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

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



Case Details

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VAERS ID: 1381541 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021634813

Write-up: Myocardial infarction; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 558353. A 91-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at he age of 91-year-old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. he patient experienced myocardial infarction (death) on an unspecified date. The patient died on an unspecified date. The outcome: of myocardial infarction was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1381542 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-14
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021634814

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 558689. A 70-years-old female 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. The patient medical history and concomitant medications were not reported. The patient experienced cerebrovascular accident on 14May2021 leading to 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/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident


VAERS ID: 1381543 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-24
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Dyspnoea, Heart rate increased
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021634815

Write-up: Dehydration; Dyspnoea; Heart rate increased; This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 558781. A 95-years-old female 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 . The patient medical history and concomitant medications were not reported. The patient experienced dehydration, dyspnoea, heart rate increased all on 24May2021. All the reported events had a fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Dehydration; Dyspnoea; Heart rate increased


VAERS ID: 1381544 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia aspiration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021634816

Write-up: Pneumonia aspiration; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority. Regulatory authority report number is 559367. A 79-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 20May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced pneumonia aspiration on 22May2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pneumonia aspiration


VAERS ID: 1381545 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: AUPFIZER INC2021634818

Write-up: Deep vein thrombosis; Pulmonary embolism; This is a spontaneous report from a contactable other health professional received via the Regulatory Authority. Regulatory authority report number is 560481. An 82-year-old female 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. The patient medical history and concomitant medications were not reported. The patient experienced deep vein thrombosis and pulmonary embolism, both on an unspecified date with fatal outcome. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Deep vein thrombosis; Pulmonary embolism


VAERS ID: 1381569 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Angiogram cerebral, Brain injury, Brain oedema, C-reactive protein, Cerebral infarction, Coagulopathy, Coma, Computerised tomogram head, Epilepsy, Facial paresis, Haemoglobin, Haptoglobin, Headache, Hemiparesis, Investigation, Legionella test, Magnetic resonance imaging head, Nervous system disorder, Oliguria, Platelet count, Respiratory failure, Seizure, Ultrasound abdomen
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (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), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 6
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL EG; ASAFLOW
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (Atrial fibrillation otherwise blank)
Allergies:
Diagnostic Lab Data: Test Date: 20210509; Test Name: APTT; Test Result: 38.3 s; Comments: extended; Test Date: 20210509; Test Name: PTT; Test Result: 63 %; Comments: low; Test Date: 20210507; Test Name: CT angio brain; Result Unstructured Data: Test Result:thrombolysis in negative; Test Date: 20210509; Test Name: CT Brain scan; Result Unstructured Data: Test Result:progressive mass effect with cerebral herniation; Comments: progressive mass effect with cerebral herniation (= displacement of the brain due to increased pressure) + infarcts + petechial hemorrhagic transformation of various infarcts (more information in FUQ) .; Test Date: 20210510; Test Name: C-reactive protein; Result Unstructured Data: Test Result:324 mg/l; Comments: increased; Test Date: 20210509; Test Name: hemoglobin; Result Unstructured Data: Test Result:12.1 g/dl; Test Date: 20210509; Test Name: haptoglobin; Result Unstructured Data: Test Result:3.69 g/l; Comments: increased; Test Date: 20210509; Test Name: ADAMTS13; Result Unstructured Data: Test Result:/; Test Date: 20210510; Test Name: ANF (= test autoimmune diseases) / ANCA (= test vasculitis); Test Result: Negative ; Test Date: 20210509; Test Name: anti-PF4-AL; Result Unstructured Data: Test Result:/; Test Date: 20210510; Test Name: Legionella antigen on urine; Test Result: Positive ; Test Date: 20210508; Test Name: MR brain; Result Unstructured Data: Test Result:extensive brain damage; Comments: Extensive recent infarcts of the cerebri anterior and posterior area on the right as well as of the posterior media area on the right and pericentral media area on the left. Several infarcts show hemorrhagic transformation.; Test Date: 20210508; Test Name: MR brain; Result Unstructured Data: Test Result:image of extensive cerebral infarcts with; Comments: image of extensive cerebral infarcts with perilesional edema. Secondary epilepsy.; Test Date: 20210509; Test Name: platelet count; Result Unstructured Data: Test Result:222,000; Comments: normal; Test Date: 20210510; Test Name: ultrasound abdomen; Result Unstructured Data: Test Result:normal size of both kidneys, no obvious congestion; Comments: normal size of both kidneys, no obvious congestion signs. Strongly elevated intrarenal resistance indices, no arguments for renal artery stenosis.
CDC Split Type: BEPFIZER INC2021597527

Write-up: Oliguria; acute renal failure; extensive brain damage; Secondary epilepsy; cerebral infarction; perilesional edema; General convulsions; acute hemiparese; Headache; comatose state; Neurological problem; Respiratory insufficiency; facial paresis right; Blood clotting problem; This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-91712. A 67-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included atrial fibrillation (Atrial fibrillation otherwise blank). Concomitant medications included bisoprolol fumarate (BISOPROLOL EG); acetylsalicylic acid (ASAFLOW). The patient experienced headache (death, hospitalization, disability, life threatening) on 07May2021, comatose state (death, hospitalization, disability, life threatening) on 07May2021, neurological problem (death, hospitalization, disability, life threatening) on 07May2021, respiratory insufficiency (death, hospitalization, disability, life threatening) on 07May2021 , cerebral infarction (death, hospitalization, disability, life threatening) on 08May2021 , perilesional edema (death, hospitalization, disability, life threatening) on 08May2021 , general convulsions (death, hospitalization, disability, life threatening) on 07May2021 , oliguria (death, hospitalization, disability, life threatening) on 09May2021 , acute hemiparese (death, hospitalization, disability, life threatening) on 07May2021 , acute renal failure (death, hospitalization, disability, life threatening) on 09May2021 , facial paresis right (death, hospitalization, disability, life threatening) on 07May2021 , blood clotting problem (death, hospitalization, disability, life threatening) on 07May2021 , extensive brain damage (death, hospitalization, disability, life threatening) on 08May2021 , secondary epilepsy (death, hospitalization, disability, life threatening) on 08May2021. Therapeutic measures were taken as a result of events. The patient died on 13May2021. It was not reported if an autopsy was performed. The outcome of events was fatal. Reporter comment: Treatment - Yes Urgent thrombolysis without result Intubation and invasive ventilation Start up hemodialysis; Evolution of the ADR - No improvement; after 1 week (07May2021): headache, acute neurological deficit (hemiparesis with facial pareses on the right) with rapid evolution to comatose state. with MRI brain (08May2021) image of extensive cerebral infarcts with perilesional edema. Secondary epilepsy. Acute renal failure with oliguria (09May2021) requiring hemodialysis distress. Respiratory failure requiring intubation.-07May2021: thrombolysis in negative CT angio brain. In view of no neurological clearance and intubation distress, the patient was transferred to hospital.-MR brain 08May2021: extensive brain damage: Extensive recent infarcts of the cerebri anterior and posterior area right as well as of the posterior media area right and pericentral media area left. Several infarcts show hemorrhagic transformation. Strong perilesional edema, fundoscopy does not prevent papilledema but CT brain check the day after (09May2021) shows progressive mass effect with cerebral herniation (= displacement of the brain due to increased pressure) + infarcts + petechial hemorrhagic transformation of various infarcts (more information in PRIVACY) .- lab (09May2021): platelet count 222,000 (normal), APTT 38.3 sec (extended), PTT 63% (low), anti-PF4-AL: /, ADAMTS13: /, hemoglobin content 12.1 g/dL (low normal), haptoglobin 3.69 g/L (increased)- lab (10May2021): CRP 324 mg/L (increased), ANF (= test autoimmune diseases) / ANCA (= test vasculitis) negative, Legionella antigen on urine positive -ultrasound abdomen 10May2021: normal size of both kidneys, no obvious congestion signs. Strongly elevated intrarenal resistance indices, no arguments for renal artery stenosis.-Patient was intubated on 12May2021 with spontaneous breathing and transferred to neurology department for palliative care. Clear epilepsy on 08May2021 after start of anti-epileptic drugs Permanently descended consciousness and complete paresis. In connection with the neurology and neurosurgery department, a very poor prognosis with irreversible brain damage without the benefit of neurosurgery. In view of irreversible damage with evolution to permanent comatose status, a comfort policy was decided in consultation with the family.-died on 13May2021. Reporter does not know if autopsy was performed. Additional information on drug: Patient was intubated on 12May2021 with spontaneous breathing. Clear epilepsy on 08May2021 after start of anti-epileptic drugs Permanently descended consciousness and complete paresis. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment: Treatment - Yes Urgent thrombolysis without result Intubation and invasive ventilation Start up hemodialysis; Evolution of the ADR - No improvement; after 1 week (07May2021): headache, acute neurological deficit (hemiparesis with facial pareses on the right) with rapid evolution to comatose state. with MRI brain (08May2021) image of extensive cerebral infarcts with perilesional edema. Secondary epilepsy.; Reported Cause(s) of Death: extensive brain damage; Respiratory insufficiency; Convulsions generalized; Headache; Nervous system disorder; Coagulation disorder; Acute renal insufficiency; Hemiparesis; Facial paresis; Comatose; Oliguria; Infarct cerebral; Oedema cerebral; Second


VAERS ID: 1381596 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-22
Onset:2021-04-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood calcium, Confusional state, Death, Dehydration, Diabetic complication, Dysphagia, Haemoglobin, Hypercalcaemia, Pneumonia aspiration
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   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? Yes
Previous Vaccinations:
Other Medications: MESTINON
Current Illness: Myasthenia gravis
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia (Hb 108 g/l); Benign prostatic hyperplasia; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: calcium; Result Unstructured Data: Test Result:3.03 mmol/L; Comments: Hypercalcemia; Test Name: Hb; Result Unstructured Data: Test Result:108 g/l
CDC Split Type: CHPFIZER INC2021634030

Write-up: confusional state; acute renal failure on dehydration and hypercalcemia 3.03 mmol / l of unexplained origin and diabetic decompensation; acute renal failure on dehydration and hypercalcemia 3.03 mmol / l of unexplained origin and diabetic decompensation; acute renal failure on dehydration and hypercalcemia 3.03 mmol / l of unexplained origin and diabetic decompensation; acute renal failure on dehydration and hypercalcemia 3.03 mmol / l of unexplained origin and diabetic decompensation; bronchoaspiration bronchopneumonia on Swallowing difficulties; bronchoaspiration bronchopneumonia on Swallowing difficulties; Death; This is a spontaneous report received from a contactable physician via a regulatory authority. Regulatory authority report number CH-SM-2021-15606. An 89-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 22Mar2021 (Batch/Lot Number: EJ6788) at 89 years old as single dose for covid-19 immunisation. Medical history included myasthenia gravis (ongoing), diabetes mellitus, benign prostatic hyperplasia, anaemia Hb 108 g/l. Concomitant medication included ongoing pyridostigmine bromide (MESTINON) taken for myasthenia gravis. The patient previously received the first dose of bnt162b2 (COMIRNATY) on 22Feb2021 at 88 years old at single dose, intramuscular (Lot number EL0725) for COVID-19 immunisation. The patient experienced death on 14Apr2021, bronchoaspiration bronchopneumonia on swallowing difficulties on an unspecified date, confusional state, acute renal failure on dehydration and hypercalcemia 3.03 mmol / l of unexplained origin and diabetic decompensation on 12Apr2021. The patient was hospitalized for confusional state, acute renal failure on dehydration and hypercalcemia 3.03 mmol / l of unexplained origin and diabetic decompensation from 12Apr2021. The patient''s hospitalization was prolonged as a result of bronchoaspiration bronchopneumonia on swallowing difficulties. Therapeutic measures were taken as a result of bronchoaspiration bronchopneumonia on swallowing difficulties (pneumonia). The outcome of the event bronchoaspiration bronchopneumonia on swallowing difficulties and death was fatal, for the other events was unknown. The patient died on 14Apr2021. An autopsy was not performed. Clinical course was as follows. Elderly man 89 years old, weight 62 kg. Known for myasthenia gravis with mestinon therapy, diabetes mellitus, benign prostatic hyperplasia and anaemia. Remaining chronic therapy not known. Vaccinated with comirnaty on 22Feb2021 and second dose on 22Mar2021. On 12Apr2021 was hospitalized in geriatrics and diagnosed with confusional state, acute renal failure on dehydration and hypercalcemia 3.03 mmol / l of unexplained origin and diabetic decompensation. The hospital stay is complicated by bilateral bronchoaspiration bronchopneumonia on Swallowing difficulties (treated with broad-spectrum antibiotic such as piperacillin tazobactam(PIPERACILLIN TAZOBACTAM PA)). The patient died on 14Apr2021. The confusional state was explained on different etiologies (acute renal failure on dehydration and hypercalcemia 3.03 mmol/l of unexplained origin and diabetic decompensation). Further course not known. This case was reported as serious with seriousness criterion results in death. A causal relationship between Comirnaty and death was assessed as being unlikely according to an assessment method. Reporter''s comment: On 14Apr2021 unexpected death. Sender''s comment (a regulatory authority): Frail elderly male patient (weight 62kg, polymorbid) on chronic therapy with Mestinon. Received 2 doses of Comirnaty (22Feb2021 and 22Mar2021). 23 days after the second dose he was hospitalised for multiple conditions including hypercalcaemia, acute renal failure on dehydration. He passed away on 14Apr2021 after a diagnosis of bilateral aspiration bronchopneumonia on 12Apr2021 treated with piperacillin tazobactam. Further course not known. Death is not a known adverse event for Comirnaty in either of the monographs and is not listed on another publication for covid-19 mRNA vaccines. Deaths following administration of the second dose of covid-19 mRNA vaccines in elderly and frail patients are not reported in the international literature. In the light of the available data, considering the patient''s comorbidities (diabetes, myasthenia gravis), the advanced age and the prolonged onset timing between vaccination and the event, a causal role between death and the vaccine is judged as unlikely. However, this judgement of causality cannot totally exclude the contribution of the vaccine in the genesis of the adverse events. No follow-up attempts needed. No further information expected.; Reporter''s Comments: On 14Apr2021 unexpected death.; Sender''s Comments: The alternate explanation for the events with fatal outcome could be comorbidities in the elderly patient reported as myasthenia gravis (ongoing), diabetes mellitus, benign prostatic hyperplasia, anaemia and diabetic decompensation ,unlikely with bnt162b2 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: He passed away on 14Apr2021 after a diagnosis of bilateral aspirational bronchopneumonia on 12Apr2021; bronchoaspiration bronchopneumonia on Swallowing difficulties; death


VAERS ID: 1381613 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-05-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 2021-05-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021597581

Write-up: Deep vein thrombosis leg; Pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100073346. A 64-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 14May2021 (at the age of 64-year-old) as unknown, 0.3 mL, single for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. On 19May2021 the patient experienced deep vein thrombosis leg, pulmonary embolism. The patient''s outcome was fatal for Deep vein thrombosis leg, fatal for Pulmonary embolism. At autopsy on 19May2021, there was an increase in the circumference of the calf u. persistent redness of the right leg after death. The patient died on 19May2021. 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: Pulmonary embolus; deep vein thrombosis leg


VAERS ID: 1381614 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-11
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, Intracranial aneurysm
SMQs:, Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm hemorrhage
Allergies:
Diagnostic Lab Data: Test Name: Computed tomography head; Result Unstructured Data: Test Result:Middle cerebral artery aneurysm; Comments: Middle cerebral artery aneurysm
CDC Split Type: DEPFIZER INC2021597615

Write-up: Middle cerebral artery aneurysm; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100073350. A 88-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Lot Number: EX3510)), via an unspecified route of administration on 05May2021 as a single dose for COVID-19 immunization. Medical history included aortic aneurysm rupture from 2007 to an unknown date. Historical vaccinations included the first dose of bnt162b2 (COMIRNATY, Lot Number unknown)), via an unspecified route of administration on 24Mar2021 for COVID-19 immunization.The patient''s concomitant medications were not reported. The patient experienced middle cerebral artery aneurysm with a fatal outcome on 11May2021. The patient underwent lab tests and procedures which included computerised tomogram head: middle cerebral artery aneurysm on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Middle cerebral artery aneurysm


VAERS ID: 1381615 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Myocarditis, Myopathy, Vaccination site inflammation
SMQs:, Rhabdomyolysis/myopathy (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: Coronary sclerosis
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021597598

Write-up: florid inflammation of the deltoid muscle in the area of ??the injection site on the left upper arm with small-sized myolysis; florid inflammation of the deltoid muscle in the area of ??the injection site on the left upper arm with small-sized myolysis; Myocarditis; Acute myocardial infarction, of anterior wall; This is a spontaneous report received from a non-contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100073355. A 56-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on left deltoid on 27Apr2021 at age of 56-year-old at single dose, unknown dose number for COVID-19 immunisation. Medical history included ongoing coronary sclerosis and severe general atherosclerosis. The patient''s weight was not reported, and height was not reported. Concomitant medications were not reported. Patient experienced myocarditis and acute myocardial infarction of anterior wall, both on 28Apr2021 with seriousness criteria of death. Pathological-anatomical diagnosis was reported as following: Severe general arteriosclerosis with extensive ulcerated arteriosclerotic plaques of the infrarenal abdominal aorta and complete stenosis of the internal carotid artery. Severe coronary artery sclerosis with arteriosclerotic plaques in all three coronary arteries and, in particular, a severely stenosing plaque in the left main trunk. Acute left ventricular anterior wall infarction with an extent of approx. 8 x 5 cm in plaque thrombosis of the left main trunk. Condition after emergency bougienage and stent placement of the left main trunk with regular position of the stent. Condition after SARS-CoV-2 vaccination the day before with florid inflammation of the deltoid muscle in the area of ??the injection site on the left upper arm with small-sized myolysis. Focal myocarditis of the left ventricular apex of the heart in an extension of approx. 2 cm with the formation of microthrombi and associated myocardial necrosis with an incipient granulocytic reaction in the sense of an occurrence several hours old. Patient died on 28Apr2021 due to acute myocardial infarction of anterior wall and myocarditis. Autopsy was performed with no autopsy result available. Outcome of acute myocardial infarction of anterior wall and myocarditis was fatal, of the other events was unknown. Reporter''s comments: Basic ailments: Severe general atherosclerosis and severe coronary artery sclerosis. Cause of death: Acute anterior wall infarction. Pathological-anatomical diagnosis: Severe general arteriosclerosis with extensive ulcerated arteriosclerotic plaques of the infrarenal abdominal aorta and complete stenosis of the internal carotid artery. Severe coronary artery sclerosis with arteriosclerotic plaques in all three coronary arteries and, in particular, a severely stenosing plaque in the left main trunk. Acute left ventricular anterior wall infarction with an extent of approx. 8 x 5 cm in plaque thrombosis of the left main trunk. Condition after emergency bougienage and stent placement of the left main trunk with regular position of the stent. Condition after SARS-CoV-2 vaccination the day before with florid inflammation of the deltoid muscle in the area of ??the injection site on the left upper arm with small-sized myolysis. Focal myocarditis of the left ventricular apex of the heart in an extension of approx. 2 cm with the formation of microthrombi and associated myocardial necrosis with an incipient granulocytic reaction in the sense of an occurrence several hours old. Relatedness of drug to reactions/events: Source of assessment: Regulatory Authority, Result of Assessment: D. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Summary of Reporter Comment: Cause of death: Acute anterior wall infarction. Pathological-anatomical diagnosis: Severe general arteriosclerosis with extensive ulcerated arteriosclerotic plaques of the infrarenal abdominal aorta and complete stenosis of the internal carotid artery. Severe coronary artery sclerosis with arteriosclerotic plaques in all three coronary arteries and, in particular, a severely stenosing plaque in the left main trunk.; Reported Cause(s) of Death: Myocarditis; Acute myocardial infarction, of anterior wall


VAERS ID: 1381616 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

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: 2021-05-12
   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: Adiposis; Impingement syndrome (in the shoulder); Lumbago (excl lumbar disc lesion); Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021597592

Write-up: Unknown cause of death; Asystolia; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-202100073356. A 67-year-old male patient received second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 11May2021 (Batch/Lot Number: EX8680) at the age of 67-year-old, as 2nd dose, 0.3ml single for covid-19 immunisation. Medical history included Impingement syndrome (in the shoulder), Smoker, Adiposis, Lumbago (excl lumbar disc lesion). Historical vaccine included first dose of bnt162b2 (COMIRNATY) on 07Apr2021 for covid-19 immunisation. The patient''s concomitant medications were not reported. The patient experienced unknown cause of death and asystolia on 12May2021. Outcome of the events was fatal. The patient died on 12May2021. An autopsy was performed and results were not provided. No follow-up attempts possible. No further information expected. Information on lot number already obtained.; Reported Cause(s) of Death: Unknown cause of death; Asystolia


VAERS ID: 1381652 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021648234

Write-up: patient died after the first dose of Comirnaty; This is a spontaneous report from a contactable physician, based on information received by Pfizer from BIONTECH-SE [Manufacturer control number 59604], license party for bnt162b2 (Comirnaty). A patient of unspecified age and gender received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died after the first dose of Comirnaty (death) on an unspecified date. It was not reported if an autopsy was performed. The physician was not sure if it was related to the vaccine as he only heard it from the mother. The information on the Lot/batch number has been requested. ; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1382750 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Blood bicarbonate, Blood creatine phosphokinase, Blood creatinine, Blood pressure measurement, C-reactive protein increased, Electrocardiogram, Interleukin therapy, Leukocytosis, Neutrophilia, Physical examination, Procalcitonin, Serum ferritin, Troponin I, Urinary tract infection, X-ray, pH body fluid
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive impairment (dependent on ABVD Barthel 10)
Allergies:
Diagnostic Lab Data: Test Name: HCO3; Result Unstructured Data: Test Result:18.3 mmol/L; Test Name: CK; Result Unstructured Data: Test Result:593; Test Name: Creatinine; Result Unstructured Data: Test Result:1.84; Test Name: blood pressure; Result Unstructured Data: Test Result:67/49 mmHg; Test Name: blood pressure; Result Unstructured Data: Test Result:90/60 mmHg; Test Name: CRP; Result Unstructured Data: Test Result:29.30; Test Name: ECG; Result Unstructured Data: Test Result:ST segment elevation in aVL, V2, and V3.; Comments: ST segment elevation in aVL, V2, and V3.; Test Name: IL-6; Result Unstructured Data: Test Result:66.64; Test Name: Leukocytosis; Result Unstructured Data: Test Result:leukocytosis at the expense of neutrophilia; Test Name: Neutrophilia; Result Unstructured Data: Test Result:leukocytosis at the expense of neutrophilia; Test Name: pH; Result Unstructured Data: Test Result:7.34; Test Name: Physical examination; Result Unstructured Data: Test Result:showed a regular general state, without speech emi; Comments: showed a regular general state, without speech emission and emitting only complaining sounds, with scattered rhonchi on auscultation; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.55 ng/ml; Test Name: Ferritin; Result Unstructured Data: Test Result:9147; Test Name: Troponin I; Result Unstructured Data: Test Result:US 23627.1; Test Name: Radiographically; Result Unstructured Data: Test Result:. Radiographically, mediastinal widening without s; Comments: . Radiographically, mediastinal widening without signs of heart failure.
CDC Split Type: ESPFIZER INC2021590839

Write-up: Acute myocardial infarction/ST elevation myocardial infarction (STEMI); A possible associated UTI; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB and received via Regulatory Authority ES-AEMPS-872154. A 79-year-old female patient received the first dose of BNT162B2 (COMIRNATY; solution for injection; Lot #: EW2239) intramuscularly on 31Mar2021 at 0.3 mL single dose in the deltoid for COVID-19 immunisation. Medical history included evolved cognitive impairment from an unspecified date and unspecified if ongoing (dependent on ABVD Barthel 10). The patient had no known allergies. Concomitant medications were not reported. On 06Apr2021, the patient experienced acute myocardial infarction/ST elevation myocardial infarction (STEMI), which was fatal on 06Apr2021 and a possible associated UTI on 06Apr2021. The clinical course was reported as follows: "The patient went to the emergency room due to deterioration in her general condition and disconnection from the environment. Upon arrival at the emergency room, hemodynamically unstable patient with blood pressure 67/49 mmHg, eupneic, with correct baseline saturations. Physical examination showed a regular general state, without speech emission and emitting only complaining sounds, with scattered rhonchi on auscultation. The ECG showed ST segment elevation in aVL, V2, and V3. Radiographically, mediastinal widening without signs of heart failure. Analytically, leukocytosis at the expense of neutrophilia and mild secondary metabolic acidosis (pH 7.34, HCO3 18.3 mmol / L), together with creatinine 1.84. In turn, elevation of myocardial damage markers (CK 593, Troponin I US 23627.1) and elevation of acute phase reactants (CRP 29.30, Ferritin 9147, IL-6 66.64), Procalcitonin 0.55 ng / mL. Initially, fluid therapy was started with a discharge of 500 cc, reaching tensions 90/60 mmHg, objectifying in Troponin screening of 23627.1 and AMI of uncertain antero-lateral chronology since according to family she had night disconnected, with some sign of pain, Also, renal failure without being able to distinguish between acute or chronic exacerbation (creatinine 1.84) together with secondary mild metabolic acidosis. The administration of fluid therapy and empirical antibiotic therapy was started for a possible associated UTI. Given the poor prognosis of the current pathology, the baseline state of the patient, it was decided that she was subject to conservative medical treatment. Antiplatelet regimen was prescribed, but before it was administered, the patient was exitus laetalis. 06Apr2021. Accompanied by her family member. RE: ST elevation myocardial infarction (STEMI)." The clinical outcome of the event a possible associated UTI was unknown. The patient died on 06Apr2021. The cause of death was reported as acute myocardial infarction/ ST elevation myocardial infarction (STEMI) and it was unknown whether and autopsy was performed. No follow-up attempts possible. No further information expected. Lot/batch number was provided; Reported Cause(s) of Death: Acute myocardial infarction/ST elevation myocardial infarction (STEMI)


VAERS ID: 1382827 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-03-27
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure (hospitalized the previous month); Pulmonary embolism (hospitalized the previous month)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021597371

Write-up: Sudden death NOS; collapsed; This is as spontaneous report received from a contactable physcican downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-2021058164. A 62-year-old male patient received first dose of bnt162b2 (COMIRNATY) intramuscular on 25Mar2021 (Batch/Lot Number: Unknown) at the age of 62-year-old, as 1st dose, single for covid-19 immunisation. Medical history included that the patient had had a pulmonary embolism with heart failure who was hospitalized the previous month. The patient''s concomitant medications were not reported. It was reported the patient experienced sudden death NOS on 27Mar2021. The patient was vaccinated 48 hours before sudden death on 27Mar2021 (found collapsed on his living room table). It was not reported if an autopsy was performed. Comments: Approximate period of onset of the adverse reaction: D3 post D1. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death NOS


VAERS ID: 1383763 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-14
Onset:2021-04-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   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: Frailty
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021597599

Write-up: DIED; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IE-HPRA-2021-071912. An 86-year-old female patient received the second dose of BNT162B2 (COMIRNATY), at an unspecified age, via an unspecified route of administration on 14Apr2021 at single dose for COVID-19 immunisation. Medical history included frailty. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) on an unspecified date at an unspecified age for COVID-19 immunisation. The patient died on 16Apr2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: DIED


VAERS ID: 1383859 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7065 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-18
   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: VERTISERC; TENORETIC; DIDROGYL; PURSENNID [SENNA ALEXANDRINA LEAF]; PRAZENE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021604105

Write-up: 10:30 vaccine administration; after vaccination felt discomfort in the left limb at the injection site; headache for which did not have lunch.13:10 sudden loss of consciousness followed by death; 10:30 vaccine administration; after vaccination felt discomfort in the left limb at the injection site; headache for which did not have lunch.13:10 sudden loss of consciousness followed by death; 10:30 vaccine administration; after vaccination felt discomfort in the left limb at the injection site; headache for which did not have lunch.13:10 sudden loss of consciousness followed by death; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number IT-MINISAL02-732237. A 74-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EY7065 and Expiry date: 31Aug2021), dose 2 intramuscular, administered in Arm Left on 18May2021 10:28 (at the age of 74-years-old) as 0.3 ml single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included betahistine hydrochloride (VERTISERC); atenolol, chlortalidone (TENORETIC); calcifediol (DIDROGYL); senna alexandrina leaf (PURSENNID); prazepam (PRAZENE). The patient experienced 10:30 vaccine administration; after vaccination felt discomfort in the left limb at the injection site; headache for which did not have lunch.13:10 sudden loss of consciousness on 18May2021. It was reported that, after 3-6 hours from vaccination, death occurred due to causes to be determined. As per clinic report attached, it was reported that at 10:30 am vaccine was administered; after vaccination felt discomfort in the left limb at the injection site and headache for which did not had lunch while at 13:10 sudden loss of consciousness followed by death. The patient died on an 18May2021. It was not reported if an autopsy was performed. The outcome for all events was fatal. Reporters comments: Administration of the first dose of the Comirnaty vaccine on 27Apr2021 at 11:40 am batch EX3599: normal. Sender''s comments: Pending clinical report of death. Attached is the clinical report of the death drawn up by the General Practitioner (20May2021) Pending further information on the subject, probable execution of the autopsy (21May2021). No follow-up attempts possible. No further information expected. Information on lot number already obtained; Reporter''s Comments: Administration of the first dose of the Comirnaty vaccine on 27Apr2021 at 11:40 am batch EX3599: normal.; Reported Cause(s) of Death: unknown


VAERS ID: 1383876 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Loss of consciousness, Resuscitation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fibromyalgia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021645879

Write-up: patient arrived in the emergency room after cardiac arrest at home, subjected to resuscitation procedures. administration of Anti COVID vaccine; patient arrived in the emergency room after cardiac arrest at home, subjected to resuscitation procedures. administration of Anti COVID vaccine; sudden loss of consciousness; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-736173. A 54-years-old female patient received second dose of bnt162b2 (anti COVID 19 PFIZER, Formulation: solution for injection, Lot Number: FA5831) via intramuscularly administered in left shoulder on 13May2021 (age at the vaccination 54-year-old) at 09:32 as 2ND DOSE, 0.3 mL, SINGLE DOSE for COVID-19 immunization. Medical history included patient affected by hypertension and fibromyalgia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 14May2021, the patient experienced standstill cardiac and reanimation. Both reported as fatal by the reporter who described the events as patient arrived in the emergency room at 23:22 of 14May2021 after cardiac arrest at home, subjected to resuscitation procedures. administration of anti covid vaccine. Reporter comments included affected by hypertension and fibromyalgia. 30May2021: The date of administration of the second dose of the vaccine was 13May2021 at 09:32 a.m. lot FA 5831 Vaccine anti COIVD 19 PFIZER. The patient arrived at the emergency room at 23:22 of 14May2021 assisted by the resuscitator who performed resuscitation maneuvers at the patient''s home for reported sudden loss of consciousness and cardiac arrest. Hospitalized in intensive care. The patient died on 15May2021. It was not reported if an autopsy was performed. Sender Comment included requested report and additional data, no response from reporter. No follow-up attempts possible. No further information expected. Information about lot number already obtained.; Reporter''s Comments: Affected by hypertension and fibromyalgia. 30May2021:The date of administration of the second dose of the vaccine was 13May2021 at 09:32 a.m. lot FA 5831 Vaccine anti COIVD 19 PFIZER. The patient arrived at the emergency room at 23:22 of 14May2021 assisted by the resuscitator who performed resuscitation maneuvers at the patient''s home for reported sudden loss of consciousness and cardiac arrest. Hospitalized in intensive care.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available; Reported Cause(s) of Death: Standstill cardiac; reanimation


VAERS ID: 1383878 (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: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790-14-006 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, 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: 2021-04-06
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchitis; Difficulty in walking; Mixed dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: SARS-CoV-2 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021639179

Write-up: Positive during a screening in nursing home PRIVACY, worsened in the following days for respiratory failure, hospitalized on 02Apr, died on 06Apr; Positive during a screening in nursing home PRIVACY, worsened in the following days for respiratory failure, hospitalized on 02Apr, died on 06Apr; Positive during a screening in nursing home PRIVACY, worsened in the following days for respiratory failure, hospitalized on 02Apr, died on 06Apr; This is a spontaneous report from a contactable physician downloaded from the European Medicines Agency (EMA) EudraVigilance-WEB, regulatory authority number IT-MINISAL02-737047. A 89-year-old female patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6790-14-006; Expiration Date: 31May2021) via intramuscular route, administered in Right Arm on 11Feb2021 10:00 as a 2nd dose, single dose for COVID-19 immunization. The patient''s medical history included mixed dementia, difficulty in walking and bronchitis. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: Not reported; Expiration Date: Not reported) via unspecified route on 18Jan2021 as 1st dose, single dose for COVID-19 immunization. On 22Mar2021, the reporter stated that, the patient underwent lab test and procedure which included SARS-CoV-2 PCR test: Positive to Covid infection, in a patient vaccinated with two doses of Comirnaty (18Jan2021 and 11Feb2021). On 02Apr2021, the reporter stated that, COVID19 outbreak in a nursing home in the province of privacy involving health workers and residents vaccinated with two doses of Comirnaty. Therapeutic measures were taken as a result of Covid-19 positive during a screening in nursing home privacy and worsened in the following days for respiratory failure included: Supportive therapy with hydration, antibiotic, EBPM, oxygen. On 06Apr2021, the reporter stated that the patient was deceased, positive genotyping for variant. It was unknown if an autopsy was performed or not. Outcome of the events reported as fatal. Health Authority Comment: COVID19 outbreak in a nursing home in the province of PRIVACY involving health workers and residents vaccinated with two doses of Comirnaty.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1383882 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Asthenia, Cerebral haemorrhage, Computerised tomogram, Eye movement disorder, Incontinence, Loss of consciousness, Shift to the left
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   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: METFORMIN; TICLOPIDINE
Current Illness: Anxiodepressive syndrome; Arthrosis; Bronchitic asthma; Hypertension arterial; Prostate adenoma; Tachyarrhythmia; Type II diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cytomegalovirus colitis; Diverticula of colon; Haemorrhoids; Polyps; Rectorrhagia
Allergies:
Diagnostic Lab Data: Test Date: 20210529; Test Name: Computerised tomogram; Result Unstructured Data: unknown; Test Date: 20210529; Test Name: CT angiography; Result Unstructured Data: unknown
CDC Split Type: ITJNJFOC20210611419

Write-up: HEMORRHAGIC STROKE; LOSS OF CONSCIOUSNESS; RIGHT BRACHIOCRURAL HYPOSTHENIA; LEFT OCULOCEPHALIC DEVIATION; SPHINCTER RELEASE; SHIFT TO THE LEFT; This spontaneous report received from a physician via a Regulatory Authority [Regulatory Authority, IT-MINISAL02-737635] concerned a 67 year old male. The patient''s weight was 68 kilograms, and height was 174 centimeters. The patient''s past medical history included diverticula of colon, rectorrhagia, polyps, cytomegalovirus colitis, and haemorrhoids, and concurrent conditions included tachyarrhythmia, anxiodepressive syndrome, hypertension arterial, type 2 diabetes mellitus, bronchitic asthma, arthrosis, and prostate adenoma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: UNKNOWN) 1 dosage forms, 1 total administered on 24-MAY-2021 for sars-cov-2 vaccination. Non-company suspect drugs included: ticlopidine (form of admin unknown, oral, batch number was not reported) dose and frequency were not reported from an unspecified date to 29-MAY-2021 for antiplatelet therapy. Concomitant medications included metformin for type 2 diabetes mellitus. On 29-MAY-2021, five days after the vaccination, the patient experienced hemorrhagic stroke, loss of consciousness, right brachiocrural hyposthenia, left oculocephalic deviation, sphincter release and shift to the left. On 29-MAY-2021, Laboratory data included: CT angiography (NR: not reported) unknown, and computerized tomogram (NR: not reported) unknown. On 29-MAY-2021, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and treatment with ticlopidine was withdrawn on 29-MAY-2021. The patient died of hemorrhagic stroke, loss of consciousness, right brachiocrural hyposthenia, left oculocephalic deviation, sphincter release and shift to the left on 29-MAY-2021. This report was serious (Death).; Reporter''s Comments: Sender''s Comments: V0: 20210611419-COVID-19 VACCINE AD26.COV2.S-hemorrhagic stroke. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY 20210611419-COVID-19 VACCINE AD26.COV2.S- loss of consciousness, right brachiocrural hyposthenia, left oculocephalic deviation, sphincter release, shift to the left. 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: 1384021 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Body temperature, Cerebral infarction, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CRESTOR; TAKEPRON; THYRADIN; BAYASPIRIN; NESINA; CORTRIL [HYDROCORTISONE]; MAGMITT; MIYA-BM; VESICARE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cancer surgery; Cerebral infarction; Dyslipidaemia; Gait disturbance; Hypertension; Laryngeal cancer; Old cerebral infarction; Parkinson''s disease; Radiotherapy; Stroke-like migraine attacks after radiation therapy; Vascular parkinsonism
Allergies:
Diagnostic Lab Data: Test Date: 20210515; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021608449

Write-up: Acute cerebral infarction/cerebral infarction; Consciousness disturbed; Weakness of the right hand; This is a spontaneous report from a contactable physician received via the Agency and from the Regulatory Authority (v21111525). A 78-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EY2173; Expiration Date: 31Aug2021), intramuscularly in the left arm, on 15May2021 at 12:00 (at the age of 78-years-old) as 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, dyslipidaemia, old cerebral infarction from an unspecified date to an unspecified date, Parkinson''s disease, laryngeal cancer, surgery for laryngeal cancer on an unspecified date, several episodes of cerebral infarction, gait disturbance due to cerebrovascular parkinsonism, radiotherapy, and SMART syndrome due to radiotherapy. It was reported that after surgery for laryngeal cancer, the patient had several episodes of cerebral infarction and gait disturbance due to cerebrovascular parkinsonism; radiotherapy-related stroke-like migraine attacks after radiation therapy (SMART) syndrome present. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included rosuvastatin calcium (CRESTOR), lansoprazole (TAKEPRON), thyroid (THYRADIN), acetylsalicylic acid (BAYASPIRIN), alogliptin benzoate (NESINA), hydrocortisone (CORTRIL), magnesium oxide (MAGMITT), clostridium butyricum (MIYA-BM), and solifenacin succinate (VESICARE). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced acute cerebral infarction/cerebral infarction on 25May2021 at 11:00 (reported as: 10 days after the vaccination), which required hospitalization from 25May2021 to an unspecified date and was reported as fatal. The patient also experienced weakness of the right hand and consciousness disturbed on 25May2021. The clinical course was reported as follows: The body temperature before vaccination was 36.3 degrees centigrade on 15May2021. On 25May2021, during the day care, the patient experienced weakness of the right hand and consciousness disturbed, due to which he was transported to a medical center by ambulance. In the intensive care unit (ICU), the patient received treatment with tissue plasminogen activator (t-PA) (no catheter-based revascularization was performed). On 26May2021 (11 days after the vaccination), the patient was admitted to the hospital (as reported). On 27May2021 (12 days after the vaccination), the patient was transferred to a general hospital. There was a contact from the family about the patient''s death on 29May2021 at 05:21 (14 days after the vaccination). Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of acute cerebral infarction/cerebral infarction was fatal and of weakness of the right hand and consciousness disturbed was unknown. The patient died on 29May2021. The cause of death was reported as cerebral infarction. It was not reported if an autopsy was performed. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The reporting physician classified cerebral infarction as fatal and assessed the causality between cerebral infarction and BNT162B2 as unassessable. Other possible causes of cerebral infarction, such as any other disease, was possible relapse of cerebral infarction as natural course. The seriousness and causality of the other events were not reported.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1384023 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-22
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Electrocardiogram
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: 2021-05-22
   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: LANSOPRAZOLE; CIBENZOLINE SUCCINATE; DESYREL; GASCON [DIMETICONE]; BAYASPIRIN; RISPERIDONE; URSODEOXYCHOLIC ACID; ASPARA POTASSIUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (details were unknown); Cerebral infarction; Dysphagia; Emaciation; Gastric cancer; Late effects of cerebral infarction; Progressive supranuclear palsy
Allergies:
Diagnostic Lab Data: Test Date: 20210519; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210522; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:showed pulseless electrical activity; Comments: at 09:54
CDC Split Type: JPPFIZER INC2021616820

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from a regulatory authority. The regulatory authority report number is v21109902. An 84-year and 1-month-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration, on 19May2021 (at the age of 84-years-old) as a single dose for COVID-19 immunisation. Medical history included advanced progressive supranuclear palsy, late effects of cerebral infarction, arrhythmia (details were unknown), gastric cancer, emaciation was progressing, and dysphagia. The patient had no family history. Concomitant medications included lansoprazole (MANUFACTURER UNKNOWN); cibenzoline succinate (MANUFACTURER UNKNOWN); trazodone hydrochloride (DESYREL); dimeticone (GASCON); acetylsalicylic acid (BAYASPIRIN); risperidone (MANUFACTURER UNKNOWN); ursodeoxycholic acid (MANUFACTURER UNKNOWN); and potassium aspartate (ASPARA POTASSIUM). The patient experienced cardio-respiratory arrest on 22May2021 at 09:43 (3 days after the vaccination), which was reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 36.4 degrees centigrade on 19May2021. The patient was hospitalized due to advanced progressive supranuclear palsy. The patient was bedridden and received tube feeding. On 24Jun2020, family member agreed not to conduct resuscitation and life-prolongation treatment. On 19May2021, the patient''s general condition was as usual and stable; thus, the patient was vaccinated. After the vaccination, the patient had no allergic symptoms, change in respiration, nor pyrexia. On 22May2021 at 09:40, a medical staff found that the patient had complexion ill and he was in a gasping condition, for which the number of staff was secured. At 09:43, the patient temporarily had respiratory arrest; however, it restored spontaneously without treatment and heart rate monitoring was initiated. When a staff was performing cardiac massage, the reporting physician arrived and instructed to stop resuscitation. At 09:54, the patient had respiratory arrest again. Electrocardiogram showed pulseless electrical activity on 22May2021 at 09:54 and bilateral pupils were fixed and dilated. No examination was conducted. At 10:45 on 22May2021, arrival of family member was waited and then death was confirmed. Therapeutic measures were taken as a result of the event as aforementioned. The patient died on 22May2021. The causes of death were reported as cardio-respiratory arrest. An autopsy was not performed. The reporting physician assessed that the event was unrelated to BNT162B2. Other possible causes of the event, such as any other diseases, were reported as follows: The patient was already bedridden and received tube feeding in addition to wasting due to gastric cancer. The patient had decreased respiration ability and expectoration ability. The reporting physician commented as follows: The patient was hospitalized due to advanced progressive supranuclear palsy, bedridden, and received tube feeding. Also, emaciation was progressing due to complication of gastric cancer. The case was progressing rapidly with marked dysphagia from the early stage; thus, large decrease in respiration ability and expectoration ability was outstanding in addition to the progression of modification in gastric cancer and undernutrition. Before vaccination, the patient probably had a large volume of sputum constantly and chronic silent aspiration and apparent aspiration repeatedly. Approximately 2 weeks after the vaccination of COMIRNATY, the patient had no particular event including pyrexia and decrease in oxygen saturation, which was also not observed immediately after the vaccination. Base on the above, causality between the vaccine and death was unrelated or unknown. Death was assessed as due to present diseases.; Sender''s Comments: Based on the information currently available the event cardiorespiratory arrest is attributed to patient''s multiple underlying medical conditions and assessed Unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1384024 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Cardiac failure, Decreased appetite, Depressed level of consciousness, Neurological examination, Pyrexia, Respiratory disorder, Vital signs measurement
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   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: Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: Late effects of cerebral infarction (right hemiplegia and speech loss); Living in nursing home; Right hemiplegia; Speech loss; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210522; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:93-98 mmHg; Comments: in the afternoon; Test Date: 20210523; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result:80s mmHg; Test Date: 20210521; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210522; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: in the morning; Test Date: 20210521; Test Name: consciousness level; Result Unstructured Data: Test Result:no problems; Test Date: 20210521; Test Name: vital signs; Result Unstructured Data: Test Result:no problems
CDC Split Type: JPPFIZER INC2021622793

Write-up: respiratory disorder; consciousness decreased; Suspected cardiac failure; Pyrexia; blood pressure gradually decreased; did not want to eat supper/could not eat; This is a spontaneous report from a contactable physician. This is a report received from a regulatory authority. Regulatory authority report number is v21110138. An 85-year-old female patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 21May2021 at 14:10 at a single dose for covid-19 immunisation. Medical history included late effects of cerebral infarction (right hemiplegia and speech loss) from 2013 to an unknown date, dementia from 2013 and ongoing, lived in geriatric health services facility (nursing care level 4), and used a wheelchair. Family history was not reported. The patient''s concomitant medications were not reported. The patient previously received the first dose of the BNT162b2 (COMIRNATY, Lot Number: EW4811, Expiration date 31Jul2021) for covid-19 immunization. The patient experienced suspected cardiac failure on 22May2021 at 18:30 and pyrexia on 22May2021. Both events were serious for death. The clinical course was as follows: on 21May2021 at 14:10 (the day of vaccination), the patient received?the second dose of BNT162b2. On 22May2021 at 18:30 (1 day 4 hours 20 minutes after the vaccination), the patient experienced suspected cardiac failure. The events were further described as: from 2013, the patient had late effects of cerebral infarction (right hemiplegia and speech loss) and dementia and lived in geriatric health services facility (nursing care level 4). Dementia was advanced and the patient used a wheelchair but was able to eat meals. On the day of vaccination, there were no problems in consciousness level and vital signs; however, the patient did not want to eat supper. On 22May2021 in the morning, the patient had pyrexia of 37.7 degrees Centigrade. The patient could not eat and received infusion. From the afternoon, blood pressure gradually decreased (93-98 mmHg). On 23May2021, blood pressure was 80s. The patient developed consciousness decreased and respiratory disorder, for which vasopressor, etc. were used. However, the patient did not respond and at 18:40, the patient died. On 23May2021 (2 days after the vaccination), the outcome of the event was fatal. The patient underwent lab tests and procedures which included blood pressure measurement: 93-98 mmHg on 22May2021 in the afternoon, blood pressure measurement: 80s mmHg on 23May2021, body temperature: 36.4 degrees Centigrade on 21May2021 before vaccination, body temperature: 37.7 degrees Centigrade on 22May2021 in the morning. Therapeutic measures were taken as a result of the events. The clinical outcome of the event did not want to eat supper/could not eat was not recovered and the outcome of the other events was fatal. The patient died on 23May2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was not provided. REPORTER COMMENT: The condition aggravated on 23May2021, which was Sunday; thus, examinations were hardly conducted. Cause of aggravation and death could not be identified. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: respiratory disorder; consciousness decreased; blood pressure gradually decreased; Suspected cardiac failure; Pyrexia


VAERS ID: 1384027 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-09
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: JPPFIZER INC2021628938

Write-up: Died due to other disease; This is an initial spontaneous report obtained from a contactable physician via Medical information. A patient of unspecified age and gender received the single dose of bnt162b2 (BNT162B2, lot number and expiry date were unknown), via an unspecified route of administration on an unspecified date for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Ten days after the vaccination, the patient died due to other disease on an unspecified date. It was not reported if an autopsy was performed. The reporter commented that no causal relationship between vaccine and the death since the patient unexpectedly died after vaccination due to other disease. Information about batch number was not available and is going to be requested.; Sender''s Comments: Based on the information currently available the reported event "the patient died due to other disease" is attributed to unedrlayng medical conditions and assessed Unrelated to BNT162B2 vaccine. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Died due to other disease


VAERS ID: 1384028 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Computerised tomogram, Pericardial effusion
SMQs:, Systemic lupus erythematosus (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210528; Test Name: CT scan; Result Unstructured Data: Test Result:findings for which acute aortic dissection and; Comments: pericardial effusion were suspected.
CDC Split Type: JPPFIZER INC2021630604

Write-up: Acute aortic dissection; Pericardial effusion; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21110432. The patient was a 91-year-old female. Body temperature before vaccination was 36.4 degrees Centigrade. The family history was not reported. The patient was orally taking an antiplatelet drug. On 28May2021 at 10:45 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA7318, Expiration date 30Sep2021) at 91 years via an unspecified route of administration as a single dose for COVID-19 immunization. On 28May2021 at 17:30 (6 hours, and 45 minutes after the vaccination), the patient experienced acute aortic dissection. On 28May2021 (the day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 28May2021 (the day of vaccination), the patient spent several hours without particular abnormalities after the vaccination. However, at 17:30 (6 hours and 45 minutes after vaccination), the patient was found to have cardio-respiratory arrest before supper in the dining room, and she was emergently transferred to the reporting hospital. At the hospital visit, the patient was in cardio-respiratory arrest, and resuscitative measures were performed. CT examination was performed for searching the cause. CT examination which was performed in the reporting hospital showed findings for which acute aortic dissection and pericardial effusion were suspected. These symptoms were considered as direct causes of death. Although resuscitative measures were performed, poor improvement was observed, and the patient was confirmed to die at 19:23 (8 hours and 38 minutes after vaccination) on the same day. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed the causality between the event and bnt162b2 as unassessable. The reporting physician commented as follows: The causality between the event and bnt162b2 was unknown. However, the patient had cardio-respiratory arrest on the day of vaccination, and thus, it was considered that the causal relationship could not be ruled out.; Reported Cause(s) of Death: Acute aortic dissection; Pericardial effusion


VAERS ID: 1384031 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chills, Circulatory collapse, Decreased appetite, Fall, Physical deconditioning, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (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), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021634969

Write-up: acute circulatory failure due to defecation shock; acute circulatory failure due to defecation shock; fell in the restroom in the middle of the night; chills; abdominal pain; physical deconditioning; Inappetence; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. An 87-year-old female received the first single dose of BNT162B2 (COMIRNATY) on 18May2021 (at the age of 87 years old), for COVID-19 immunisation. Family history, medical history and concomitant medications were not provided. On 18May2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccine. On 18May2021 (after the vaccination), the patient experienced inappetence. On 27May2021 (9 days after vaccination), the patient experienced chills and abdominal pain. On 28May2021 (10 days after the vaccination), the patient experienced acute circulatory failure due to defecation shock with fatal outcome. The patient died on 28May2021. It was unknown if an autopsy was performed. The other events outcome was unknown. The course of the events was as follows: The patient was an 87-year-old female. On 18May2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On an unknown date in May2021 (unknown days after vaccination), the patient experienced inappetence after the vaccination. On 27May2021 (9 days after vaccination), the patient complained of physical deconditioning such as chills and abdominal pain. On 28May2021 (10 days after vaccination), the patient fell in the restroom in the middle of the night and she was confirmed to die. The patient was diagnosed with acute circulatory failure due to defecation shock. The seriousness criteria of the event and the causality between the event and BNT162b2 were not provided. The reporting physician commented as follows: there was no direct causal relationship; however, the event might be indirectly related to the BNT162b2. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the temporal relationship, the association between the event acute circulatory failure due to defecation shock with COMIRNATY use can not be fully 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: acute circulatory failure due to defecation shock; acute circulatory failure due to defecation shock


VAERS ID: 1384109 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6564 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Mental retardation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:2.6 mg/l
CDC Split Type: NOPFIZER INC2021639036

Write-up: The patient fell the same day as the vaccination, and this resulted in back pain afterwards; The patient fell the same day as the vaccination, and this resulted in back pain afterwards; Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uwzy12. A 29-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number- EX6564) intramuscularly on 07May2021 as 2nd dose, single dose (at the age of 29-years-old) for COVID-19 immunization. Patient medical history included intellectual disability from an unknown date and ongoing. The concomitant medications were not reported. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. The patient experienced cardiac arrest on 17May2021, the patient fell the same day as the vaccination (07May2021) and this resulted in back pain afterwards. The patient underwent lab tests and procedures which included fibrin d dimer: 2.6 mg/l in May2021. The patient died on 17May2021. The Center assessed the causal relationship between BNT162b2 (COMIRNATY) and the reported event as possible case narrative including clinical course, therapeutic measures, outcome and additional relevant information: A 29-year-old female with cardiac arrest (death) 10 days after vaccination with covid-19 vaccine (Comirnaty), second dose. The patient fell the same day as the vaccination, and this resulted in back pain afterwards. She was assessed in hospital twice and discharged to a health facility for pain relief and mobilization. Patient with mental retardation. The patient will be autopsied. The outcome of the event back pain and fall was not recovered while for the event cardiac arrest was fatal. No follow-up attempts are possible. No further information is expected. Health Authority Comment: 21May2021, Health Authority: Additional information has been requested. The patient fell the same day as the vaccination, and this resulted in back pain afterwards. She was assessed in hospital twice and discharged to a health facility for pain relief and mobilization. The patient will be autopsied.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1384116 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6775 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea, Dysuria, Renal disorder
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: CLONAZEPAM; HALOPERIDOL; GABAPENTIN; ELECTROLYTE SOLUTIONS [ELECTROLYTES NOS]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis; Bedridden; Communication disorder; End stage Parkinson''s disease; Hyponatremia; Nasogastric tube feeding; Normal pressure hydrocephalus; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: PAPFIZER INC2021634176

Write-up: died; problems with his breathing and kidneys (he stopped urinating); problems with his breathing and kidneys (he stopped urinating); problems with his breathing and kidneys (he stopped urinating); This is a spontaneous report from a contactable consumer (patient''s daughter) by Medical Information Team. A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 13:00 (Lot Number: EP6775) as single dose for covid-19 immunisation. Medical history included type 2 diabetes, hyponatraemia, end-stage Parkinson''s, normal pressure hydrocephalus, ankylosing bedridden patient, did not speak of 3 years ago and gastric tube feeding. Concomitant medications included clonazepam (CLONAZEPAM); haloperidol (HALOPERIDOL); gabapentin (GABAPENTIN) and electrolyte solutions [electrolytes nos] (ELECTROLYTE SOLUTIONS [ELECTROLYTES NOS]) all taken for an unspecified indication, start and stop date were not reported. The patient experienced problems with his breathing and kidneys (he stopped urinating) on 27Feb2021. The patient died on 28Feb2021. An autopsy was performed because it was a national issue but still have no response or a death certificate. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: died


VAERS ID: 1384817 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-22
Submitted: 0000-00-00
Entered: 2021-06-09
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: 2021-05-22
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210607177

Write-up: UNKNOWN CAUSE OF DEATH; This spontaneous report received from a physician via a Regulatory Authority concerned a 71 year old female (unspecified race and ethnic origin). The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: X0959 expiry: UNKNOWN) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAY-2021, the subject died from unknown cause of death. It was reported that, the patient death occurred next day after receiving the vaccine. On 22/05/2021 It was not reported, if an autopsy was performed. Last updated patient body was sent for forensic department. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210607177- Covid-19 vaccine ad26.cov2.s-unknown cause of 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: 1385686 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-04-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Cardiovascular disorder, Decreased appetite, Diarrhoea, Fatigue, Hypotension, Malaise, Oral candidiasis, Septic shock
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Toxic-septic shock conditions (narrow), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASAFLOW; NEBIVOLOL; EFEXOR; MOXONIDINE; ZANIDIP; BURINEX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertensive (usually hypertensive patient)
Allergies:
Diagnostic Lab Data: Test Name: biology (blood test results); Result Unstructured Data: Test Result:unknown results
CDC Split Type: BEPFIZER INC2021597491

Write-up: Septic shock; Hypotension (usually hypertensive patient); Appetite lost; severe oral yeast infection/severe oral thrush; Fatigue; Malaise; Cardiovascular disorder; major diarrhea; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. Regulatory authority report number is BE-FAMHP-DHH-N2021-91719. An 88-year-old female patient received BNT162B2 (COMIRNATY) dose 1, via an unspecified route of administration, on 17Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. The patient''s medical history was not reported although it was also provided patient was usually hypertensive patient. Concomitant medication(s) included acetylsalicylic acid (ASAFLOW) taken for an unspecified indication, start and stop date were not reported; nebivolol (NEBIVOLOL) taken for an unspecified indication, start and stop date were not reported; lercanidipine hydrochloride (ZANIDIP) taken for an unspecified indication, start and stop date were not reported; venlafaxine hydrochloride (EFEXOR) taken for an unspecified indication, start and stop date were not reported; moxonidine (MOXONIDINE) taken for an unspecified indication, start and stop date were not reported; and bumetanide (BURINEX) taken for an unspecified indication, start and stop date were not reported. The patient was vaccinated on 17Apr2021 with BNT162B2 (first dose administered). On 19Apr2021 the patient experienced events of "hypotension (usually hypertensive patient)," appetite lost, severe oral yeast infection (oral fungal infection), fatigue, malaise, cardiovascular disorder, and major diarrhea. On 19Apr2021 patient was put on daktarin oral gel and fluconazole. The patient had fatal outcome: patient died on 23Apr2021. It was also reported that "first dose administered then death in septic shock on 23Apr2021." Onset date of septic shock was not specified. The outcome of malaise, fatigue, cardiovascular disorder, severe oral yeast infection, appetite lost, diarrhea, hypotension, and septic shock was fatal. Reporter comment: Treatment - yes on 19Apr2021 put on daktarin oral gel and fluconazole. Evolution of the adverse event - death. Examinations - biology (blood test results) in emergencies not communicated. AE description - severe oral thrush loss of appetite major diarrhea hypotension arterial (usually hypertensive patient). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: treatment - yes on 19Apr2021 put on daktarin oral gel and fluconazol evolution of the AE - death examinations - biology (blood test results) in emergencies not communicated AE description - severe oral thrush loss of appetite major diarrhea hypotension arterial (usually hypertensive patient); Reported Cause(s) of Death: malaise; fatigue; Cardiovascular disorder; severe oral yeast infection/severe oral thrush; Appetite lost; Diarrhea; Hypotension; DEATH IN SEPTIC SHOCK


VAERS ID: 1385691 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0904 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral thrombosis, Computerised tomogram, Headache, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-26
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 11 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial obstruction NOS; Surgery
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:indicated that (privacy) had a large blood clot in; Comments: indicated that (privacy) had a large blood clot in his brain
CDC Split Type: CAPFIZER INC2021605536

Write-up: Blood clot in the right hemisphere; massive headache/excruciating head pain; lost consciousness; This is a spontaneous report from a contactable consumer (patient''s partner). A 72-year-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in deltoid left on 08Apr2021 12:00 (Batch/Lot Number: EX0904) as 1st dose, single at the age of 72-year-old for covid-19 immunisation. Medical history included ongoing diabetic type 2 from 2006 (onset 2006 until death), plugged arteries (not sure) onset unknown and heart surgery in Apr2020. The patient''s concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered: Public Health Clinic/Administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Consumer was writing this report on behalf of the deceased partner, (privacy). On 08Apr2021, (privacy) received his first PFIZER vaccine at (privacy) centre. On 15Apr2021, (privacy) complained of a massive headache for which he took 2 tablets of paracetamol (TYLENOL). He then lost consciousness. 911 was called and the Emergency Responders took (privacy) to the Hospital. CT Scan indicated that (privacy) had a large blood clot in his brain. An open-brain surgery was conducted, but (privacy) had never his consciousness. He subsequently was transferred to the Hospice where (privacy) died at 5:10 p.m. on 26Apr2021. (privacy) had no prior medical history of blood clot. PRIVACY called to report his partner''s death after he received the bnt162b2 vaccine 7 days prior. Blood clot in the right hemisphere leading to death onset 15Apr2021 with seriousness reported as resulted in death. Required visit to emergency room. Outcome fatal. Treatment with brain surgery. Consumer called to report the death of his partner (reporter insisted on giving his partner''s full name) after receiving the first dose of the bnt162b2. He called and left a voice message at 8:29am 26May2021 and was called back at 11:20am. He confirmed that his partner received bnt162b2 on 08Apr2021. On 15Apr2021, his partner woke up with excruciating head pain. He took 2 paracetamol and laid down on the couch. At that point he was unconscious. Reported called 911 and his partner was taken to the hospital. During brain surgery they found a blood clot in his right hemisphere. Apparently the clot was so big that it crushed the left hemisphere. Reporter does not think there was an autopsy done but was not sure. His partner has type 2 diabetes since 2006 and had a heart surgery in Apr2010 due to plugged arteries but the reporter is not sure. He said he did not have any history of blood clots. The reporter says he knew he was taking medications but did not know which ones exactly. The adverse event result in emergency room/department or urgent care. The treatment was received for the adverse event included (privacy) received an open-brain surgery. The patient was hospitalized for 11 days. The patient died on 26Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Blood clot in the right hemisphere


VAERS ID: 1385728 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Mobility decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021603962

Write-up: Pulmonary embolism on both sides/lung embolism/bilateral central and peripheral pulmonary artery embolism; This is a spontaneous report received from a non-contactable consumer downloaded from a regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021073433, and the Safety report unique identifier is DE-PEI-202100067669. A 74-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, strength: 0.3 ml (as reported)), via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) as unknown, single dose for COVID-19 immunisation. The patient''s medical history included ongoing heart disorder, and decreased mobility. The patient''s concomitant medications were not reported. On 06May2021, the patient experienced pulmonary embolism on both sides/lung embolism/bilateral central and peripheral pulmonary artery embolism with fatal outcome. The patient died on 06May2021. Sender Comment: Report of a regulatory authority: A necropsy was performed on a 74-year-old woman who was reported to have received a vaccination against COVID-19 (Biontech vaccine) on 30Apr2021. She was last seen on 03May2021 and found dead on 06May2021. The necropsy showed bilateral central and peripheral pulmonary artery embolism. The deceased was cardiac and only marginally mobile, but we could not exclude a temporal relationship to the vaccination on 30Apr2021. Further information has already been requested and will be sent by e-mail. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Autopsy-determined Cause(s) of Death: bilateral central and peripheral pulmonary artery embolism


VAERS ID: 1385729 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: Mental disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Dependence drug (NOS); Drug rehabilitation (He was successfully released from rehab 3 weeks ago.); Opium addiction (Two years ago a spinal disc operation was carried out, which resulted in an opiate addiction.); Spine manipulation (Two years ago a spinal disc operation was carried out, which resulted in an opiate addiction.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021603958

Write-up: sudden death, unexplained; This is a spontaneous report received from a non-contactable consumer downloaded from a regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021073566, Safety report unique identifier DE-PEI-202100067850 and DE-CADRPEI-2021073566. A 46-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3ml), dose 1 via an unspecified route of administration on 12May2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included opiate addiction with not ongoing (two years ago a spinal disc operation was carried out, which resulted in an opiate addiction), spinal disc operation (two years ago a spinal disc operation was carried out, which resulted in an opiate addiction), rehab (he was successfully released from rehab 3 weeks ago), dependence drug (NOS) (10012337) and ongoing mentally abnormal. The patient''s concomitant medications were not reported. The patient experienced sudden death, unexplained (unknown cause of death) on 12May2021. The patient died on 12May2021. An autopsy was not performed. Relatedness of drug to reactions/events was unclassifiable as per a regulatory authority. Sender Comment: The 47-year-old male patient was vaccinated on 12May2021 around noon and collapsed suddenly about 12h later at a friend''s house. The ambulance service, which was called in, determined that the man was dead but was unable to resuscitate him. The coroner examined a "natural cause of death" so that the public prosecutor will not arrange an autopsy. The man was mentally abnormal according to the doctor. without previous cardiovascular diseases. Two years ago, a spinal disc operation was carried out, which resulted in an opiate addiction. He was successfully released from rehab 3 weeks ago. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: sudden death, unexplained


VAERS ID: 1385730 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood electrolytes, Death, pH body fluid
SMQs:

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: Test Name: electrolyte; Result Unstructured Data: Test Result:massive electrolyte imbalance; Test Name: pH; Result Unstructured Data: Test Result:6.78
CDC Split Type: DEPFIZER INC2021603965

Write-up: Pulseless electrical activity, resuscitation, death; This is a spontaneous report received from a non-contactable consumer downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-CADR2021074076, Safety report unique identifier DE-PEI-202100068022. A 78-year-old male patient received first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 13May2021 (Batch/Lot Number: Unknown) as 1ST DOSE, 0.3 ML SINGLE for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced pulseless electrical activity, resuscitation, death on 14May2021. It was reported that the patient initially collapsed on the balcony, and there was no lay resuscitation. When the emergency services were called in immediately, there was a pulse-free electrical activity. after a cumulative resuscitation of 1 hour, which in the course of the disease, degenerated into an asystole. When admitted to the clinic with a constant resuscitation, massive electrolyte imbalance and metabolic acidosis with a pH of 6.78 only resulted in death. The patient underwent lab tests and procedures which included blood electrolytes: massive electrolyte imbalance and ph body fluid: 6.78 both on unspecified date. The patient died on 14May2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1385731 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Factor V deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021603919

Write-up: Deep vein thrombosis leg; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021078112. Safety report unique identifier DE-PEI-202100070855. A 70-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 20Apr2021 (at the age of 70 years old) (Lot Number: EX3510) as single dose for covid-19 immunisation. Medical history included ongoing Factor V deficiency, condition after deep vein thrombosis. The patient''s concomitant medications were not reported. On 28Apr2021, the patient experienced Deep vein thrombosis leg. The patient died on 28Apr2021. It was unknown if an autopsy was performed. This report was serious - death. The patient''s outcome was fatal for Deep vein thrombosis leg. Sender Comment: Information on risk factors or previous illnesses, Factor V Leiden mutation, condition after deep vein thrombosis / woman born on PRIVACY. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Deep vein thrombosis leg


VAERS ID: 1385764 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-04-19
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001176 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Intracardiac thrombus, Physical examination
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? 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: PULMICORT; ELIQUIS; VIBEDEN; CRESTOR; AMLODIPINE
Current Illness: Cardiac thrombosis (Previously cardiac thrombosis (approximately 25 years ago))
Preexisting Conditions: Medical History/Concurrent Conditions: Artificial cardiac pacemaker wearer (Due to Cardiac conduction disorders); Electroneurography (Examined for neuropathy in legs and feet)
Allergies:
Diagnostic Lab Data: Test Date: 20210419; Test Name: Physical examination; Result Unstructured Data: The patient was fit compared to his age
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: Cardiac thrombosis; Cardiac arrest; This regulatory authority case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (Cardiac thrombosis) and CARDIAC ARREST (Cardiac arrest) in an 81-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001176) for COVID-19 vaccination. The patient''s past medical history included Artificial cardiac pacemaker wearer (Due to Cardiac conduction disorders) in November 2019 and Electroneurography (Examined for neuropathy in legs and feet) on 16-Apr-2021. Concurrent medical conditions included Cardiac thrombosis (Previously cardiac thrombosis (approximately 25 years ago)). Concomitant products included BUDESONIDE (PULMICORT) from 21-Dec-2017 to an unknown date for Asthma prophylaxis, ROSUVASTATIN CALCIUM (CRESTOR) from 31-Oct-2019 to an unknown date for Hypercholesterolaemia, AMLODIPINE from 31-Oct-2019 to an unknown date for Hypertension, APIXABAN (ELIQUIS) from 30-Oct-2019 to an unknown date for Thrombosis prophylaxis, HYDROXOCOBALAMIN (VIBEDEN) from 14-Oct-2020 to an unknown date for Vitamin B12 deficiency. On 27-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced INTRACARDIAC THROMBUS (Cardiac thrombosis) (seriousness criteria death and medically significant) and CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant). The patient died on 19-Apr-2021. The reported cause of death was Cardiac arrest and Cardiac thrombosis. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Physical examination: normal (normal) The patient was fit compared to his age. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. Company Comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded although the patient''s history of cardiac thrombus confounds assessment. Event terms, onset dates and outcomes captured per reporting.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded although the patient''s history of cardiac thrombus confounds assessment. Event terms, onset dates and outcomes captured per reporting.; Reported Cause(s) of Death: Cardiac arrest; Cardiac thrombosis


VAERS ID: 1385765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 1 - / 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? Yes
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: LOSARTAN; CITALOPRAM MYLAN; FORTAMOL; ACTIVELLE
Current Illness: Arterial hypertension; Back pain; Depression
Preexisting Conditions: Medical History/Concurrent Conditions: Hormone therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021603866

Write-up: occurrence of sudden death (died suddenly the day after covid vaccine); This is as spontaneous report received from a contactable physician downloaded from the Regulatory Authority -WEB DK-DKMA-WBS-0065048. A 64-years-old female patient received BNT162B2 (COMIRNATY), first dose intramuscularly on 28Apr2021 (Lot Number: EY4834; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. Patient''s concurrent conditions included depression, back pain and arterial hypertension. The patient was also in hormone therapy and was otherwise healthy. Concomitant medications included losartan potassium (LOSARTAN) taken for hypertension from 01Jan2019; citalopram hydrobromide (CITALOPRAM MYLAN) taken for depression from 01Jan2012; codeine, paracetamol (FORTAMOL) taken for back pain from 01Jun2014; estradiol, norethisterone acetate (ACTIVELLE) taken for hormone therapy from 01Jan2014. The patient experienced the occurrence of sudden death (died suddenly the day after covid vaccine) on 29Apr2021. The patient died on 29Apr2021. An autopsy was not performed(Autopsy would be performed). No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death


VAERS ID: 1385766 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, C-reactive protein, C-reactive protein increased, Hypercalcaemia, Hypokalaemia, Pancytopenia, Renal failure, Respiratory failure, Sepsis, Toxicity to various agents
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), 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), Drug abuse and dependence (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: LIXIANA; METOPROLOLSUCCINAT HEXAL; LOMUSPRAY; BRICANYL TURBUHALER
Current Illness: Age-related macular degeneration; Dehydration (The patient is dehydrated and therefore has not been able to eliminate Methotrexate); Psoriatic arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atrial fibrillation; Runny nose
Allergies:
Diagnostic Lab Data: Test Name: Blood test; Result Unstructured Data: Test Result:Kidney failure; Test Name: Blood test; Result Unstructured Data: Test Result:Pancytopenia; Test Name: Blood test; Result Unstructured Data: Test Result:Hypercalcaemia; Test Name: Blood test; Result Unstructured Data: Test Result:Hypokalemia; Test Name: C-reactive protein; Result Unstructured Data: Test Result:100; Comments: Unit not specified
CDC Split Type: DKPFIZER INC2021603915

Write-up: Respiration failure; Pancytopenia; Methotrexate poisoning suspected; Hypercalcaemia; Sepsis suspected; CRP increased; Hypokalemia; Kidney failure; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number DK-DKMA-WBS-0065427. An 81-year-old female patient received BNT162b2 (COMIRNATY), second dose intramuscular on 04May2021 (batch/ lot number: EW6126; Expiration Date: 31Jul2021) as single dose for Covid-19 immunisation; methotrexate sodium (METEX), subcutaneous from 2020 (Batch/Lot Number: asked but unknown) to 07May2021, at 25 mg, weekly for rheumatoid arthritis. Concurrent conditions included ongoing dehydration (the patient is dehydrated and therefore has not been able to eliminate methotrexate), ongoing age-related macular degeneration, ongoing Psoriatic arthritis, asthma, atrial fibrillation, runny nose and the patient was also treated with thrombosis prophylaxis medication. Concomitant medications included edoxaban tosilate (LIXIANA) taken for thrombosis prophylaxis from 14Feb2020; metoprolol succinate (METOPROLOLSUCCINAT HEXAL) taken for atrial fibrillation from 14Feb2020; cromoglicate sodium (LOMUSPRAY) (it also reported as "LOMUSPRAY (Ipratropium Bromide)") taken for runny nose from 15Mar2021; terbutaline sulfate (BRICANYL TURBUHALER) taken for asthma from 13Dec2017. The patient previously received first dose of bnt162b2 (COMIRNATY) on 16Mar2021 (batch/lot number: ER2659, expiration date: 30Jun2021) for covid-19 immunisation. The clinical course was as below: On an unknown date in 2020 the patient started treatment with METEX PEN dosed 25 mg once a week for rheumatoid arthritis and on 16Mar2021 she was vaccinated with the first dose and on 04May2021 with the second dose of BNT162b2 (COMIRNATY) (batch numbers: ER2659; EW6126) for Covid-19 immunisation. On 07May2021 the patient developed pancytopenia, kidney failure, hypokalemia, CRP increased, hypercalcemia, sepsis and drug poisoning and on 09May2021 she developed respiratory failure. Kidney failure, hypokalemia, CRP increased, hypercalcemia, sepsis, drug poisoning and respiratory failure were by the physician reported as causing hospitalisation and being fatal (the patient died on 09May2021). Pancytopenia was reported as causing hospitalisation. No treatment or medical proceduredue to the ADRs was reported. Test results (at hospitalisation) included: C-reactive protein: 100 (unit not specified), blood test: pancytopenia, hypokalemia, hypercalcemia, kidney failure. Metex Pen was withdrawn. Kidney failure, hypokalemia, CRP increased, hypercalcaemia, sepsis, drug poisoning and respiratory failure were reported being fatal and pancytopenia was reported not recovered, however the event resulted in death (AS REPORTED). Reported cause of death: respiratory failure (as reported). An inquest had been performed and autopsy was awaited. Causality was that the reporting physician stated that due to pancytopenia, kidney failure, hypokalemia, hypercalcaemia and CRP increased, methotrexate poisoning and sepsis are suspected. The patient was treated for dehydration since was dehydrated and therefore had not been able to eliminate methotrexate. The patient was recently (04May2021) vaccinated with Comirnaty, and it was assessed, that it cannot be excluded that the ADRs were caused by Comirnaty. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hypercalcaemia; Kidney failure; Sepsis; Drug poisoning; Hypokalemia; CRP increased; Respiration failure


VAERS ID: 1385767 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-05-07
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001176 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray, Dyspnoea, Echocardiogram, International normalised ratio, Pericardial haemorrhage, Platelet count, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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: PREVENAR 13
Current Illness: COPD
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210508; Test Name: Thorax X-ray; Test Result: Inconclusive ; Result Unstructured Data: Result: Not possible to detect lung embolism; Test Date: 20210508; Test Name: Echocardiography; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive; Test Date: 20210508; Test Name: INR; Test Result: Inconclusive ; Result Unstructured Data: 5.2; Test Date: 20210507; Test Name: Thrombocyte count; Test Result: Inconclusive ; Result Unstructured Data: 348
CDC Split Type: DKMODERNATX, INC.MOD20211

Write-up: The patient has blood in the pericardium; Suspicion of lung embolism (not possible to verify); Hospitalised with difficulty breathing; This regulatory authority case was reported by a physician and describes the occurrence of PERICARDIAL HAEMORRHAGE (The patient has blood in the pericardium), PULMONARY EMBOLISM (Suspicion of lung embolism (not possible to verify)) and DYSPNOEA (Hospitalised with difficulty breathing) in a 64-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 3001654 and 3001176) for COVID-19 vaccination. Concurrent medical conditions included COPD. Concomitant products included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) from 17-Mar-2021 to an unknown date for Pneumococcal immunisation. On 18-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced PERICARDIAL HAEMORRHAGE (The patient has blood in the pericardium) (seriousness criteria death, hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (Suspicion of lung embolism (not possible to verify)) (seriousness criteria death, hospitalization, medically significant and life threatening) and DYSPNOEA (Hospitalised with difficulty breathing) (seriousness criteria death, hospitalization and life threatening). The patient died on 09-May-2021. The reported cause of death was Pericardial haemorrhage, Lung embolism and hospitalised with difficulty breathing. An autopsy was not performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Platelet count: 348 (Inconclusive) 348. On 08-May-2021, Chest X-ray: inconclusive (Inconclusive) Result: Not possible to detect lung embolism. On 08-May-2021, Echocardiogram: inconclusive (Inconclusive) Inconclusive. On 08-May-2021, International normalised ratio: 5.2 (Inconclusive) 5.2. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Fibrin D dimer test was not performed. The patient was too weak to make a computerized tomogram scan of thorax. No treatment information was provided by the reporter. This is a case of death of a 64-year-old female patient, 24 days after receiving second dose of vaccine (Lot number 3001654). A possible confounding factor is the patient''s medical history of Chronic obstructive pulmonary disease (COPD). Very limited information regarding the clinical details pertaining to death and the concomitant medications was provided at this time. No further information is expected.; Sender''s Comments: This is a case of death of a 64-year-old female patient, 24 days after receiving second dose of vaccine (Lot number 3001654). A possible confounding factor is the patient''s medical history of Chronic obstructive pulmonary disease (COPD). Very limited information regarding the clinical details pertaining to death and the concomitant medications was provided at this time. No further information is expected.; Reported Cause(s) of Death: Pericardial haemorrhage; Lung embolism; Hospitalised with difficulty breathing


VAERS ID: 1385792 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Angiogram, Auscultation, Blood bicarbonate, Blood creatinine, Blood fibrinogen, Blood glucose, Blood potassium, Blood pressure diastolic, Blood pressure systolic, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Computerised tomogram, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, Heart rate, Ischaemic stroke, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Prothrombin level, Scan brain, Troponin I, White blood cell count, pH body fluid
SMQs:, Cardiac failure (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-13
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CARVEDILOL; TELMISARTAN HCTZ; EUTHYROX; OMEPRAZOLE; ROPINIROLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Continuous positive airway pressure; Ex-smoker (Severe ex-smoker for more than 20 years); Hypertension arterial; Hypothyroidism; Left ventricular hypertrophy; Obstructive sleep apnea hypopnea syndrome; Polymyalgia rheumatica
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: ANGIOTAC MULTIPHASE; Result Unstructured Data: Test Result:Acute ischemia of the entire left middle cerebral; Comments: Right carotid artery: Mild calcified atheromatosis at the origin of the internal carotid, without significant stenosis. Right vertebral artery: Hypoplastic its origin, as well as its distal segment, leaving the basilar artery at the expense of the contralateral vertebral vascularization. Left vertebral artery: Permeable and of preserved caliber. Progressive opacification defect that begins immediately from the origin of the left internal CA that continues to include the entire ipsilateral M1 segment and one of the proximal M2 branches. Doubtful isolated short segment repermeabilization is identified at the level of the carotid in the cavernous segment. We suggest tandem obstruction. TC PERFUSION: In the entire territory of the left Middle cerebral artery, a decrease in time maps as well as flow and volume is identified. There is no mismatch. Impression / Judgment Diagnosis: Acute ischemia of the entire left middle cerebral territory with a filling defect from the proximal internal carotid to distal M1. Another filling defect is identified in M2. We suggest tandem obstruction. There is no mismatch.; Test Name: Auscultation; Result Unstructured Data: Test Result:rhythmic, without significant murmurs; Test Date: 20210510; Test Name: Bicarbonate; Result Unstructured Data: Test Result:29.1; Test Date: 20210510; Test Name: Creatinine; Result Unstructured Data: Test Result:1.24; Test Name: Fibrinogen; Result Unstructured Data: Test Result:50; Test Date: 20210510; Test Name: Glucose serum; Result Unstructured Data: Test Result:132; Test Date: 20210510; Test Name: Potassium; Test Result: 4.1 l; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:100 mmHg; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:190/95; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:180 mmHg; Test Date: 20210510; Test Name: Sodium; Result Unstructured Data: Test Result:146; Test Date: 20210510; Test Name: Urea; Result Unstructured Data: Test Result:44; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Test Date: 20210510; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Acute Pulmonary Edema; Comments: Acute Pulmonary Edema Heart Disease Hypertension; Test Name: Cranial CT; Result Unstructured Data: Test Result:hemorrhagic transformation; Comments: hemorrhagic transformation of the left middle cerebral artery stroke, with significant expansiveness and midline displacement.; Test Date: 20210511; Test Name: Cranial CT; Result Unstructured Data: Test Result:Corticosubcortical hypodensity; Comments: CT of the skull without contrast: Corticosubcortical hypodensity with effacement of furrows in the superficial territory of the left middle cerebral artery affecting M4, M5, M6, M1 and doubtful M2, compatible with acute ischemic injury. It also presents the hyperdense left middle cerebral sign compatible with thrombosis. I don''t see clear injuries in deep territory. He presents old infarcts in the right caudate nucleus, right internal capsule and also areas of hypodensity in white matter of semioval centers. No hemorrhages are observed. Impression / Diagnostic judgment: thrombosis of the left middle cerebral artery with lesions of acute ischemic appearance in the superficial territory; Test Date: 20210512; Test Name: Cranial CT; Result Unstructured Data: Test Result:rank increase in expansiveness; Comments: Compared to the previous study, a frank increase in expansiveness in the left cerebral hemisphere / left Middle cerebral artery territory stands out, which continues to be observed hypodense with respect to the contralateral, with corticosubcortical dedifferentiation. In addition, a hyperdense, ill-defined intraaxial collection of about 38 mm is observed, located in the left base ganglia, which opens to the ventricular system, identifying a hemorrhagic component mainly in the contralateral occipital horn. Additionally, we identified a hyperdense component in cortical sulci and left sylvian valleys compatible with hemorrhagic suffusion (SAH) / contrast extravasation. Overall, these findings condition a midline shift to the right side of about 23mm, subtotal collapse of the left ventricular system, descending transtentorial / uncal herniation, and partial obliteration of the ipsilateral cistern ambiens. Impression / Diagnosis Judgment: Severe expansiveness at the expense of the territory of the left Middle cerebral artery with open intraparenchymal hemorrhagic transformation to the ventricular system.; Test Date: 20210510; Test Name: C-reactive protein; Test Result: 0.6 mg/dl; Test Date: 20210510; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1362; Test Date: 20210510; Test Name: Estimated Glomerular Filtrate; Result Unstructured Data: Test Result:56; Test Date: 20210510; Test Name: Hematocrit; Result Unstructured Data: Test Result:45.1; Test Date: 20210510; Test Name: Hemoglobin; Result Unstructured Data: Test Result:15.5; Test Name: Heart rate; Result Unstructured Data: Test Result:89 bpm; Test Date: 20210510; Test Name: Neutrophils; Test Result: 69.1 %; Test Date: 20210510; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1246; Test Date: 20210510; Test Name: Calculated O2 Saturation; Result Unstructured Data: Test Result:93; Test Name: Oxygen saturation; Test Result: 92 %; Test Date: 20210510; Test Name: pCO2; Result Unstructured Data: Test Result:47; Test Date: 20210510; Test Name: pH; Result Unstructured Data: Test Result:7.40; Test Name: Physical examination; Result Unstructured Data: Test Result:Bilateral crackles AP. Abdomen without pain; Comments: Bilateral crackles AP. Abdomen without pain. Minimal pretibial edema LES; Test Date: 20210510; Test Name: Platelet count; Result Unstructured Data: Test Result:183,000; Test Date: 20210510; Test Name: pO2; Result Unstructured Data: Test Result:67; Test Date: 20210510; Test Name: Prothrombin; Result Unstructured Data: Test Result:95; Test Date: 20210511; Test Name: Scan brain; Result Unstructured Data: Test Result:Acute CMD Ictus; Test Date: 20210512; Test Name: Scan brain; Result Unstructured Data: Test Result:Hemorrhagic transformation; Test Date: 20210510; Test Name: Troponin I; Result Unstructured Data: Test Result:30-26; Test Date: 20210510; Test Name: White blood cell count; Result Unstructured Data: Test Result:6.2
CDC Split Type: ESPFIZER INC2021604045

Write-up: Ischaemic stroke; Acute edema of lung, unspecified; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority (RA)-WEB ES-AEMPS-876281. Male patient of 77 years old received second dose of Comirnaty (lot number: EY7015 ) on 05May2021 Intramuscular for COVID-19 immunisation.Medical history included Active life. Severe ex-smoker for more than 20 years. Obstructive sleep apnea and hypopnea syndrome with Continuous positive airway pressure. Hypertension with left ventricular hypertrophy. Chronic renal failure with Fibrinogen around 50. Hypothyroidism. Polymyalgia rheumatica. Surgical intervention: Tympanoplasty + bilateral mastoidectomy. Appendectomy Anal fistula. Concomitant medications included Carvedilol, Telmisartan-HCTZ, Euthyrox, Omeprazole, Ropirinol. Patient previously received the first dose of Comirnaty for COVID-19 immunisation. On the morning of 10May2021 while carrying weight, rapidly progressive dyspnea along with a sensation of chest tightness. Arrives at the ER(emergency room). Primary care team establishing Non-invasive ventilation. In the last three months she has reported self-limited episodes of dyspnea. Examination: Temperature: 36 C, Systolic blood pressure: 180 mmHg, Diastolic blood pressure: 100 mmHg, Heart rate: 89 bpm, SATO2: 92%. After NIV: Well perfused, dry, IY, 100 x ''rhythmic Auscultation, without significant murmurs. Bilateral crackles AP)anteroposterior). Abdomen without pain. Minimal pretibial edema Lower limbs.Analytics 10May2021: Serum Glucose 132, Serum Urea 44, Serum Creatinine 1.24, Estimated Glomerular Filtrate (CKD-EPI) 56, Serum Sodium 146, Serum Potassium 4.1 I, NT-proBNP (N-terminal prohormone brain natriuretic peptide) Serum 1246, Protein C Reactive in mg / dl 0.6. Prothrombin Ab 95, D-Dimer 1362. Leukocytes 6.2, Neutrophils (%) 69.1, Hemoglobin 15.5, Hematocrit 45.1, Platelets 183,000. GASOMETRY: Arterial pH 7.40, Arterial pCO2 47, Arterial pO2 67, Arterial Bicarbonate 29.1, Calculated O2 Saturation.Arterial 93.Troponin I Ultrasensitive serum 30 -- 26.Chest X-ray: Acute Pulmonary Edema.Diagnosis: Acute Pulmonary Edema Heart Disease Hypertension.While awaiting admission, she began at 16:30 with dysarthria, right central facial and paresis. Right extremities 0/5 in the upper right extremity 1/5 in the lower right extremity. On11May2021 CT(computed tomography) of the skull without contrast: Corticosubcortical hypodensity with effacement of furrows in the superficial territory of the left middle cerebral artery affecting M4, M5, M6, M1 and doubtful M2, compatible with acute ischemic injury. It also presents the hyperdense left middle cerebral sign compatible with thrombosis. I don''t see clear injuries in deep territory. He presents old infarcts in the right caudate nucleus, right internal capsule and also areas of hypodensity in white matter of semioval centers. No hemorrhages are observed. Impression / Diagnostic judgment: thrombosis of the left middle cerebral artery with lesions of acute ischemic appearance in the superficial territory. On 11May2021 ANGIOTAC MULTIPHASE: Right carotid artery: Mild calcified atheromatosis at the origin of the internal carotid, without significant stenosis. Right vertebral artery: Hypoplastic its origin, as well as its distal segment, leaving the basilar artery at the expense of the contralateral vertebral vascularization. Left vertebral artery: Permeable and of preserved caliber. Progressive opacification defect that begins immediately from the origin of the left internal CA(carotid artery) that continues to include the entire ipsilateral M1 segment and one of the proximal M2 branches. Doubtful isolated short segment repermeabilization is identified at the level of the carotid in the cavernous segment. We suggest tandem obstruction. CT PERFUSION: In the entire territory of the left MCA(middle cerebral arteries), a decrease in time maps as well as flow and volume is identified. There is no mismatch. Impression / Judgment Diagnosis: Acute ischemia of the entire left middle cerebral territory with a filling defect from the proximal internal carotid to distal M1. Another filling defect is identified in M2. We suggest tandem obstruction. There is no mismatch. On12May2021 CT BRAIN AFTER THROMBECTOMY TO RULE OUT NEW INJURIES It is compared with a previous study conducted on 11May2021. Compared to the previous study, a frank increase in expansiveness in the left cerebral hemisphere / Middle cerebral artery and left territory stands out, which continues to be observed hypodense with respect to the contralateral, with corticosubcortical dedifferentiation. In addition, a hyperdense, ill-defined intraaxial collection of about 38 mm is observed, located in the left base ganglia, which opens to the ventricular system, identifying a hemorrhagic component mainly in the contralateral occipital horn. Additionally, we identified a hyperdense component in cortical sulci and left sylvian valleys compatible with hemorrhagic suffusion (SAH) / contrast extravasation. Overall, these findings condition a midline shift to the right side of about 23mm, subtotal collapse of the left ventricular system, descending transtentorial / uncal herniation, and partial obliteration of the ipsilateral cistern ambiens. Impression / Diagnosis Judgment: Severe expansiveness at the expense of the territory of the Middle cerebral artery and left with open intraparenchymal hemorrhagic transformation to the ventricular system.EVOLUTION: at 7am on May 12, 2021, the level of consciousness decreased. On exploration on the night of 11May2021 it was stable without changes. He had spent the night calm, although around 4 am he began to be somewhat restless and with a tendency to high blood pressure (systolic blood pressure 190), with improvement after paracetamol and falling asleep.Blood pressure subsequently in range so far (systolic blood pressure 190/95). When I assess him, he is comatose, with no response to stimuli, with a focused gaze, middle pupils with reactive right and reactive left, abolished left corneal reflex and preserved right and without oculocephalic reflex. It does not mobilize Extremities except for withdrawal of the lower left extremity due to pain. A half urapidil ampulla is passed, it is extracted analytically and a cranial computed axial omography is performed, which shows a large left hematoma with ventricular extension, midline deviation and uncal herniation. Ictus code was activated and he was transferred to the intensive care unit, and a mechanical thrombectomy was performed. An urgent cranial CT scan was performed, which revealed hemorrhagic transformation of the left middle cerebral artery stroke, with significant expansiveness and midline displacement. Neurosurgical treatment was rejected.He remained sedated until 13May2021, when the electroencephalogram showed electroencephalographic inactivity, which together with the neurological examination is compatible with a diagnosis of brain death. Death is certified on 13May2021.Time Interval between Last Dose of Drug and Start of Reaction / Event: 6 and 7 days. Outcome of events were fatal. No follow-up attempts possible. No further information expected. Information about batch number already obtained.; Reported Cause(s) of Death: Haemorrhagic cerebral infarction


VAERS ID: 1385795 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-04-12
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose increased, Cardiomegaly, Computerised tomogram thorax, Confusional state, Hyperhidrosis, Loss of consciousness, Pulmonary embolism, Pulmonary infarction, Respiratory failure, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-14
   Days after onset: 2
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: TOUJEO; APIDRA; FUROSEMIDA CINFA; NATECAL D FLASH; JARDIANCE; PREDNISONA CINFA; PROLIA; PANTOPRAZOL CINFA; RISPERIDONA CINFA
Current Illness: Alzheimer''s disease; Brachial plexopathy (right); Cervical radiculopathy (Bilateral C5-C6); Cognitive impairment; Hyperlipidemia; Monoclonal gammopathy of unknown significance (monoclonal IgG kappa band with positive Bence-Jones); Polymyalgia rheumatica (Corticodependent); Polyneuropathy; Rigidity bodily (predominantly in the right half of the body); Spinal discopathy (L3-L4 and L4-L5); Tremor (predominantly in the right half of the body); Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation (of both eyes); Cholecystectomy; Ex-smoker (for more than 20 years of more than 1 pack a day); Femoral artery embolism; Spinal stenosis
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: blood glucose; Result Unstructured Data: Test Result:190; Test Date: 20210412; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:Bilateral central thrombopulmonary embolism with d; Comments: Bilateral central thrombopulmonary embolism with dilatation of the right heart chambers. Peripheral pulmonary focal condensations in middle lobe, lingula and left lower lobe that could be related to pulmonary infarcts.
CDC Split Type: ESPFIZER INC2021603517

Write-up: Syncope episode; Unconscious; Sweaty; Confused; Blood glucose was 190; Bilateral central thrombopulmonary embolism; Dilatation of the right heart chambers; Peripheral pulmonary focal condensations in middle lobe, lingula and left lower lobe that could be related to pulmonary infarcts; Respiratory failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (Regulatory Authority report number: ES-AEMPS-876343). A 86-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: EK9788; Expiration date was not reported), intramuscular on 01Feb2021 as a 2nd dose, single dose, for COVID-19 immunization. Medical history included ongoing rigidity bodily predominantly in the right half of the body; cataract operation of both eyes; ongoing tremor predominantly in the right half of the body; ongoing monoclonal gammopathy of unknown significance (monoclonal IgG kappa band with positive Bence-Jones) from 2010; ongoing right brachial plexopathy; ongoing spinal discopathy (L3-L4 and L4-L5); ongoing type 2 diabetes mellitus with polyneuropathy; right femoral embolism from 1994 to an unspecified date; ongoing corticodependent polymyalgia rheumatica; ongoing hyperlipidemia; ongoing Alzheimer''s disease; ongoing cervical radiculopathy (bilateral C5-C6); cholecystectomy; was an ex-smoker for more than 20 years of more than one pack a day; ongoing functional and cognitive impairment from 2012; and mild canal stenosis. Concomitant medications included insulin glargine (TOUJEO) from 05Oct2017 to 14Apr2021; insulin glulisine (APIDRA) from 08Jul2020 to 14Apr2021; furosemide (FUROSEMIDA CINFA) from 13Nov2020 to 14Apr2021; calcium carbonate, colecalciferol (NATECAL D FLASH) from 08Jul2020 to 14Apr2021; empagliflozin (JARDIANCE) from 16Dec2019 to 17Apr2021; prednisone (PREDNISONA CINFA) from 13Jan2020 to 14Apr2021; denosumab (PROLIA) from 02Nov2015 to 14Apr2021; pantoprazole sodium sesquihydrate (PANTOPRAZOL CINFA) from 17Nov2015 to 14Apr2021; and risperidone (RISPERIDONA CINFA) from 03Jul2020 to 14Apr2021. The patient had previously received the first dose of BNT162B2 (COMIRNATY, Lot number: EJ6796; Expiration date was not reported) on 11Jan2021 for COVID-19 immunization. On 12Apr2021, the patient was brought from the Residence for presenting a syncope episode around 07:00 in the morning. The workers of the center reported finding the patient unconscious on the floor, sweaty and confused, and they estimated that she may have stayed there for minutes. The reported events had resulted into an emergency room visit, and the patient was hospitalized on an unspecified date in 2021 due to the events. They carried out blood glucose at 07:00 which was 190. The patient was in recovery in duration of minutes. The patient did not report dyspnea prior to the episode on the previous days. There was no increase in the perimeter of lower limbs. No other clinic associated with organs. On 12Apr2021, the patient''s computerized tomogram (CT) pulmonary angiogram showed bilateral central thrombopulmonary embolism with dilatation of the right heart chambers; and peripheral pulmonary focal condensations in middle lobe, lingula and left lower lobe that could be related to pulmonary infarcts. Since the hospital admission on 12Apr2021, the patient was in a situation of respiratory failure. The outcome of the events was recovered on 12Apr2021 for syncope episode, unconscious, sweaty, confused and blood glucose of 190; and was unknown for ''bilateral central thrombopulmonary embolism'', ''dilatation of the right heart chambers'' and ''peripheral pulmonary focal condensations in middle lobe, lingula and left lower lobe that could be related to pulmonary infarcts''. The patient had died on 14Apr2021 due to respiratory failure. It was unknown if an autopsy was performed. The role of advanced age and the patient''s history in triggering the process cannot be ruled out. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: respiratory failure


VAERS ID: 1385798 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-05-01
   Days after vaccination:88
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram thorax, Deep vein thrombosis, Fibrin D dimer, Oedema peripheral, Pain in extremity, Pulmonary embolism, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: OPTOVITE B12; PROFER [FERRIMANNITOL OVALBUMIN]; OMEPRAZOLE MYLAN [OMEPRAZOLE]; BROMAZEPAM NORMON; PARACETAMOL MYLAN; HYDREA
Current Illness: Amaurosis unilateral (left eye); Hemiparesis (left) (mild left hemiparesis); Incontinence urinary; Mixed dementia (vascular and senile); Paresis (secondary left facial paresis); Polycythaemia vera (JAK-2 +); Vitamin B12 deficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Acoustic neurinoma (Suspicion of rest / recurrence of a 6 mm diameter left intracanalicular neurinoma); Basal cell carcinoma face (surgical intervention); Cataract operation (right eye cataracts); Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: left cerebellopontine angle tumor, Start Date Format: 602, Start Date: 1990, Comment: Surgical Intervention of left cerebellopontine angle tumor (neurinoma)
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result:Bilateral PE without signs of right overload; Comments: Faint infiltrate in LUL of subpleural location suggesting pulmonary infarction. Subsegmental atelectasis at the lingula and RLL level.; Test Name: D-dimer; Result Unstructured Data: Test Result:7650 ng/ml; Test Date: 20210512; Test Name: Venous Doppler ultrasound LLE; Result Unstructured Data: Test Result:Extensive thrombosis; Comments: Extensive thrombosis from the bifurcation of inferior vena cava to the left tibiofibular trunks.
CDC Split Type: ESPFIZER INC2021603573

Write-up: Pulmonary thromboembolism; Deep vein thrombosis leg; LLE (lower extremities) edema; Pain in LLE; This is a spontaneous report from a contactable physician downloaded from a regulatory authority-WEB, regulatory authority number ES-AEMPS-876614. An 85-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via intramuscular on 02Feb2021 (Lot Number: EK9788) as 0.3 mL, single for covid-19 immunisation. Medical history included cataract operation as right eye cataracts; ongoing polycythaemia vera JAK-2+; ongoing urinary incontinence; ongoing amaurosis left eye; basal cell carcinoma with surgical intervention; ongoing mild left hemiparesis; ongoing mixed dementia (vascular and senile); acoustic neuroma from 2012 (Suspicion of rest/recurrence of a 6 mm diameter left intracanalicular neurinoma); ongoing paresis (secondary left facial paresis); ongoing Vitamin B12 deficiency; left cerebellopontine angle tumor (neurinoma) from 1990. Concomitant medications included cyanocobalamin (OPTOVITE B12) from 29Oct2016 to 14May2021; ferrimannitol ovalbumin (PROFER) from 05Nov2018 to 14May2021; omeprazole (OMEPRAZOLE MYLAN) from 07Sep2017 to 14May2021; bromazepam (BROMAZEPAM NORMON) from 18Oct2017 to 14May2021; paracetamol (PARACETAMOL MYLAN) from 16Oct2019 to 14May2021; hydroxycarbamide (HYDREA) from 20Feb2019 to 14May2021. Historical Vaccine included the first dose of bnt162b2 (COMIRNATY) via intramuscular on 12Jan2021 (Lot Number: EM0477) as 0.3 mL, single for covid-19 immunisation. The patient experienced pulmonary thromboembolism on 12May2021 for 3 days and deep vein thrombosis leg on 11May2021 for 4 days, and experienced LLE edema and Pain in LLE between 11May2021 and 12May2021. The patient died of pulmonary thromboembolism and deep vein thrombosis leg on 14May2021. It was not reported if an autopsy was performed. Event outcome of LLE edema and Pain in LLE was unknown. The clinical course was reported as follows: Referred to the emergency department by a resident doctor, due to LLE (lower extremities) edema of 48-72h evolution. Pain in LLE. No complaints of dyspnea. No complaints of chest pain. The infirmary of the residential center comments that the LLE edema appeared acutely between 11May2021 and 12May2021. Tests (biochemical): D-dimer 7,650 ng / mL. Examination on 12May2021: Venous Doppler ultrasound LLE - Extensive thrombosis from the bifurcation of inferior vena cava to the left tibiofibular trunks. Pulmonary artery CT angio - Bilateral PE without signs of right overload. Faint infiltrate in LUL of subpleural location suggesting pulmonary infarction. Subsegmental atelectasis at the lingula and RLL level. Development: On admission, treatment with anticoagulants and oxygen therapy is started, as well as her usual treatment. After initial stabilization, she presented sudden deterioration on 13May2021 in the afternoon, with severe respiratory failure and a preagonal situation. Family members are informed about extremal seriousness and decision-making is discussed with family members. Palliative care was started and she died on 14May2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pulmonary thromboembolism; Deep vein thrombosis leg


VAERS ID: 1385802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Dementia Alzheimer's type
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (narrow), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ROCOZ [QUETIAPINE FUMARATE]; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021604079

Write-up: Alzheimer''s type dementia; Acute respiratory failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-876985. An 84-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 11Mar2021 (Lot Number: ET1831) as 1ST DOSE, 0.3 ML, SINGLE for covid-19 immunisation. Medical history included very advanced Alzheimer''s dementia (classified as an advanced chronic disease and death expected at any time). Concomitant medications included quetiapine fumarate (ROCOZ) 50mg (100mg/day); paracetamol 1g/12h. The patient died 24 hours on 12Mar2021 after administration of the first dose of COVID-19 vaccine. She had not had COVID-19. No information is available on the circumstances of death, but the medical history lists Alzheimer''s type dementia as the initial cause of death and acute respiratory failure as the immediate cause. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Acute respiratory failure; Alzheimer''s type dementia


VAERS ID: 1386431 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-03
Onset:2021-05-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 LA / OT

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

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: ARIPIPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Epilepsy; Living in residential institution; Psychomotor retardation (patient living in an institution)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021597714

Write-up: a little more tired lately; Death unexplained; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021054568. A 58-year-old female patient received BNT162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 03May2021 (Batch/Lot Number: EX7389) as a single dose for COVID-19 immunization. Medical history included epilepsy, psychomotor retardation (patient living in an institution), depression. Concomitant medications included aripiprazole. No past history of COVID-19. No cardiovascular history. In the days that followed, no fever, stable blood pressure, no desaturation. No infectious episode. The patient seemed a little more tired lately. On 10May2021, the patient was found dead in her bed. On 10May2021, there was unexplained death of the patient. No evidence in favor of a fall. No obvious cause found. The conclusion was unexplained death of a 58-year-old patient, treated long-term with aripiprazole, 8 days after a first injection of the BNT162b2 vaccine. No obvious cause found. It was not reported if an autopsy was performed. The outcome of tired was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1386435 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-20
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, Drug ineffective, Fibrin D dimer, Oxygen saturation, Respiratory rate, SARS-CoV-2 antibody test, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 16
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: COVID-19; Dementia vascular; Fibrosis; Lymphoma (Lymphoma treated with IPC 12 years ago (Anti-peritoneal fibrosis).)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Chest CT scan; Result Unstructured Data: Test Result:areas of ground glass, 30-40% of affected lung; Comments: consistent with COVID-19 infection; Test Date: 2021; Test Name: D-Dimer; Result Unstructured Data: Test Result:0.6 ug/ml; Test Date: 2021; Test Name: Oxygen saturation; Test Result: 93 %; Test Date: 2021; Test Name: respiratory rate; Result Unstructured Data: Test Result:40/min; Test Date: 20210505; Test Name: Covid IgG serology; Test Result: Negative ; Comments: 8 AU / ml; Test Date: 20210420; Test Name: SARS-CoV-2 test (PCR); Test Result: Positive ; Test Date: 20210427; Test Name: SARS-CoV-2 test (PCR); Test Result: Positive ; Test Date: 20210501; Test Name: SARS-CoV-2 test (PCR); Test Result: Positive ; Comments: for the UK variant
CDC Split Type: FRPFIZER INC2021597963

Write-up: COVID + PCR test with positive result/COVID-19 infection/COVID-19 confirmed by positive COVID-19 test; COVID + PCR test with positive result/COVID-19 infection/COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-2021057635. An 88-year-old female patient received BNT162B2 (COMIRNATY) via intramuscular at 1st dose, single on unspecified date (unknown lot number and expiration); and via intramuscular in right arm at 2nd dose, single on 26Feb2021 (at the age of 88 years old; Lot Number: EP2166, unknown expiration) for COVID-19 vaccination. Medical history included dementia vascular, lymphoma (treated with IPC 12 years ago; Anti-peritoneal fibrosis), COVID-19, and fibrosis. The patient''s concomitant medications were not reported. On 20Apr2021 and 27Apr2021, the patient had COVID + PCR test with positive result. On 30Apr2021, the patient had hospitalization in the emergency room for desaturation and dyspnea at home on O2. SaO2 was 93% without O2, put under 3L; respiratory rate 40/min, sign of struggle with indrawing; D-Dimer 0.6 ug/ml; and Chest CT scan showed areas of ground glass, 30-40% of affected lung parenchyma, consistent with COVID-19 infection (in 2021). The patient developed a COVID-19 infection at day 70 after dose 2 vaccination with COMIRNATY. COVID-19 confirmed by positive COVID-19 test. On 01May2021, new positive PCR test for the UK variant. On 05May2021, negative COVID IgG serology (8 AU/ml). The events resulted in emergency room visit. Death of the patient was on 06May2021. The patient died due to COVID-19 on 06May2021. Outcome of the remaining event was unknown. It unknown if an autopsy was performed. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: COVID + PCR test with positive result/COVID-19 infection/COVID-19 confirmed by positive COVID-19 test; COVID + PCR test with positive result/COVID-19 infection/COVID-19 confirmed by positive COVID-19 test


VAERS ID: 1386442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-04-26
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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: IXPRIM; LODOZ; ELIQUIS; VESICARE; CANDESARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arrhythmia; Cataract bilateral NOS; Hypercholesterolaemia; Hypertension arterial; Knee prosthesis insertion; Obesity; Shoulder osteoarthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: Oxygen saturation; Test Result: 95 %; Test Date: 20210426; Test Name: Sars-Cov-2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021597723

Write-up: Vaccination failure; COVID-19 confirmed by positive COVID-19 test; This is as spontaneous report received from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-NY20210874, Safety report unique identifier FR-AFSSAPS-2021046807. A 82-year-old male patient received the second dose of BNT162B2 (COMIRNATY), intramuscular on 09Feb2021 (Batch/Lot Number: Unknown) as a single dose, and received the first dose of BNT162B2 intramuscular on 19Jan2021 (Batch/Lot Number: Unknown) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis from an unknown date and unknown if ongoing, knee arthroplasty from an unknown date and unknown if ongoing, hypercholesterolaemia from an unknown date and unknown if ongoing, cataract from an unknown date and unknown if ongoing, atrial fibrillation from an unknown date and unknown if ongoing, complete arrhythmia by atrial fibrillation from an unknown date; arterial hypertension from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing. Concomitant medications included paracetamol/tramadol hydrochloride (IXPRIM) for an unspecified indication, start and stop date were not reported; bisoprolol fumarate/hydrochlorothiazide (LODOZ) for an unspecified indication, start and stop date were not reported; apixaban (ELIQUIS) for an unspecified indication, start and stop date were not reported; solifenacin succinate (VESICARE) for an unspecified indication, start and stop date were not reported; candesartan for an unspecified indication, start and stop date were not reported. On 26Apr2021, the patient experienced vaccination failure and COVID-19 confirmed by positive covid-19 test, both fatal events for which she was hospitalized from 28Apr2021 to an unknown date. The patient underwent lab tests and procedures which included oxygen saturation: 95 % on 28Apr2021, SARS-COV-2 test: positive on 26Apr2021. Clinical course: 19Jan2021, first injection of the COMIRNATY vaccine. 09Feb2021, second injection of the COMIRNATY vaccine. On 26Apr2021, patient tested positive for COVID-19 South African variant. On 28Apr2021, patient hospitalized for respiratory distress. Bilateral multifocal frosted glass surfaces, alveolar condensation with air bronchogram of the two basal pyramids, more marked on the right. Absence of proximal pulmonary embolism. No pleural reaction. No dilation of the right heart chambers. Severe COVID lung disease greater than 40% progressing to a known interstitial syndrome. Oxygen dependent patient with 4L oxygen for 95% saturation. Patient presenting with confusional syndrome. Start of treatment with SALBUTAMOL 5 mg / 2.5 mg, dexamethasone 4 mg, paracetamol, ROCEPHINE 1 gram, ROVAMYCIN, MEDIATENSYL. On the evening of 28Apr2021, rapid deterioration of the patient leading to cardio-respiratory arrest progressing to death. Conclusion: Severe COVID-19 infection resulting in the death of an 82-year-old patient, more than 2 months after the second injections of the COMIRNATY vaccine (batches not specified). PCR Covid-19 positive. The patient died on 28Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 confirmed by positive COVID-19 test; Vaccination failure


VAERS ID: 1386893 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-23
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 62676IA / 1 - / OT

Administered by: Unknown       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: HUMODERNATX, INC.MOD20211

Write-up: Death; This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 94-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 62676IA) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. Death occurred on an unknown date 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. No concomitant medications nor treatment information was reported. Action taken with mRNA-1273 in response to the events was not applicable. Due to lack of information and unsuccessful follow-up, the causal relationship cannot be assessed between the adverse event and the suspected drug. The case is serious because the outcome was fatal. Further information is expected. Very limited information regarding the event has been provided at this time. No follow up is possible.; Sender''s Comments: Due to lack of information and unsuccessful follow-up, the causal relationship cannot be assessed between the adverse event and the suspected drug. The case is serious because the outcome was fatal. Further information is expected. Very limited information regarding the event has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1386899 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

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: Chest infection (Treated with steroids (unspecified).)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021639206

Write-up: VOMITING; FOUND DEAD / DEATH; This is a spontaneous report from a contactable consumer. This is a report received from Regulatory Authority. Regulatory authority report number IE-HPRA-2021-072941. An 80-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01May2021 (Batch/Lot Number: Unknown) as an unspecified dose at the age of 80-year-old for COVID-19 immunisation. Medical history included chest infection treated with steroids (unspecified). The patient''s concomitant medications were not reported. The patient experienced vomiting on an unspecified date and was found dead / death on 02May2021. The patient died on 02May2021. The outcome of events was fatal. The clinical course was reported as follows: Initial report was received by the RA on 03May2021 via second-hand source. The initial report was considered invalid. The report concerned a female who experienced vomiting and died following vaccination with an unknown COVID-19 vaccine. The patient''s concomitant medication included steroids. The patient''s medical history/concurrent conditions included chest infection. On an unknown date, the patient was vaccinated with her second dose of COVID-19 vaccine (brand name and batch number: unknown). On an unknown date, the patient experienced vomiting. It was reported that the patient was found dead in her home on 02May2021. Follow-up information was received by the RA from a Medical Examiner on 25May2021: It was reported that an 80 year old female died approximately 24 hours following vaccination with her second dose of Comirnaty on 01May2021. A Coroner''s autopsy was directed. At the time of reporting, the post-mortem results were pending. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1386906 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Headache, 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: 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: ITJNJFOC20210613817

Write-up: DEATH (4 DAYS AFTER GETTING JANSSEN COVID-19 VACCINE); THROMBOSIS; HEADACHE; TIREDNESS (EXPERIENCING FOR ALL THE ENTIRE WEEKEND); This spontaneous report received from a patient via a company representative via social media concerned a 62-year-old male of unknown race and ethnicity. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced thrombosis, headache, and tiredness (experiencing for all the entire weekend). On an unspecified date (4 days after vaccination), patient died due to unknown cause. Investigation are being carried out to know if the patient suffered from some pathology that patient was unaware. It was unknown whether autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause and the outcome of headache, tiredness (experiencing for all the entire weekend) and thrombosis was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0:20210613817-COVID-19 VACCINE AD26.COV2.S -Death and thrombosis. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1386921 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-04-19
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cough, Dyspnoea, Pyrexia, Respiratory distress, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 14
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: LASIX [FUROSEMIDE]; DILZENE; PEPTAZOL [LANSOPRAZOLE]; LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis multiple; Chronic atrial fibrillation; Hip prosthesis user (In 2011 surgery for total right hip prosthesis); Varicose veins of lower extremities; Venous insufficiency (Venous insufficiency of lower limbs)
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: COVID-19 PCR test; Test Result: Positive
CDC Split Type: ITPFIZER INC2021604123

Write-up: fever; cough; SARS-CoV-2 PCR test positive; SARS-CoV-2 PCR test positive; respiratory distress; Dyspnea; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-730845. A 92-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left (reported as left shoulder) on 15Mar2021 (Batch/Lot Number: ET1831) (age at vaccination: unknown) as 0.3 ML SINGLE, dose 1 intramuscular, administered in Arm Left (reported as left shoulder) on 21Feb2021 (Batch/Lot Number: EJ6790) (age at vaccination: unknown) as 0.3 ML SINGLE for covid-19 immunisation. Medical history included Venous insufficiency (Venous insufficiency of lower limbs), Arthrosis multiple, Varicose veins of lower extremities, Chronic atrial fibrillation from 01Jan2017 to an unknown date, Hip prosthesis user from 01Jan2011 to an unknown date (In 2011 surgery for total right hip prosthesis). Concomitant medications included furosemide (LASIX [FUROSEMIDE]) taken for an unspecified indication, start and stop date were not reported; diltiazem hydrochloride (DILZENE) taken for an unspecified indication, start and stop date were not reported; lansoprazole (PEPTAZOL [LANSOPRAZOLE]) taken for an unspecified indication, start and stop date were not reported; edoxaban tosilate (LIXIANA) taken for an unspecified indication, start and stop date were not reported. On 19Apr2021, the patient had fever with cough, respiratory distress/Dyspnea; on 23Apr2021, hospitalization for respiratory distress/Dyspnea, on admission emergency room swab positive, death in hospital setting on 03May2021, family member reported 30% lung involvement. COVID-19 PCR test on 30Apr2021 was positive. The events were reported as serious due to death and hospitalization. It was unknown if an autopsy was performed. Reporter''s comments: performed 1st covid vaccination inoculation 21Feb2021 Pfitzer mRNA COMIRNATY EJ6790; 2nd on 15Mar2021 Pfitzer mRNA COMIRNATY ET1831. 192Apr20021 fever with cough; 23Apr2021 hospitalization for respiratory distress on admission emergency room swab positive death in hospital setting, family member reported 30% lung involvement; Reporter''s Comments: performed 1st covid vaccination inoculation 21Feb2021 Pfitzer mRNA COMIRNATY EJ6790; 2nd on 15Mar2021 Pfitzer mRNA COMIRNATY ET1831. 192Apr20021 fever with cough; 23Apr2021 hospitalization for respiratory distress on admission emergency room swab positive death in hospital setting, family member reported 30% lung involvement; Reported Cause(s) of Death: cough; SARS-CoV-2 PCR test positive; Vaccination failure; respiratory distress; Dyspnea; Fever


VAERS ID: 1386928 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-08
Onset:2021-05-14
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021653354

Write-up: 6 days before death, the patient received the pfizer vaccine.; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-732021. A 71-year-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for Injection, Batch/Lot Number: EX7389), via intramuscular route of administration, administered in deltoid right (right shoulder) on 08May2021 at a 1st dose, 0.3 ml total single dose for COVID-19 immunization. The patient medical history included diabetes. The patient''s concomitant medications were not reported. The patient experienced sudden death on 14May2021. The event was described as 6 days before death, the patient received the pfizer vaccine. It was not reported if an autopsy was performed. Outcome of the event was fatal. Impact on quality of life (1/10). No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: diabetes; Reported Cause(s) of Death: 6 days before death, the patient received the pfizer vaccine.


VAERS ID: 1386984 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-16
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021604313

Write-up: Death; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-733130. An 88 years old female patient received the second dose of BNT162B2 (COMIRNATY, COVID 19 VACCINE (PFIZER)) on unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported patient was death on 16Mar2021. The patient''s outcome was fatal for unknown cause of death. It is unknown if autopsy was done. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1387001 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-03-22
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790-14-006 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GLUCOBAY; INSULIN; FUROSEMIDE; SELEPARINA; BISOPROLOL; TAPAZOLE; PAROXETINE; PARACETAMOL; OMEPRAZOLE; LORAZEPAM; MACROGOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; COPD; Diabetes mellitus; IHD
Allergies:
Diagnostic Lab Data: Test Date: 20210322; Test Name: SARS-CoV-2 RT-PCR test; Test Result: Positive ; Comments: Positive genotyping for variant
CDC Split Type: ITPFIZER INC2021638906

Write-up: Positive RT-PCR for SARSCoV2 on 22Mar2021 in a subject vaccinated with two doses of COMIRNATY (18Jan2021 and 11Feb2021). Deceased on 01Apr2021. Positive genotyping for variant; Positive RT-PCR for SARSCoV2 on 22Mar2021 in a subject vaccinated with two doses of COMIRNATY (18Jan2021 and 11Feb2021). Deceased on 01Apr2021. Positive genotyping for variant; This is a spontaneous report received from a contactable physician downloaded from a regulatory authority-WEB. The regulatory authority report number is IT-MINISAL02-736211. A 94-year-old male patient received BNT162b2 (COMIRNATY, Solution for injection) of 2nd dose, single dose (Lot number- EJ6790-14-006, Expiration date: 31May2021) via intramuscularly in right arm on 11Feb2021 at 09:00 and 1st dose, single dose (Lot number: unknown) via unspecified route of administration on 18Jan2021 for COVID-19 immunization. Medical history included diabetes mellitus, COPD, IHD, chronic renal failure. Concomitant medication (before hospitalization) included acarbose (GLUCOBAY), insulin, furosemide, nadroparin calcium (SELEPARINA), bisoprolol, thiamazole (TAPAZOLE), paroxetine, paracetamol, omeprazole, lorazepam (LORAZEPAM), macrogol. It was reported that covid 19 comirnaty vaccine (pfizer) 195FL 0.45ML. On 22Mar2021, Positive RT-PCR and subsequent detection of the specific country variant of SARSCoV2 at the genotyping performed and resulted positive at the Local Healthcare Area. It was reported that addition of antibiotic therapy, enoxaparin 6000UI qd (daily) and Oxygen Therapy Reservoir - Actions taken (Hospitalization, Repeated Testing of Healthcare Workers and other guests of the Nursing Home, genotyping, cohortization of guests). On 01Apr2021, patient was died due to COVID-19 respiratory infection. It was not reported if an autopsy was performed. The outcome of the events was fatal. Reporter''s comments: Outbreak of COVID19 in the Nursing Home involving health workers and residents vaccinated with two doses of Comirnaty Sender''s comments: 28May2021: adverse reaction updated; Reporter''s Comments: Outbreak of COVID19 in the Nursing Home involving health workers and residents vaccinated with two doses of Comirnaty; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-2021650363 Original Case : 2021638906; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1387005 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-05-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1131 / UNK 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: 2021-05-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021653223

Write-up: Death sudden; This is a spontaneous report from a contactable Pharmacist downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-737182. A 51-year-old male patient (age at vaccination: 51 year) received a dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FC1131 and expiry date was not provided), via intramuscularly, in Deltoid Left, on 30May2021 at 14:55, as single dose, 0.3 mL, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 30May2021, the patient had sudden death. Following an anamnesis evaluated by the vaccinator who did not show contraindications neither for the remote pathological history, nor for the pharmacological one, nor for the allergological one, the vaccine was administered at 14.55 (left deltoid); furthermore, there were no previous COVID positivity, and no swabs performed in the past. The patient did not experience any adverse effects or reactions in the observation period following the administration of the vaccine. The death occurred at the home a few hours after the vaccination. The outcome of the event was fatal. It was not reported if an autopsy was performed. Reporter''s comments: Additional information requested at emergency health service Follow -up attempts are possible. No further information is expected.; Reporter''s Comments: Additional information requested at emergency health service; Reported Cause(s) of Death: Death sudden


VAERS ID: 1387245 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-17
Onset:2021-05-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-22
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021622798

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician. This is a report received from Agency Regulatory Authority. Regulatory authority report number is v21110119. A 76-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 17May2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included diabetes mellitus. No information on family history was provided. The patient''s concomitant medications included unspecified tranquilizer. On 22May2021, the patient experienced cardio-respiratory arrest, which was medically significant and serious for death. The clinical course was as follows: on 17May2021 at 10:00 (the day of vaccination), the patient received the first dose of BNT162b2. On 22May2021 (5 days after the vaccination), the patient died of cardio-respiratory arrest. The event was further described as: on 22May2021, according the patient''s family, the patient was found in cardio-respiratory arrest by his family. The patient underwent lab tests and procedures which included body temperature: 36.4 degrees Centigrade on 17May2021 before vaccination. The clinical outcome of the event was fatal. The patient died on 22May2021 due to cardio-respiratory arrest. 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. It was not provided if there was other possible cause of the event such as any other diseases. REPORTER COMMENT: the causal relationship with BNT162b2 was unassessable.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1387246 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cerebral 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: 2021-05-24
   Days after onset: 25
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: Blood pressure; Result Unstructured Data: Test Result:133/96; Comments: at vaccination; not high; Test Date: 20210428; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021622826

Write-up: Cerebral haemorrhage; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. The regulatory authority report number is v21110222. An 87-year and 6-month-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration, on 28Apr2021 at 14:30 (at the age of 87-years-old) as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. 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). The patient experienced cerebral haemorrhage on 29Apr2021 at 06:30 (16 hours after the vaccination), which required hospitalization from 29Apr2021 to an unspecified date and was reported as fatal. The clinical course was reported as follows: The body temperature before vaccination was 36.4 degrees Centigrade on 28Apr2021. The reporting physician stated the blood pressure was not high at 133/96 at the time of vaccination on 28Apr2021. On 29Apr2021, at 06:30 (16 hours after vaccination), the patient''s response to call was disappeared, and the patient was emergently transferred to another hospital at 07:20 (16 hours and 50 minutes after vaccination) on the same day. The patient had cerebral haemorrhage, and he was admitted to the hospital for treatment. Therapeutic measures were taken as a result of the event, which included unspecified treatment. The patient died on 24May2021 (26 days after the vaccination). The cause of death was reported as cerebral haemorrhage. It was not reported if an autopsy was performed. The reporting physician assessed the causality between the event and BNT162B2 as unassessable. Other possible cause of the event, such as any other diseases, was unknown.; Reported Cause(s) of Death: cerebral haemorrhage


VAERS ID: 1387247 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram, Pulmonary alveolar haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (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? Yes
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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ill-defined disorder; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: CT examination; Result Unstructured Data: Test Result:the cause of death was diagnosed as pulmonary; Comments: alveolar haemorrhage
CDC Split Type: JPPFIZER INC2021623010

Write-up: Pulmonary alveolar haemorrhage; cardio-respiratory arrest; This is a spontaneous report from a contactable physician and consumer via a Pfizer sales representative. An 88-year-old male patient received the first dose of BNT162B2 (COMIRNATY), intramuscularly, on 18May2021 as 0.3 mL, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome and other unspecified conditions (as reported). The patient''s concomitant medications were not reported. The patient experienced pulmonary alveolar haemorrhage on 20May2021 (2 days after the vaccination), which was reported as life-threatening and fatal. The patient also experienced cardio-respiratory arrest on 20May2021. The clinical course was reported as follows: On 18May2021, the patient received the first dose of BNT162B2. On 19May2021, the patient visited the reporting hospital for rehabilitation as usual. On the morning of 20May2021, the patient''s wife found the patient in a condition of cardio-respiratory arrest. The patient was emergently transported to the reporting hospital. As a result of computerized tomogram (CT) examination, the cause of death was diagnosed as pulmonary alveolar haemorrhage in May2021 and a certificate of death was made as such. The clinical outcome of pulmonary alveolar haemorrhage was fatal and of cardio-respiratory arrest was unknown. The patient died on 20May2021. The cause of death was reported as pulmonary alveolar haemorrhage. It was not reported if an autopsy was performed. The reporting physician assessed that the event, pulmonary alveolar haemorrhage, was unrelated to BNT162B2. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender''s Comments: Based solely on chronological connection to the vaccine a causal relationship between events pulmonary alveolar haemorrhage and cardio-respiratory arrest and BNT162B2 (COMIRNATY) vaccine cannot be completely excluded. The case will be reevaluated should additional information become 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: Pulmonary alveolar haemorrhage


VAERS ID: 1387250 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 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? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLODIPINE; INISYNC; METFORMIN; GLIMEPIRIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021634953

Write-up: suddenly died; This is a spontaneous report from a contactable physician received via a regulatory authority. The patient was a 67-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products.Other medical history included diabetes mellitus, hypertension, and asthma.On 28May2021 at 10:30 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization.The patient received amlodipine; alogliptin benzoate, metformin hydrochloride (INISYNC); metformin; glimepiride.On 01Jun2021(4 days after the vaccination), the patient was confirmed alive until around 13:00.On 01Jun2021 at 15:00 (4 days, 4hours and 30minutes after the vaccination), the patient suddenly died. An autopsy was being carried out by the police. The event resulted in death. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (Life threatening).Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Apart from a plausible temporal association, there are no specific elements supporting a causative role of BNT162B2 vaccine for the reported sudden death. Of note, the patient''s medical history was positive for diabetes mellitus and hypertension, both risk factors for sudden death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: suddenly died


VAERS ID: 1387254 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Loss of consciousness, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   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: Abdominal aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021642553

Write-up: abdominal aortic aneurysm rupture; loss of consciousness; state of shock; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21110993. A 94-year and 5-month-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 27May2021 (Batch/Lot number was not reported) (at the age of 94-year-old) as single dose for COVID-19 immunisation. Medical history included abdominal aortic aneurysm from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 27May2021, the patient received a dose of BNT162b2 (COMIRNATY). On 29May2021 at around 17:00 (2 days after the vaccination), the patient experienced abdominal aortic aneurysm rupture. The patient was hospitalized on that day. On 30May2021 at around 08:09 (3 days after the vaccination), the patient died of abdominal aortic aneurysm rupture. It was not reported if an autopsy was performed. The course of the event was as follows: body temperature before vaccination was not reported. On 29May2021 at around 17:00, the patient was transferred to the reporter''s hospital because of loss of consciousness. Abdominal aortic aneurysm had been noted from before, and it was considered that she was in a state of shock caused by aortic aneurysm rupture. On the same day, the patient was emergently hospitalized. On 30May2021 at 08:09, the patient died. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. Abdominal aortic aneurysm that had been present since before was other possible cause of the event. The reporting physician commented as follows: on the day after the patient died, the reporter received a query from her family regarding the vaccination she received on 27May2021. The causal relationship with BNT162b2 was not actively suspected, however, as the event occurred after the vaccination, just to be safe, this case was reported. The information on the lot/batch number has been requested.; Reported Cause(s) of Death: loss of consciousness; state of shock; abdominal aortic aneurysm rupture


VAERS ID: 1387255 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Cardio-respiratory arrest, Heart rate, Imaging procedure
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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: 2021-05-28
   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: BONALON; SENNOSIDE [SENNOSIDE A+B]; MAGMITT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210528; Test Name: Heart rate; Result Unstructured Data: Test Result:0; Comments: confirmed on ECG monitor; Test Name: autopsy imaging; Result Unstructured Data: Test Result:no obvious lesions
CDC Split Type: JPPFIZER INC2021642673

Write-up: acute cardiac failure; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21111053. The patient was a 87-year and 7-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. The family history was not reported. The patient had medical histories of osteoporosis and hypertension. The oral concomitant medications included alendronate sodium hydrate (BONALON), sennoside, and magnesium oxide (MAGMITT). On 28May2021 at 10:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 28May2021 at 19:10 (8 hours, and 55 minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 28May2021 (the day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 28May2021 at 10:15 (the day of vaccination), the patient had no physical deconditioning and was not different from any other day, and received the first dose of BNT162b2 vaccination after he was examined by his attending physician. On 28May2021 at around 18:00 (7 hours and 45 minutes after the vaccination), the patient ate dinner on his own, and he excreted but it was not different from any other day. On 28May2021 at 18:50 (8 hours and 35 minutes after the vaccination), when the caregiver visited the patient''s room, he was in a supine position, and thus, the caregiver spoke to him and provided the stimulus. However, no response was obtained. Since the pulse rate, the blood pressure, the body temperature, and the SpO2 were unable to be measured, and the respiratory rate was 1 beat/minute like labored breath, an ambulance was called. On 28May2021 at 19:20 (9 hours and 5 minutes after the vaccination), in the ambulance, ECG monitor confirmed that the heart rate was 0, and cardiac massage was initiated. The patient was transferred to reporting hospital. Although cardiopulmonary resuscitation (CPR) was performed, DNAR (do not attempt resuscitation order) was confirmed by the family members. At 20:06 (9 hours and 51 minutes after the vaccination), the CPR was discontinued. At 22:02 (11 hours and 47 minutes after the vaccination), the patient was pronounced dead. An autopsy imaging (AI) showed no obvious lesions, and it was judged that the patient had an acute cardiac failure. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases was acute cardiac failure. The reporting physician commented as follows: Although the direct causality between the event and BNT162b2 was unknown, the patient died on the day of the vaccination, and thus, this case was reported.; Reported Cause(s) of Death: acute cardiac failure; Cardio-respiratory arrest


VAERS ID: 1387256 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: Common bile duct stone; Dementia; Hypertension; Sleeplessness
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021646895

Write-up: Death/ On 03Jun2021 at 06:00, a nurse confirmed that the patient was not breathing. At 09:27 on the same day, the patient was confirmed dead.; This is a spontaneous report from a contactable physician through a Pfizer sales representative. An 88-years-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscular on 02Jun2021 (Lot Number: EW4811; Expiration Date: 31Jul2021) as 0.3 ml single for covid-19 immunisation. Medical history included dementia, hypertension, insomnia, common bile duct stone. The patient''s concomitant medications were not reported. Historical vaccine included that he patient previously received the first dose of BNT162b2 (COMIRNATY, Lot Number and Expiration date unknown) on an unspecified date for covid-19 immunisation. On 02Jun2021, the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EW4811; Expiration Date: 31Jul2021) intramuscular, at a dose of 0.3 ml single, for COVID-19 immunization. On 03Jun2021, the patient died. The course of the event was as follows: On 03Jun2021 at 3:00 (the day after vaccination), the patient was confirmed alive. On 03Jun2021 at 06:00, a nurse confirmed that the patient was not breathing. At 09:27 on the same day, the patient was confirmed dead. The cause of death was unknown. An autopsy was requested. It was unknown if an autopsy was performed. The physician classified the events as serious (fatal). The causality with BNT162b2 was assessed to be unknown as of this report because no autopsy results were obtained.; Sender''s Comments: Lacking any details on the circumstances and cause of patient'' demise, the reported Death is considered related to BNT162B2 as a cautionary measure only until additional information will be available. .; Reported Cause(s) of Death: death


VAERS ID: 1387257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Loss of consciousness, Physical deconditioning
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre 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: 2021-06-03
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension ((chronic disease))
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021650811

Write-up: Unconscious; Physical deconditioning; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was an 80-year-old female. Medical history included hypertension (chronic disease). Concomitant medications were not reported. On 01Jun2021 in the afternoon (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 02Jun2021 at an unknown time (1 day after the vaccination), the patient experienced physical deconditioning. On 03Jun2021 at 15:00 (2 days after the vaccination), the family found her unconscious. As of the reporting date, the outcome of the event physical deconditioning was unknown. The course of the events was as follows: On 01Jun2021 in the afternoon (the day of vaccination), the patient received the first vaccination. On 02Jun2021 around in the afternoon (1 day after the vaccination), the patient complained of physical deconditioning (the temperature was not measured). On 03Jun2021 (2 days after the vaccination), the patient was sleeping, but around 15:00, the family found her unconscious. Paramedics were called, but resuscitation was not performed because postmortem rigidity was noted. It was reported that autopsy was planned to be performed. The reporting physician classified the event (unconscious) as serious (death) and assessed that the event (unconscious) was probably related to BNT162b2. The seriousness and causality of the event physical deconditioning were not reported. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information, and on a reasonable temporal association, causality cannot be completely excluded between the event Loss of consciousness, with fatal outcome, and the suspect vaccine BNT162B2 (COMIRNATY). It was reported that autopsy was planned to be performed. 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: Unconscious


VAERS ID: 1387258 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, C-reactive protein increased, Cardio-respiratory arrest, Cerebral infarction, Computerised tomogram, Computerised tomogram abdomen, Computerised tomogram thorax, Fibrin D dimer, Haematocrit, Haemoglobin, Red blood cell count, Seizure, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Systemic lupus erythematosus (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), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoporosis; Thyroid cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210530; Test Name: Computerised tomogram; Result Unstructured Data: Test Result:extensive cerebral infarction (embolism); Comments: in the left hemisphere. Vascular occlusion of the middle cerebral artery was suspected; Test Date: 20210530; Test Name: Abdominal CT; Result Unstructured Data: Test Result:no obvious abnormalities in whole; Test Date: 20210530; Test Name: Chest CT; Result Unstructured Data: Test Result:no pleural effusion, no significant change; Comments: in the lung fields, and no enlarged heart; Test Date: 20210530; Test Name: CRP; Result Unstructured Data: Test Result:4.1; Test Date: 20210530; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:79.03; Test Date: 20210530; Test Name: heamatocrit; Test Result: 46.3 %; Comments: no abnormality; Test Date: 20210530; Test Name: haemoglobin; Result Unstructured Data: Test Result:14.0; Test Date: 20210530; Test Name: RBC; Result Unstructured Data: Test Result:3970000; Test Date: 20210530; Test Name: WBC increased; Result Unstructured Data: Test Result:12100
CDC Split Type: JPPFIZER INC2021651251

Write-up: atrial fibrillation; convulsive seizure with a groan; cardio-respiratory arrest; Cerebral infarction; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. The patient was an 87-year-old female at the time of vaccination and event onset time. Body temperature before vaccination was not provided. The patient family history was not provided. The medical history included hypertension, postoperative thyroid cancer and osteoporosis. On 28May2021 at (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular, at a dose of 0.3 mL, single for COVID-19 immunization. On 30May2021 (2 days after the vaccination), the patient experienced cerebral infarction. On 30May2021 (2 days after the vaccination), the outcome of the event was fetal. The course of the event was as follows: On 28May2021 (the day of vaccination), the patient received BNT162b2 vaccination via intramuscular route. No adverse reactions were observed. There were no appreciable abnormalities such as allergy on the medical interview. On 30May2021 (2 days after vaccination), at around 10:30 (2 days, 10 hours, and 30 minutes after vaccination), since the patient repeated convulsive seizure with a groan, an ambulance was called. At 10:54 (2 days, 10 hours, and 54 minutes after vaccination), an ambulance arrived. Since the patient had been already in cardio-respiratory arrest, cardiopulmonary resuscitation was performed. The patient was transferred to another hospital, where the heart rate was resumed once with an intravenous injection of adrenaline 1 mg and intratracheal intubation. At 11:18 (2 days, 11 hours, and 18 minutes after vaccination), the patient had cardiac arrest again (Bosmin 1 mg was administered). At 11:28 (2 days, 11 hours, and 28 minutes after vaccination), the heart rate was resumed. At 11:37 (2 days, 11 hours, and 37 minutes after vaccination), the patient had cardiac arrest. The patient already had pupils dilated to 6 mm, and the pupillary light reflex was not observed. At 12:07 (2 days, 12 hours, and 7 minutes after vaccination), the patient had atrial fibrillation. CT findings showed extensive cerebral infarction (embolism) in the left hemisphere. Vascular occlusion of the middle cerebral artery was suspected. Chest CT findings showed no pleural effusion, no significant change in the lung fields, and no enlarged heart. Abdominal CT showed no obvious abnormalities in whole. Lab data included White blood cell count of 12100, C-reactive protein of 4.1, D-dimer of 79.03, Red blood cell count of 3970000, haemoglobin 14.0 and Heamatocrit of 46.3%(no abnormality). The reporting physician classified the event as serious (death) and assessed that the event was probably related to BNT162b2. The outcome of cerebral infarction was fatal, of other events was unknown.; Sender''s Comments: Based on the information currently available and due to a plausible temporal relationship, a possible contribution of the suspect drug administration to the reported events cannot be excluded. It is worth noting that this elderly patient presented hypertension, that is a risk factor for cerebral infarction. 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 infarction


VAERS ID: 1387305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET9096 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Dyspnoea, Fatigue, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 12 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung fibrosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021597885

Write-up: DYSPNEA; DISEASE AGGRAVATION (LUNG FIBROSIS); DISEASE AGGRAVATION (LUNG FIBROSIS); TIREDNESS; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Uap4p9, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00028968. An 88-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscularly on 16Apr2021 (Batch/Lot Number: ET9096) as 2nd dose, single dose for COVID-19 immunisation. Medical history included lung fibrosis. The patient''s concomitant medications were not reported. On 17Apr2021 (the day after vaccination with COVID-19 vaccine (Comirnaty), second dose), the patient experienced dyspnea, tiredness (fatigue) and aggravation of lung fibrosis. She was hospitalized six days after the vaccination (as reported), and she died three weeks after the vaccination. Patient with known lung fibrosis. Significant aggravation of lung fibrosis at hospitalization, compared to earlier. The patient was hospitalized due to the events from 24Apr2021 to 06May2021 (as reported). The patient was discharged to a nursing home the day before she died. The patient died on 07May2021 due to dyspnea, tiredness (fatigue) and aggravation of lung fibrosis. It was not reported if an autopsy was performed. Reporter Comment: - Aggravation of lung fibrosis the day after vaccination. Significant aggravation of lung fibrosis at hospitalization, compared to earlier. - She was hospitalized six days after the vaccination. - Discharged to a nursing home the day before she died. Sender comment: Since the vaccine is new, it will be subject to special monitoring to identify any new safety information as soon as possible. It is especially important that serious and/or unusual side effects be reported. Your message is therefore important to expand knowledge about adverse reactions that were not discovered in the studies, and it is an important contribution to international cooperation to maintain safe vaccination worldwide. Reports of the coronavirus vaccination in the Register of Adverse Reactions are processed by the Institute in collaboration with the Medicines Information Centers. The Agency publishes weekly summaries of reports of suspected adverse reactions following vaccination. If you have any more information about the course of events, such as outcome information, a copy of the medical record / discharge summary / laboratory response, and/or other reports, you can send them as a reply to this message. The information is processed in a secure manner and deleted automatically after 4 months. Processing and storage of personal data takes place in accordance with the Act. Causality is assessed according to international criteria. We do not currently have the capacity to send individual adverse reaction reports. For updated information and advice on the use of vaccines, together with precautions, please refer to the Vaccination Guide. The Primary Source Reporter assessed the causal relationship between bnt162b2 (COMIRNATY) and all the reported events as Possible. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: - Aggravation of lung fibrosis the day after vaccination. Significant aggravation of lung fibrosis at hospitalization, compared to earlier. - She was hospitalized six days after the vaccination. - Discharged to a nursing home the day before she died.; Reported Cause(s) of Death: DYSPNEA; DISEASE AGGRAVATION (LUNG FIBROSIS); DISEASE AGGRAVATION (LUNG FIBROSIS); TIREDNESS


VAERS ID: 1387325 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-26
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis, Cardiac arrest, Cerebrovascular disorder, Diarrhoea
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021597801

Write-up: Diarrhea; Atherosclerosis generalized; Secondary cause of death cerebral circulatory disorder. Direct cause of death exacerbation cerebral circulation disorders; Cardiac arrest, unspecified/SCA I46.9; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is PL-URPL-3-640-2021. An 86-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EL8723; Expiration Date: 31May2021), intramuscular, administered in arm left on 11Feb2021 at 09:03 (at the age of 86-years-old) as 1st dose, 0.3 ml single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 26Feb2021 at 16:59, in the submitted adverse reaction report after vaccination, symptoms were listed: diarrhea. Description of the reaction: Death on 26Feb2021. Vaccination against Covid 19 on 11Feb2021. Cause of death - generalized atherosclerosis, secondary cause of cerebral circulation disorder, direct cause - exacerbation of cerebral circulation disorders, Cardiac arrest, unspecified (SCA I46.9). Health result: death. The outcome of the event diarrhea was unknown, while of the rest was fatal. The patient died on 26Feb2021. It was unknown if an autopsy was performed. Sender Comment: Diarrhea is an expected side effect described following the administration of Comirnata. The temporal relationship speaks for a cause-and-effect relationship. Generalized atherosclerosis, cerebral circulation disorders, exacerbation of cerebral circulation disorders, unspecified cardiac arrest are unexpected symptoms. Their relationship to the administration of the vaccine is questionable. There is a temporal relationship between the administration of the vaccine and the occurrence of these side effects, however they believes that they occurred in a temporal coincidence with vaccination. Until 18May2021, single cases of arteriosclerosis, cerebrovascular disorder were reported in the database. Cases of cardiac arrest and condition aggravated have also been reported. The person reporting it qualified it as severe. Due to this assessment and the health outcome - the death of the assessed the application as severe. Cardiac arrest, Cerebral circulatory disorder, Atherosclerosis generalized Relatedness of drug to reactions/events Source of assessment: Method of assessment: Result of Assessment: Unlikely Diarrhea Relatedness of drug to reactions/events Source of assessment: Method of assessment: Result of Assessment: Probable No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.; Reported Cause(s) of Death: Secondary cause of death cerebral circulatory disorder. Direct cause of death exacerbation cerebral circulation disorders; ICD10 I46.9 - Cardiac arrest, unspecified; Initial cause of death atherosclerosis generalized


VAERS ID: 1387355 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-11
Onset:2021-03-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Haemorrhagic stroke, Pulmonary embolism
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), Embolic and thrombotic events, venous (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-24
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021597797

Write-up: Pulmonary embolism; Brain swelling; Hemorrhagic stroke; This is a spontaneous report from a contactable consumer (patient''s granddaughter), downloaded from the Regulatory Authority (RA)-WEB. The regulatory authority number is PL-URPL-DML-MLP.4401.2.286.2021. The notification was sent to Regulatory Authority on 15Apr2021. A 73-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscularly (IM) on 11Mar2021 at the age of 73 years old (Batch/Lot Number: ER7812, Expiration date: unknown) as the 2nd dose, single dose for COVID-19 immunization. The patient previously received the 1st dose of bnt162b2 (COMIRNATY), IM on 18Feb2021 (at the age of 72 years old) for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 18Mar2021 at 14:00, the patient experienced pulmonary embolism, brain swelling, and hemorrhagic stroke (further reported as pulmonary embolism and haemorrhagic stroke with major cerebral oedema), which all led to hospitalization and death. The patient was hospitalized for pulmonary embolism, brain swelling, and hemorrhagic stroke for 7 days. The patient died on 24Mar2021. It was not reported if an autopsy was performed. The person making the report did not classify the severity of the report. Regulatory Authority classified the report as severe due to the nature of the adverse reactions, the patient''s hospitalisation and death. Sender Comment: The reported adverse reactions are unexpected in the Summary of Product Characteristics of the medicinal product in question As of 12May2021, 16 cases of haemorrhagic stroke and 83 cases of pulmonary embolism have been reported in the database with a patient death outcome Regulatory Authority does not have information on possible additional circumstances (medications used, chronic diseases, allergies, etc.) that may have resulted in the adverse reactions described. The temporal relationship argues for a cause and effect relationship. Regulatory Authority classified the report as severe due to the nature of the adverse reactions, the hospitalisation and the patients death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Pulmonary embolism; Brain swelling; Hemorrhagic stroke


VAERS ID: 1387362 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Cough, Diarrhoea, Heart rate increased, Hyperhidrosis, Oxygen saturation decreased, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-16
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Antibiotic therapy (Before hospitalization, the patient was taking an antibiotic)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021597790

Write-up: Oxygen saturation decreased/saturation decreased quickly; Pulse increased/very strong pulse; Fever/Fluctuating fever; Diarrhea; Cough; Weakness generalised/general weakness; Chills; Sweating/very strong sweating; This is a spontaneous report from a contactable consumer (patient''s wife) downloaded from the regulatory authority-WEB PL-URPL-DML-MLP.4401.2.311.2021. A 70-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: ER7812), via an unspecified route of administration on 16Mar2021 (at the age of 70-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included antibiotic therapy (Before hospitalization, the patient was taking an antibiotic) from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 16Mar2021, the description of the report stated: cough immediately after vaccination; sweating, fever, diarrhea, chills, general weakness, saturation decreased quickly, very strong pulse, very strong sweating. Fluctuating fever, death. Result: death (date of death: 16Apr2021). Additional information: The patient was hospitalized (period: two weeks, including one week under a ventilator, the exact dates of hospitalization were not given). Before hospitalization, the patient was seen by a doctor who prescribed an antibiotic. The patient was taking a prostate drug (product name not given). The reporting person did not classify the severity of the report. Due to hospitalization and death of the patient, regulatory authority classified the application as "severe". Therapeutic measures were taken as a result of oxygen saturation decreased/saturation decreased quickly. The patient died on 16Apr2021. It was unknown if an autopsy was performed. Senders comment: Pyrexia, diarrhea and chills are the expected side effects of Comirnaty administration. The SmPC did not include the weakness but reported the overall weakness as expected. Strong sweating and a high heart rate often accompany fever. Decreased saturation and coughing are not expected measures. regulatory authority has no information on any additional circumstances (medications used, chronic diseases, allergies, etc.) that could have resulted in the described side effects. A strict temporal relationship speaks for a cause-and-effect relationship. Regulatory authority, due to the nature of the side effects, hospitalization and death of the patient, classified the report as "severe". Comirnaty/ Fever, Diarrhea, Chills, Sweating/ NCA , WHO / Probable Comirnaty/ Cough, Weakness generalised, Pulse increased, Oxygen saturation decreased/ NCA , WHO / Possible No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: oxygen saturation decreased/saturation decreased quickly; pulse increased/very strong pulse; fever/fluctuating fever; diarrhea; cough; weakness generalised/general weakness; chills; sweating/very strong sweating


VAERS ID: 1387370 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Cardiac arrest, Dyspnoea, Gait inability, Haemoptysis, Headache, Muscular weakness, Sensory loss
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dystonia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210306; Test Name: Blood pressure; Result Unstructured Data: Test Result:90/43
CDC Split Type: PLPFIZER INC2021597795

Write-up: Difficulty breathing; weakness in legs; unable to walk; cardiac arrest; Blood pressure decreased; Headache; The patient did not feel feet massaging; Blood streaked sputum; This is a spontaneous report from a contactable consumer (patient''s son) downloaded from the regulatory authority-WEB, regulatory authority number PL-URPL-DML-MLP.4401.2.322.2021. An elderly (age reported as over 80 years of age) male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration in Mar2021 (reported as early March) (Batch/Lot Number: Unknown) as 2nd dose, single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received the first dose of bnt162b2 on unknown date for COVID-19 immunization, without any reaction. On 06Mar2021, the patient experienced blood pressure decreased, headache, the patient did not feel feet massaging and blood streaked sputum. On unspecified date (as reported), the patient had difficulty breathing, weakness in legs and unable to walk. The patient underwent lab tests and procedures which included blood pressure measurement: 90/43 on 06Mar2021. The patient had feeling of loss of breath in chest, on the day of death after spitting a thick a suspension, bloodstained, clotted (according to the reporting person - thrombotic), very strong headache, unable to walk (weakness in legs, the patient did not feel too much massaging feet), in the evening drop of blood pressure, last measurement: 90/43. After the first dose there was no "ndl" (as reported). Result: death (date of death: 06Mar2021, cause of death: cardiac arrest (this was written in the death certificate according to the reporting person, autopsy was not performed). Additional information included that the patient in very good mental and physical condition, without lung disease. The reporting person did not classify the severity of the report. Regulatory authority classified the report as "serious" due to the nature of the adverse reaction and the patient''s death. The data contained in the electronic report are all available to regulatory authority - if additional information is obtained, another version will be sent. The patient died on 06Mar2021. An autopsy was not performed. Event Assessment for event Headache: NCA: WHO: Probable and All other events than headache: NCA: WHO: Possible. Reporter Comment: Headache is an expected side effect after administration of Comirnaty. Other adverse reactions are not listed in the SmPC of Comirnaty. It cannot exclude the possibility that the feeling of feeling of breath loss, the headache and also loss of sensation in the feet (the patient did not feel the foot massage) could be a symptom of thrombotic lesions suspected by the Patient''s son. Regulatory authority is not aware of any additional circumstances (medications used, chronic diseases, allergies, etc.) which may have led to the occurrence of these side effects. The reporter emphasized that the patient was in very good mental and physical condition without lung disease. The temporal relationship supports a cause and effect relationship. Regulatory authority classified the report as "serious" due to the nature of the adverse reactions and the Patient''s death. No follow-up attempts are possible; information on batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Headache is an expected side effect after administration of Comirnaty. Other adverse reactions are not listed in the SmPC of Comirnaty. It cannot exclude the possibility that the feeling of feeling of breath loss, the headache and also loss of sensation in the feet (the patient did not feel the foot massage) could be a symptom of thrombotic lesions suspected by the Patient''s son.; Reported Cause(s) of Death: Cardiac arrest; Blood pressure decreased; Headache; The patient did not feel feet massaging; Blood streaked sputum; Difficulty breathing; weakness in legs; unable to walk


VAERS ID: 1387420 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   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: ELIQUIS
Current Illness: Atrial fibrillation; Cardiac failure; Chronic renal failure; Hypertension; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021653532

Write-up: deadly cerebral bleeding; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-044059. An 83-year-old male patient received bnt162b2 (COMIRNATY, lot number: EY2172), dose 2 via an unspecified route of administration in May2021 as 2nd dose, single dose for covid-19 immunisation; apixaban (ELIQUIS), oral from an unspecified date, at 5 mg, twice a day, 1x2 for thromboembolism. Medical history included cerebral haemorrhage, ongoing cardiac failure, ongoing chronic kidney disease, ongoing hypertension, ongoing type 2 diabetes mellitus , ongoing atrial fibrillation. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 Immunization. Reported suspect adverse event was deadly cerebral bleeding. The physician reported that the patient was found dead in his bed the day after he received dose two of the vaccine. The physician states according to the autopsy report that the cause of death was cerebral bleeding. There is no more information stated in the report regarding the man''s death. The patient died in May2021. An autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral bleeding; Autopsy-determined Cause(s) of Death: Cerebral bleeding


VAERS ID: 1388678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-29
Onset:2021-04-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW6126 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Coma, Computerised tomogram, Confusional state, Death, Headache, Hypertension, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DAFALGAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (She was not seriously ill, but afterwards she developed blood clots in the blood vessels of her legs); Pain; Thrombosis leg (Due to clots in the blood vessels of the legs, she had a toe amputation a month before her death); Toe amputation (a month before her death)
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: CT scan; Result Unstructured Data: Test Result:a massive brain haemorrhage at the brain stem
CDC Split Type: BEPFIZER INC2021627691

Write-up: A few hours later, she died; a massive cerebral haemorrhage to the brainstem; mother was already in coma when she arrived at the emergency department; was confused; had to vomit; Headache; the next morning a very high blood pressure; Nausea; This is a spontaneous report from a contactable consumer (patient''s child) downloaded from the Agency Regulatory Authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-92910. A 73-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 29Apr2021 (Batch/Lot Number: EW6126) as 1st dose, single for covid-19 immunisation. Medical history included patient had covid in Dec2020, she was not seriously ill but afterwards she developed blood clots in the blood vessels of her legs; Due to clots in the blood vessels of the legs, she had a toe amputation (in Mar2021) a month before her death; and pain. Concomitant medications included paracetamol (DAFALGAN) taken for pain and anticoagulants. Reported adverse drug reaction (ADR)''s: nausea, headache, hypertension, confusion, vomiting, coma, cerebral hemorrhage, death, all on 30Apr2021. Evolution of the ADR was Deceased. Situations - Other: Suspected combination vaccine with blood thinners. Examinations - Scan that identified a massive brain haemorrhage in the brain stem. The patient had very high blood pressure the next morning (30Apr2021), was confused, had headaches and vomited. Blood pressure did not drop after blood pressure lowering medicine and she was transferred from the rehabilitation centre to the emergency room. The patient was already in a coma when she entered the emergency department. A CTR scan indicated a massive brain haemorrhage at the brain stem. A few hours later she died. Therapeutic measures were taken as a result of high blood pressure. The patient died on 30Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Reporter''s comments: Treatment - Evolution of the ADR - Deceased Situations - Other: Suspected combination vaccine with blood thinners. Examinations - Scan that identified a massive brain haemorrhage in the brain stem.; Reporter''s Comments: Treatment - Evolution of the ADR - Deceased Situations - Other: Suspected combination vaccine with blood thinners. Examinations - Scan that identified a massive brain haemorrhage in the brain stem. ADR description - in the narrative; Reported Cause(s) of Death: A few hours later, she died


VAERS ID: 1388679 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-25
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Cardiovascular disorder, Chest pain, Circulatory collapse, Foaming at mouth, Hyperhidrosis, Malaise, Sense of oppression, Skin discolouration, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021627720

Write-up: Retrosternal pain; tightness; Sweating; massive amounts of pink foam flowing from the mouth; Cardiac arrest; Cardiovascular disorder; Vomiting; grey colour; collapse; Sudden death; sudden unwellness; This is as spontaneous report received from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-93461. A 61-year-old male patient received BNT162B2 (COMIRNATY), first dose via an unspecified route of administration on 04May2021 (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiovascular disorder, unwell (sudden unwellness), cardiac arrest (immobilisation during transfer to hospital), vomiting, retrosternal pain, sweating, skin discolouration (grey colour), sense of oppression (tightness), circulatory collapse, foaming at mouth (massive amounts of pink foam flowing from the mouth), sudden death on 25May2021. The patient had suddenly unwell at work this morning on 25May2021; stopped during transfer to hospital; unsuccessful resuscitation resulting in death. The patient would not have shown any symptoms in the course of the previous days according to family. It was unclear whether there was a relation between vaccination and death. The patient died on 25May2021. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s): (All events) Source of assessment: FAMHP Method of assessment: WHO Result of assessment: unclassifiable No follow-up attempts possible. Information on lot and batch numbers cannot be obtained. ; Reported Cause(s) of Death: Sudden death; tightness; Sweating; massive amounts of pink foam flowing from the mouth; Cardiac arrest; Cardiovascular disorder; Vomiting; grey colour; collapse; sudden unwellness; Retrosternal pain


VAERS ID: 1388680 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Death, General physical health deterioration, Malaise, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data: Test Name: blood analysis; Result Unstructured Data: Test Result:ok; Test Name: Covid test; Test Result: Negative
CDC Split Type: BEPFIZER INC2021639105

Write-up: Quickly deteriorated until her death; Quickly deteriorated until her death; feeling unwell; This is a spontaneous report from a non-contactable consumer or other non HCP (child of the patient) downloaded from the regulatory authority-WEB, regulatory authority number BE-FAMHP-DHH-N2021-93761.This is a spontaneous report from the Health Authority. An 83-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19Jan2021 at the age of 83 years old (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient quickly deteriorated on 19Jan2021 until her death and experienced feeling unwell on 19Jan2021. The patient died on 04Feb2021. It was unknown if an autopsy was performed. The patient was dementing and was placed in a nursing home form 01Dec2020. Until the first vaccination she would be mostly in the common relaxation room. The reporter''s father visited her daily and also on 19Jan2021. The day after the father told the reporter that the condition of the patient had completely changed, she did not go out of her room and quickly deteriorated until her death. Every organ function was in order, COVID tests were negative, blood analyses ok. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Quickly deteriorated until her death; feeling unwell; Quickly deteriorated until her death


VAERS ID: 1388681 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

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

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Hospitalisation
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021628482

Write-up: The patient died at 2:30 p.m. after administration of his vaccine.; This is as spontaneous report received from a contactable other health professional and a physician downloaded from the regulatory authority-WEB. The regulatory authority report number is BE-FAMHP-DHH-N2021-93850. An 82-years-old male patient received BNT162B2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on 20May2021 11:45 (Lot Number: EP9598) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), hospitalized from unknown date to 19May2021. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) on 08Apr2021 as single dose for COVID-19 immunisation. The patient experienced the patient died at 2:30 p.m. on 20May2021 after administration of his vaccine. The patient died on 20May2021. It was unknown if an autopsy was performed. Reporter Comment: The patient had been hospitalized for a while but was allowed to leave the hospital on 19May2021. He returned on 20May2021 for his vaccine at the vaccination center. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained.; Reporter''s Comments: The patient had been hospitalized for a while but was allowed to leave the hospital on 19May. He returned on 20May for his vaccine at the vaccination center.; Reported Cause(s) of Death: The patient died at 2:30 p.m. after administration of his vaccine.


VAERS ID: 1388732 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? Yes
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: ANOPYRIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021639018

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number CZ-CZSUKL-21006083. A 69-year-old male patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of administration on 11May2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ANOPYRIN). The patient experienced pulmonary embolism (death, life threatening) on 14May2021. The patient died on 14May2021. 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: Pulmonary embolism


VAERS ID: 1388733 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Gastrointestinal inflammation, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific inflammation (broad), Ischaemic colitis (broad), Noninfectious diarrhoea (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 31
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Hearing aid therapy; Vision decreased
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021645205

Write-up: inflammation of intestine and other internal parts; muscle weakening; weakness; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority, regulatory authority number CZ-CZSUKL-21006304. A 73-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 19Apr2021 (Batch/Lot Number: Unknown) as 1st dose, single for covid-19 immunisation. Medical history included ongoing hearing aid therapy, ongoing visual decreased, otherwise healthy. The patient''s concomitant medications were not reported. The patient experienced inflammation of intestine and other internal parts (death, hospitalization, life threatening) on May2021, weakness (death, hospitalization) on 24Apr2021, muscle weakening (death, hospitalization) on May2021. The patient was complicated by the initiation of severe worsening of health after 5 days, weakness occurred and the patient was transported to a hospital. After 3 days she was released but a weakness reappeared and then she was transported to a hospital again where she stayed for 15 days, inflammations of the intestine and other internal parts appeared. She improved after a release and she was transported to a hospital after 5 days again where she died after 5 days on 25May2021. Medical history: healthy, only bad eyesight and hearings aids. Outcome of the events was fatal. The reporter does not wish to contact a physician. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: inflammation of intestine and other internal parts; weakness; muscle weakening


VAERS ID: 1388737 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, Laryngeal oedema, Oral mucosal exfoliation, Pharyngeal swelling, Swollen tongue
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergic reaction to bee sting (Known allergy to bee sting. swelling of the airways.); Dementia; Diabetes mellitus; Hypertension arterial; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021645376

Write-up: Swelling of tongue; Pharyngeal swelling; Laryngeal oedema; Oral mucosal exfoliation; Allergic reaction; This is a spontaneous report downloaded from the Regulatory Authority-WEB DE-DCGMA-21189027; additional regulatory number DE-PEI-202100047666. A 96-year-old male patient received second dose of BNT162B2 (COMIRNATY) via unspecified route single dose for COVID-19 vaccination on 16Mar2021, at 96-year-old. Medical history included ongoing allergic reaction to bee sting (known allergy to bee sting, swelling of the airways), ongoing hypertension arterial, ongoing renal insufficiency, ongoing dementia, ongoing diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced swelling of tongue, pharyngeal swelling, laryngeal oedema, oral mucosal exfoliation, allergic reaction; all were on 16Mar2021 with fatal outcome. The patient died on an unspecified date. An autopsy was performed and results were not available. Causality: COMIRNATY: Regulatory Authority: Unclassifiable Reporter''s comments: AE course: swelling of the tongue and the mucous membranes of the throat and larynx. Detachment of the esophageal mucosa. Allergic reaction. Fatal outcome. Occurred on March 16-17, 2021, developed over hours. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: swelling of tongue; pharyngeal swelling; laryngeal oedema; oral mucosal exfoliation; allergic reaction


VAERS ID: 1388738 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / OT

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

Life Threatening? Yes
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: Adiposis (clear obesity (probably BMI$g 35 or$g 40)); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021645582

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-DCGMA-21189527, Safety Report Unique Identifier DE-PEI-202100081364. A 56-year-old male patient received bnt162b2 (COMIRNATY, strength: 0.3 ml, Lot# unknown), intramuscular on 09Apr2021 at single dose for covid-19 immunisation. The patient''s medical history included adiposis(clear obesity (probably BMI$g 35 or$g 40)) and hypertension, all ongoing. Concomitant medications were not reported. On 14Apr2021 the patient experienced Death. The case of death was unknown. Autopsy was not performed.The event was considered serious as death, life threatening. The outcome of the event was fatal. Result of Assessment as Unclassifiable. Reporters comments: Police were informed about the unclear cause of death. Further investigation may be initiated by the public prosecutors office. According to Reporter: The public prosecutors office did not consider an autopsy to be necessary.Previous illnesses included clear obesity (probably BMI$g 35 or$g 40) and hypertension, nothing else known. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1388739 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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: Alcohol addiction; Opioid type dependence
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021645374

Write-up: Death; This is a spontaneous report received from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB [regulatory authority number DE-PEI-202100047658, number DE-DCGMA-21189596]. A 50-year-old male patient received BNT162B2 (COMIRNATY), intramuscularly on 13Apr2021 at single dose for COVID-19 immunisation. Medical history included opioid type dependence, and alcohol addiction. The patient''s concomitant medications were not reported. The patient experienced death on 16Apr2021. Outcome of the event was fatal. It was not reported if an autopsy was performed. Reporter''s comments: Substitution 15 ml (75 mg levomethadone hydrochloride (L-POLAMIDON)/day). Causality had been assessed as "D. Unclassifiable " by the Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1388741 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abrasion; Aortic valve insufficiency (minimal wihout treatment); Asthma bronchial; Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627689

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB, Safety Report Unique Identifier DE-PEI-202100035446. A 45-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 24Mar2021 (Batch/Lot Number: ER7812) as single dose for covid-19 immunisation at age of 45-year-old. Medical history included ongoing migraine, ongoing asthma bronchial, ongoing abrasion, ongoing minimal aortic valve insufficiency without treatment. The patient''s concomitant medications were not reported. The patient died on 02Apr2021. An autopsy was performed and results were not provided. Relatedness of drug to reaction(s)/event(s): D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1388744 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 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: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627649

Write-up: Sudden death unexplained; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, company number DE-PEI-202100079087. A 79-years-old male patient received bnt162b2 (COMIRNATY, Strength: 0.3 ml), dose 2 via an unspecified route of administration on 21May2021 (Lot Number: EX7823) at age of 79-years-old as 2nd dose, single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (COMIRNATY, Strength: 0.3 ml), on 16Apr2021 for COVID-19 immunization. The patient experienced sudden death unexplained on 26May2021. This report is serious as death. The patient died on 26May2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1388746 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-27
Onset:2021-03-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas; Diabetes mellitus; Diabetic polyneuropathy; Gammopathy; Plasmacytoma; Renal insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627839

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-202100080137. An 85-year-old female patient received BNT162B2 (COMIRNATY, Lot number ER7812) at single dose for COVID-19 immunisation on 27Mar2021. The patient was treated with Comirnaty (Batch/ lot number: ER7812), unknown dosage. The patient''s medical history included: Plasmacytoma, Gammopathy, Adipositas, Diabetes mellitus, Diabetic polyneuropathy, Renal insufficiency. Concomitant medication was not reported. On 31Mar2021 the patient experienced Unknown cause of death. Relatedness of drug to reaction(s)/event(s): Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1388747 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-16
Onset:2021-05-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7823 / 2 - / -

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

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627492

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100080139. An 80-year-old male patient received bnt162b2 (COMIRNATY), at the age of 80-year-old dose 2 via an unspecified route of administration on 16May2021 (Batch/Lot Number: EX7823) as 2nd dose, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY, strength: 0.3 ml) on 11Apr2021 for covid-19 immunisation. The patient experienced unknown cause of death on 16May2021. The patient died on 16May2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: This report was received from a Physician and concerns a patient (Male), age: unknown (born: PRIVACY). This report is serious - death. The patient''s medical history and concurrent conditions included: no relevant medical history reported. The patient''s weight was not reported, and height was not reported. The patient was treated with Comirnaty (mRNA TOZINAMERAN), unknown dosage, Batch/lot number: EX7823. Concomitant medications were: no concomitant medication reported. On 16May2021 the patient experienced Unknown cause of death. The patient''s outcome was: fatal for Unknown cause of death. "summary (full translation available upon request)". Comirnaty/ Death/ Unclassifiable. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1388748 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic stenosis; Arterial hypertension; Coronary disease; Heart valve stenosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021639239

Write-up: Unknown cause of death; Tiredness; Groggy; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100081477. A 79-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: 1C007A), via an unspecified route of administration on 18May2021 at single dose for COVID-19 immunisation. Medical history included coronary disease, aortic stenosis, heart valve stenosis, and arterial hypertension. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY) on 19Apr2021 for COVID-19 immunisation. The patient experienced tiredness, and groggy on 19May2021, and unknown cause of death on 20May2021. This report was serious - death. Outcome of the events was fatal. The patient died on 20May2021. It was not reported if an autopsy was performed. Causality has been assessed as "D. Unclassifiable " for all events by the Regulatory Authority. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Tiredness; Groggy; Unknown cause of death


VAERS ID: 1388749 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, General physical health deterioration, Respiratory failure, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: DEPFIZER INC2021645290

Write-up: Respiratory insufficiency; General physical condition decreased; COVID-19 PCR test positive; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-202100085098. A 85-year-old female patient received bnt162b2 (COMIRNATY, mRNA TOZINAMERAN, lot number: EW8904) via an unspecified route of administration on 10Apr2021 at unknown 0.3 mL single dose for prophylactic vaccination. Medical history and concomitant medications were not reported. On 20Apr2021 the patient experienced COVID-19 PCR test positive. On 22Apr2021 the patient experienced General physical condition decreased, Respiratory insufficiency. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Apr2021. The events resulted in death. The patient died on 25Apr2021. It was unknown if an autopsy was performed. The cause of death was respiratory insufficiency, General physical condition decreased, and COVID-19 PCR test positive. The outcome of events was fatal. No follow-up attempts needed, no further information is expected.; Reported Cause(s) of Death: COVID-19 PCR test positive; General physical condition decreased; Respiratory insufficiency


VAERS ID: 1388751 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1C007A / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021645406

Write-up: Unknown cause of death; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB [regulatory authority number DE-PEI-202100085950]. A 42-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 19May2021 (Lot Number: 1C007A, at age of 42 years old) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of COMIRNATY on 28Apr2021 for COVID-19 immunisation. On 25May2021 the patient experienced Unknown cause of death. The patient died on 25May2021. It was unknown if an autopsy was performed. Causality has been assessed as "D. Unclassifiable " by the Regulatory Authority. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1388757 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-07
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001941 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20211

Write-up: Cerebral haemorrhage; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) in an 84-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3001941) for COVID-19 vaccination. No Medical History information was reported. On 24-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 07-May-2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral haemorrhage) (seriousness criteria death and medically significant). The patient died on 07-May-2021. The reported cause of death was Cerebral haemorrhage. It is unknown if an autopsy was performed. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting; Sender''s Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded. Event term, onset date and outcome captured per SD Authority reporting; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1388758 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-07
Onset:2021-04-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma scale, Febrile infection, Hypoxia, Influenza virus test, Laboratory test, Oxygen saturation, Pyrexia, Respiratory failure, SARS-CoV-2 test, Somnolence, Urine analysis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210408; Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:3; Test Name: influenza test; Test Result: Negative ; Test Name: infection parameters; Result Unstructured Data: Test Result:clearly elevated; Test Name: sp02; Result Unstructured Data: Test Result:unknown results; Test Name: covid-19 PCR test; Test Result: Negative ; Test Name: urine status; Result Unstructured Data: Test Result:urosepsis was excluded; Comments: urosepsis was excluded
CDC Split Type: DEPFIZER INC2021627867

Write-up: somnolence; high-fever infection; Pyrexia; hypoxia; respiratory insufficiency; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority (RA)-WEB DE-PEI-CADR2021078241, Safety Report Unique Identifier DE-PEI-202100071121. An 84 years old female patient received first dose BNT162B2 (COMIRNATY), via an unspecified route of administration on 07-APR-2021 at the 84 years old at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. On 08Apr2021 the patient experienced Pyrexia. On 10Apr2021 the patient experienced respiratory insufficiency. On 08Apr2021 the patient experienced Somnolence. On 10Apr2021 the patient experienced hypoxia. One day after the vaccination on 08Apr2021, she had a high-fever infection with somnolence Glasgow Coma Scale 3 since 08Apr2021, and respiratory insufficiency with hypoxia since 10Apr2021 and fatal outcome. Supported by clinical examination, laboratory showed clearly elevated infection parameters, monitoring, Sp02 examination and urine status. Covid-19 PCR test was negative, influenza negative, urosepsis was excluded. The patient was hospitalized in 2021 due to event Pyrexia, high-fever infection and somnolence. The patient underwent lab tests and procedures, which included Glasgow Coma Scale on 08-APR-2021:3; influenza test: negative; sp02 unknown results; covid-19 PCR test: negative; urine status: urosepsis was excluded; infection parameters: clearly elevated. The patient died on an unknown date in 2021. It''s not reported if an autopsy was performed. The cause of death was Respiratory insufficiency and Hypoxia. The outcome of events Pyrexia, Somnolence, high-fever infection was not recovered, for event Respiratory insufficiency and Hypoxia was fatal. No follow-up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: hypoxia; respiratory insufficiency


VAERS ID: 1388759 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-04-22
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / -

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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627856

Write-up: died 14 days after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021078413, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100071306. A 92-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EW8904), via an unspecified route of administration on 08Apr2021 (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on 22Apr2021, died 14 days after vaccination. This report is serious-death. The patient''s outcome was fatal. It was unknown if an autopsy was performed. Comirnaty/ Death/ Regulatory Authority/ Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died 14 days after vaccination


VAERS ID: 1388760 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angina pectoris, Myocardial infarction
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: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627890

Write-up: Angina pectoris symptoms; Infarct myocardial; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021078456, Safety report unique identifier DE-PEI-202100070924. A 61-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 28Apr2021 (Batch/Lot Number: Unknown) as 0.3 ml single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced infarct myocardial on Apr2021, angina pectoris symptoms on an unspecified date with outcome of not recovered. Therapeutic measures were taken as a result of infarct myocardial and angina pectoris symptoms (Medically Significant). The patient died on Apr2021. It was not reported if an autopsy was performed. The patient''s outcome was: fatal for Infarct myocardial, not recovered/not resolved for Angina pectoris. This report is serious - death. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? No; Information on risk factors or previous illnesses None known / Angina Pectoris symptoms, myocardial infarction, resuscitation, cardiac catheterization, death. Relatedness of drug to reactions/events, Source of assessment: Regulatory Authority, Result of Assessment: D. Unclassifiable. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained. ; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1388761 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
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: Asthma bronchial; Multiple sclerosis; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627852

Write-up: Unknown cause of death; Breast pain; shortness of breath; This is a spontaneous report from a non-contactable consumer from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021079198, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100072780. A 49-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15May2021 (at unknown age) as single dose for COVID-19 immunisation. The patient''s medical history included: Multiple sclerosis, Asthma bronchial, Type 2 diabetes mellitus, all ongoing and food allergy. Concomitant medications were not reported. This report is serious-death. On 18May2021 the patient experienced Unknown cause of death, Breast pain, shortness of breath. The patient''s outcome was fatal for Unknown cause of death, not recovered for Breast pain, unknown for shortness of breath. The patient died on 18May2021. It was unknown if an autopsy was performed. Comirnaty/ (Breast pain, Unknown cause of death/Regulatory Authority/ Unclassifiable No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1388762 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-10
Onset:2021-04-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9480 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Headache, Pancytopenia, Pyrexia
SMQs:, Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   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: Aortic valve insufficiency; Hepatic cirrhosis; Mitral incompetence
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627478

Write-up: Pyrexia; Chills; Headache; Pancytopenia; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021079364. A 74-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 10Apr2021 (Lot Number: ER9480) as 1ST DOSE, 0.3ML SINGLE for covid-19 immunisation. Medical history included ongoing Mitral incompetence, ongoing Aortic valve insufficiency, ongoing hepatic cirrhosis. The patient''s concomitant medications were not reported. The patient experienced pancytopenia on 14Apr2021, pyrexia on 14Apr2021, chills on 14Apr2021, headache on 14Apr2021. The patient died on 24Apr2021. It was not reported if an autopsy was performed. Events pyrexia and chills were reported as serious due to hospitalization. Outcome of pancytopenia was fatal, outcome of pyrexia, chills and headache was not recovered. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No Information on risk factors or previous illnesses Known mitral regurgitation I-II: Aortic valve insufficiency I cirrhosis of the liver with ascites formation, initially fever, headache and chills (on 14Apr). Fever slightly decreased after administration of paracetamol. AZ deterioration on the evening of the following day. Briefing in the clinic. Pneumonia is suspected. In the further course of the disease, meningitis was suspected and pancytopenia was diagnosed. Deceased on 24Apr2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pancytopenia


VAERS ID: 1388763 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-27
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, COVID-19 pneumonia, Cardiac failure, Pulmonary congestion, SARS-CoV-2 test, Vaccination failure, X-ray
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), 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: 2021-03-11
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FUROSEMIDE; MERONEM; CLEXANE; APIDRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary heart disease; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210227; Test Name: x-ray; Result Unstructured Data: Test Result:covid-19 pneumonia
CDC Split Type: DEPFIZER INC2021627880

Write-up: Pulmonary congestion, ARDS, cardiac decompensation; Pulmonary congestion, ARDS, cardiac decompensation; Pulmonary congestion, ARDS, cardiac decompensation; COVID-19; COVID-19 pneumonia; Vaccination failure; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021079508, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100072522. An 84-year-old female patient received bnt162b2 (COMIRNATY, 0.3 ml), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EP9598) as single dose, dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included type II diabetes mellitus, CHD (coronary artery disease). Concomitant medications included furosemide; meropenem trihydrate (MERONEM); enoxaparin sodium (CLEXANE); insulin glulisine (APIDRA). On 27Feb2021 the patient experienced pulmonary congestion (fatal, hospitalization), ARDS (acute respiratory distress syndrome) (death, hospitalization), Vaccination failure, COVID-19, COVID-19 pneumonia, Decompensated heart failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 27Feb2021, x-ray: covid-19 pneumonia on 27Feb2021. The affected person was hospitalized and died. She received both vaccinations with Comirnaty. One week after the second vaccination, a Covid-19 infection was detected by means of PCR (27Feb2021). Sequencing was not performed. Symptoms (from 27Feb2021): Covid pneumonia (confirmed by X-rays), pulmonary congestion, Acute Respiratory Distress Syndrome, cardiac decompensation. The person concerned died on 11Mar2021. An autopsy was not performed. The patient''s outcome reported as fatal for Acute Respiratory Distress Syndrome, fatal for Decompensated heart failure, not recovered for other events. This report is serious - death. Sender Comment: Information on risk factors or previous illnesses. Comirnaty/ all events/ Regulatory Authority/ Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; Decompensated heart failure; Pulmonary congestion; COVID-19; COVID-19 pneumonia; ARDS


VAERS ID: 1388764 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-05
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

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:
Current Illness: Arterial hypertension (in treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627859

Write-up: The emergency doctor could not clearly determine the cause of death: heart attack or pulmonary embolism; The emergency doctor could not clearly determine the cause of death: heart attack or pulmonary embolism; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021079557, Safety Report Unique Identifier DE-PEI-202100072624. An 83-year-old female patient received bnt162b2 (COMIRNATY) dose 2 via an unspecified route of administration on 21Apr2021 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunisation. Medical history included ongoing arterial hypertension in treatment. There were no known allergies. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 for COVID-19 immunisation and no reaction was reported. No (reported) complaints after 2nd vaccination. The patient experienced heart attack and pulmonary embolism on 05May2021. It was sudden fatal collapse. The emergency doctor could not clearly determine the cause of death: heart attack or pulmonary embolism. The patient died on 05May2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Infarct myocardial; Lung embolism


VAERS ID: 1388766 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-27
Onset:2021-04-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Myocarditis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   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 (High-grade general atherosclerosis)
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery sclerosis (high-grade coronary artery sclerosis)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627501

Write-up: Infarct myocardial; Myocarditis; This is a spontaneous report received from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021082426, Safety report unique identifier DE-PEI-202100075228. A 56-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 27Apr2021 (Batch/Lot number was not reported) as 1st dose, 0.3 ml single for covid-19 immunisation. Medical history included ongoing arteriosclerosis (High-grade general atherosclerosis), coronary artery sclerosis (high-grade coronary artery sclerosis). The patient''s concomitant medications were not reported. On 28Apr2021 the patient experienced Infarct myocardial, Myocarditis, both with outcome of fatal. The patient died on 28Apr2021. Cause of death: Acute anterior wall infarction. Pathologic anatomic diagnosis: High-grade general arteriosclerosis with extensively ulcerated arteriosclerotic plaques of the infrarenal abdominal aorta and complete stenosis of the dextra internal carotid artery. High-grade coronary artery sclerosis with arteriosclerotic plaques in all three coronary arteries and, in particular, a highly stenosing plaque in the left main stem. Acute left ventricular anterior wall infarction extending approximately 8 x 5 cm with plaque thrombosis of the left main trunk. Condition after emergency bougienage and stent placement of the left main stem with regular location of the stent. Condition after SARS-CoV-2 inoculation the day before with florid inflammation of the deltoid muscle in the area of the injection site on the left upper arm with small-focal myolyses. Focal myocarditis of the left ventricular apex of the heart extending approximately 2 cm-with formation of microthrombi and small-foci associated myocardial necrosis with incipient granulocytic reaction in the sense of an event several hours old. Signs of acute cardiovascular failure with flaccid dilatation of the heart and massive blood stasis and edema of the lungs. Mild chronic bronchitis as well as evidence of masses of pigment-laden alveolar macrophages in the sense of condensate pneumopathy. Mild large-droplet hepatic epithelial fatty degeneration of about 10 %. Relatedness of drug to reactions from Regulatory Authority was "Unclassifiable". No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Myocarditis; Acute myocardial infarction, of anterior wall


VAERS ID: 1388767 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-07
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3674 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ataxia, Auditory disorder, Disorientation, Dysphagia, Hypoacusis, Paralysis, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627482

Write-up: Ataxia; flaccid paralysis; Hearing and vision impairment; Swallowing disorder; Hearing and vision impairment; Disorientated; Hearing and vision impairment; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021082557. An 86-years-old female patient received second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 02Apr2021 (Lot Number: ET3674) at the age of 86-years-old as 0.3ML single for covid-19 immunisation (as prophylactic vaccination). Medical history included multiple myeloma from Dec2019 and ongoing. Concomitant medication(s) was not provided. On 07Apr2021 the patient experienced Ataxia, Disorientated, Hearing and vision impairment (Auditory disorder (NOS)), Swallowing disorder, flaccid paralysis (Palsy). Rapidly progressive, complex neurological symptoms with ataxia, disorientation, hearing and visual disorders, swallowing disorders, and finally flaccid paralysis. Until 07Apr2021, still mobile in her own home with support. Treatment discontinuation of the underlying disease (multiple myeloma): Revlimid and bisphosphonates on 09Apr2021. Due to the age and the existing underlying disease, no intensive diagnostic or therapeutic measures were carried out. Palliative care, death at home on 30Apr2021. The patient died on 30Apr2021 due to ataxia. The patient outcome was: fatal for Ataxia, not recovered/not resolved for Disorientated, Hearing and vision impairment, Swallowing disorder, flaccid paralysis (Palsy), Auditory disorder (NOS). An autopsy was not performed. The reported cause of death was ataxia. Other events was assessed as non-serious. Sender Comment: Information on risk factors or previous illnesses multiple myeloma, diagnosis: Dec2019. Relatedness of drug to reaction(s)/event(s): Ataxia, Disorientated, Auditory disorder (NOS), Swallowing disorder, Palsy, Visual disturbance Source of assessment: Regulatory Authority Result of Assessment: Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ataxia


VAERS ID: 1388768 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627901

Write-up: death/Unknown cause of death; Malaise; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority (RA)-WEB, regulatory authority number DE-PEI-CADR2021083137, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100075813 and DE-CADRPEI-2021083137. A 75-year-old female patient received bnt162b2 (COMIRNATY, strength: 0.3 ml), dose 2 via an unspecified route of administration on 02May2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was smoker. The patient experienced malaise, tried taking breakfast in the morning of 10May2021 and the patient was death (unknown cause of death) on 10May2021. The patient died on 10May2021. It was not reported if an autopsy was performed. The outcome of event ''malaise'' was not recovered. Sender Comment: Not any allergies for the patient. Causality of product for all events was unclassifiable as per Health Agency. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1388769 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Incorrect route of product administration
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), Drug abuse and dependence (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   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: Functional blood flow disorder
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627910

Write-up: Stroke 4 days after vaccination with Pfizer / BioNTech - resulting in death 3 days after the stroke.; BNT162B2 via route intravenously; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021083201, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100076571. An 84-year-old female patient received BNT162B2 (COMIRNATY, lot number and expiration date not provided), intravenously on 07Mar2021 as a single dose for covid-19 immunisation. Medical history included ongoing functional blood flow disorder, cardiovascular disorder. The patient''s concomitant medications were not reported. The patient experienced stroke (also described as accident cerebrovascular) 4 days after vaccination with Pfizer / biontech on 11Mar2021, resulted in death 3 days after the stroke on 15Mar2021. The patient died on 15Mar2021. An autopsy was not performed. Clinical course: This spontaneous report was received from a Consumer or other non health professional and concerns a patient (Female), age: 84 Year (born: unknown date). This report is serious - death. The patient''s medical history and concurrent conditions included: Functional blood flow disorder. The patient''s weight was 87 kg, and height was 174 cm. The patient was treated with Comirnaty (mRNA TOZINAMERAN), unknown dosage. Concomitant medications were: no concomitant medication reported. On 11Mar2021 the patient experienced Accident cerebrovascular. The patient''s outcome was: fatal for Accident cerebrovascular. Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No. Information on risk factors or previous illnesses: Circulatory disorders and cardiovascular disorders / As already described: Stroke resulting in death. Comirnaty/Accident cerebrovascular/Unclassifiable No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1388770 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Disturbance in attention, Dyspnoea, Fatigue, Glassy eyes, Hyperhidrosis, Oedema peripheral
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Asthma (chronic asthma for many years); Breath shortness (after periods of exertion); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627876

Write-up: heart failure; concentration decreased; increasing shortness of breath; Water in the legs, later also in the arms; severe fatigue; glazed eyes; sweat on the forehead; This is a spontaneous report received from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021084162, Safety report unique identifier DE-PEI-202100077033. A 93-year-old female patient received BNT162B2 (COMIRNATY) dose 1 via an unspecified route of administration on 29Mar2021 (Batch/Lot Number: Unknown) as 1st dose, single; dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: Unknown) as 2nd dose, 0.3 ml single dose for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing chronic asthma for many years, breath shortness from Feb2021 and ongoing after periods of exertion. The patient suffered from shortness of breath already before the vaccination (about Feb2021) after periods of exertion, had been taking medications for a long time, including blood pressure control medications, and had had chronic asthma for many years. The patient''s concomitant medications were not reported. About a week after the initial Biotech/Pfizer vaccination, patient had had water in her legs, later also in the arms for the first time in her life, also a cardiac insufficiency had had never been diagnosed before. In addition, there was overall severe fatigue, glazed eyes, lack of concentration, sweat on the forehead, and shortness of breath even after small efforts. About a week after the second vaccination with Biotech/Pfizer, these symptoms worsened significantly once more and culminated in heart failure (cardiac arrest) resulting in death on the night of 04May2021 to 05May2021. On 05Apr2021 the patient experienced oedema of legs, breath shortness, mental concentration decreased, heart failure. The outcome of event heart failure was fatal, events oedema of legs, breath shortness, mental concentration decreased was not recovered and other events was unknown. This report was serious with death. The patient died on 05May2021. An autopsy was not performed. No follow-up attempts are possible. Information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Heart failure


VAERS ID: 1388771 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-14
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Dizziness, Dyspnoea, Pulmonary embolism
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic 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), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   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: Adrenal insufficiency (kidney insufficiency level 2-3); Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021627871

Write-up: Lung embolism; shortness of breath; dizziness/Light headedness; Abdominal pain/Belly ache; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021084325. A 84-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Apr2021 (Batch/Lot Number: EX3510) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient''s medical history and concurrent conditions included ongoing ad adrenal insufficiency, ongoing hypertension. No allergies Information on risk factors or previous illnesses high blood pressure, kidney insufficiency level 2-3. The patient''s concomitant medications were not reported. The patient previous took first dose of COMIRNATY on an unspecified date for Covid-19 immunisation. On 14May2021 the patient experienced shortness of breath, dyspnoea, abdominal pain, belly ache, dizziness, light headedness, lung embolism. The patient''s outcome was not recovered/not resolved for dyspnoea, not recovered/not resolved for belly ache, not recovered/not resolved for light headedness, fatal for Lung embolism. The patient died on 16May2021. It was not reported if an autopsy was performed. This report is serious-death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1388802 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Increased bronchial secretion
SMQs:, Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 19
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: MEMANTINE RATIOPHARM; RIVASTIGMIN ORION; CALCIUM +VIT D; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; CLOPIDOGREL KRKA [CLOPIDOGREL HYDROCHLORIDE]; PAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Constipation; Dementia; Pain (treated with paracetamol)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021639114

Write-up: accumulation of secretion; patient died 07Feb2021 (cause of death unknown); This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB DK-DKMA-WBS-0063266. An 88-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: EJ6134; Expiration Date: 30Apr2021) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included dementia, constipation and pain (treated with paracetamol). Historical vaccine included 1st dose of BNT162B2 (Batch number: EJ6797; expiry date 30Apr2021) on 29Dec2020 for covid-19 immunisation. Concomitant medications included memantine hydrochloride (MEMANTINE RATIOPHARM) taken for dementia from 08Dec2017 to an unspecified stop date; rivastigmine hydrogen tartrate (RIVASTIGMIN ORION) taken for dementia from 04Dec2017 to an unspecified stop date; calcium, colecalciferol (CALCIUM +VIT D) taken for nutritional supplementation from 25Feb2016 to an unspecified stop date; macrogol 3350/ potassium chloride/ sodium bicarbonate/ sodium chloride (MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]) taken for constipation from 05Nov2015 to an unspecified stop date; clopidogrel hydrochloride (CLOPIDOGREL KRKA [CLOPIDOGREL HYDROCHLORIDE]) taken for thrombosis prophylaxis from 20Nov2015 to an unspecified stop date; paracetamol (PAMOL) taken for pain from 06Feb2019 to an unspecified stop date. On19Jan2021 the patient developed airway secretion excessive (accumulation of secretion). The ADR were by the reporter reported as resulting in hospitalisation (date unknown). No treatment or medical procedures due to the ADR was reported. The ADR airway secretion excessive was not recovered. The patient died 07Feb2021 (cause of death unknown). No test results reported. It was unknown if autopsy was done or not. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: patient died 07Feb2021 (cause of death unknown)


VAERS ID: 1389353 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-06-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature abnormal, COVID-19, Cough, Fall, Fluid imbalance, General physical health deterioration, Hospitalisation, Impaired quality of life, Mobility decreased, Oxygen saturation abnormal, Oxygen saturation decreased, Oxygen therapy, Pyrexia, SARS-CoV-2 test, Social problem, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Accidents and injuries (narrow), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VALSARCOMP; VOLTAREN EMULGEL; VALSARTAN SANDOZ; THROMBO ASPIRIN; NOVALGIN [CAFFEINE;PARACETAMOL;PROPYPHENAZONE]; HIBADREN; HYLO DUAL; OLEOVIT D3; HYSAN SCHNUPFENSPRAY; MYCOSTATIN; RIVOTRIL; LASIX [FUROSEMIDE]; CONCOR; FOSTER [BECLOMETASONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angiodysplasia (After therapy for angiodysplasias in the rectum); Below knee amputation; Cholecystectomy (After Cholecystectomy); Coxarthrosis (Coxarthrosis bilateral); Drug intolerance (ACE inhibitor intolerance); Enthesopathy (Right ventricle insertion on tendinopathy of the hamstring muscle right); Femoral neck fracture (After Femoral neck fracture); Herniotomy (After inguinal both sides Hernieotomy); Hydrocele (Hydrocele bilateral); Lymphoma (Right ventricle lymphoma); Penicillin allergy (Severe penicillin allergy); Phacoemulsification (phacoemulsification + Posterior chamber lens oculus dexter); Prostatic cancer (After Prostatic cancer); Retroperitoneal mass; Scheuermann''s disease; Sigmoid diverticulitis; Stroke (After stroke)
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: COVID-19 antigen test; Test Result: Positive ; Comments: COVID-19 antigen test positive; Test Date: 20210308; Test Name: PCR; Test Result: Positive ; Comments: PCR result Positive; Test Date: 20210209; Test Name: SARS-CoV-2 Antigen Test; Test Result: Negative ; Comments: Negative; Test Date: 20210212; Test Name: SARS-CoV-2 Antigen Test; Test Result: Negative ; Comments: Negative
CDC Split Type: ATPFIZER INC2021653550

Write-up: 5L 02 not sufficient at hospital; COVID-19 antigen test positive; Fall, risk; limited mobility; social interaction is impaired; Fluid balance impaired; Development of resources impaired; 5L O2 not sufficient at Hospital; Akinesia deterioration, General condiction further reduced; 92% saturation O2 5L; 83% saturation O2 4L; Cough and fever; Cough and fever; Body temperature abnormal; Vaccination failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB AT-BASGAGES-2021-29987. A 83-year-old male patient received BNT162b2 (COMIRNATY; solution for injection, Lot Number: EJ6796, Expiration date: Unknown), via an unspecified route of administration on 12Jan2021 as 1st dose, single dose for COVID-19 immunisation; received BNT162b2 (COMIRNATY; solution for injection, Lot Number: EJ6797, Expiration date: Unknown), via an unspecified route of administration on 02Feb2021 as 2nd dose, single dose for COVID-19 immunisation. Medical history included Phacoemulsification (phacoemulsification and Posterior chamber lens oculus dexter) from an unknown date in Nov2019 and unknown if ongoing, Angiodysplasia in the rectum from an unknown date in Jun2015 and taken therapy, Femoral neck fracture from an unknown date in Oct2018 and unknown if ongoing, Stroke from an unknown date in Apr2015 and unknown if ongoing, Below knee amputation from 1971 and unknown if ongoing, Cholecystectomy from an unknown date in Nov2018 and unknown if ongoing and Scheuermann''s disease, Retroperitoneal mass, Sigmoid diverticulitis, Coxarthrosis bilateral, Right ventricle lymphoma, Hydrocele bilateral, ACE inhibitor intolerance, Enthesopathy (Right ventricle insertion on tendinopathy of the hamstring muscle right), inguinal both sides herniotomy, Prostatic cancer, Severe penicillin allergy from an unknown date and unknown if ongoing. Concomitant medications included hydrochlorothiazide, valsartan (VALSARCOMP) from 11Dec2020 to 10Mar2021; diclofenac diethylamine (VOLTAREN EMULGEL) from 01Mar2021 to 10Mar2021; valsartan (VALSARTAN SANDOZ) from 11Dec2020 to 10Mar2021; acetylsalicylic acid (THROMBO ASPIRIN) from 14Dec2018 to 10Mar2021; caffeine, paracetamol, propyphenazone (NOVALGIN [CAFFEINE;PARACETAMOL;PROPYPHENAZONE]) from 15Feb2021 to 10Mar2021; doxazosin mesilate (HIBADREN) from 14Dec2018 to 10Mar2021; ectoine, hyaluronate sodium (HYLO DUAL) from 02Dec2019 to 10Mar2021; colecalciferol (OLEOVIT D3) from 09Dec2019 to 10Mar2021; xylometazoline hydrochloride (HYSAN SCHNUPFENSPRAY) from 01Mar2021 to 10Mar2021; nystatin (MYCOSTATIN) from 18May2020 to 10Mar2021; clonazepam (RIVOTRIL) from 14Sep2020 to 10Mar2021; furosemide (LASIX [FUROSEMIDE]) from 04Jan2021 to 10Mar2021; bisoprolol fumarate (CONCOR) from 07Jan2019 to 10Mar2021; beclometasone dipropionate, formoterol fumarate (FOSTER [BECLOMETASONE DIPROPIONATE;FORMOTEROL FUMARATE]) from 08Mar2021 to 10Mar2021; cimicifuga racemosa, cyclamen purpurascens, gelsemium sempervirens, iris versicolor, spigelia anthelmia (RESTAXIL) from 11Oct2019 to 10Mar2021; ascorbic acid, biotin, calcium carbonate, calcium pantothenate, colecalciferol, copper sulfate, cyanocobalamin, dl-alpha tocopheryl acetate, ferrous oxalate, folic acid, magnesium oxide, manganese sulfate, nicotinamide, olea europaea oil, panax ginseng, potassium iodide, pyridoxine hydrochloride, retinol, riboflavin, sodium molybdate, sodium selenite, thiamine mononitrate, zinc oxide (SUPRADYN VITAL 50+ [ASCORBIC ACID;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;COLECALCIFEROL;COPPER SULFATE;CYANOCOBALAMIN;DL-ALPHA TOCOPHERYL ACETATE;FERROUS OXALATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE SULFATE;NICOTINAMIDE;OLEA EUROPAEA OIL;PANAX) from 04Mar2019 to 10Mar2021; mometasone furoate (MOMETASON RATIOPHARM) from 28Apr2020 to 01Mar2021; all for unknown indications. The patient experienced COVID-19 antigen test positive (death, hospitalization) and body temperature abnormal on 05Mar2021, cough and fever on 06Mar2021, 83% saturation o2 4l on 07Mar2021, akinesia deterioration, general condition further reduced and 92% saturation o2 5l on 08Mar2021, 5l 02 not sufficient at hospital on 09Mar2021, vaccination failure on an unknown date in Mar2021 and fall, risk; limited mobility; fluid balance, development of resources, social interaction was impaired on an unknown date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05Mar2021, COVID-19 PCR test: positive on 08Mar2021, sars-cov-2 test: negative on 09Feb2021, sars-cov-2 test: negative on 12Feb2021. Diagnoses together: After Adverse Event, After test, Special nursing diagnosis: Fall, risk; limited mobility; fluid balance, development of resources, social interaction, impaired. The patient died on 10Mar2021. It was not reported if an autopsy was performed. Diagnoses together: After Adverse Event, After test. The outcome of Fall, risk; limited mobility; fluid balance, development of resources, social interaction was impaired was unknown and rest of the all events was reported as fatal. Sender Comment: Regulatory Authority comment: Follow-up information has been requested 2nd dose Comirnaty: Batch/lot number: EJ6796 1st dose Comirnaty: Batch/lot number: EJ6796 The Reporter assessed the causal relationship between bnt162b2 (COMIRNATY) and all events as Related. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


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