure, Asymptomatic bacteriuria, Deep vein thrombosis of the left upper limb (Left jugular, subclavian, axillary, humeral vein). Old ischemic stroke, with residual right hemiplegia. (Infarction in the territory of the left middle cerebral artery and in the right parietal lobe). FA of indeterminate date. Anticoagulation was started with LMWH (Low molecular weight heparin), hydroelectrolyte replacement due to severe difficulty in swallowing nasogastric tube for oral feeding. In the late evening of 13May2021, greater deterioration with disconnection from the environment, persistence of arterial hypotension. It was exitus on 14May2021. The patient underwent lab tests and procedures on 11May2021 which included aPTT (activated partial thromboplastin time): 28.6, Glutamic pyruvic transaminas: 27, Glutamic oxaloacetic transaminase: 47, albumin: 2.2, creatine phosphokinase: 17, creatinine: 0.59, fibrinogen: 796, fibrinogen: 94 , glucose: 126, lactate dehydrogenase: 173, potassium: 4.9, blood pressure measurement: 84/44, sodium: 143, blood test: Hemogram: 14 MCV81 Leukocytes 16600 (S83 L7 M9) platelets 287000, Biochemistry: Systemic negative nitrites, normal rest. 100 leukocytes, 50-100 red blood cells. Urea: 87, Body temperature: 36 Centigrade, Thorax X-ray: Badly positioned, no masses, no condensations. X-ray of the abdomen without significant findings, normal psoas line. Coagulation: TP Prothrombin time 83% (13.2sg) aPTT 28.6 fibrinogen 796, D-dimer 2031. ECODOPPLER DEL MSI: Jugular, subclavian, axillary, left humeral non-compressible veins, with the presence of hyperechogenic material and absence of flow inside. Findings related to deep vein thrombosis. Compressible and permeable right jugular vein. Electrocardiogram: FA at 120 l / m. Prothrombin: 5.8. CRANIAL TAC WITHOUT CONTRAST: Normal. There are no signs of intra- or extra-axial bleeding. Hypodense image with cortico-subcortical dedifferentiation that affects the territory of the left middle cerebral artery in relation to chronic ischemic injury, already present in the previous study and without notable changes. Another hypodense image of smaller size and similar characteristics is observed in the right parietal lobe, also in relation to a chronic ischemic lesion. Signs of leukoaraiosis. Ventricular system and subarachnoid space of increased size in relation to cortico-subcortical atrophy. Undisplaced midline. Posterior fossa without notable findings. The patient died on 14May2021. The outcome of the events was fatal. It was not reported if an autopsy was performed. The report was considered as serious due to death and hospitalization. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Axillary vein thrombosis; Subclavian vein thrombosis; Deep vein thrombosis of Left jugular; Deep vein thrombosis of humeral vein; deep vein thrombosis in the common femoral vein up to the superficial femoral vein of the Lower right limb; transient re


VAERS ID: 1351808 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-08
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Blood pressure measurement, Body mass index, Cognitive disorder, Fumbling, Gait disturbance, Incoherent, Mental impairment, Platelet count, Sudden death, Swelling face, Vaccination complication
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: DIAZEPAM; SIMVASTATINA CINFA; PARACETAMOL NORMON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial pressure high (without diagnose of arterial hypertension); Late systolic murmur; Morbid obesity (BMI 42.89)
Allergies:
Diagnostic Lab Data: Test Name: BP; Result Unstructured Data: Test Result:high; Comments: without diagnose of hypertension; Test Name: BMI; Result Unstructured Data: Test Result:42.99; Test Date: 20210408; Test Name: Platelet count; Result Unstructured Data: Test Result:123000
CDC Split Type: ESPFIZER INC2021566036

Write-up: possible acute lung edema; her face swelled up; cognitive state it got worse; saying some incoherence and with awkward speech; Difficulty walking (clumsiness); Mental dullness; Vaccination related malaise; Sudden death; Fumbling; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB ES-AEMPS-866159. This is the first of two cases concerning this report. An 86-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EW6126), intramuscular on 04May2021 as second dose, single for covid-19 immunization. Medical history included blood pressure increased (without diagnose of arterial hypertension), morbidly obese (BMI 42.89), multifocal protosystolic murmur; all from an unknown date and unknown if ongoing. The patient previous received first dose of bnt162b2 (COMIRNATY) on 13Apr2021 for covid-19 immunization and her general condition began to deteriorate. Concomitant medications included diazepam taken for an unspecified indication from 28Apr2021 to an unspecified stop date; simvastatin (SIMVASTATINA CINFA) taken for an unspecified indication from 04Feb2016 to an unspecified stop date; paracetamol (PARACETAMOL NORMON) taken for an unspecified indication from 01Jul2010 to an unspecified stop date. The patient experienced sudden death on 12May2021, mental dullness on an unspecified date, vaccination related malaise on an unspecified date, fumbling on 08May2021, her face swelled up on an unspecified date. This morning (12May21), around 8 am, her son found her dead. He says that about 6 o''clock he had come to see her and she was fine. The family reports that after the first dose of the covid vaccine (13Apr2021), after a few days her general condition began to deteriorate, which worsened after the second dose (04May2021): her cognitive state it got worse, saying some incoherence and with awkward speech; Difficulty walking (clumsiness). She had gone to the health center (28Apr2021), where she was assessed by detecting a possible cognitive impairment (disorientation), for which complementary tests were requested. After the second dose, she worsens the cognitive symptoms, she marches with anteropulsion. She reports that her face swelled up. Upon arriving from her, we found her in her bed, with no apparent signs of physical violence, which her examination corroborates. Signs of death are determined. The coroner indicates that she has seen it and appreciates signs of possible acute lung edema. The patient underwent lab tests and procedures which included blood pressure: high without diagnose of hypertension on an unknown date, body mass index: 42.99 on an unknown date, platelet count: 123000 on 08Apr2021. The outcome of events for sudden death, mental dullness, vaccination related malaise, fumbling and acute lung edema was fatal, for other events was unknown. The patient died on 12May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: acute lung edema; Fumbling; Vaccination related malaise; Mental dullness; Sudden death


VAERS ID: 1351831 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3014 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, C-reactive protein increased, Death, Diarrhoea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VI-SIBLIN S; ATRODUAL; JANUVIA [SITAGLIPTIN PHOSPHATE]; EFEXOR; THYROXIN; LANTUS; OPAMOX; OFTAGEL; SOMAC; OVESTIN; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; LITALGIN [METAMIZOLE SODIUM;PITOFENONE HYDROCH
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Epilepsy; Hemiparesis (left); Hypercholesterolemia
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: Body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Test Date: 20210505; Test Name: CRP; Result Unstructured Data: Test Result:123
CDC Split Type: FIPFIZER INC2021579869

Write-up: Death; Pyrexia; Vomiting; Diarrhoea; C-reactive protein increased; This is as spontaneous report received from a contactable nurse downloaded from a regulatory authority-WEB. The regulatory authority report number is FI-FIMEA-20212621. An 85-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 05May2021 at the age of 85-years-old (Batch/Lot Number: EY3014) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included diabetes, left side hemiparesis, epilepsy, RR disease (as reported), hypercholesterolemia all from an unknown date. Concomitant medications included plantago ovata husk (VI-SIBLIN S) taken for an unspecified indication from 05Jul2019 to an unspecified stop date; ipratropium bromide, salbutamol sulfate (ATRODUAL) taken for an unspecified indication from 27Mar2021 to an unspecified stop date; sitagliptin phosphate (JANUVIA) taken for an unspecified indication from 13Mar2015 to an unspecified stop date; venlafaxine hydrochloride (EFEXOR) taken for an unspecified indication from 21Jul2018 to an unspecified stop date; levothyroxine sodium (THYROXIN) taken for an unspecified indication from 26Feb2009 to an unspecified stop date; insulin glargine (LANTUS) taken for an unspecified indication from 14Nov2018 to an unspecified stop date; oxazepam (OPAMOX) taken for an unspecified indication from 24Sep2020 to an unspecified stop date; carbomer (OFTAGEL) taken for an unspecified indication from 09Dec2019 to an unspecified stop date; pantoprazole sodium sesquihydrate (SOMAC) taken for an unspecified indication from 23Mar2020 to an unspecified stop date; estriol (OVESTIN) taken for an unspecified indication from 15May2019 to an unspecified stop date; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for an unspecified indication from 07Jan2019 to an unspecified stop date; metamizole sodium, pitofenone hydrochloride (LITALGIN) taken for an unspecified indication from 03Aug2015 to an unspecified stop date; prochlorperazine maleate (STEMETIL) taken for an unspecified indication from 27May2013 to an unspecified stop date; zopiclone (IMOVANE) taken for an unspecified indication from 29Jan2013 to an unspecified stop date; salbutamol sulfate (VENTOLINE) taken for an unspecified indication from 25Feb2020 to an unspecified stop date; ketoprofen (ORUDIS) taken for an unspecified indication from 30Jan2013 to an unspecified stop date; carbamazepine (NEUROTOL) taken for an unspecified indication from 26Feb2009 to an unspecified stop date; acetylsalicylic acid (PRIMASPAN) taken for an unspecified indication from 26Feb2009 to an unspecified stop date; calcium carbonate, colecalciferol (KALCIPOS-D) taken for an unspecified indication from 26Feb2009 to an unspecified stop date; montelukast sodium (MONTELUKAST ORION) taken for an unspecified indication from 03Apr2020 to an unspecified stop date; ibuprofen (BURANA) taken for an unspecified indication from 27May2020 to an unspecified stop date; orphenadrine citrate, paracetamol (NORGESIC) taken for an unspecified indication from 25Jun2020 to an unspecified stop date; atorvastatin calcium (ATORBIR) taken for an unspecified indication from 26Jan2010 to an unspecified stop date; paracetamol (PANADOL FORTE) taken for an unspecified indication from 29Jan2013 to an unspecified stop date; mometasone furoate (NASONEX) taken for an unspecified indication from 25Jun2020 to an unspecified stop date; melatonin taken for an unspecified indication from 13Nov2015 to an unspecified stop date; furosemide (FURESIS) taken for an unspecified indication from 21Oct2015 to an unspecified stop date; metoprolol succinate (METOHEXAL) taken for an unspecified indication from 28Jul2010 to an unspecified stop date; quetiapine fumarate (KETIPINOR) taken for an unspecified indication from 15May2019 to an unspecified stop date; fentanyl (MATRIFEN) taken for an unspecified indication from 23Mar2020 to an unspecified stop date; glyceryl trinitrate (NITROGLYCERIN ORION) taken for an unspecified indication from 27May2013 to an unspecified stop date; aluminium hydroxide, calcium carbonate, sodium alginate, sodium bicarbonate (GAVISCON) taken for an unspecified indication from 19Feb2021 to an unspecified stop date; fluticasone propionate, salmeterol (SERETIDE EVOHALER) taken for an unspecified indication from 17Feb2020 to an unspecified stop date; oxycodone hydrochloride (OXYCONTIN) taken for an unspecified indication from 11Sep2020 to an unspecified stop date; oxycodone hydrochloride (OXYNORM) taken for an unspecified indication from 09Jul2020 to an unspecified stop date. Historical Vaccine included 1st dose of Comiranty vaccine for COVID-19 Immunisation and no symptoms from the first dose. On 05May2021, the patient experienced pyrexia, vomiting, diarrhoea, c-reactive protein increased, the patient died on 06May2021. The patient experienced vomiting, diarrhea, fever ad 39.5. CRP rise ad 123, death. Consulted a home hospital, antipyretic medication given. Died before the home hospital had time to consult a doctor. The outcome of the events pyrexia, vomiting, diarrhoea, c-reactive protein increased was fatal. The patient died on 06May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vomiting; diarrhea; Pyrexia; C-reactive protein increased; death


VAERS ID: 1351835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-19
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Cardio-respiratory arrest, Myocardial infarction, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (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 (narrow), Respiratory failure (broad), COVID-19 (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: KARDEGIC; COKENZEN; ATORVASTATIN ACCORD; ALLOPURINOL MYLAN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: RTPCR Sars-Cov2; Test Result: Negative ; Comments: Post-mortem sample
CDC Split Type: FRPFIZER INC2021579892

Write-up: heart attack; slight stomach ache; Cardio-respiratory arrest; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-2021051687. The consumer reported two reports for different vaccine doses, this is first of two reports. A 77-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 06Apr2021 (Batch: ER9470) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient previously received the bnt162b2 (COMIRNATY), dose 1 intramuscular administered in Arm Left on 08Mar2021 (Batch: EP2166) as single dose for covid-19 immunisation, the next evening after the first injection, the patient experienced hemorrhagic left eye. Concomitant medications included acetylsalicylate lysine (KARDEGIC), candesartan cilexetil, hydrochlorothiazide (COKENZEN), atorvastatin calcium trihydrate (ATORVASTATIN ACCORD), allopurinol (ALLOPURINOL MYLAN) taken for an unspecified indication, start and stop date were not reported. The patient experienced cardio-respiratory arrest on 19Apr2021 and result in death. slight stomach ache on 19Apr2021 with outcome of unknown, heart attack on 19Apr2021 15:00 with fatal outcome. The patient underwent lab tests and procedures which included RT PCR Sars-Cov2: negative on 20Apr2021 (Post-mortem sample). Therapeutic measures were taken as a result of cardio-respiratory arrest included cardiac massages. The patient died on 19Apr2021 16.30. The clinical course was reported as: 14th day after the second injection, "slight stomach ache in the morning on 19/04 then heart attack at 3 pm". Death of the patient at 4.30 p.m. "Firefighters and ambulance services arrived immediately, treatments carried out by them (cardiac massages). Transport to hospital and death on arrival". Death noted on arrival with the Emergency Medical Service at 4.30 p.m. Death certificate drawn up without obstacles. Family warned. Post-mortem sample on 04/20 at 9:30 am: RTPCR Sars-Cov2: negative. No follow-up attempts are possible, batch number already obtained.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021582859 same patient, different dose; Reported Cause(s) of Death: Cardio-respiratory arrest; heart attack


VAERS ID: 1352035 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-03-27
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, COVID-19 pneumonia, Computerised tomogram, Oxygen saturation, SARS-CoV-2 test, Serology 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: 2021-04-27
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; MOPRAL [OMEPRAZOLE]; MODOPAR; LANTUS; DIAMOX [ACETAZOLAMIDE]; OROCAL D3
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib (rhythmic heart disease: non-anticoagulated AFib); Chondrocalcinosis; Clavicle fracture; Cognitive disorders; Extrapyramidal disorder; Hypertension arterial; Kidney failure chronic (Creat = 115 mcmol / L); Neurodegenerative disorder; Osteoporosis; Polyarthropathy (excl rheumatoid arthritis); Presbycusis; Type II diabetes mellitus; Wrist fracture
Allergies:
Diagnostic Lab Data: Test Date: 20210424; Test Name: CT angiography; Result Unstructured Data: Test Result:No pulmonary embolism; Comments: No pulmonary embolism until sub-segmental first order. The trunk of the pulmonary artery of normal caliber, measured at 26 mm in diameter. Global stability of bilateral parenchymal involvement made up of frosted glass hyperdensity areas and condensations, more marked in the right lower lobe. Discreet increase in the right pleural fluid effusion of average abundance, in the pleural cavity and in the great fissure. Disappearance of the left pleural effusion. No pericardial effusion. Rest of imagery unchanged.; Test Date: 20210328; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Test Date: 20210331; Test Name: chest CT scan; Result Unstructured Data: Test Result:Appearance compatible with Covid 19 pneumonia; Comments: Appearance compatible with Covid 19 pneumonia with moderate (10-25%) abnormalities. Presence of signs of bacterial superinfection: bronchiolar micronodules and systematized parenchymal condensations; Test Date: 20210412; Test Name: Computed tomography thorax-abdomen-pelvis; Result Unstructured Data: Test Result:Increase in parenchymal pulmonary condensations; Comments: Increase in parenchymal pulmonary condensations especially on the right with appearance of a bilateral pleural effusion of low abundance. No detectable deep intra-abdominal infectious focus. Low abundance ascites.; Test Date: 20210328; Test Name: desaturation; Test Result: 75 %; Test Date: 20210327; Test Name: antigenic test for SARS CoV2; Test Result: Positive ; Comments: (specific country variant); Test Date: 20210329; Test Name: antigenic test for SARS CoV2; Test Result: Positive ; Comments: (specific country variant); Test Date: 20210329; Test Name: serology; Test Result: Negative ; Comments: possible delayed immune reaction to the vaccine, and possible onset of immunity with IgG Anti-S at 33 (threshold at 50).
CDC Split Type: FRPFIZER INC2021579572

Write-up: COVID-19 pneumonitis; Vaccination failure; This is as spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-PS20211030, Safety report unique identifier FR-AFSSAPS-2021054740. Portal declaration 20210402154338111 and information obtained via orbis. A 95-year-old female patient received BNT162B2 (COMIRNATY), dose 1 via intramuscular in right arm on 29Jan2021 (Lot Number: EJ6795) as single dose, dose 2 via intramuscular in left arm on 19Feb2021 (Lot Number: EM6950) as single dose for COVID-19 immunisation. Medical history included hypertension arterial, rhythmic heart disease: non-anticoagulated AFib, presbycusis, Type II diabetes mellitus, osteoporosis, clavicle and left wrist fracture, Kidney failure chronic (Creat = 115 mcmol / L), chondrocalcinosic arthritis, neurocognitive disorders, neurodegenerative disorders, extra-pyramidal, Polyarthropathy (excl rheumatoid arthritis). The patient had no history of COVID. Concomitant medications included bisoprolol 1.25 mg in the morning; omeprazole (MOPRAL) 20 mg in the evening; benserazide hydrochloride, levodopa (MODOPAR) 62.5mg morning and evening; insulin glargine (LANTUS) 7 IU in the morning; acetazolamide (DIAMOX) 250 mg morning and evening; calcium carbonate, colecalciferol (OROCAL D3) 500 mg morning and evening. The patient experienced COVID-19 pneumonitis and vaccination failure. On 27Mar2021, the patient antigenic test was positive for SARS CoV2 (systematic screening) i.e. 36 days after the 2nd injection. On 28Mar2021, the patient had fever at 39.4 C with 75% desaturation, bronchial congestion and agitation. The patient was put on ceftriaxone then switch amoxicillin / clavulanic acid (AUGMENTIN) in front of a possible pneumopathy of inhalation and hydration by G5%. Bolus of methylprednisolone (SOLUMEDROL) and switch to a high concentration mask at 9 L of O2 in the face of respiratory worsening. On 29Mar2021, the patient was transferred to the acute geriatric unit in a COVID unit for further support. Positive SARS CoV2 PCR test (specific country variant) 38 days after the 2nd injection. Negative serology: possible delayed immune reaction to the vaccine, and possible onset of immunity with IgG Anti-S at 33 (threshold at 50). Due to her age and underlying pathologies, a transfer to intensive care unit for COVID will not be considered. From 30Mar2021 to 17Apr2021, the patient was under implementation of corticosteroid therapy with dexamethasone. From 30Mar2021 to 08Apr2021, the patient was under implementation of antibiotic therapy with cefotaxime and metronidazole (FLAGYL) for bronchial secondary infection. On 31Mar2021, the patient had chest CT without injection: Appearance compatible with COVID 19 pneumonia with moderate (10-25%) abnormalities. Presence of signs of bacterial superinfection: bronchiolar micronodules and systematized parenchymal condensations. On 12Apr2021, Computed tomography thorax-abdomen-pelvis: Increase in parenchymal pulmonary condensations especially on the right with appearance of a bilateral pleural effusion of low abundance. No detectable deep intra-abdominal infectious focus. Low abundance ascites. From 14Apr2021 to 22Apr2021, faced with the persistence of the outbreak and clinical deterioration, spectrum broadened by piperacillin / tazobactam (TAZOCILLIN) 4g IV every 8 hours as a probabilistic treatment for nosocomial pneumonitis. On 14Apr2021, transfusion 1 red blood cell pellet for anemia. On 23Apr2021, new respiratory degradation with increased oxygen requirements at 15 L / min with febricula. On 24Apr2021, regressing biological inflammatory syndrome and thoracic CT angiography: No pulmonary embolism until sub-segmental first order. The trunk of the pulmonary artery of normal caliber, measured at 26 mm in diameter. Global stability of bilateral parenchymal involvement made up of frosted glass hyperdensity areas and condensations, more marked in the right lower lobe. Discreet increase in the right pleural fluid effusion of average abundance, in the pleural cavity and in the great fissure. Disappearance of the left pleural effusion. No pericardial effusion. Rest of imagery unchanged. Death of the patient on 27Apr2021, i.e. 67 days after the second injection of the vaccine. Conclusion: Respiratory distress in a severe hypoxemic infectious pneumonitis with SARS Cov2 (specific country variant) leading to the death of a 95-year-old patient with a main history of arterial hypertension, atrial fibrillation as well as insulin-dependent diabetes and having received two injections of Comirnaty vaccine according to the established vaccination schedule (PCR positive for the specific countries variant on D38 of the second injection =$g confirmed vaccine failure). 1) Chronologically, the data are compatible with confirmed vaccine failure (PCR positive on D38 of the second injection). 2) On the semiological level, the cause of death retained is severe hypoxemic infectious pneumonia caused by SARS COV-2. 3) The cases of death are analyzed in a regulatory authority The cases of serious infection with Covid-19 following vaccination are also analyzed, 201 cases in total are reported. During the reporting period (02Apr2021-15Apr2021) 45 cases were reported, among which 30 cases completed the vaccination schedule with more than 14 days, a table of COVID19 infection, including 6 cases with death (5 cases with identified strain: 2 with the the countries variant, 2 with the countries variant, 1 with the classic strain). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; COVID-19 pneumonitis


VAERS ID: 1352455 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001414 / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
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 heart disease
Preexisting Conditions: Medical History/Concurrent Conditions: Fracture of humerus
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: COVID-19; This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001414) for COVID-19 vaccination. The patient''s past medical history included Fracture of humerus. Concurrent medical conditions included Ischaemic heart disease. On 30-Mar-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced COVID-19 (COVID-19) (seriousness criterion death). The patient died on 17-Apr-2021. The reported cause of death was covid-19. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered COVID-19 (COVID-19) to be unlikely related. Concomitant product use was not provided. This case concerns a 79year old male patient, with a medical history of Ischemic heart disease, who experienced a serious unexpected event of death (fatal) 18 days after receiving his unknown dose of mRNA-1273 vaccine. However, Very limited information has been provided at this time and require exact dates for further evaluation.; Sender''s Comments: This case concerns a 79year old male patient, with a medical history of Ischemic heart disease, who experienced a serious unexpected event of death(fatal) 18 days after receiving his unknown dose of mRNA-1273 vaccine. However, Very limited information has been provided at this time and require exact dates for further evaluation.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1352676 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   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: MAINTATE; CONSTAN [ALPRAZOLAM]; BIOFERMIN [BIFIDOBACTERIUM NOS]; LOXONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Insomnia
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: Before vaccinaiton; Test Date: 20210520; Test Name: body temperature; Result Unstructured Data: Test Result:40 Centigrade; Comments: in the afternoon
CDC Split Type: JPPFIZER INC2021579229

Write-up: pyrexia (40 degrees Celsius); This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21108131. The patient was a 98-year and 11-month-old female. Body temperature before vaccination was 36.0 degrees centigrade. The patient had no particular family history. The patient had medical history of chronic cardiac failure, insomnia/sleep disorder and atrial fibrillation. Concomitant medications included bisoprolol fumarate (MAINTATE tablet) oral at 1.25 mg daily for chronic cardiac failure, alprazolam (CONSTAN tablet) oral at 0.4 mg daily for sleep disorder, bifidobacterium NOS (BIOFERMIN tablet) oral at 3 tablets daily. On 19May2021 at 08:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) intramuscularly at 0.3 mL, single for COVID-19 immunization. On 20May2021 in the afternoon (one day after the vaccination), the patient experienced pyrexia (40 degrees Celsius). On 20May2021 (one day after the vaccination), the patient died. The course of the event was as follows: On 20May2021 at around 15:00 (one day after vaccination), the reporter was consulted by telephone about pyrexia of 40 degrees Celsius which the patient experienced. The patient was instructed to orally take acetylsalicylic acid; aluminium glycinate; magnesium carbonate (BUFFERIN). Thereafter, the patient was emergently transferred, and she died at 19:28 at another hospital. It was unknown if autopsy was done or not. The reporting physician classified the event as serious (death) and assessed that event as definitely related to BNT162b2. There was no other possible cause of the event such as any other diseases.; Sender''s Comments: Based on the compatible temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported fatal event pyrexia. 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: pyrexia (40 degrees Celsius)


VAERS ID: 1352678 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7449 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood pressure decreased, Blood pressure measurement, Blood test, Body temperature, Computerised tomogram, Gastrointestinal necrosis, Haematochezia, Hepatic function abnormal, Inflammatory marker increased, Mesenteric arterial occlusion, Oxygen saturation, Oxygen saturation decreased, Renal impairment, Respiratory acidosis, Respiratory rate, Tachypnoea
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, arterial (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Ischaemic colitis (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Charcot-Marie-Tooth disease; Disuse syndrome; Pneumonia aspiration
Allergies:
Diagnostic Lab Data: Test Date: 20210518; Test Name: Blood gases; Result Unstructured Data: Test Result:compensated respiratory acidosis; Test Date: 20210518; Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Comments: 10:00; Test Date: 20210518; Test Name: blood test; Result Unstructured Data: Test Result:increased inflammatory markers and decreased renal; Comments: increased inflammatory markers and decreased renal/liver functions were noted; Test Date: 20210517; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210518; Test Name: Chest/abdominal CT; Result Unstructured Data: Test Result:small intestinal necrosis; Test Date: 20210518; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Comments: 10:00; Test Date: 20210518; Test Name: respiratory rate; Result Unstructured Data: Test Result:tachypnoea; Comments: 10:00
CDC Split Type: JPPFIZER INC2021585061

Write-up: SpO2 decreased; Tachypnoea; Blood pressure decreased; Bloody stool; Small intestinal necrosis; superior mesenteric arterial occlusion; increased inflammatory markers and decreased renal/liver functions were noted; increased inflammatory markers and decreased renal/liver functions were noted; increased inflammatory markers and decreased renal/liver functions were noted; Compensated respiratory acidosis; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory Authority report number is v21108333. An 86-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 17May2021 at 10:07 (at the age of 86-year-old) (Lot Number: ER7449; Expiration Date: 30Jun2021) as single dose for COVID-19 immunisation. Relevant medical history included Charcot-Marie-Tooth disease and disuse syndrome after pneumonia aspiration. The patient had no significant family history. No information on concomitant medication was provided. Body temperature on 17May2021 before vaccination was 36.9 degrees Centigrade. On 18May2021 at 04:00 (1 day after the vaccination), the patient experienced bloody stool. On 18May2021 at 18:21 (1 days after the vaccination), the patient died. It was not reported if an autopsy was provided. The course of the event was as follows: there was fluctuation in his level of alertness on a routine basis. On 17May2021 at 10:07, the patient received the first dose of the vaccination. On 18May2021 at 04:00, a small amount of blood was noted in the diaper. No abnormalities were noted in his vital signs. There were no abdominal symptoms. On 18May2021 at 07:30, no abnormalities were noted in his vital signs. On 18May2021 at 10:00, decreased SpO2 (oxygen saturation percutaneous), tachypnoea and decreased blood pressure were noted, and there was an emergency call. Increased inflammatory markers and decreased renal/liver functions were noted in the blood test. Compensated respiratory acidosis was seen by blood gas monitoring. There was no complaint of symptoms. Chest/abdominal CT indicated small intestinal necrosis. The family did not wish the patient to undergo emergency surgery. The patient''s death was confirmed at 18:21 on the same day. The reporting physician classified the event bloody stool as serious (Life-threatening) and assessed the causality between the event and BNT162b2 as unassessable. Small intestinal necrosis was reported as another possible cause of the event. The reporting physician commented as follows: Small intestinal necrosis due to superior mesenteric arterial occlusion was suggested. Since the event occurred on the next day of the vaccination and the patient did not have atrial fibrillation, the causal relationship between the event and BNT162b2 was uncertain.; Reported Cause(s) of Death: superior mesenteric arterial occlusion; bloody stool; small intestinal necrosis


VAERS ID: 1352679 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac failure, Pain, Pneumonia, Respiratory failure, Swelling
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: blood pressure; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021585062

Write-up: Cardiac failure; pneumonia; respiratory failure; local swelling and pain; local swelling and pain; This is a spontaneous report from a contactable physician received from a regulatory authority. Regulatory authority report number is v21108165. A 98-year-old (reported as 98-year and 1-month-old) female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17May2021 at afternoon (Lot Number: EX3617; Expiration Date: 31Aug2021) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was 36.2 degrees Centigrade. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On 17May2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 18May2021 (1 day after vaccination), the patient had local swelling and pain. On 19May2021 (2 days after vaccination), the patient visited the reporting hospital with a chief complaint of dyspnoea. The patient was diagnosed with pneumonia and cardiac failure, and she was admitted to the hospital. On 20May2021 (3 days after the vaccination), the outcome of the events (pneumonia and cardiac failure) was fatal. The patient died due to respiratory failure. The reporting physician classified the events (cardiac failure, pneumonia) as serious (death) and assessed that the events was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The causes of death were pneumonia and cardiac failure. The causality between the event and BNT162b2 was not strongly suspected according to the clinical course. The outcome of the events cardiac failure, pneumonia and respiratory failure was fatal, of the other events was unknown.; Sender''s Comments: Based on the information currently available the events cardiac failure and pneumonia are attributed to intercurrent medical conditions that were not related to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: respiratory failure; pneumonia; cardiac failure


VAERS ID: 1352680 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   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: Living in nursing home (before the vaccination); Loss of consciousness (Admitted to a nearby hospital because of a chief complaint of loss of consciousness (before vaccination))
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021588604

Write-up: Loss of consciousness; Respiratory arrest; This is a spontaneous report from a contactable nurse received from a company representative. An 89-year and 4-month-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number not provided), via intramuscular, on 21May2021 at 11:40 (at the age of 89-year and 4-month-old) at single dose for COVID-19 immunisation. Medical history included residing in the geriatric health services facility (before the vaccination) and admitted to a nearby hospital because of a chief complaint of loss of consciousness (before the vaccination). Concomitant medications were not reported. After the vaccination, she had no problem at the time of the assisted oral intake. At 13:30, the patient was seen talking with an unspecified person. At 14:36 (2 hours and 56 minutes after the vaccination), the nurse found the patient in a state of loss of consciousness and respiratory arrest, after which she was confirmed dead. It was unknown if an autopsy was performed. Information about Batch/Lot number has been requested.; Sender''s Comments: Based on the available information and known product profile, the causal relationship between the reported state of loss of consciousness and respiratory arrest with fatal outcome and the use of BNT162B2 cannot be fully excluded. However, the patient was reported to have been admitted to a nearby hospital because of a chief complaint of loss of consciousness (before the vaccination) thus confounding the reported drug event pairs. 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 Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Loss of consciousness; Respiratory arrest


VAERS ID: 1352681 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-16
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: REZALTAS; VESICARE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebellar haemorrhage; Cerebral haemorrhage; Cerebral infarction; Gait disturbance; Hypertension; Intracerebral haematoma evacuation; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 20210516; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed atrial flutter
CDC Split Type: JPPFIZER INC2021588764

Write-up: Apnoea; Respiratory arrest; Cardiac arrest; Lethal arrhythmia; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21108528. An 84-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 11May2021 at 09:50 (Batch/Lot Number: ET9096; Expiration Date: 31Jul2021) at 84-years-old as a single dose for COVID-19 immunization. Medical history included craniotomy for intracerebral haematoma evacuation due to cerebral haemorrhage in 2003, craniotomy for intracerebral haematoma evacuation due to cerebral haemorrhage in 2018 , cerebral infarction in 2018, hypertension from an unknown date and unknown if ongoing, pollakiuria from an unknown date and unknown if ongoing, gait disturbance from an unknown date and unknown if ongoing, cerebellar haemorrhage from an unknown date and unknown if ongoing, wheelchair user from an unknown date and unknown if ongoing. Concomitant medications included azelnidipine, olmesartan medoxomil (REZALTAS) taken for hypertension from an unspecified start date and ongoing; solifenacin succinate (VESICARE) taken for pollakiuria from an unspecified start date and ongoing. The patient previously received dose 1 of the bnt162b2 (COMIRNATY) for COVID-19 immunization on an unknown date. On 16May2021 at 02:35, the patient experienced: apnoea (death, medically significant), respiratory arrest (death, medically significant). On 16May2021, the patient experienced: cardiac arrest (death, medically significant), and lethal arrhythmia (death, medically significant). The clinical course was reported as follows: The patient was an 84-year-old female. Body temperature before vaccination was 36.3 degrees Centigrade. Family history was not reported. Medical history included craniotomy for intracerebral haematoma evacuation due to cerebral haemorrhage in 2003, cerebellar haemorrhage in 2018, cerebral infarction in 2018, hypertension, and pollakiuria. The patient had no past adverse effect history. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not reported). Concomitant medication included azelnidipine, olmesartan medoxomil (REZALTAS LD) taken orally for hypertension and solifenacin succinate (VESUCARE) taken orally for pollakiuria, start dates were not reported and ongoing. On 11May2021 at 09:50 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number ET9096, Expiration date 31Jul2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 16May2021 at 02:35 (4 days 16 hours 45 minutes after the vaccination), the patient experienced apnoea. On 16May2021 (5 days after the vaccination), the outcome of the event was fatal (death). The course of the event was as follows: Although the patient had gait disturbance, the patient led a life in a wheelchair without serious problem in cognitive function and ate meals at full volume every day. On 11May2021 in the morning, the patient received the second vaccination and had no marked adverse reaction. On 15May2021, the patient had remote meeting with her son and talked for about 1 hour, seeing each other doing well. On the same day, the patient ate supper at full volume as usual and went to bed. On 16May2021 at around 01:30, a care worker found the patient awake, which was unusual, and talked with the patient. At 01:40, the care worker patrolled again and found the patient waving to the care worker. At 02:35, the care worker went to the patient''s room again and found that the patient had pallor facial and respiratory arrest. The care worker immediately called the hospital and the patient was seen by a physician on duty. During medical examination, electrocardiogram showed atrial flutter. Oxygen 10 L was administered, breathing was assisted with AMBU bag, and cardiac massage was initiated; however, the patient had cardiac arrest. At 03:02, resuscitation was stopped. At 06:51, after the patient''s family arrived at the hospital, death was confirmed, and the patient was transferred to a medical examiner''s hospital. However, it was reported that autopsy was not conducted, and death certificate was made with the diagnosis of lethal arrhythmia. The reporting physician classified the event as serious (death) and assessed that 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 as follows: It was a sudden death of the elderly who had been living without problem within 5 days of the vaccination. After the vaccination, the patient had no adverse reaction such as pyrexia. Cause of sudden death was not identified; thus, causal relationship between the vaccine and the event could not be identified. The patient underwent lab tests and procedures which included body temperature: 36.3 Centigrade on 11May2021 (before vaccination), electrocardiogram: showed atrial flutter on 16May2021. Therapeutic measures were taken as a result of the events. The clinical outcome of the events was fatal. The patient died on 16May2021 due to Lethal arrhythmia, Cardiac arrest, Apnoea, and Cardio-respiratory arrest (as reported). An autopsy was not performed. ; Reported Cause(s) of Death: Cardiac arrest; Apnoea; Cardio-respiratory arrest; Lethal arrhythmia


VAERS ID: 1352826 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021573243

Write-up: Unexpected death 6 days after vaccination/Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00541714. A 65-year-old female patient received bnt162b2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 08May2021 as unknown, 0.3 mL single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. No diagnostic procedures. The patient experienced unexpected death 6 days after vaccination/sudden death on 14May2021. The patient died on 14May2021. It was not reported if an autopsy was performed. Reporter Comment: BioNTech / Pfizer Vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no, Unexpected death 6 days after vaccination. Additional information ADR: unexpected death, cause of death unknown. BSN available: yes. COVID19: Previous COVID-19 infection: No. Other: diagnostic procedures: no. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer Vaccine (Comirnaty), Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no, Unexpected death 6 days after vaccination. Additional information ADR: unexpected death, cause of death unknown. BSN available: yes. COVID19: Previous COVID-19 infection: No. Other: diagnostic procedures: no.; Reported Cause(s) of Death: Unexpected death 6 days after vaccination/Sudden death


VAERS ID: 1352836 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX2405 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Condition aggravated, Dyspnoea, Illness, Right ventricular failure
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Supraventricular tachyarrhythmias (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CORDARONE; VENTOLINE [SALBUTAMOL SULFATE]; IMOVANE; BURINEX; SELO-ZOK; CIRCADIN; EPLERENON ACCORD; DIGOXIN; TRIMBOW; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial flutter (Known atrial flutter was treated with ablation in 2019.); Cardiac ablation (Known atrial flutter was treated with ablation in 2019.); Right heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021579690

Write-up: Atrial fibrillation Seizures with exacerbation of right-sided heart failure; Atrial fibrillation Seizures with exacerbation of right-sided heart failure; Atrial fibrillation Seizures with exacerbation of right-sided heart failure; ill; laboured breathing; This is a spontaneous from a contactable physician downloaded from the Agency Regulatory Authority-WEB. This is a report received [NOMAADVRE] Regulatory authority report number [NO-NOMAADVRE-FHI-2021-U4nymj] A 66-year-old male patient received second dose of BNT162B2 (COMIRNATY, Lot Number: EX2405) intramuscular single dose for COVID-19 immunisation on 22Apr2021. Medical history included known atrial flutter treated with ablation in 2019, cardiac ablation from 2019, right-sided heart failure. Concomitant medications included: amiodarone hydrochloride (CORDARONE) for atrial flutter from 09May2021 to 09May2021; salbutamol sulfate (VENTOLINE) for chronic obstructive pulmonary disease (COPD); zopiclone (IMOVANE) for sleep problem; bumetanide (BURINEX) for heart failure; metoprolol succinate (SELO-ZOK) for atrial flutter from 08May2021 to 09May2021; melatonin (CIRCADIN) for sleep problem; eplerenone (EPLERENON ACCORD) for heart failure; digoxin for atrial flutter from 08May2021 to 09May2021; beclometasone dipropionate, formoterol fumarate, glycopyrronium bromide (TRIMBOW) for COPD; prednisolone. The patient experienced atrial fibrillation seizures with exacerbation of right-sided heart failure (death, hospitalization) on 23Apr2021. The patient was hospitalized from 08May2021. The patient was admitted on 08May2021 due to worsening of known right-sided heart failure (cor pulmonale and tricuspid insufficiency, not a candidate for surgery) and episodes of atrial flutter. The patient had previously experienced atrial flutter for which he was treated with ablation in 2019. The patient could not indicate a clear time of onset of symptoms. The patient was habitual before the second dose of BNT162B2, but that immediately after this he became ill and experienced laboured breathing. The question was whether the general reaction to the second dose of the vaccine caused him to have episodes of atrial flutter that ended up with him dying of heart failure. He arrived at the hospital very late in the process. The patient died on 09May2021. It was unknown if an autopsy was performed. Outcome of the event atrial fibrillation seizures with exacerbation of right-sided heart failure was fatal, outcome of the events ill and laboured breathing was unknown. Ventoline - Drug-reaction(s) / Event(s) Matrix: Source of assessment: Regional Pharmacist Relatedness of drug to reaction(s)/event(s): Possible No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Atrial fibrillation Seizures with exacerbation of right-sided heart failure; Atrial fibrillation Seizures with exacerbation of right-sided heart failure; Atrial fibrillation Seizures with exacerbation of right-sided heart failure


VAERS ID: 1352870 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRADAXA; CLEMASTINE; METHADONE; INSULIN LISPRO; LOKREN; LISIHEXAL; GABAPENTIN; DULSEVIA; DIUVER; DIGOXIN; HYDROXYZINE; PREGABALINA; SUVARDIO; FUROSEMID; INSUMAN BASAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis obliterans; Atrial fibrillation; Cardiovascular disorder; Chronic pain; Chronic renal failure; Depression; Diabetic polyneuropathy; Discopathy; Dyslipidemia; Hypertension; Leg amputation; Post-traumatic epilepsy; Type 2 diabetes mellitus; Varicose veins of lower extremities
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021579704

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number PL-URPL-3-621-2021. A 57-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 21Apr2021 12:00 (Lot Number: EW9127; Expiration Date: 31Jul2021) as 1ST DOSE, 0.3 mL, single for covid-19 immunisation. Medical history included post-traumatic epilepsy, diabetic neuropathy, Chronic pain, hypertension, Discopathy , cardiovascular disorder, leg amputation from 2019, dyslipidaemia, atrial fibrillation, depression, Chronic renal failure, Varicose veins of lower extremities, Type 2 diabetes mellitus, Arteriosclerosis obliterans. Concomitant medications included dabigatran etexilate mesilate (PRADAXA); clemastine ; methadone; insulin lispro ; betaxolol hydrochloride (LOKREN); lisinopril dihydrate (LISIHEXAL); gabapentin; duloxetine hydrochloride (DULSEVIA); torasemide (DIUVER); digoxin; hydroxyzine; pregabalina; rosuvastatin calcium (SUVARDIO); furosemide; insulin human injection, isophane (INSUMAN BASAL). The patient experienced death on 22Apr2021 18:10. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.


VAERS ID: 1352886 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2197 / 1 - / OT

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: 2021-04-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: 5q minus myelodysplastic syndrome; COPD; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021579722

Write-up: CVA (Cerebrovascular accident); This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB [PT-INFARMED-T202105-27]. An 82-year-old male patient received first dose of BNT162B2 (COMIRNATY, strength 30 ?g/0.3 mL), parenterally on 20Apr2021 (lot number EW2197) at 0.3mL single dose for COVID-19 immunization. Medical history included 5q minus myelodysplastic syndrome, COPD (chronic obstructive pulmonary disease), Type 2 diabetes mellitus. Concomitant medications were not reported. The patient had a CVA "Cerebrovascular accident" on 25Apr2021. The event led to the patient''s death 4 days later. The patient died on 29Apr2021. It was not known if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: CVA (Cerebrovascular accident)


VAERS ID: 1352930 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Pneumonia, Sepsis
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), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Artificial cardiac pacemaker user; Atrial fibrillation; Cardiac failure; Crohn''s; Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Sepsis
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021579874

Write-up: Died of sudden cardiac arrest; pneumonia; Sepsis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-039946. An 84-year-old female patient received second dose bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Mar2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation, ongoing cardiac failure, ongoing Crohn''s, ongoing hypertension, ongoing artificial cardiac pacemaker user, sepsis from an unknown date and unknown if ongoing. The patient previously received first dose bnt162b2 (COMIRNATY), on an unspecified date for COVID-19 immunisation and had fever and vomiting. The patient''s concomitant medications were not reported. Reported suspect vaccine was Comirnaty (covid-19 vaccines). Reported suspect adverse events were death due to cardiac arrest in Mar2021. The reporter stated that the woman died at the hospital, clinical autopsy showed pneumonia and sepsis. Furthermore, it appeared that the woman felt completely well before the vaccination according to relatives. The patient died on an unspecified date. An autopsy was performed that revealed sepsis and pneumonia. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest; Autopsy-determined Cause(s) of Death: pneumonia; Sepsis


VAERS ID: 1352934 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Body temperature, Body temperature decreased, Cardiac failure chronic, Chest X-ray, Chills, Coronary artery disease, Dyspnoea, Laboratory test, Left ventricular hypertrophy, N-terminal prohormone brain natriuretic peptide, Pneumonia, Prostatitis, Pyelonephritis, Urinary tract infection, Urosepsis
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Other ischaemic heart disease (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   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: Arterial hypertension; Cardiac failure chronic; Chronic kidney disease; Chronic obstructive lung disease; Organic anxiety disorder; Pulmonary embolism; Senile cataract; Tuberculosis; Vein disorder (vein disorder of lower extremities)
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Result Unstructured Data: Test Result:155 umol/l; Test Date: 20210303; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Test Name: chest X-ray; Result Unstructured Data: Test Result:Unknown results; Test Name: Laboratory tests; Result Unstructured Data: Test Result:Unknown results; Test Name: NT-proBNP; Result Unstructured Data: Test Result:5252 pg/L
CDC Split Type: SKPFIZER INC2021578842

Write-up: shivering; dyspnoea aggravated; body temperature 35.7 Cel; Cardiac failure chronic aggravated/acute decompensation of chronic cardiac failure/acute heart failure; urinary tract infection; urosepsis; purulent microabscedent pyelonephritis; purulent prostatitis; incipient purulent pneumonia; eccentric hypertrophy of the left ventricular; septic activation of the spleen in severe coronary heart disease; This is a spontaneous report from two contactable physicians (one of pathologist) downloaded from a regulatory authority-WEB SK-SUKLSK-20211988. An 82-year-old male patient received his first dose of BNT162B2(COMIRNATY, Lot Number: ET1831; Expiration Date: Jun2021), intramuscular on 03Mar2021 13:00 at single dose for covid-19 immunisation. Medical history included cardiac failure chronic, chronic obstructive lung disease, tuberculosis, arterial hypertension, pulmonary embolism, chronic kidney disease, vein disorder, senile cataract and organic anxiety disorder. The patient''s concomitant medications were not reported. The patient experienced cardiac failure chronic aggravated on 03Mar2021. At about 3.30 pm on the same day, the patient experienced shivering, body temperature 35.7 Cel, dyspnoea aggravated and the patient was admitted to hospital with an acute decompensation of chronic cardiac failure. Laboratory tests and chest X-ray were performed. The patient was treated for acute heart failure and with antibiotics due to urinary tract infection. Despite treatment, the clinical condition worsened and the patient exited on 04Mar2021 at 23.45. The cause of death was reported as urosepsis caused by purulent microabscedent pyelonephritis, purulent prostatitis, incipient purulent pneumonia and septic activation of the spleen in severe coronary heart disease with eccentric hypertrophy of the left ventricular. The patient underwent lab tests included blood creatinine: 155 umol/l on unspecified date, body temperature: 35.7 centigrade on 03Mar2021, n-terminal prohormone brain natriuretic peptide (NT-proBNP): 5252 pg/l on unspecified date. The outcome of event shivering, dyspnoea aggravated and body temperature 35.7 Cel were unknown, other events was fatal. The patient died on 04Mar2021. It was not reported if an autopsy was performed. A contacted physician (pathologist) added that the causality was assessed as not related to vaccination (unlikely). Sender Comment: This case was verified by the physician (pathologist) and the causality was assessed as not related to vaccination (unlikely). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the available information, the company concurs with the physician (pathologist), considering that the events were unrelated to suspect vaccine BNT162B2. The patient''s elderly age and pre-existing multimorbidity were significant risk factors.; Reported Cause(s) of Death: urinary tract infection; urosepsis; purulent prostatitis; incipient purulent pneumonia; eccentric hypertrophy of the left ventricular; septic activation of the spleen in severe coronary heart disease; purulent microabscedent pyelonephritis; Cardiac f


VAERS ID: 1352935 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Confusional state, Fatigue
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PRESTARIUM [PERINDOPRIL ARGININE]; EBRANTIL [URAPIDIL]; LUSOPRESS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (arterial hypertension class III); Dyspnoea (last few days deteriorating health); Immobile (last few days deteriorating health); Ischaemic heart disease (class III); Morbid obesity; Multimorbidity
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKPFIZER INC2021578782

Write-up: cardiac arrest; Weakness; Confusion state; Fatigue; This is a spontaneous report from two contactable physicians downloaded from the regulatory authority-WEB SK-SUKLSK-20213673. A 67-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via intramuscular on 07Apr2021 (lot number: ET7205) as single dose for COVID-19 immunisation. The relevant medical history included multimorbidity, ischaemic heart disease (class III), arterial hypertension (class III), morbid obesity, cardiogenic dyspnoea and immobility (last few days deteriorating health), all from unspecified date. Concomitant medications included perindopril arginine (PRESTARIUM), urapidil (EBRANTIL), nitrendipine (LUSOPRESS). 10 minutes after vaccination the patient experienced weakness, confusion state and fatigue. On the way home, the patient could not drive a car, he felt asleep. They hit the curb and the towing service had to tow them. At home at about 3.30 pm he lay down in bed, drank tea and fell asleep. After about 2 hours his wife stopped hearing his snoring, came to bed, wiped his spilled saliva and found that he was not breathing. She called 155 and started cardiopulmonary resuscitation until the ambulance arrived. The ambulance arrived within 16 minutes, they continued resuscitation, but stated exitus letalis at 7 pm. A contacted physician (pathologist) added: the patient with multimorbidity, morbid obesity (weight approx. 170 kg), hypertension was significantly decompensated at the time of the examination (sec. dg. AH III WHO / ESC, ischaemic heart disease painful form). The wife mentioned a week of difficulty, the last few days deteriorating health in terms of cardiogenic dyspnoea and immobility. Significant bilateral oedema of the lower extremities was presented and the patient died in his sleep approximately 9 hours after vaccination on 07Apr2021. The examining physician did not indicate autopsy to clarify the causes of death other than after vaccination. Autopsy was not done. From a pathological-anatomical point of view, this was not a death associated with vaccination against COVID-19. Cause of death was reported as: disease or condition directly leading to death - cardiac arrest. Antecedent causes - morbid obesity, arterial hypertension class III. Other significant condition - ischaemic heart disease, class III. The patient was cremated. Additional details were not reported. Therapeutic measures were taken as a result of the events. The outcome of the event cardiac arrest was fatal, while other events were unknown. Sender Comment: This case was verified by the physician (pathologist) and the causality was assessed as not related to vaccination (unlikely). No follow-up attempts possible. No further information expected.; Sender''s Comments: The event cardiac arrest is considered not related to BNT162B2. The multiple underlying diseases may contribute to the event cardiac arrest. Based on temporal association, the events weakness, confusion state and fatigue are considered related to BNT162B2.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1353701 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-19
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001650 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-27
   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: GLICLADA; UROXAL; COVERCARD PLUS; PENTOXYL-EP; ERGOTOP; FRONTIN; NEBIBETA; KALDYUM; FURON; KERBERAN; MYDETON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Stroke; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: COVID-19 was detected 13 days after vaccination with COVID-19 VACCINE MODERNA
CDC Split Type: HUMODERNATX, INC.MOD20211

Write-up: COVID-19 pneumonia; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 PNEUMONIA (COVID-19 pneumonia) in an 82-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 Stroke, Type II diabetes mellitus and Hypertension. Concomitant products included GLICLAZIDE (GLICLADA), Oxybutynin (UROXAL), AMLODIPINE BESILATE, INDAPAMIDE, PERINDOPRIL ARGININE (COVERCARD PLUS), pentoxifylline (PENTOXYL-EP), nicergoline (ERGOTOP), ALPRAZOLAM (FRONTIN), NEBIVOLOL HYDROCHLORIDE (NEBIBETA), POTASSIUM CHLORIDE (KALDYUM), furosemide (FURON), CLOPIDOGREL BESYLATE (KERBERAN) and lidocaine, tolperisone (MYDETON) for an unknown indication. On 06-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter. On 19-Apr-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria death and hospitalization). The patient died on 27-Apr-2021. The reported cause of death was cardiovascular insufficiency caused by the infection, Asystole and COVID-19 pneumonia. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive (Positive) COVID-19 was detected 13 days after vaccination with COVID-19 VACCINE MODERNA. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: COVID-19 was detected 13 days after vaccination with COVID-19 VACCINE MODERNA. The patient died due to asystole, and cardiovascular insufficiency caused by the infection. Immunity does not develop within 13 days after vaccination. The causality between the vaccine and the event is unlikely. The case is serious due to fatal outcome. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up was received on 18-may-2021 and contains no newinformation; Sender''s Comments: COVID-19 was detected 13 days after vaccination with COVID-19 VACCINE MODERNA. The patient died due to asystole, and cardiovascular insufficiency caused by the infection. Immunity does not develop within 13 days after vaccination. The causality between the vaccine and the event is unlikely. The case is serious due to fatal outcome.; Reported Cause(s) of Death: cardiovascular insufficiency caused by the infection; asystole; COVID-19 pneumonia


VAERS ID: 1353707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-15
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myalgia, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITJNJFOC20210542565

Write-up: MILD MYALGIA ONLY THE DAY AFTER THE VACCINE UPON TAKING PARACETAMOL. THE DAY AFTER GENERAL WELL-BEING. THE FOLLOWING DAY FOUND DEAD WITHOUT APPARENT CAUSE; MILD MYALGIA ONLY THE DAY AFTER THE VACCINE UPON TAKING PARACETAMOL. THE DAY AFTER GENERAL WELL-BEING. THE FOLLOWING DAY FOUND DEAD WITHOUT APPARENT CAUSE; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-729631] concerned a 60 year old male. The patient''s weight was 73 kilograms, and height was 175 centimetres. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 21C10-03 expiry: UNKNOWN) .5 ml, administered on 12-MAY-2021 for covid-19 vaccination. No concomitant medications were reported. On 13-MAY-2021, the patient experienced moderate myalgia without any fever and called the physician and asked if he could take Paracetamol for the same. On 14-MAY-2021, the patient was feeling well, and had no more pain or fever and especially no headache. On 15-MAY-2021, the patient expired and his son found him dead in the early afternoon, leaning over the bath bidet, with a bruised lesion on the nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of sudden death and myalgia on 15-MAY-2021. This report was serious (Death). Sender''s Comments: V0: 20210542565-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, Myalgia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: DEATH


VAERS ID: 1353962 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-04-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-22
   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: BEMODERNATX, INC.MOD20211

Write-up: COVID-19; This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in an 80-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion death). The patient died on 22-Apr-2021. The reported cause of death was covid-19. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No concomitant products were reported. Action taken with mRNA-1273 in response to the events was not applicable. ADR description - Covid; Sender''s Comments: Based on biological plausibility, the event is assessed as unlikely related to mRNA-1273. The event of COVID-19 was consistent with infection in pandemic set up.; Reported Cause(s) of Death: COVID-19


VAERS ID: 1353989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Death
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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEJNJFOC20210548196

Write-up: DEATH; BRAIN STROKE; This spontaneous report received from a patient''s husband via a company representative concerned an adult female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced brain stroke. The patient died from unknown cause of death. It was reported that, death was related to stroke but no official information was reported. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date and outcome of brain stroke was not reported. This report was serious (Death and Other Medically Important Condition).; Sender''s Comments: V0:20210548196-COVID-19 VACCINE AD26.COV2.S-Death ,Brain stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1354020 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000496 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19 pneumonia, Computerised tomogram, SARS-CoV-2 test, Sepsis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Invasive mechanical ventilation
Preexisting Conditions: Medical History/Concurrent Conditions: Asbestos exposure (ED 10/19); Coronary disease (Single vessel coronary disease); COVID-19 pneumonia (1st ARDS in COVID-19 pneumonia with bacterial superinfection.); Endotracheal intubation; Mechanical ventilation (invasive); Nicotine abuse (Nicotine use stopped, cumulative 30 pack years); Pleural thickening (discrete pleural thickening on the right after inhalative exposure to asbestos.); Tracheostomy
Allergies:
Diagnostic Lab Data: Test Date: 20210330; Test Name: 10010228; Result Unstructured Data: initially showed bipulmonary peripheral and peribronchovascular ground glass opacities, image morphologically and quantitatively consistent with mild pulmonary COVID case; Test Date: 20210326; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: ARDS in COVID- 19 pneumonia with bacterial superinfection
CDC Split Type: CHMODERNATX, INC.MOD20211

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 PNEUMONIA, ACUTE RESPIRATORY DISTRESS SYNDROME, SEPSIS, and VACCINATION FAILURE (COVID-19) in a 67-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3000496) for COVID-19 vaccination. The patient''s past medical history included COVID-19 pneumonia (1st ARDS in COVID-19 pneumonia with bacterial superinfection.) in October 2019, Nicotine abuse (Nicotine use stopped, cumulative 30 pack years), Asbestos exposure (ED 10/19) in October 2019, Coronary disease (Single vessel coronary disease), Pleural thickening (discrete pleural thickening on the right after inhalative exposure to asbestos.) in October 2019, Endotracheal intubation on 04-Apr-2021, Mechanical ventilation (invasive) on 04-Apr-2021, Tracheostomy on 09-Apr-2021 and Invasive mechanical ventilation from 04-Apr-2021 to 13-Apr-2021. On 25-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced COVID-19 PNEUMONIA (seriousness criteria death and medically significant), ACUTE RESPIRATORY DISTRESS SYNDROME (seriousness criteria death and medically significant), SEPSIS (seriousness criteria death and medically significant), and VACCINATION FAILURE (COVID-19) (seriousness criterion death). The patient died on 13-Apr-2021. The reported cause of death was multiple organ dysfunction syndrome. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, SARS-CoV-2 test: (Positive) ARDS in COVID- 19 pneumonia with bacterial superinfection. On 30-Mar-2021, Computerised tomogram: (abnormal) initially showed bipulmonary peripheral and peribronchovascular ground glass opacities, image morphologically and quantitatively consistent with mild pulmonary COVID case. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered COVID-19 PNEUMONIA (COVID-19), ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS COVID-19), SEPSIS and VACCINATION FAILURE (COVID-19) to be unlikely related. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. No relevant concomitant medications were reported. Based on the fact the vaccine itself does not contain the virus that would be transmitted and capable of causing the COVID-19 infection in the patient receiving the vaccine, the event COVID-19 and the associated events are assessed as unlikely related to mRNA-1273. Treatment information included, invasive endotracheal ventilation (from 04/04/2021 until his death) and tracheostomy (on 04/09/2021), dexamethasone 6mg/d from 30 Mar 2021 to -09 Apr 2021, piperacillin-tazobactam 2x4.5g 05 Apr 2021 , 09 Apr 2021, meropenem 1g2x daily iv from 09 Apr 2021 -13 APR 2021, complex treatment due to multi-resistant organisms (COVID-19) from 30 Mar 2021 - 13 Apr 2021, was provided. Patient hospitalization was required on March 30th. Based on the fact the vaccine itself does not contain the virus that would be transmitted and capable of causing the COVID-19 infection in the patient receiving the vaccine, the event COVID-19 and the associated events are assessed as unlikely related to mRNA-1273. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 20-MAY 2021 contains translation document.; Sender''s Comments: Based on the fact the vaccine itself does not contain the virus that would be transmitted and capable of causing the COVID-19 infection in the patient receiving the vaccine, the event COVID-19 and the associated events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: Multiple organ dysfunction syndrome


VAERS ID: 1355427 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-29
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: Unknown cause of death; This regulatory authority case was reported by a physician and describes the occurrence of DEATH (Unknown cause of death) in a 57-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for Prophylactic vaccination. No Medical History information was reported. On 23-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. Death occurred on 29-Apr-2021 The patient died on 29-Apr-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. An autopsy was performed (results not provided). Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Sender''s Comments: Very limited information regarding these events has been provided at this time. No further follow-up information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1355450 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / 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: 2021-04-23
   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: Disease Parkinson''s; Invasive cervix cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20211

Write-up: Sudden death unexplained; This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in an 82-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. The patient''s past medical history included Invasive cervix cancer and Disease Parkinson''s. On 23-Apr-2021, the patient received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 23-Apr-2021. The cause of death was not reported. An autopsy was not performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use was not reported. Treatment information was not reported. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1355481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-13
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: Aortocoronary bypass (with quadruple bypass surgery); COPD; Disease coronary artery
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021591149

Write-up: Arrest cardiac; This is as spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-2021056279. A 71-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, Lot number ET7205), via intramuscular in the left arm, on 30Mar2021 as single dose for COVID-19 immunisation. Relevant medical history included coronary artery disease with quadruple bypass surgery and chronic obstructive pulmonary disease (COPD). No relevant concomitant medications were provided. On 13Apr2021 (at day 14 of the vaccination) when the patient was mounted on his roof because of fire in the chimney, he experienced sudden death, probable cardiac arrest. According to the attending physician, no fever or other symptoms in the days following vaccination, no consultation between vaccination and death. No autopsy was performed. Link with the vaccine considered by the notifier to be unlikely Note.: Imputation made without prejudice to the elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1355658 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2020-12-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ1688 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Choking, Death, Diarrhoea, Speech disorder
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021575041

Write-up: Death; Choking; Speech disorder; Diarrhoea; This is a spontaneous report received from a contactable physician from a regulatory authority. The regulatory authority report number is GB-MHRA-ADR 25290762. A 93-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 (Lot Number: EJ1688) as single dose for covid-19 immunisation. The patient medical history was not reported. Patient in not pregnant. The patient''s concomitant medications were not reported. The patient experienced speech disorder, choking, diarrhoea on 31Dec2020 with unknown outcome, and death on Feb2021. Daughter felt the vaccine led to a reaction involving altered speech, choking, diarrhoea. Died approximately 2 months later. The patient died on Feb2021. Reported cause of death: unknown cause of death. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


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