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

Found 15,386 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 90 out of 154

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VAERS ID: 1146793 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021320784

Write-up: General physical health deterioration; This is a spontaneous report from a contactable other Health Professional. This is a spontaneous report received from the Regulatory Authority. Regulatory authority report number is 524083. A 77-year-old male patient received BNT162B2 (COMIRNATY, Lot number was not reported), via an unspecified route of administration on 03Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Suspect (8 days) and experienced general physical health deterioration onset date 11Mar2021 with a fatal outcome. The patient died on an unspecified date in Mar2021. It was not reported if an autopsy was performed. No follow up attempts are needed, no further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: General physical health deterioration


VAERS ID: 1146810 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm, Aortic dissection, Cardiogenic shock, Computerised tomogram thorax, Echocardiogram, Electrocardiogram, Haemothorax
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Accidents and injuries (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT-Thorax; Result Unstructured Data: Test Result:Diagnosis confirmed; Comments: Cardiogenic shock and Hemothorax and Dissecting aortic aneurysm; Test Name: Echo; Result Unstructured Data: Test Result:Diagnosis confirmed; Comments: Cardiogenic shock and Hemothorax and Dissecting aortic aneurysm; Test Name: EKG; Result Unstructured Data: Test Result:Diagnosis confirmed; Comments: Cardiogenic shock and Hemothorax and Dissecting aortic aneurysm
CDC Split Type: DEPFIZER INC2021317739

Write-up: Aortic dissection; Aortic aneurysm; Cardiogenic shock; Hemothorax; 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-PEI2021003600. An 80-year-old female patient received first dose of bnt162b2 (COMIRNATY, Lot Number: ER2659), via an unspecified route of administration on 14Mar2021 (at age of 80 years old) at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced aortic dissection/ Dissecting aortic aneurysm, aortic aneurysm, cardiogenic shock and hemothorax on 15Mar2021 (also reported as 2 day(s) after vaccination). Events were reported as fatal. The patient was dead. Diagnosis was confirmed by Echo (Echocardiogram), CT-Thorax (Computerised tomogram thorax), EKG (Electrocardiogram) on unknown date. Death cause was reported as Aortic aneurysm rupture. The patient died on 15Mar2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot# already obtained.; Reported Cause(s) of Death: Aortic dissection/Dissecting aortic aneurysm; Aortic aneurysm; Cardiogenic shock; Hemothorax; Aortic aneurysm rupture


VAERS ID: 1146816 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Respiration abnormal
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiovascular disease, unspecified (Cardiovascular disease (excluding HTA)); Hypertension arterial (HTA)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021317342

Write-up: Respiration abnormal; This is a spontaneous report from a contactable other health care professional downloaded from the Agency Regulatory Authority-WEB ES-AEMPS-795075. A 92-years-old female patient received the first dose of bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP9598), via an unspecified route of administration on arm left on 18Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included hypertension arterial (HTA), cardiovascular disease (excluding HTA). The patient''s concomitant medications were not reported. The patient experienced respiration abnormal on 19Feb2021 and caused death. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No information expected.; Reported Cause(s) of Death: respiration abnormal


VAERS ID: 1146818 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-09
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Scan myocardial perfusion
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EXELON [RIVASTIGMINE]; MEMANTINE MERZ; TRIOBE [CYANOCOBALAMIN;FOLIC ACID;PYRIDOXINE HYDROCHLORIDE]; DIVISUN; AVODART; CALCICHEW D3 APPELSIINI
Current Illness: Alzheimer''s disease; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: heart film; Result Unstructured Data: Test Result:he was in good shape due to his athletic; Comments: background and he had a strong heart
CDC Split Type: FIPFIZER INC2021317416

Write-up: Death; This is a spontaneous report from a contactable consumer, downloaded from the Regulatory Authority-WEB FI-FIMEA-20211120. An 80-year-old male patient (reporter''s father) received BNT162B2 (COMIRNATY) via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: UNKNOWN) at single dose for COVID-19 immunization. Medical history included ongoing advanced Alzheimers and ongoing living in nursing home. No allergies. No reactions to vaccines in the past. The patient had had a heart film taken maybe a year/ couple of years earlier and his own geriatrician said that despite the memory impairment, the father might well live up to ten years, because he was in good shape due to his athletic background and he had a strong heart. Concomitant medications included rivastigmine (EXELON) for dementia alzheimer''s type; memantine hydrochloride (MEMANTINE MERZ) for dementia alzheimer''s type; cyanocobalamin/ folic acid/ pyridoxine hydrochloride (TRIOBE) for an unspecified indication; colecalciferol (DIVISUN) for an unspecified indication; dutasteride (AVODART) for benign prostatic hyperplasia; calcium carbonate/ colecalciferol (CALCICHEW D3 APPELSIINI) for an unspecified indication; all start and stop date were not reported. According to the nurses, the patient had no symptoms after the vaccination and was doing well. On 09Feb2021 on the day of his death he ate well, went to pedicure and in the afternoon he passed away. The face looked calm, but the pictures showed that the face was sweating. The patient lived in a nursing home. There had been no downs in patient''s condition, and the situation was stable as it was for a long time. There were no warning signs of the upcoming and death came unexpectedly. Therefore, it came inevitably to the report''s mind that the vaccine could be the cause of the father''s death. It was not reported if an autopsy was performed. The cause of death was unknown. No follow-up attempts are possible. Information about lot/batch number could not be obtained.; Reported Cause(s) of Death: passed away


VAERS ID: 1146844 (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: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Asymptomatic COVID-19; Ischaemic heart disease; Osteoarthritis knee; Thrombosis venous deep (3 episodes in 2010)
Allergies:
Diagnostic Lab Data: Test Date: 202009; Test Name: covid-19 virus test; Test Result: Positive ; Comments: asymptomatic form
CDC Split Type: FRPFIZER INC2021317447

Write-up: Dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-CF20210307. A 92-year-old female patient received her second dose BNT162B2 (COMIRNATY, Lot Number: EP9598), intramuscular at arm left on 11Mar2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension, ischemic heart disease, thrombosis venous deep (3 episodes in 2010) and advanced knee osteoarthritis. This patient was diagnosed with Covid-19 Positive in Sep2020 (asymptomatic form). The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Comirnaty, Lot: EM 6950) injection, on 19Feb2021 for Covid-19 immunisation. On 12Mar2021, this patient presented with sudden onset dyspnea requiring emergency hospitalization. The patient underwent lab tests included covid-19 virus test: positive on Sep2020 (asymptomatic form). The patient died in hospital on 14Mar2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Dyspnoea


VAERS ID: 1146868 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-03-12
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac arrest, Electrocardiogram, Investigation, Pyrexia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   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: HALDOL; CLOZAPINE MYLAN; GUTRON
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deglutition disorder (swallowing disorder requiring a diet with adapted textures and a special chair for sleeping); Huntington''s chorea; Hypotension orthostatic (orthostatic hypotension treated with GUTRON); Schizophrenia
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210216; Test Name: Electrocardiographic monitoring; Result Unstructured Data: Test Result:regular; Test Date: 20210216; Test Name: counts; Result Unstructured Data: Test Result:regular; Test Name: antigen test; Test Result: Negative ; Test Name: Covid-19 PCR test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021317566

Write-up: Heart arrest; Fever; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-MA20210872. A 51 years old female patient received BNT162B2 (COMIRNATY, Lot Number: EP9605) dose 1 intramuscular on 11Mar2021 as single dose for covid-19 immunisation; haloperidol (HALDOL) oral from 10Feb2021 and ongoing at 40 drop, daily for schizophrenia; clozapine (CLOZAPINE MYLAN) oral from 10Feb2021 at 200 mg, daily and via an unspecified route of administration from an unspecified date at 125 twice daily for schizophrenia; midodrine hydrochloride (GUTRON) oral from an unspecified date and ongoing at 2.5 mg, daily for orthostatic hypotension. The patient lives in a specialized accommodation center for Huntington disease with swallowing disorder requiring a diet with adapted textures and a special chair for sleeping and orthostatic hypotension treated with GUTRON. The patient is installed in her special chair for the night, she is monitored regularly and remains afebrile. She is also schizophrenic with a state of agitation having is subject to modification of treatment in Feb2021: reduction in dosage of CLOZAPINE from 125x 2 to 100x 2 (there is a plasma dosage of CLOZAPINE in the therapeutic values expected before the reduction in dosage) and replace Xenazine by HALDOL. The patient''s concomitant medications were not reported. The patient previously took xenazine. The patient presented a fever 36 hours after the first dose of COMIRNATY on 12Mar2021 19:00, feverish peak at 38 Centigrade and presence of foam around the mouth, antigen test and Covid-19 PCR negative. Cardiac arrest with death the next day on 13Mar2021 08:00, Adrenaline massage and return to sinus rhythm. Recurrence of cardiac arrest and death at 9:30 a.m. Electrocardiographic monitoring and counts are regular and within the standards, last count on 16Feb2021. No Covid-19 history. The action taken in response to events for haloperidol, clozapine and midodrine hydrochloride was dose not changed. The outcome of events fatal. The patient was died on 13Mar2021. Causes of death were reported as fever and cardiac arrest. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; cardiac arrest


VAERS ID: 1146870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   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: HYDROCHLOROTHIAZIDE; TELMISARTAN
Current Illness: Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021317503

Write-up: HEMORRHAGIC STROKE; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-MP20210545. This is a report received from the Regulatory Authority. An 86-years-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular administered in left arm on 10Mar2021 (Lot Number: EP9605) at single dose for COVID-19 immunisation. Medical history included ongoing hypertension arterial, did not have history of COVID-19. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for hypertension arterial; telmisartan (TELMISARTAN) taken for hypertension arterial. The patient was died due to hemorrhagic stroke on 12Mar2021. The patient died on 12Mar2021 at 7 p.m. at the hospital. The clinical course was reported as follows: on 12Mar2021, 48 hours after vaccination, headache and dizziness. Call from emergency medical service (EMS) service. Supported by medical firefighter team at home for discomfort in front of witnesses with trusted person at 3:30 p.m. and rapidly coma, bilateral mydriasis reactive to support. Other contributive additional examinations: CTc: Fisher 4 subarachnoid hemorrhage associated with acute hydrocephalus. Lack of vascularization of the bilateral V3 V4 portions, the basilar trunk and the posterior arteries in connection with intracranial hypertension. Lack of individualized aneurysm formation. Tonsillus commitment. Evolution: Death on 12Mar2021 at 7 p.m. at the hospital. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1146877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Asthenia, Blood albumin, Blood calcium, Blood creatinine, Blood parathyroid hormone, Blood thyroid stimulating hormone, Death, Hyperthyroidism, International normalised ratio, International normalised ratio increased, Rectal haemorrhage, SARS-CoV-2 test, Thyroxine
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Ischaemic colitis (broad), Hyperthyroidism (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   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: COUMADINE; LEVOTHYROX; OROCAL [CALCIUM CARBONATE]; GRANIONS DE ZINC; ATROVENT; FUROSEMIDE; NEVIBOLOL DCI; DELURSAN; UVEDOSE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anorexia; Arterial hypertension; Atrial fibrillation; Cardiac failure; Cognitive impairment; Diabetes mellitus; Thyroidectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: blood serum; Result Unstructured Data: Test Result:149 mmol/L; Test Date: 20210211; Test Name: calcium; Result Unstructured Data: Test Result:2.07 mmol/L; Test Date: 20210211; Test Name: serum creatinine; Result Unstructured Data: Test Result:78 umol/l; Test Date: 20210211; Test Name: pth; Result Unstructured Data: Test Result:112 pg/mL; Test Date: 20210211; Test Name: blood tsh; Result Unstructured Data: Test Result:0.26 MiU/L; Test Date: 20210104; Test Name: international normalized ratio test; Result Unstructured Data: Test Result:2.51; Test Date: 20210202; Test Name: international normalized ratio test; Result Unstructured Data: Test Result:2.58; Test Date: 20210216; Test Name: international normalized ratio test; Result Unstructured Data: Test Result:above 10; Test Date: 20210217; Test Name: international normalized ratio test; Result Unstructured Data: Test Result:3.42; Test Date: 20201124; Test Name: SARS -CoV-2 test; Result Unstructured Data: Test Result:negative; Test Date: 20210211; Test Name: blood T4; Result Unstructured Data: Test Result:22.4 pmol/L
CDC Split Type: FRPFIZER INC2021272547

Write-up: Death; very weakened; anuria; International normalised ratio increased; Rectal bleeding; Hyperthyroidism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-PO20211018. A 96-year-old female patient received second dose of BNT162B2 (COMIRNATY), intramuscular, administered in arm left on 10Feb2021 (Lot Number: EJ6789) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus, arterial hypertension, cardiac failure, atrial fibrillation, thyroidectomy, each from an unknown date and unknown if ongoing, cognitive impairment and anorexia, both from 09Feb2021. Concomitant medications included warfarin sodium (COUMADINE) at 3 mg daily; levothyroxine sodium (LEVOTHYROX) at 50 ug daily; calcium carbonate (OROCAL) at 2 dose form daily; zinc (GRANIONS DE ZINC, formulation: oral solution) one dose form daily; ipratropium bromide (ATROVENT, formulation: inhalation vapour, solution) at 3 dose form daily; furosemide at 40 mg daily; nebivolol hydrochloride (NEVIBOLOL DCI) at 2.5 mg daily; ursodeoxycholic acid (DELURSAN) at 3 dose form daily and colecalciferol (UVEDOSE, formulation: oral solution, strength: 10000 iU) one ampoule every two weeks, all taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) on 15Jan2021 and experienced no adverse effects. The patient experienced hyperthyroidism on 11Feb2021, rectal bleeding on 15Feb2021, international normalized ratio (INR) increased on 16Feb2021, anuria and very weakened, both on 17Feb2021. Therapeutic measures were taken as a result of the bleeding and included vitamin K on 15Feb2021. All events were serious (medically significant). The patient underwent lab tests and procedures which included blood albumin (136-145 mmol/L): 149 mmol/l on 11Feb2021, blood calcium: 2.07 mmol/l on 11Feb2021, blood creatinine: 78 umol/l on 11Feb2021, blood parathyroid hormone (PTH) (15-68): 112 pg/ml on 11Feb2021, blood thyroid stimulating hormone (THS): 0.26 miu/l on 11Feb2021, international normalized ratio (INR): 2.51 on 04Jan2021 , 2.58 on 02Feb2021, above 10 on 16Feb2021, 3.42 on 17Feb2021, SARS-COV-2 test: negative on 24Nov2020, thyroxine (T4) (6-19): 22.4 pmol/l on 11Feb2021. The patient outcome of the events was not recovered. The patient died on 18Feb2021. It was not reported if an autopsy was performed, the cause of death was unknown. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1146881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-19
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   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: Medical History/Concurrent Conditions: Arterial hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Sars-cov-2 test; Result Unstructured Data: Test Result:negative
CDC Split Type: FRPFIZER INC2021317595

Write-up: Death unexplained/death during her sleep; This is a spontaneous report from a contactable consumer (the patient''s son) downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PS20210528. An 86-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 11Feb2021 (Batch/Lot Number: UNKNOWN) at single dose (reported as 1 DF) for covid-19 immunisation. Medical history included arterial hypertension. The patient''s concomitant medications were not reported. The patient experienced death unexplained on 19Feb2021, 8 days after vaccination with bnt162b2, description of the effect: Occurrence on 19Feb2021 of a death during her sleep, while the patient had no serious pathology. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Jan2021. It was unknown if an autopsy was performed. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: Death unexplained/death during her sleep


VAERS ID: 1146926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-14
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BICALUTAMIDE; ENALAPRIL; SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021317709

Write-up: Massive brain haemorrhage; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number NL-LRB-00480280. A 88-year-old male patient received first dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 18Feb2021 (Lot Number: EJ6789, expiration date was unknown) as single dose for covid-19 immunisation; apixaban (ELIQUIS) via an unspecified route of administration from 2020 to an unspecified date at 5mg per 12 hours as blood thinner for cerebral infarction. Medical history included cerebral infarction from 2020. Patient did not have any past drug therapy with comirnaty. He did not have previous COVID-19 infection. Concomitant medications included bicalutamide, enalapril and simvastatin. The patient experienced massive brain haemorrhage on 14Mar2021. The patient died due to massive brain haemorrhage on an unspecified date in 2021. The action taken in response to the event for apixaban was not applicable. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: massive brain haemorrhage


VAERS ID: 1146964 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-31
Submitted: 0000-00-00
Entered: 2021-03-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Alanine aminotransferase, Alanine aminotransferase increased, Anuria, Arteriosclerosis, Aspartate aminotransferase, Aspartate aminotransferase increased, Base excess, Blood lactic acid, Cervical spinal stenosis, Contusion, Cyanosis, Cytomegalovirus test, Hepatitis B core antibody, Hypersensitivity, Hypotonia, Intervertebral disc protrusion, Magnetic resonance imaging neck, Metabolic acidosis, Oxygenation index, PCO2, PO2, Paralysis, Paraparesis, Prostatic specific antigen, Prostatic specific antigen increased, Respiratory failure, Spinal cord compression, Swelling, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Lactic acidosis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Tumour markers (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Prostate tumours of unspecified malignancy (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:high; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:high; Test Name: Base excess; Result Unstructured Data: Test Result:22.7; Test Name: Lactates; Result Unstructured Data: Test Result:16.31; Test Name: CMV IgG antibody; Result Unstructured Data: Test Result:$g 250; Test Name: CMV IgM antibody; Result Unstructured Data: Test Result:0.13; Test Name: Anti-HBc antibody; Result Unstructured Data: Test Result:7.47; Test Name: Cervical MRI; Result Unstructured Data: Test Result:At the C5 / C6 level, herniated intervertebral; Comments: At the C5 / C6 level, herniated intervertebral disc with edge osteophytosis compresses the spinal cord with depletion of the perspinal fluid reserve. Features of large swelling to the back of the spine. The lesions are most visible on the right side at C2-C5 level, but extend to the level of the thoracic spine. Increased degenerative stenosis. It is most pronounced at the C5 / C6 level of the spinal cord with depletion of the fluid reserve with an increased signal dependent. features of compression at this level (a few illegible words); Test Name: Oxygenation index; Result Unstructured Data: Test Result:1.0; Test Name: Partial pressure CO2; Result Unstructured Data: Test Result:14.8; Test Name: pH; Result Unstructured Data: Test Result:7.108; Test Name: Partial pressure O2; Result Unstructured Data: Test Result:101; Test Name: PSA; Result Unstructured Data: Test Result:308.97
CDC Split Type: PLPFIZER INC2021323078

Write-up: AST (Aspartate aminotransferase) high; ALT (Alanine aminotransferase) high; total PSA (Prostatic specific antigen): 308.97; Respiratory failure requiring intubation and mechanical ventilation; Herniated intervertebral disc with edge osteophytosis compresses the spinal cord; Distal cyanosis of the extremities (generalized advanced atherosclerosis); Increased degenerative stenosis; most pronounced at the C5 / C6 level of the spinal cord; Herniated intervertebral disc with edge osteophytosis compresses the spinal cord with depletion of the peri spinal fluid reserve; Allergic reaction (erythema multiforme); Paralysis of the right upper limb; Paresis of both lower limbs; Anuria; Abdominal pain lower; Distal cyanosis of the extremities (generalized advanced atherosclerosis); Hypotonia; Metabolic acidosis; Features of large swelling to the back of the spine; Bruising of the limbs; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB PL-URPL-3-306-2021. A contactable physician reported that a 68-year-old male patient received second dose of BNT162B2 (COMIRNATY; Solution for injection; Lot Number: EJ6136; Expiration Date: 30Jan2021), intramuscular on arm left on an unspecified date at 0.3 ml, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 31Jan2021, the doctor indicated allergic reaction (erythema multiforme), bruising of the limbs. In the report, the doctor gave: AST (Aspartate aminotransferase) and ALT (Alanine aminotransferase) high, total PSA (Prostatic specific antigen): 308.97, anti-HBc antibodies: 7.47, CMV and IgG above 250, CMV (Cytomegalovirus test) and IgM: 0.13. paralysis of the right upper limb, paresis of both lower limbs, hypotonia, distal cyanosis of the limbs (generalized advanced atherosclerosis), respiratory failure requiring intubation and mechanical ventilation, FiO2 (oxygen content in the respiratory mixture): 1.0, anuria, metabolic acidosis, lactated: 16,31, BE (excess alkaline) in blood: 22.7, standard carbohydrate concentration: 4.6, pCO2 (carbon dioxide partial pressure): 14.8, pO2 (oxygen partial pressure): 101, Ph: 7.108, abdominal pain in the lower abdomen. MRI (Magnetic resonance imaging) of the cervical spine: at the C5 / C6 level, herniated intervertebral disc with edge osteophytosis compresses the spinal cord with depletion of the peri spinal fluid reserve. Features of large swelling to the back of the spine. The lesions are most visible on the right side at C2-C5 level but extend to the level of the thoracic spine. Increased degenerative stenosis. It is most pronounced at the C5 / C6 level of the spinal cord with depletion of the fluid reserve with an increased T2 signal features of compression at this level (a few illegible words). The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient death, URPL qualified the report as severe. The patient died on 01Feb2021. It was unknown if an autopsy was performed or not. The outcome of the events ALT high, AST high and PSA increased was reported as unknown whereas for other events it was reported as fatal. Causality assessment: For the drug COMIRNATY, the events Metabolic acidosis, Paralysis, Paraparesis, Anuria, Respiratory failure, Hypotonia, Acrocyanosis, Erythema multiforme were possible as per NCA and WHO scale. The events Intervertebral disc herniation, Spinal stenosis in cervical region, Local swelling were Unlikely as per NCA and WHO scale. Health Authority Comments: COMIRNATY is an mRNA vaccine against COVID-19 (with modified nucleosides). All reported adverse reactions are not included in COMIRNATY Summary of Product Characteristics. It cannot be ruled out that the paralysis of the upper limb and the paresis of the lower limbs were caused by numerous diseases within the spine, which was detected by MRI (intervertebral disc hernia with edge osteophytosis, spine edema, degenerative stenosis). Due to the descendant of the aforementioned spine diseases (chronic diseases), it was decided to give an unlikely cause-and-effect relationship between their occurrence and the administration of COMIRNATY. Distal extremity cyanosis may be due to generalized advanced atherosclerosis, and metabolic acidosis may be due to respiratory failure. Until 07Mar2021 in the database, 21 cases of paralysis, 19 cases of paresis, 47 cases of respiratory failure, 5 cases of anuria (anuria) were reported. URPL has no information on any additional circumstances (medications used, allergies, etc.) that could have resulted in the described side effects. The temporal relationship speaks for a cause, effect and relationship. The reporting person classified them as severe. Due to the assessment of the reporting person, the nature of the side effects and the patient death, URPL qualified the report as severe. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Distal cyanosis of the extremities (generalized advanced atherosclerosis); Herniated intervertebral disc with edge osteophytosis compresses the spinal cord with depletion of the peri spinal fluid reserve; Bruising of the limbs; Metabolic acidosis; He


VAERS ID: 1148621 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-08
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood alkaline phosphatase, Blood bicarbonate, Blood lactate dehydrogenase, Blood potassium, Blood sodium, Blood test, C-reactive protein, Chest X-ray, Computerised tomogram, Cough, Cytomegalovirus test negative, Differential white blood cell count, Drug resistance, Dyspnoea, Haematocrit, Haemoglobin, Histology, Lymphocyte count, Lymphocyte count abnormal, Malaise, Monocyte count abnormal, Multiple organ dysfunction syndrome, Neutrophil count, Neutrophil count abnormal, Neutrophil/lymphocyte ratio increased, Oxygen saturation, Oxygen saturation decreased, Pneumocystis jirovecii infection, Pneumonia, Red blood cell count, Respiratory disorder, SARS-CoV-2 antibody test, Troponin, Urine analysis, Vitamin D deficiency, White blood cell count
SMQs:, Anaphylactic reaction (broad), Haematopoietic leukopenia (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (broad), Opportunistic infections (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: D-CURE; CARVEDILOL EG; TRIPLIXAM; CLEXANE; COVERSYL [PERINDOPRIL ERBUMINE]; DOMPERIDONE EG; ASAFLOW; ALGOSTASE MONO; ATORVASTATINE SANDOZ; ENTEROL [FURAZOLIDONE]; CLOPIDOGREL EG; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Cerebrovascular accident (ischemic, at right Middle cerebral artery area (thrombosis of right internal carotid and left internal carotid stenosis of 60%)); Contusion of knee (- restrictive lung disease second to morbid obesity - Right adrenal nodule with diameter up to 3.2 cm. - Cholesterol papules in the gallbladder have no signs of cholecystitis or bile duct dilation. - Prominent pancreatic head and proximal body, slightly inhomogeneous, which may be part of edematous pancreatitis. - Chronic lumbo-sciatica due to multilevel spinal canal stenosis.); Foot fracture (left foot fracture base MT 2-3, for which lower leg cast); Pelvic fracture; Smoking cessation therapy; Transient ischemic attack
Allergies:
Diagnostic Lab Data: Test Date: 20210215; Test Name: lung examination; Result Unstructured Data: Test Result:Compression zone infrailar to the right and diffus; Comments: Compression zone infrailar to the right and diffuse bronchial reinforcement lung drama drawing bilateral with slightly blurred areas of compaction: more probably infectious. No pleural effusions.; Test Date: 20210217; Test Name: lung examination; Result Unstructured Data: Test Result:Bilaterally extensive flaky compaction zones: righ; Comments: Bilaterally extensive flaky compaction zones: right more than left: increased compared to February 15th. Small amount of pleural fluid bibasal.; Test Date: 20210220; Test Name: lung examination; Result Unstructured Data: Test Result:Scattered blurred areas of compaction bilateral: v; Comments: Scattered blurred areas of compaction bilateral: virtually unchanged compared to February 19, 2021 study. No pleural effusions.; Test Date: 20210222; Test Name: lung examination; Result Unstructured Data: Test Result:clinical information: bilateral pneumonia. Mechani; Comments: clinical information: bilateral pneumonia. Mechanical ventilation. Spotty compaction zones spread over both lung fields: earlier similar picture; Test Date: 20210217; Test Name: chest CT scan; Result Unstructured Data: Test Result:clinical information: dyspnoea, increased D-dimers; Comments: clinical information: dyspnoea, increased D-dimers, pneumonia. No central pulmonary embolisms, no peripheral pulmonary embolisms. Very extensive confluent lung compactions in both lower lobes and multifocal in both upper lobes: most likely infectious, covid cannot be ruled out. Small amount of pleural fluid on the right. Nodule with diameters up to 3 cm in the adrenal gland on the right: most likely still adenoma.; Test Date: 20210215; Test Name: CRP; Result Unstructured Data: Test Result:213.2 mg/l; Test Date: 20210217; Test Name: CRP; Result Unstructured Data: Test Result:200.7 mg/l; Test Date: 20210218; Test Name: CRP; Result Unstructured Data: Test Result:203.6 mg/l; Test Name: CMV; Result Unstructured Data: Test Result:no CMV was detected; Test Date: 20210215; Test Name: Immature myeloid cells; Result Unstructured Data: Test Result:2.6; Test Date: 20210217; Test Name: Immature myeloid cells; Result Unstructured Data: Test Result:2.0; Test Date: 20210218; Test Name: Immature myeloid cells; Result Unstructured Data: Test Result:2.0; Test Date: 20210215; Test Name: hematocrit; Result Unstructured Data: Test Result:34; Test Date: 20210217; Test Name: hematocrit; Result Unstructured Data: Test Result:32; Test Date: 20210218; Test Name: hematocrit; Result Unstructured Data: Test Result:32; Test Date: 20210215; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.6 g/dl; Test Date: 20210217; Test Name: haemoglobin; Result Unstructured Data: Test Result:10 g/dl; Test Date: 20210218; Test Name: haemoglobin; Result Unstructured Data: Test Result:9.9 g/dl; Test Name: histopathological examination; Result Unstructured Data: Test Result:post-mortem pre-evaluation of lung tissue for hist; Comments: post-mortem pre-evaluation of lung tissue for histopathological examination was performed: Extensive changes in the lung parenchyma appropriate in the context of diffuse alveolar damage with predominantly organizing component (ARDS spectrum); Test Date: 20210215; Test Name: lymphocyte; Test Result: 6 %; Test Date: 20210217; Test Name: lymphocyte; Test Result: 5.9 %; Test Date: 20210218; Test Name: lymphocyte; Test Result: 7.1 %; Test Date: 20210215; Test Name: Abs. lymphocyte count; Result Unstructured Data: Test Result:0.83 x10 9/l; Test Date: 20210217; Test Name: Abs. lymphocyte count; Result Unstructured Data: Test Result:0.92 x10 9/l; Test Date: 20210218; Test Name: Abs. lymphocyte count; Result Unstructured Data: Test Result:1.16 x10 9/l; Test Date: 20210215; Test Name: Abs. monocyte count; Result Unstructured Data: Test Result:1.13 x10 9/l; Test Date: 20210217; Test Name: Abs. monocyte count; Result Unstructured Data: Test Result:1.08 x10 9/l; Test Date: 20210218; Test Name: Abs. monocyte count; Result Unstructured Data: Test Result:1.13 x10 9/l; Test Date: 20210215; Test Name: Neutrophil segment nucleus; Test Result: 81.2 %; Test Date: 20210217; Test Name: Neutrophil segment nucleus; Test Result: 83.7 %; Test Date: 20210218; Test Name: Neutrophil segment nucleus; Test Result: 83.7 %; Test Date: 20210215; Test Name: Abs. neutrophil count; Result Unstructured Data: Test Result:11.23 x10 9/l; Test Date: 20210217; Test Name: Abs. neutrophil count; Result Unstructured Data: Test Result:13.07 x10 9/l; Test Date: 20210218; Test Name: Abs. neutrophil count; Result Unstructured Data: Test Result:13.66 x10 9/l; Test Date: 20210215; Test Name: Neutrophil / lymphocyte ratio; Result Unstructured Data: Test Result:13.53; Test Date: 20210217; Test Name: Neutrophil / lymphocyte ratio; Result Unstructured Data: Test Result:14.21; Test Date: 20210218; Test Name: Neutrophil / lymphocyte ratio; Result Unstructured Data: Test Result:11.78; Test Date: 20210212; Test Name: oxygen saturation; Test Result: 84 %; Comments: with 2l O2, few opportunities to give more.; Test Name: pneumocystis; Result Unstructured Data: Test Result:no pneumocystis detected.; Test Date: 20210215; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.9 x10 12/l; Test Date: 20210217; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.6 x10 12/l; Test Date: 20210218; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.7 x10 12/l; Test Date: 20210208; Test Name: covid test; Result Unstructured Data: Test Result:negative; Test Date: 20210215; Test Name: hs-troponin; Result Unstructured Data: Test Result:23 ng/L; Test Date: 20210212; Test Name: urine test; Result Unstructured Data: Test Result:suspected contaminated sample. The patient has no; Comments: suspected contaminated sample. The patient has no urinary complaints; Test Date: 20210215; Test Name: white blood cell count; Result Unstructured Data: Test Result:13.8 x10 9/l; Test Date: 20210217; Test Name: white blood cell count; Result Unstructured Data: Test Result:15.6 x10 9/l; Test Date: 20210218; Test Name: white blood cell count; Result Unstructured Data: Test Result:16.3 x10 9/l; Test Date: 20210215; Test Name: Alkaline Phosphatase; Result Unstructured Data: Test Result:123 IU/l; Test Date: 20210215; Test Name: Sodium bicarbonate; Result Unstructured Data: Test Result:32; Test Date: 20210217; Test Name: Sodium bicarbonate; Result Unstructured Data: Test Result:30; Test Date: 20210218; Test Name: Sodium bicarbonate; Result Unstructured Data: Test Result:32; Test Date: 20210215; Test Name: LDH; Result Unstructured Data: Test Result:370 IU/l; Test Date: 20210215; Test Name: potassium; Result Unstructured Data: Test Result:3.32 mmol/L; Test Date: 20210217; Test Name: potassium; Result Unstructured Data: Test Result:3.08 mmol/L; Test Date: 20210218; Test Name: potassium; Result Unstructured Data: Test Result:2.93 mmol/L; Test Date: 20210215; Test Name: sodium; Result Unstructured Data: Test Result:144 mmol/L; Test Date: 20210217; Test Name: sodium; Result Unstructured Data: Test Result:148 mmol/L; Test Date: 20210218; Test Name: sodium; Result Unstructured Data: Test Result:149 mmol/L; Test Date: 20210212; Test Name: blood test; Result Unstructured Data: Test Result:inflammatory blood picture and vitamin D deficienc
CDC Split Type: BEPFIZER INC2021283111

Write-up: Respiratory disorder; Acute respiratory failure; Drug resistance; Multi organ failure; Bilateral pneumonia; Dyspnea; Oxygen saturation low; Vitamin D deficiency; Coughing; General malaise; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB regulatory authority BE-FAMHP-DHH-N2021-80761. A 73-year-old female patient received her second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The patient had recevied the first dose of vaccine on 12Jan2021. Medical history included smoking cessation therapy from 2019 to an unknown date (nicotine abuses, pack a day, started at age 17), cerebrovascular accident from 2003 to an unknown date, ischemic, at right Middle cerebral artery area (thrombosis of right internal carotid and left internal carotid stenosis of 60%), contusion right knee from 2019 to an unknown date, restrictive lung disease second to morbid obesity, Right adrenal nodule with diameter up to 3.2 cm. Cholesterol papules in the gallbladder have no signs of cholecystitis or bile duct dilation. Prominent pancreatic head and proximal body, slightly inhomogeneous, which may be part of edematous pancreatitis. Chronic lumbo-sciatica due to multilevel spinal canal stenosis, transient ischaemic attack from 2019 to an unknown date , foot fracture from 2020 to an unknown date (left foot fracture base MT 2-3, for which lower leg cast), pelvic fracture from 2020 to an unknown date , arterial hypertensionfrom an unknown date. Concomitant medications included amlodipine besilate, indapamide, perindopril arginine (TRIPLIXAM); enoxaparin sodium (CLEXANE) taken from 26Feb2021; perindopril erbumine (COVERSYL); domperidone taken for nausea; acetylsalicylic acid (ASAFLOW), paracetamol (ALGOSTASE MONO) taken for pain; atorvastatin calcium; furazolidone (ENTEROL) taken for diarrhoea; clopidogrel bisulfate; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for constipation; colecalciferol (D-CURE); carvedilol. The patient experienced respiratory disorder on an unspecified date, acute respiratory failure on 17Feb2021, general malaise on 08Feb2021 , multi organ failure on 17Feb2021 , bilateral pneumonia on 17Feb2021 , dyspnea on 12Feb2021, oxygen saturation low on 12Feb2021, vitamin d deficiency on 12Feb2021, coughing on 12Feb2021, drug resistance on 17Feb2021. The events were assessed as serious for fatal outcome. The patient died on 23Feb2021. it was unknow if an autopsy was performed. Clinical course was the following since 08Feb2021 general malaise, since 12Feb2021 cough and dyspnoea. Covid tested negative and policy with Amoxiclav instituted. Blood test on 12Feb2021: inflammatory blood picture and vitamin D deficiency. Urine test on 12Feb2021 suspected contaminated sample. The patient has no urinary complaints. In a nursing home with difficulty up to 84% saturation with 2l O2, few opportunities to give more. Admission of lung disease on 15Feb2021 starting: Tazocin, Solu-Medrol, UtraK, Clexane, Combivent. Rx thorax at bed: Compression zone infrailar to the right and diffuse bronchial reinforcement lung drama drawing bilateral with slightly blurred areas of compaction: more probably infectious. No pleural effusions. On chest CT 17Feb2021: clinical information: dyspnoea, increased D-dimers, pneumonia. No central pulmonary embolisms, no peripheral pulmonary embolisms. Very extensive confluent lung compactions in both lower lobes and multifocal in both upper lobes: most likely infectious, covid cannot be ruled out. Small amount of pleural fluid on the right. Nodule with diameters up to 3 cm in the adrenal gland on the right: most likely still adenoma. Admitted to the intensive care unit on 18Feb2021 because of dyspnoea until death on 23Feb2021. Rx thorax at bed on 19feb2021: Bilaterally extensive flaky compaction zones: right more than left: increased compared to 15Feb2021. Small amount of pleural fluid bibasal. Chest x-ray at bed on 20Feb2021: Scattered blurred areas of compaction bilateral: virtually unchanged compared to 19Feb2021 study. No pleural effusions. Chest x-ray in bed on 22Feb2021: clinical information: bilateral pneumonia. Mechanical ventilation. Spotty compaction zones spread over both lung fields: earlier similar picture. Main diagnosis: bilateral pneumonia. Additional diagnosis: acute (on chronic?) respiratory insufficiency, hypotension, respiratory acidosis, hypercapnia, significantly decreased lung compliance (multifactorial), acute renal failure, oluguria, obesity, hypernatremia, increased troponins, tachycardia, hypokalaemia. Evolution: All therapy (hydromineral perfusion, stress ulcer and DVT prophylaxis, corticoids, bronchidilators, broad spectrum antibiotics (pip / tazo 15/2$g ...), respiratory support therapy (Optiflow and physiotherapy), intubation (19/02), mechanical ventilation (19/02$g ...), analgosis / curarisation, vasopressors, enteral nutrition), the evolution is unfavorable. Patient progressing to multi-organ failure with therapy-resistant respiratory failure up to her death. Post-mortem pre-evaluation of lung tissue for histopathological examination was performed: Extensive changes in the lung parenchyma appropriate in the context of diffuse alveolar damage with predominantly organizing component (ARDS spectrum). Cause of this cannot be determined histologically (infection? toxic?). No CMV was detected, no pneumocystis detected. The patient underwent lab tests and procedures which included blood alkaline phosphatase: 123 iu/l on 15Feb2021, blood bicarbonate: 32 on 15Feb2021, blood bicarbonate: 30 on 17Feb2021, blood bicarbonate: 32 on 18Feb2021, blood lactate dehydrogenase: 370 iu/l on 15Feb2021, blood potassium: 3.32 mmol/l on 15Feb2021, blood potassium: 3.08 mmol/l on 17Feb2021, blood potassium: 2.93 mmol/l on 18Feb2021, blood sodium: 144 mmol/l on 15Feb2021, blood sodium: 148 mmol/l on 17Feb2021, blood sodium: 149 mmol/l on 18Feb2021, blood test: inflammatory blood picture and vitamin d deficiency on 12Feb2021, chest x-ray: on 15Feb2021 Compression zone infrailar to the right and diffuse bronchial reinforcement lung drama drawing bilateral with slightly blurred areas of compaction: more probably infectious. No pleural effusions, chest x-ray: on 17Feb2021 Bilaterally extensive flaky compaction zones: right more than left: increased compared to February 15th. Small amount of pleural fluid bibasal; chest x-ray: on 20Feb2021 Scattered blurred areas of compaction bilateral: virtually unchanged compared to February 19, 2021 study. No pleural effusions; chest x-ray: on 22Feb2021: clinical information: bilateral pneumonia. Mechanical ventilation. Spotty compaction zones spread over both lung fields: earlier similar picture. Chest CT scan on 17Feb2021 : clinical information: dyspnoea, increased D-dimers, pneumonia. No central pulmonary embolisms, no peripheral pulmonary embolisms. Very extensive confluent lung compactions in both lower lobes and multifocal in both upper lobes: most likely infectious, covid cannot be ruled out. Small amount of pleural fluid on the right. Nodule with diameters up to 3 cm in the adrenal gland on the right: most likely still adenoma. Hemoglobin 18Feb2021: 9.9 g / dL - 17Feb2021: 10.0 - 15Feb2021: 10.6; Hematocrit 18Feb2021: 32 - 17Feb2021: 32 - 15Feb2021: 34; Red blood cells 18Feb2021: 3.7 x10 * 12 / L - 17Feb2021: 3.6 x10 * 12 / L - 15Feb2021: 3.9 x10 * 12 / L; White blood cells 18Feb2021: 16.3 x10 * 9 / L - 17Feb2021: 15.6 x10 * 9 / L - 15Feb2021: 13.8 x10 * 9 / L; Neutrophil segment nucleus 18Feb2021: 83.7%) - 17Feb2021: 83.7 - 15Feb2021: 81.2; Lymphocytes 18Feb2021: 7.1% - 17Feb2021: 5.9 - 15Feb2021: 6.0; Neutrophil / lymphocyte ratio 18Feb2021: 11.78 - 17Feb2021: 14.21 - 15Feb2021: 13.53; Abs. neutrophil count 18Feb2021: 13.66 x10 * 9 / L - 17Feb2021: 13.07 x10 * 9 / L - 15Feb2021: 11.23 x10 * 9 / L; Abs. lymphocyte count 18Feb2021: 1.16 x10 * 9 / L -17Feb2021: 0.92 x10 * 9 / L - 15Feb2021: 0.83 x10 * 9 / L; Abs. monocyte count 18Feb2021: 1.13 x10 * 9 / L - 17Feb2021: 1.08 x10 * 9 / L - 15Feb2021: 1.13 x10 * 9 / L; Immature myeloid cells 18Feb2021: 2.0 - 17Feb2021: 2.0 - 15Feb2021: 2.6; Platelets 18Feb2021: 493x10 * 9 / L - 17Feb2021: 480x10 * 9 / L - 15Feb2021 487x10 * 9 / L; hs-Troponin T 15Feb2021: 23 ng / L; CRP 18Feb2021: 203.6 mg / L - 17Feb2021: 200.7 - 15Feb2021 213.2. Comirnaty to all events reported as unclassifiable by Agency using WHO method of assessment. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Respiratory disorder; Acute respiratory failure; General malaise; Multi organ failure; Bilateral pneumonia; Dyspnea; Oxygen saturation low; Vitamin D deficiency; Coughing; Drug resistance


VAERS ID: 1149544 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-26
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: General physical health deterioration
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 24
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cachexia (Cachexia); Down''s syndrome (Down''s Syndrome); Lung fibrosis (Pulmonary fibrosis); Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021283079

Write-up: General condition deteriorated for 3 days, then again relatively good general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority- AT-BASGAGES-2021-13928. A 67-years-old male patient received the first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EJ6797), intramuscular on 20Jan2021 as SINGLE DOSE for covid-19 immunisation . Medical history included ongoing pulmonary fibrosis Pulmonary fibrosis , ongoing renal failure , ongoing cachexia, ongoing trisomy 21 Down''s Syndrome. The patient''s concomitant medications were not reported. Patient''s weight was not reported, and height was not reported. On 26Jan2021, The patient experienced general condition deteriorated for 3 days, then again relatively good general condition (medically significant) on 26Jan2021. Clinical course is as follows On 26Jan2021 the patient experienced Reduced general condition, other. The patient''s outcome was: recovered/resolved for Reduced general condition no concomitant medication reported with known cachexia, NINS and pulmonary fibrosis. 6 days after 1st vaccination (20Jan2021): General condition deterioration for 3 days, then again relatively good general condition. The male patient was already in a poor general condition. After the 1st vaccination (batch number EJ6796), the general condition was very poor, the doctor believed that the patient would not survive and after his recovery was not sure whether she should give the second vaccination The clinical outcome of the event reduced general condition was recovered. Source of assessment : BASGAGES, Result of Assessment : possible Senders comment : The report is for one patient. No mail was sent to reporters. Date of death: 19Feb2021 (Refer To Linked Report) No follow-up attempts possible. No further information expected. COMIRNATY batch already obtained.; Sender''s Comments: Linked Report(s) : 2021283085 same patient, different dose (first dose), different events


VAERS ID: 1149562 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CZPFIZER INC2021310296

Write-up: death; This is a spontaneous report from a contactable physician, downloaded from the WEB, regulatory authority number CZ-CZSUKL-21002656. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection; lot number: EP2166, expiration date was unknown), intramuscularly on 01Mar2021 at 0.3 mL, single for COVID-19 immunization. The patient''s medical history was not reported. The patient did not take any concomitant medicinal products. The patient experienced death on 05Mar2021. The patient died on 05Mar2021 after the first vaccination with COMIRNATY. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: death/ patient died


VAERS ID: 1149583 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-28
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM6950 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Thrombotic microangiopathy, Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: CONDROSULF; BETAHISTINE; ENALAPRIL + HIDROCLOROTIAZIDA; METOCLOPRAMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Hypertension arterial; Vertigo
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021311735

Write-up: Thrombotic microangiopathy; Thrombotic thrombocytopenic purpura; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority number ES-AEMPS-793023. A 92-year-old female patient received her first dose of bnt162b2 (COMIRNATY; lot number: EM6950; expiration date: unknown), at unknown vaccination age via an unspecified route of administration on 15Feb2021 as a single dose for covid-19 prophylaxis (covid-19 immunization). Medical history included hypertension arterial, vertigo and arthrosis. Concomitant medications included chondroitin sulfate sodium (CONDROSULF) for arthrosis; betahistine for vertigo from 25Feb2021 to an unspecified stop date; enalapril maleate, hydrochlorothiazide (ENALAPRIL + HIDROCLOROTIAZIDA) for hypertension arterial from 12Jul2018 to an unspecified stop date; and metoclopramide for vertigo from 25Feb2021 to an unspecified stop date. On 28Feb2021, the patient presented a thrombotic microangiopathy of the Thrombotic Thrombocytopenic Purpura type, ten days later she died (10Mar2021). Awaiting follow-up information for further clinical details. It was reported that the stop date for both events was 10Mar2021. The event''s seriousness criterion was death. The outcome of the events was fatal. The patient died on 10Mar2021. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Thrombotic microangiopathy; Thrombotic thrombocytopenic purpura


VAERS ID: 1149589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-09
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Blood test, COVID-19, Drug ineffective, Lymphopenia, Renal failure, Renal function test, SARS-CoV-2 test, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (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), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CANDESARTAN CILEXETIL; PRAVASTATIN SODIUM; PANTOPRAZOLE; MOVICOL [MACROGOL 4000;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; DOLIPRANE; HYDROCHLOROTHIAZIDE; PREDNISONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive airways disease; Double inguinal hernia; Dupuytren''s contracture; Fracture, closed, colles'' (fracture Beam Glues left); Haemorrhoids; Hypercholesterolemia; Living in residential institution; Nasal polyps; Oesophagitis ulcerative (stage IV); Pleuritis; Pyelonephritis; Shoulder dislocation; Venous peripheral insufficiency (lower limbs)
Allergies:
Diagnostic Lab Data: Test Name: anemia; Result Unstructured Data: Test Result:11.6 g/dl; Test Name: clearance; Result Unstructured Data: Test Result:44.2 ml/min; Comments: stage 3 renal failure with a clearance of 44.2mL / min.; Test Date: 20210209; Test Name: PCR SarS-CoV-2; Test Result: Positive ; Test Name: lymphopenia; Result Unstructured Data: Test Result:0.93 g/l
CDC Split Type: FRPFIZER INC2021311770

Write-up: COVID-19 aggravated; COVID-19 aggravated; Anemia; Lymphopenia; Stage 3 renal failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-AM20210581. A 100-year-old male patient living in a retirement home received first dose of bnt162b2 (COMIRNATY) intramuscular, administered in Deltoid Left on 21Jan2021 (Lot Number: EM0477) as single dose for covid-19 immunisation. Medical history included double inguinal hernia, fracture, closed, colles'' (fracture beam glues left), nasal polyps, venous peripheral insufficiency (lower limbs), haemorrhoids, oesophagitis ulcerative (stage IV), chronic obstructive airways disease, hypercholesterolaemia, pyelonephritis, dupuytren''s contracture, shoulder dislocation and pleuritis. Concomitant medications included candesartan cilexetil (CANDESARTAN CILEXETIL), pravastatin sodium (PRAVASTATIN SODIUM), pantoprazole (PANTOPRAZOLE), macrogol 4000, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL), paracetamol (DOLIPRANE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), prednisone (PREDNISONE). On 21Jan2021, the patient received his first injection of COMIRNATY. Four weeks after his vaccination, on 09Feb2021, in front of a pulmonary symptomatology, realization of a PCR SarS-CoV-2 which returned positive. Support was as follows: amoxicillin, clavulanic acid (AUGMENTIN) and levofloxacin (LOVENOX). On 16Feb2021, faced with the development of a severe form of COVID-19, he was hospitalized. The management was as follows: bi antibiotic therapy with ceftriaxone sodium (ROCEPHIN) and erythromycin, high flow oxygen therapy (12L/ min). No intensive care. On unknown date, on the laboratory assessment, anemia at 11.6g/ dL, lymphopenia at 0.93G/ L, stage 3 renal failure with a clearance of 44.2mL/ min. From 17Feb2021 to 22Feb2021 degradation of the patient requiring sedation. Patient died on 22Feb2021 due to COVID-19. An autopsy was not performed. Outcome of the events renal failure, lymphopenia and anemia was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Drug ineffective; Drug ineffective; COVID-19


VAERS ID: 1149638 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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: FRPFIZER INC2021311854

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the regulatory authority FR-AFSSAPS-TO20211616. An 85-year-old female patient received bnt162b2 (COMIRNATY, Injection: D2), dose 2 intramuscular on 04Mar2021 (Lot Number: EP2166) as single dose (in "left") for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY), dose 1 on an unspecified date (Lot Number: unknown) as single dose for COVID-19 immunization. The patient experienced infarct myocardial on 04Mar2021 (fatal). HISTORY OF THE CASE: Sudden death the night following the injection by myocardial infarction. The patient had no known cardiological history. EVOLUTION: Not reinstated on declaration date // 2021). The patient died on an unspecified date. It was not reported if an autopsy was performed. "Covid test: unknown" File in progress: request for additional information (atcd, other signs before death) No follow-up attempts are possible.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1149874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-14
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 molecular test; Result Unstructured Data: Test Result:positive; Test Name: rapid antigen swab; Result Unstructured Data: Test Result:positive
CDC Split Type: ITPFIZER INC2021323047

Write-up: After the 1st dose, the patient became ill with COVID-19.; After the 1st dose, the patient became ill with COVID-19.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB IT-MINISAL02-703039. A 92-year-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EJ6790; Expiration Date: 31Mar2021), intramuscular, administered on the right arm on 24Feb2021 as 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 14Mar2021, following serious asthenia, the other healthcare professional was contacted and performed a rapid positive antigenic swab and transported to the emergency room where positivity was confirmed with a molecular test. In ER, bilateral interstitial pneumonia was diagnosed and death occurs on 16Mar2021. Therapeutic measures were taken as a result of the event. The patient died on 16Mar2021. It was not reported if an autopsy was performed. Reporter''s comment: Onset of Covid 19 with bilateral interstitial pneumonitis about 2 weeks after 1st vaccination.; Reporter''s Comments: Onset of Covid 19 with bilateral interstitial pneumonitis about 2 weeks after 1st vaccination.; Reported Cause(s) of Death: bilateral interstitial pneumonia; Covid-19


VAERS ID: 1149875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-08
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: histological examination of the lungs; Result Unstructured Data: Test Result:awaiting for the result
CDC Split Type: ITPFIZER INC2021323046

Write-up: suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination; This is as spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is IT-MINISAL02-703463. A 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY, COVID 19 COMIRNATY VACCINE (PFIZER): Booster dose number 1, formulation: Solution for injection, lot number: EP2166; Expiration date: not reported), via intramuscular route on 06Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Mar2021, The patient experienced suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination. Reporter commented as, the patient died in hospital a few hours after admission two days after the first dose of the COMIRNATY vaccine. Diagnostic finding with suspicion of death due to pulmonary embolism (awaiting histological confirmation), Emergency department access documentation and autopsy report will be posted as soon as available. The patient underwent lab tests and procedures which included histological examination of the lungs: awaiting for the result on 11Mar2021. Outcome of the event was fatal. No follow-up attempts possible. No further information expected ad information on lot# already obtained.; Reporter''s Comments: Patient died in hospital a few hours after admission two days after the first dose of the Comirnaty vaccine . Diagnostic finding with suspicion of death due to pulmonary embolism (awaiting histological confirmation); Reported Cause(s) of Death: suspected pulmonary embolism, during the diagnosis of a person who died in hospital, pending confirmation by histopathological examination


VAERS ID: 1149892 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Fall, Fatigue, Femoral neck fracture, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFORMIN ACTAVIS; FOLVIDON; PANODIL; FELODIPINE; MEMANTINE SANDOZ; HALDOL; CANDEXETIL; INSUMAN BASAL; OXIS TURBOHALER; LEVAXIN; SIMVASTATIN SANDOZ; BISOPROLOL SANDOZ; ELIQUIS; RIVASTIGMINE ACTAVIS; MOXALOLE; SYMBICORT TURBOHALER; BETOLVIDO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Atrial fibrillation; Blood pressure low; Chronic ischemic heart disease, unspecified; Hallucinations; Hypothyroidism; Type 2 diabetes mellitus; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210108; Test Name: blood pressure; Result Unstructured Data: Test Result:110/70 mmHg; Test Date: 202102; Test Name: blood pressure; Result Unstructured Data: Test Result:130 mmHg
CDC Split Type: SEPFIZER INC2021282975

Write-up: low blood pressure; Tiredness; fall; broke her femoral neck; unknown cause of death; passed away; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-007695. An 83-year-old female patient received the second dose of bnt162b2 (COMIRNATY) via an unspecified route of administration on 04Feb2021 (Lot Number: unknown) as single dose for covid-19 immunisation. Medical history included asthma, atrial fibrillation, hallucination, hypothyroidism, myocardial ischaemia, type 2 diabetes mellitus, vascular dementia, all from unknown dates and unknown if ongoing. Previous low blood pressure during the fall of 2020, which improved after adjustment of medication. Concomitant medications included metformin hydrochloride (METFORMIN ACTAVIS) from 06May2020 to an unspecified stop date; folic acid (FOLVIDON) from 14May2020 to an unspecified stop date; paracetamol (PANODIL) from 06May2020 to an unspecified stop date; felodipine from an unspecified start date to Feb2021; memantine hydrochloride (MEMANTINE SANDOZ) from 06May2020 to an unspecified stop date; haloperidol (HALDOL) from 06May2020 to an unspecified stop date; candesartan cilexetil (CANDEXETIL) from 11Jun2020 to an unspecified stop date; insulin human injection, isophane (INSUMAN BASAL) from 06May2020 to an unspecified stop date; formoterol fumarate (OXIS TURBOHALER) from 06May2020 to an unspecified stop date; levothyroxine sodium (LEVAXIN) from 06May2020 to an unspecified stop date; simvastatin (SIMVASTATIN SANDOZ) from 06May2020 to an unspecified stop date; bisoprolol fumarate (BISOPROLOL SANDOZ) from 06May2020 to an unspecified stop date; apixaban (ELIQUIS) from 06May2020 to an unspecified stop date; rivastigmine hydrogen tartrate (RIVASTIGMINE ACTAVIS) from 17Sep2020 to an unspecified stop date; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOXALOLE) from 06May2020 to an unspecified stop date; budesonide, formoterol fumarate (SYMBICORT TURBOHALER) from 06May2020 to an unspecified stop date; cyanocobalamin (BETOLVIDON) from 06May2020 to an unspecified stop date; furosemide (IMPUGAN [FUROSEMIDE]) from 06May2020 to an unspecified stop date; all taken for an unspecified indication. The patient previously received the first dose of COMIRNATY on 07Jan2021 for COVID-19 immunization. The patient experienced low blood pressure and tiredness on 06Feb2021. These events were reported as serious (medically significant). Clinical course was reported as follows. Reported suspect vaccine was COMIRNATY (covid-19 vaccine). Reported suspect adverse events were tiredness and low blood pressure. The patient was vaccinated with 1st dose on 07Jan2021 and 2nd dose on 04Feb2021. On 06-07Feb2021, the patient had low blood pressure and was tired. On 08Feb2021, her blood pressure was 110/70 mmHg. Treatment with felodipine 10 mg once daily was withdrawn and after that, the patient felt better. No blood pressure was taken after felodipine was withdrawn. In late Feb2021, the patient had a fall and broke her femoral neck. No blood pressure was taken in conjunction with the fall. Upon arrival at the hospital, systolic blood pressure was 130 mmHg, but according to the reporter, the patient was probably in pain at this point. During surgery, the patient passed away. The reporter writes that she has seen an unusual number of cases with low blood pressure and falls in blood pressure among her patients following vaccination with COMIRNATY. She also writes that each individual case can be explained by concomitant illness, medication and so on, but that the number of patients affected has been remarkable. The reporter has reported 11 valid cases alongside this letter, and two non-valid cases to showcase that low blood pressure can occur even without vaccination. Outcome of the events tiredness, low blood pressure, fall, and broke her femoral neck was unknown. The patient died with unknown cause of death on an unspecified date in Feb2021. Unknown if autopsy was done. No follow-up attempts are possible; information about LOT/batch number cannot be obtained.; Reported Cause(s) of Death: unknown cause of death; passed away


VAERS ID: 1149897 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Haematemesis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (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: Anxiety; Depression; Diverticulitis; Hypertension; Lung sarcoid; Osteoporosis; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021311771

Write-up: the patient died 2 days after vaccination; The patient was found dead with coffee sump like vomiting; This is as spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is SE-MPA-2021-017039, other case identifier is SE-MPA-1615556907316. A elderly male patient received bnt162b2 (COMIRNATY, lot number: EP2163, expiration date: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient''s medical history included hypertension, depression, lung sarcoid, type 2 diabetes mellitus, diverticulitis, osteoporosis, and anxiety. The patient''s concomitant medications were not reported. On an unspecified date, the patient died 2 days after vaccination. The patient was found dead with coffee sump like vomiting. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: the patient died 2 days after vaccination


VAERS ID: 1149898 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Thrombosis
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bipolar disorder; Blood sugar increased
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021311754

Write-up: SEVERAL OF THROMBOSES; severe abdominal pain; This is a spontaneous report from a contactable nurse downloaded from the regulatory authority-WEB, regulatory authority numberSE-MPA-2021-018721. Other Case identifier number: SE-MPA-1615843203133. An 83-year-old female patient received first dose of bnt162b2 (COMIRNATY; Lot Number: EL0725) via an unspecified route of administration, on Feb2021, as SINGLE DOSE for covid-19 immunisation. Medical history included blood glucose increased and bipolar disorder. The patient''s concomitant medications were not reported. In Feb2021, 6 day after the vaccine, the patient developed severe abdominal pain and went to a hospital, where multiple thrombosis in her body was discovered. The woman died the following day. This was completely unexpected and sudden, is described as an alert woman who managed her life on her own. Outcome of abdominal pain was unknown while it was fatal for several thromboses. Cause of death was reported as several of thromboses. No autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: several of thromboses


VAERS ID: 1151734 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021314531

Write-up: pneumonia; This is a spontaneous report from a contactable consumer (Administration spoke person) via Pfizer colleague. This consumer (Administration spoke person) reported same events for two patients. This is one of two reports. A male patient in his mid 80s received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Mar2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A source close to the patient said the patient was previously well before the vaccine, and rapidly deteriorated the following day. The patient experienced pneumonia on an unspecified date in Mar2021. The outcome of the event was fatal. The patient died on 13Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : AU-PFIZER INC-2021314530 same reporter, event, different patient; Reported Cause(s) of Death: pneumonia


VAERS ID: 1151746 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-20
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   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: Alzheimer''s disease; Ischemic cardiomyopathy
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021328256

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority-WEB. Health authority report number is BE-FAMHP-DHH-N2021-82433. A 90-year-old male patient received BNT162B2 (COMIRNATY; Unknown lot number and expiration), via an unspecified route of administration on 10Feb2021 at a single dose for COVID-19 immunisation. Medical history included ischemic cardiomyopathy and advanced Alzheimer''s. The patient''s concomitant medications were not reported. The patient experienced sudden death on 20Feb2021. It was unknown if an autopsy was performed. Reporter''s comments: Treatment - Unknown. Evolution of the ADR - ADR description - Died on 20Feb2021, probably not linked to vaccine due to ischemic cardiomyopathy and advanced Alzheimer''s disease. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : BE-FAMHP-DHH-N2021-82433 FAMHP; Reported Cause(s) of Death: Sudden death


VAERS ID: 1151755 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Dehydration, Nausea, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic kidney disease (Further information not known)
Preexisting Conditions: Medical History/Concurrent Conditions: Renal failure; SARS-CoV-2 infection (Further information not known); Upper gastrointestinal hemorrhage (Recent (further information not known))
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: Fever; Result Unstructured Data: Test Result:39 Centigrade
CDC Split Type: CHPFIZER INC2021328075

Write-up: Death; Vomiting; Fever of 39 degree centigrade; Nausea; Dehydration; This is a spontaneous report from a contactable physician via the regulatory authority with regulatory authority report number CH-SM-2021-11463. An 89-year-old female patient received bnt162b2 (COMIRNATY; unknown lot number and expiration date), at vaccination age of 89-year-old intramuscular on 05Feb2021 as a single dose for covid-19 immunisation. Medical history included ongoing chronic kidney disease, advanced renal failure, covid-19 infection from 15Jan2021 to an unknown date and recent upper gastrointestinal haemorrhage, all had further information as not known. The patient''s concomitant medications were not reported. The patient experienced death on 09Feb2021, fever on 07Feb2021, nausea on 05Feb2021, dehydration on 05Feb2021 and vomiting on 08Feb2021. It was reported that the patient showed nausea on 05Feb2021 then pyrexia (39 degree Centigrade) on 07Feb2021 and vomiting on 08Feb2021 which exitus as a result of dehydration on 09Feb2021. The outcome of the events was fatal. The patient died on 09Feb2021. It was not reported if an autopsy was performed. A causal relationship between Comirnaty and death was assessed as being unlikely. A causal relationship between Comirnaty and all other events was assessed as being possible. regulatory authority assessed this case as serious, results in death. Reporter''s Comment: Vaccination on 05Feb2021; Fever 39 degree on 07Feb2021; From 08Feb2021 rec. vomiting; Death case 09Feb2021 Sender''s comment: Elderly patient following vaccination with Comirnaty (05Feb2021) manifested nausea, pyrexia (3 days of latency) and vomiting (4 days of latency) that led to a state of dehydration and, therefore, death. Notoriety, nausea (common) is reported under Gastrointestinal disorders and pyrexia (very common, 14.2%) under Systemic diseases and conditions related to the site of administration, whereas vomiting is not listed among the adverse events, as are death and dehydration. In contrast the, the FDA''s Comirnaty datasheet (1) includes a table indicating the "Frequency and percentage of participants with systemic adverse reactions elicited after each dose, by degree of severity, within 7 days of each dose-participants $g=56 years of age-population safety subgroup reactivity analysis" and vomiting is listed here, specifying various levels of severity ("any degree," "mild," "moderate","severe." ) From a literature search, Micromedex (3) reports vomiting (incidence: 0.5%-1.9%) among gastrointestinal adverse events. UpToDate (4), however, indicates that nausea and vomiting may also be symptoms attributable to advanced renal failure and (5) also highlights the increased morbidity in the case of advanced renal disease. Serious adverse reaction (death). According to current knowledge, the causal link - related to the adverse reactions nausea, fever, vomiting - is considered possible, given the close temporal correlation with the vaccination (chronological criterion) and the notoriety (1, 2, 3) of the adverse events manifested by the patient. These adverse events may have contributed to a state of dehydration that, however, is also attributable to and/or exacerbated by the patient''s underlying comorbidities (recent upper gastrointestinal bleeding and COVID-19 infection; advanced renal pathology: 4,5). In conclusion, it is plausible to assume that it was this state of dehydration to determine, in the final analysis, the death of the patient and - although we can not exclude that the vaccine, in a patient with such copatologies, may have contributed to dehydration - the death is not directly attributable to vaccination (causal link unlikely). (1): "Study 2 - Frequency and Percentages of Participants with Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After Each Dose - Participants 56 Years of Age and Older - Reactogenicity Subset of the Safety Population: Vomiting (Any, Mild, Moderate, Severe)". (3): "Gastrointestinal Effects - Vomiting: Incidence: 0.5% to 1.9%". (4): "A wide range of disorders may develop as a consequence of the loss of kidney function. These include (...) nausea, vomiting". (5): "End-stage kidney disease - Compared with individuals who had an eGFR of 60 mL/min per 1.73 m2 or more, the relative risks for ESKD among those who had an eGFR between 45 and 59 mL/min per 1.73 m2 were 3.1 (95% CI, 1.1-8.3) in those younger than 65 years and 3.4 (95% CI, 1.6-7.2) in those older than 65 years. In contrast to cardiovascular mortality, absolute rates of ESKD were lower in those older than 65 years". No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Reporter''s Comments: Vaccination on 05Feb2021; Fever 39 degree on 07Feb2021; From 08Feb2021 rec. vomiting; Death case 09Feb2021; Sender''s Comments: The reported death is most likely the consequence of nausea, fever, vomiting, dehydration in the context of concurrent medical conditions of chronic kidney disease, advanced renal failure, covid-19 infection, unlikely directly related to the administration of the COVID19 vaccine, BNT162B2. 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 RA, IEC, as appropriate.; Reported Cause(s) of Death: Dehydration


VAERS ID: 1151774 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory failure
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), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Lung cancer
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021317258

Write-up: Respiratory failure; 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-PEI2021003607. A 66-year-old male patient received first dose of bnt162b2 (COMIRNATY), via intramuscular on 17Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing palliative situation with lung cancer (CA). The patient''s concomitant medications were not reported. On the same day after vaccination the patient developed respiratory insufficiency, lasting for unknown. The patient died on 17Mar2021. Death cause was reported as respiratory failure. It was not reported if an autopsy was performed. Relatedness of drug to event assessed by PEI as indeterminate. No Follow-Up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 1151775 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-25
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
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: 2021-02-25
   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 INC2021317243

Write-up: Vaccination adverse reaction; This is a spontaneous report downloaded from the regulatory authority-WEB DE-PEI-PEI2021003616. This is a report received from the Regulatory Authority. A male patient of an unspecified age received BNT162B2 (COMIRNATY, LOT# unknown), via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 25Feb2021, after vaccination, the patient developed vaccination adverse reaction, lasting for unknown, which resulted to death on 25Feb2021. The patient died on 25Feb2021. Unknown if autopsy was performed. Event assessment: Comirnaty: for all events / PEI/ D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination adverse reaction


VAERS ID: 1151776 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure congestive, Metabolic disorder, Pyrexia
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021317251

Write-up: Fieber; Decompensated heart failure; Metabolic imbalance in diabetes; This is a spontaneous report received from a non-contactable physician downloaded from the regulatory Agency-WEB. The regulatory authority report number is DE-PEI-PEI2021003619. A 96-year-old male patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EP9598) via an unspecified route of administration on 08Mar2021 at single dose for covid-19 immunisation. Medical history included diabetes mellitus. Historical Vaccine included first dose of bnt162b2 (COMIRNATY) on 15Feb2021 for covid-19 immunisation, and patient had been tolerated. The patient''s concomitant medications were not reported. The patient experienced fieber, decompensated heart failure, metabolic imbalance in diabetes on 13Mar2021. Events seriousness criteria was death. It was reported that 5 days after vaccination the patient developed Fever and Congestive cardiac failure and Metabolic disorder NOS, lasting for 5 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to all events assessed by PEI as Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fieber; Decompensated heart failure; Metabolic imbalance in diabetes


VAERS ID: 1151778 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Lymphopenia, Thrombocytopenia
SMQs:, Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Lack of efficacy/effect (narrow), Systemic lupus erythematosus (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: 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 INC2021328289

Write-up: Symptomatic Covid-19 Infection; Thrombopenia; Lymphopenia; Symptomatic Covid-19 Infection; This is a spontaneous report received from a non-contactable physician downloaded from the WEB. The regulatory authority report number is DE-PEI-PEI2021003640. An 88-year-old male patient received bnt162b2 (COMIRNATY), first dose via an unspecified route of administration on 01Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that on 18-Mar-2021 after vaccination the patient developed COVID-19 (reported as Symptomatic Covid-19 Infection) and Lymphopenia and Thrombopenia, lasting for unknown. The patient is dead. Relatedness of drug to all event(s) assessed by PEI as Unclassifiable. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on lot and batch numbers cannot be obtained. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Symptomatic Covid-19 Infection; Lymphopenia; Thrombopenia; Symptomatic Covid-19 Infection


VAERS ID: 1151780 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity
SMQs:, Angioedema (broad), 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021328307

Write-up: suspected allergic reaction; 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-PEI2021003648. A 94-year-old male patient received the second dose of BNT162B2 (COMIRNATY; lot/batch number and expiration date not reported) via an unspecified route of administration on 16Mar2021 at a 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 24Feb2021 for COVID-19 immunisation (had been tolerated). The patient experienced suspected allergic reaction on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Relatedness of drug to reactions/events was unclassifiable per Regulatory Authority. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: suspected allergic reaction


VAERS ID: 1151784 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Cerebral haemorrhage, Chills, Fall, Feeling cold, Malaise, Myalgia, Pyrexia, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021328786

Write-up: severe cerebral hemorrhage due to fall trauma; severe cerebral hemorrhage due to fall trauma; syncope; chills; fever; felt cold; circulation problems; pain must have been muscle pain due to the vaccination; did not feel well; This is a spontaneous report based on information received by Pfizer from Biontech, manufacturer control number: 25400], license party for Comirnaty. A contactable consumer reported that a 89-year-old female patient received the second dose bnt162b2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration on 08Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunization and experienced mild vaccination site pain. The reporter stated that the patient was fit and healthy despite of her age. Her death could have been avoided if they had known that the patient should not be left alone after vaccination. The patient saw the reporter on 07Mar2021 and they went on a long walk. The patient had to "wait" 15 minutes after the vaccination on 08Mar2021. In the evening of 08Mar2021, the reporter''s aunt and sister spoke to the patient on the phone and she was well. She was very happy that life would go on as usual and she would be able to go to the gym 3 times weekly. The reporter spoke to the patient on the phone on 09Mar2021 between 9.30 to 10 am. She had no complaints due to the vaccination by then. They thought everything was fine because she had no side-effects after the first vaccination except for mild vaccination site pain. The reporter''s aunt was not able to reach the patient on the evening of 09Mar2021. They both tried reaching the patient on 10Mar2021 until the early evening unsuccessfully. Afterwards the reporter went to check on her. The reporter found her on the kitchen floor. She lay on her back like sleeping. The police and the emergency physician came fast and confirmed her death. The autopsy has been performed on 11Mar2021 according to instruction of the prosecution department. The reporter''s mother died due to severe cerebral hemorrhage caused by trauma. The cause of death was fall. They were able to find out what must have happened before her death. Due to a neighbor''s observations and the fact that the reporter''s aunt was not able to reach her, they suspect that she died between 10 am and before dawn on 09Mar2021. The heating was extremely turned on. They suspect that she had chills or fever and felt cold. Additionally, she was looking for painkillers in her draw despite not taking any medication otherwise. She has taken a painkiller "in prop form" NOS (as reported) from the draw and went towards the kitchen probably in order to get some water. The patient collapsed at the entrance of the kitchen and fell backwards on the floor or against a metal leg of a small table. According to the physicians she was dead at once, a so called "second death". The physicians in their family explained to the reporter the cause of death described in the autopsy. Due to the heat in the apartment, the patient probably experienced circulatory problems, the pain must have been muscle pain due to the vaccination. She usually drank enough, but it is possible that she did not drink enough that day because she did not feel well. The outcome of the events syncope, chills, fever, felt cold, muscle pain, did not feel well and circulation problems was unknown. The patient died on 09Mar2021 due to severe cerebral hemorrhage due to fall trauma. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: severe cerebral hemorrhage due to fall trauma; severe cerebral hemorrhage due to fall trauma


VAERS ID: 1151790 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-13
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Pulmonary embolism, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; DEXAMETHASONE; DEXAMETHASONE; ONYTEC; FERRO DURETTER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adrenal cortical insufficiency (concurrent medical condition); Adrenogenital syndrome (concurrent medical condition); Constipation (concurrent medical condition); Dermatophytosis of nail (concurrent medical condition); Iron deficiency (concurrent medical condition)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021322753

Write-up: Lung embolism; Feeling unwell; Neck swelling; This is a spontaneous report downloaded from the regulatory agency WEB [DK-DKMA-WBS-0054206]. The case was received from a contactable physician via The regulatory Agency, additional safety reference number DK-DKMA-ADR 24940761. An 88-year-old female patient received the first dose of bnt162b2 (COMIRNATY, batch/Lot Number: ER2659; Expiration Date: 30Jun2021), via an unspecified route of administration on 01Mar2021 as SINGLE DOSE for Covid-19 immunisation. The patient''s medical history were Adrenogenital syndrome, Adrenal cortical insufficiency, Constipation and Dermatophytosis of nail, iron deficiency (all concurrent medical conditions). Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) for constipation from 14Feb2018 to 13Mar2021; dexamethasone for adrenal insufficiency from 14Feb2018 to 13Mar2021; dexamethasone for adrenogenital syndrome from 23Jan2020 to 13Mar2021; ciclopirox (ONYTEC) for dermatophytosis of nail from 15May2020 to 13Mar2021; ferrous sulfate (FERRO DURETTER) for iron deficiency from 14Feb2018 to 13Mar2021. The patient experienced feeling unwell, neck swelling and lung embolism on 13Mar2021. No treatment or medical procedure performed for the events reported. The lung embolism was reported as being Fatal. The patient died on 13Mar2021. The outcome of event neck swelling was not recovered; for feeling unwell was unknown. An autopsy was not performed. There was no information regarding test results. Causality: The reporter stated that the patient had the age where embolism / acute myocardial infarction occurs, so it probably had nothing to due with the vaccine. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the available information the event is most likely related to the patient''s predisposition to an inter current or underlying condition due to advanced age hence event assessed as unrelated to the suspect drug.; Reported Cause(s) of Death: Lung embolism


VAERS ID: 1151806 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-02-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Atrial fibrillation, Auscultation, Cardiac failure, Dyspnoea, Eating disorder, Heart rate, Tachycardia, Vomiting
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Infective pneumonia (broad), Dehydration (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: Alzheimer''s disease; Cardiovascular disease, unspecified (Cardiovascular disease (excluding hypertension)); Neuropsychiatric symptoms
Allergies:
Diagnostic Lab Data: Test Name: cardiac auscultation; Result Unstructured Data: Test Result:Tachycardiac arrhythmia; Test Name: heart rate; Result Unstructured Data: Test Result:130
CDC Split Type: ESPFIZER INC2021311631

Write-up: Atrial fibrillation with rapid ventricular response; Tachycardiac arrhythmia. Heart rate: 130; does not eat; dyspnea; abdominal discomfort; Vomiting; Decompensation cardiac; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB and received via Regulatory Authority ES-AEMPS-783800. A 93-year-old female patient received bnt162b2 (COMIRNATY, lot number: EL0725), dose 1 unknown route of administration on 25Feb2021, single dose for covid-19 immunisation. Medical history included Cardiovascular disease (excluding hypertension), Alzheimer''s disease, Neuro-psychiatric disorders. The patient previously took lormetazepam, quetiapine, edoxaban, donepezil, memantine, omeprazole. The patient''s concomitant medications were not reported. Patient was referred from primary care due to Atrial fibrillation with rapid ventricular response. According to reports after a dose of COVID 19 vaccination a week ago, she presents vomiting and abdominal discomfort unspecified. Also associated dyspnea sensation. Cardiac Auscultation: Tachycardiac arrhythmia. Heart rate: 130 She was given concor 2.5: 1/2-0-1/2 and dilutol 1 and 1/2-0-0. She still does not eat practically anything, she has not vomited again. Her daughter finds her dead. Decompensation cardiac also reported with stop date 6-MAR-2021. Vomiting and Decompensation cardiac reported start date was 26Feb2021 (reported also as time Interval between Beginning of Drug Administration and Start of AEs : 2 days). The outcome of the events vomiting and Decompensation cardiac were reported as fatal by the reporter. The outcome of the other events was unknown. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: vomiting; Decompensation cardiac


VAERS ID: 1151812 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-11
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 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? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: GABAPENTIN; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Cholelithiasis (resolved by endoscopic retrograde cholangiopancreatography); Hypertension; Pancreatitis (resolved by endoscopic retrograde cholangiopancreatography)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021311680

Write-up: Sudden death; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB ES-AEMPS-790777. An 89-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: ET1831), intramuscular on 04Mar2021 as a single dose for covid-19 immunisation. Medical history included hypertension, cholelithiasic pancreatitis, resolved by endoscopic retrograde cholangiopancreatography, and cholecystectomy. Concomitant medications included gabapentin taken for an unspecified indication from 02Oct2019; losartan taken for hypertension from 12Sep2012. The patient''s condition when she was vaccinated was stable, without serious pathologies. Then it was reported that the patient had a sudden death on 11Mar2021 (duration of 8 hours as reported). The outcome of the event was fatal. The cause of death was unknown. The patient died on 11Mar2021. It was unknown if an autopsy was performed. Additional information on ADRs: The registered patient was vaccinated on March 4, 2021 with the first dose of the PFIZER covid vaccine. On March 11, her death was reported. The patient''s condition when she was vaccinated was stable, without serious pathologies. 11Mar2021 the daughter comments to me that last night was ok, talked with her and met with her that morning to go to auditory center. "I call the family and at the end the home emergency services have signed the certificate of death of." 11Mar2021 the patient has died, home emergency services at her home did not certify death, because the family has told them that the deceased was phenomenal and they did not know what cause to put. There are no signs of violence. Under these circumstances I am not going to sign the certificate either. No toxic habits. Hypertension. No diabetes mellitus. No dislipemia. Cholelithiasic pancreatitis, resolved by endoscopic retrograde cholangiopancreatography. No other pathological history. Background surgery: Cholecystectomy No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1151825 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Asthenia, COVID-19 pneumonia, Drug ineffective, Pyrexia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (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: 2021-03-14
   Days after onset: 35
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: APIXABAN; DIFFU K; FUROSEMIDE; ALLOPURINOL; HYDROCORTISONE; MIANSERIN; OXYCODONE; PANTOPRAZOLE; PHLOROGLUCINOL; ZOPICLONE; SYMBICORT
Current Illness: Angina attack; Asthma; Atrial fibrillation; Generalised arthritis; Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210308; Test Name: SARS-COV-2 PCR; Test Result: Positive ; Comments: COVID-19 variant
CDC Split Type: FRPFIZER INC2021333550

Write-up: Acute respirtory distress syndrome; asthenia; fever; vaccination failure; COVID-19 pneumonia aggravated; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number is FR-AFSSAPS-BS20210414. A 92-year-old female patient received first dose of BNT162B2 (COMIRNATY) intramuscularlyon 14Jan2021 at single dose (lot EM0477) and second dose of BNT162B2 (COMIRNATY)i ntramuscularly on 04Feb2021 at single dose (lot EJ6788) for Covid-19 immunisation. Medical History included continuous atrial fibrillation, Heart failure, angina, asthma, arthritis. Concomitant medications included apixaban, potassium chloride (DIFFU K), furosemide, allopurinol, hydrocortisone, mianserin, oxycodone, pantoprazole, phloroglucinol, zopiclone, budesonide, formoterol fumarate (SYMBICORT). It was reported variant covid-19 infection on day 25 (07Feb2021) after a complete, well-conducted vaccination schedule. No conservation condition problem reported. On day 29 (05Mar2021), the patient experienced 1st symptoms, with fever and asthenia. On day 32 (08Mar2021), positive PCR variant, sequencing in progress. On day 33 (09Mar2021), Hospitalization for dyspnea on covid-19 infection, rapidly oxygen-retaining. On day 38 (14Mar2021): death. On 08Mar2021, SARS-COV-2 PCR resulted positive . The outcome of asthenia and fever was unknown. The patient died on 14Mar2021 due to COVID-19 pneumonia aggravated, Drug ineffective and Acute respiratory distress syndrome. No autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021333507 same reporter, same drug, different patient and events; Reported Cause(s) of Death: COVID-19 pneumonia aggravated; drug ineffective; Acute respiratory distress syndrome


VAERS ID: 1151834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-06
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: Cardiovascular disease, unspecified; Diabetes; Diarrhea; Weight loss
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021333521

Write-up: Hemorrhage of gastrointestinal tract, unspecified; This is a spontaneous report received from a contactable consumer or other non-HCP downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-LM20210562. Verbatim: Not medically confirmed. Patient notification Lot no EP2166, 1st dose 03Mar2021, left arm. Medical History, current diseases, context : COVID-19 disease history: NO, diabetes and cardiovascular disease. Description of Adverse Effect: Death of digestive hemorrhage on D3 of vaccination. The patient who lost weight due to diarrhea for a few weeks before vaccination. Brief observation, no further information available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Hemorrhage of gastrointestinal tract, unspecified


VAERS ID: 1151858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Asthenia, Blood pressure measurement, Blood test, Body temperature, Brain natriuretic peptide, C-reactive protein, Cardiac failure, Dyspnoea, Echocardiogram, Electrocardiogram, Heart rate, Malaise, Oxygen saturation, Pulmonary embolism, Tachycardia, Troponin
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: THYROZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperthyroidism (controlled)
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: BP; Result Unstructured Data: Test Result:9/6; Test Date: 20210302; Test Name: BP; Result Unstructured Data: Test Result:13/8; Test Date: 201911; Test Name: blood test; Result Unstructured Data: Test Result:normal; Test Date: 20210301; Test Name: Body temperature; Result Unstructured Data: Test Result:no temperature; Test Date: 20210302; Test Name: Body temperature; Result Unstructured Data: Test Result:no temperature; Test Date: 20210301; Test Name: BNP; Result Unstructured Data: Test Result:17920; Test Date: 20210301; Test Name: CRP; Result Unstructured Data: Test Result:55; Test Date: 20210302; Test Name: echocardiography; Result Unstructured Data: Test Result:possible signs of pulmonary embolism; Test Date: 20210301; Test Name: ECG; Result Unstructured Data: Test Result:normal; Test Date: 20210301; Test Name: pulse; Result Unstructured Data: Test Result:90; Test Date: 20210301; Test Name: SaO2; Result Unstructured Data: Test Result:87-88 %; Test Date: 20210302; Test Name: SaO2; Result Unstructured Data: Test Result:93-94 %; Test Date: 20210302; Test Name: SaO2; Result Unstructured Data: Test Result:86-87 %; Test Date: 20210302; Test Name: tachycardia; Result Unstructured Data: Test Result:115; Test Date: 20210301; Test Name: Troponin; Result Unstructured Data: Test Result:79
CDC Split Type: FRPFIZER INC2021312118

Write-up: Arrhythmia NOS; Feeling sick; possible signs of pulmonary embolism; flare-up of heart failure; Dyspnoea; Asthenia; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-TO20211456. An 86-year-old female patient received BNT162B2 (COMIRNATY, Batch/Lot Number: unknown) dose 2 intramuscular on 24Feb2021 as single dose for covid-19 immunisation. Medical history included controlled hyperthyroidism, independent patient living at home. Concomitant medication included thiamazole (THYROZOL) 5 mg for a well-controlled hyperthyroidism. Following the COVID-19 vaccination (24Feb2021), the patient presented with severe asthenia on 25Feb2021. On 28Feb2021, asthenia persisted with the presence of shortness of breath (Dyspnoea) on exertion (walking, climbing stairs). On 01Mar2021, clinical examination showed drowsiness, no particular pain, Sa02 87-88%, BP 9/6, pulse at 90, no temperature, no sign of DVT of the lower limbs. The blood assessment showed BNP 17920, Troponin 79, CRP 55 (previous blood test carried out in Nov2019 strictly normal). Apparently normal ECG. Suspicion of flare-up of heart failure. Furosemide 20 mg IV administration seemed to be getting better. On 02Mar2021, fairly good general condition, BP 13/8, Sa02 93-94%, get up and have a little lunch Lasilix injection and prescription for further oral treatment. At noon seemed to be doing better, eat a little without finishing his meal, however. At the end of the afternoon, no alarming sign but at 7 p.m., the situation will degenerate as not feeling well (sick), dyspnea plus, SaO2 86-87%, tachycardia 115, no temperature, no pain would lengthen. At 8:20 pm, arrival of the firefighters with discomfort with rhythm disturbances (arrhythmia) in the ambulance. Hospitalization, unsuccessful resuscitation attempt; The resuscitator found on echocardiography possible signs of pulmonary embolism. The patient was hospitalized due to above events. The outcome of events flare-up of heart failure and pulmonary embolism was unknown and other events was fatal. The patient was died on 02Mar2021. It was unknown if an autopsy was performed. Cause of death was reported as arrhythmia, feeling sick, asthenia and dyspnoea. No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Arrhythmia; Feeling sick; Asthenia; Dyspnoea


VAERS ID: 1151860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-06
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19 pneumonia, Haemoglobin, Platelet count, Vaccination failure, Ventilation/perfusion scan, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-12
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiodepressive syndrome; Atrial fibrillation; Cardiac failure; COVID-19; Hepatic damage; Hypothyroidism; Ischemic stroke; Living in nursing home; Neutropenia; Thrombocytopenia
Allergies:
Diagnostic Lab Data: Test Name: CRP; Result Unstructured Data: Test Result:233; Test Name: Hb; Result Unstructured Data: Test Result:12; Test Name: platelets; Result Unstructured Data: Test Result:82000; Comments: thrombocytopenia; Test Name: lung scanner; Result Unstructured Data: Test Result:large areas of frosted glass scattered; Comments: large areas of frosted glass scattered around the 2 typical COVID19 lung fields. More than 50% attack; Test Name: leukocytes; Result Unstructured Data: Test Result:0.53; Comments: leucopenia
CDC Split Type: FRPFIZER INC2021333512

Write-up: COVID-19 pneumonia; Vaccination failure; This is a spontaneous report from a contactable physician from the regulatory authority-WEB FR-AFSSAPS-TO20211864. A 92 years old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ6789) on 11Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included Hepatic damage, Neutropenia, COVID-19, Anxiodepressive syndrome, Atrial fibrillation, Ischemic stroke, Thrombocytopenia, Hypothyroidism, Cardiac failure and living in nursing home. Concomitant medications were not reported. The patient received first dose of BNT162B2 on an unspecified date at single dose. On 06Mar2021 the was diagnosed with COVID-19 Pneumonia. Possible vaccination failure occurred. Covid 19 was evolving into severe form. Patient had an Emergency hospitalization on 11Mar2021 with respiratory distress. He was put under O2 15 liters. Performed lab test included CRP at 233, Hb at 12, leukopenia 0.53, thrombocytopenia 82 000. On the scanner: large areas of frosted glass scattered around the 2 typical COVID19 lung fields. More than 50% attack. The patient died on 13Ma2021 due to COVID-19 pneumonia and suspected vaccination failure. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; vaccination failure


VAERS ID: 1152831 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-19
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Clot retraction, Confusional state, Constipation, Dehydration, Infection, Investigation, Limb discomfort, Peripheral swelling, SARS-CoV-2 test, Urinary tract infection
SMQs:, Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypoglycaemia (broad), Dehydration (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure; Dementia
Allergies:
Diagnostic Lab Data: Test Name: Lab tests; Result Unstructured Data: Test Result:Unknown results; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021306665

Write-up: Poorly dehydrated; Constipated; Urine infection; Became more confused; left leg became very swollen and heavy; left leg became very swollen and heavy; infection; Clot retraction; This is a spontaneous report from a contactable consumer (patient child). This is a report received from the Agency Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202103190919451600, Safety Report Unique Identifier is GB-MHRA-ADR 24975124. An 84-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Batch/Lot number: Unknown), via an unspecified route of administration on 31Dec2020 as a single dose for COVID-19 immunization. Medical history included dementia and blood pressure. Patient has not had symptoms associated with COVID-19 and is not enrolled in clinical trial. The patient''s concomitant medications were not reported. On an unspecified date the patient was poorly dehydrated, constipated, urine infection, became more confused, left leg became very swollen and heavy and infection. On 19Jan2021, the patient experienced clot retraction (until 20Jan2021, as reported). The patient was taken to A&E of a hospital where the tests were performed (Unknown results). The clinical course was reported as follows: The patient had the vaccine and after that became very poorly dehydrated, constipated and more serious a urine infection she became more confused as she had been suffering from dementia then suddenly left leg became very swollen and heavy. Ambulance was called and patient was diagnosed as having a blood clot and infection and she was dehydrated. On an unspecified date, the patient had COVID-19 virus test and the result was No - Negative COVID-19 test. The case is serious, events causing hospitalization; event clot retraction is fatal. Patient has not tested positive for COVID-19 since having the vaccine. The cause of death was clot retraction. The outcome for events poorly dehydrated, constipated, urine infection, became more confused, left leg became very swollen and heavy and infection was unknown; clot retraction was fatal. An autopsy was not performed. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Clot retraction


VAERS ID: 1152835 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-02-21
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial thrombosis, Malaise, SARS-CoV-2 test, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021306489

Write-up: Felt unwell; a large blood clot was discovered in the artery to the bowel; Death sudden; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority (RA). Regulatory authority report number: GB-MHRA-WEBCOVID-202103201901276170, Safety Report Unique Identifier: GB-MHRA-ADR 24986407. A 90-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4243, expiration date: unknown), via an unspecified route of administration on 21Jan2021 (at the age of 90 years old) at a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medication included simvastatin. The patient has not had symptoms associated with COVID-19 and was not enrolled in clinical trial. It was reported that the patient felt unwell on unspecified date immediately after the COVID vaccine. The patient continued to feel unwell and a large blood clot was discovered in the artery to the bowel and was admitted to hospital on Thursday, 04Feb2021. It was further reported that the patient deteriorated and died (sudden death) on 21Feb2021 (also reported as 10Feb2021). The patient underwent lab tests and procedures which included COVID-19 virus test: no - negative COVID-19 test on 05Feb2021. Since the vaccination, the patient had not tested positive for COVID-19. Outcome of the events felt unwell and a large blood clot was discovered in the artery to the bowel was unknown. The patient died on 21Feb2021. It was unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1152839 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-15
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021327233

Write-up: Stroke; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The Regulatory authority report number is (GB-MHRA-WEBCOVID-202103222059565510) and the Safety Report Unique Identifier is (GB-MHRA-ADR 25002071). A patient of unspecified age and gender received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EK1768), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient experienced stroke on 15Jan2021 and then died on 03Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1152860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-08
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021328892

Write-up: Cardiac arrest; The initial case was missing the following minimum criteria: first-hand knowledge of the event. Upon receipt of follow-up information on 28Mar2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer, with follow-up from a nurse (colleague of the patient). A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly in Feb2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. It was unknown if the patient had been tested for COVID-19 since the vaccination. It was unknown if the patient received any other vaccine within four weeks of the suspect vaccine. It was unknown if the patient was diagnosed with COVID prior to vaccination. The patient''s medical history included hypertension from an unknown date and unknown if ongoing. It was unknown if the patient had allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (COMIRNATY) for COVID-19 immunization on an unknown date in Jan2021 (intramuscularly; (Batch/Lot Number: Unknown).On 08Feb2021, the patient experienced cardiac arrest, which was assessed as medically significant and resulted in death. It was unknown if treatment was received for the cardiac arrest. It was initially reported that the reporter mentioned that she was talking to someone casually. That person said to the reporter that she knew someone, who was a nurse, in the age group 50-60, and was vaccinated with the second dose of the Pfizer COVID vaccine, and some days later died. The patient died on an unspecified date in 2021 due to cardiac arrest. An autopsy was not performed. Follow-up attempts have been completed and no further information is expected.; Sender''s Comments: Limited information precludes a medically meaningful assessment of the case. Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Cardiac arrest cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1152869 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4241 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Diabetic ketoacidosis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure (CHF); Diabetes mellitus (DM); Hyperlipidemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330143

Write-up: Circumstances of death: was hospitalized on the background of DKA (Diabetic ketoacidosis); This is a spontaneous report from a contactable healthcare professional via the regulatory Authority. A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4241) as a single dose for COVID-19 immunization. Medical history included hypertension, hyperlipidemia, diabetes mellitus, and CHF. The patient''s concomitant medications were not reported. Circumstances of death: was hospitalized on the background of DKA (Diabetic ketoacidosis). 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.; Sender''s Comments: Based on the current available information, the event Diabetic ketoacidosis is most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: DKA (Diabetic ketoacidosis)


VAERS ID: 1152870 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
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: Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330151

Write-up: collapsed in the ER convolution and VF (Ventricular fibrillation); collapsed in the ER convolution and VF (Ventricular fibrillation); This is a spontaneous report from a contactable healthcare professional received via regulatory authority. A 51 years old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK4238) on an unknown date, for COVID-19 immunisation. Medical history included diabetes. Concomitant medications were not reported. On an unspecified date the patient collapsed in the ER convolution and VF (ventricular fibrillation), as reported. The events required hospitalization and were reported with a fatal outcome. The patient died on an unknown date. It was unknown if an autopsy was performed. No follow-up attempts possible. No information expected.; Sender''s Comments: Limited information does not allow a medically meaningful assessment for the events "collapsed in the ER convolution and VF (Ventricular fibrillation)". Details regarding the drug-event temporal association, complete medical history, concomitant medication, hospitalization summary and autopsy results are not provided. The case will be re-evaluated if more information is 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: convolution and VF (Ventricular fibrillation); convolution and VF (Ventricular fibrillation)


VAERS ID: 1152871 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Ischemic heart disease; Rheumatoid factor
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330247

Write-up: was found dead in her home; This is a spontaneous report received from a contactable other HCP via regulatory authority. A 77-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EK4238) via an unspecified route of administration on an unspecified date (at the age of 77-year-old), at single dose for COVID-19 immunisation. Relevant medical history included ischemic heart disease, rheumatoid factor (as reported), hypertension and diabetes. Concomitant medications were not reported. The patient was found dead in her home on the day of the vaccine. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event is likely due to underlying disease, however, unless further information regarding specific cause of death is provided, at present, the reported event death, cause unknown, is assessed as possibly related to BNT162B2, as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: was found dead in her home


VAERS ID: 1152872 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea, Heart rate, Investigation, Loss of consciousness, Pulmonary embolism, Pulseless electrical activity, Pupil fixed, Respiratory arrest, Right ventricular enlargement, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Exposure to COVID-19; Penicillin allergy
Allergies:
Diagnostic Lab Data: Test Name: pulse; Result Unstructured Data: Test Result:without pulse; Test Name: investigation nos; Result Unstructured Data: Test Result:she was without a pulse and independent breathing; Comments: the pupils were dilated did not react to light; Test Name: ultrasound; Result Unstructured Data: Test Result:right ventricle enlarged
CDC Split Type: ILPFIZER INC2021330256

Write-up: loss consciousness at home later a week of breathing difficulty.; loss consciousness at home later a week of breathing difficulty.; she was without a pulse and independent breathing; Asystola/PEA/she was without a pulse; Asystola/PEA; lung embolism; the pupils were dilated did not react to light; Right ventricle enlarged; This is a spontaneous report from a contactable other health professional reporting for a patient received from the regulatory Authority. Regulatory Authority number was not provided. A 42-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot Number: EK4240) as SNIGLE DOSE for covid-19 immunisation, age of vaccination was unknown. Medical history included penicillin allergy and exposure to a confirmed ill person (COVID-19) from an unknown date. The patient''s concomitant medications were not reported. The patient was generally healthy and was allergic to penicillin. She was in quarantine because of exposure to a confirmed ill person. She was brought to a hospital while being resuscitated after she collapsed in her home. About a week ago (unspecified date) she started to suffer from difficulty breathing that became worse in the morning. After she collapsed, her partner started heart massage and alerted the emergency services staff. The ambulance team found the patient unconscious and continued with resuscitation activities (including airways and heart massage). When she was admitted to the hospital, she was without a pulse and independent breathing and the pupils were dilated did not react to light. The hospital staff continued with resuscitation activities. In a bedside ultrasound right ventricle enlarged was noted. Due to the possibility that this was a lung embolism she was treated with TPA. In the course of the long resuscitation peaks of Asystola/PEA appeared that were dealt with accordingly and also an attempt at external pace-making did not succeed. After about an hour and a half of resuscitation activity, her death was certified, and a message was sent to the partner who did not agree to conduct an autopsy after the death. She was given the first dose of the vaccine for COVID-19 it seems on 19Jan2021. Therapeutic measures were taken as a result of loss consciousness at home later a week of breathing difficulty, she was without a pulse and independent breathing, asystola/pea/she was without a pulse, asystola/pea, and lung embolism. Outcome of the events loss consciousness at home later a week of breathing difficulty, she was without a pulse and independent breathing, asystola/pea/she was without a pulse, asystola/pea was fatal. Outcome of other events was unknown. The patient died on an unspecified date. An autopsy was not performed. No follow-up attempts possible. No further information expected. Information on lot number has been obtained.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2020517122; Reported Cause(s) of Death: she was without a pulse and independent breathing; asystola/PEA/She was without a pulse; Asystola/PEA; loss consciousness at home later a week of breathing difficulty; loss consciousness at home later a week of breathing difficulty


VAERS ID: 1152873 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4237 / 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: Medical History/Concurrent Conditions: Prostatic hyperplasia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330262

Write-up: Under inquiry(Unknown cause of death); This is a spontaneous report from a contactable healthcare professional. A 73-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4237), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history included prostatic hyperplasia. The patient''s concomitant medications were not reported. The patient''s circumstance of death was under inquiry on an unspecified date. The patient died on an unspecified date. The cause of death was unknown. It was not reported if an autopsy was done. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Under inquiry(Unknown cause of death)


VAERS ID: 1152874 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330296

Write-up: was found dead in his home; This is a spontaneous report received from Health Care Professional via Agency Regulatory Authority. A 74-years-old male patient received the second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4238) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient was found dead in his home on an unspecified date. the cause of patient''s death was unknown at the reporting time. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow up attempts are possible, no further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1152875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Ejection fraction
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Congestive heart failure (CHF EF 35%,); Hypertension; Paroxysmal supraventricular tachycardia
Allergies:
Diagnostic Lab Data: Test Name: EF; Test Result: 35 %
CDC Split Type: ILPFIZER INC2021330325

Write-up: was found lifeless at her home; This is a spontaneous report from a contactable other hcp received via regulatory authority. A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK4238) on an unknown date at single dose for COVID-19 immunization. medical history included congestive hear failure (CHF) EF 35%, hypertension, ventricular tachicardia paroxysmal. Concomitant drugs were unknown. The patient was found dead in her home 4 days after vaccination. No follow-up attempts possible. No information expected.; Sender''s Comments: Based on the information currently available, the patient''s underlying diseases might have contributed to patient''s demise. However, unless further information regarding specific cause of death provided, at present, the reported event death, cause unknown, is assessed as possibly related to suspect drug, as a cautionary measure and for reporting purposes. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 same source, diffrent patient; Reported Cause(s) of Death: was found lifeless at her home


VAERS ID: 1152876 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Cardiac arrest, Chronic obstructive pulmonary disease, Haematemesis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (~~~); Atrial fibrillation; Chronic heart failure; COPD (~~~); Diabetes; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:drop
CDC Split Type: ILPFIZER INC2021330454

Write-up: Brought to the emergency room due to worsening of COPD; black vomit; asystole in the monitor; drop in blood pressure; This is a spontaneous report from a contactable other health care professional. An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4242) as single dose for covid-19 immunisation. Medical history included Atrial fibrillation, diabetes, hypertension, chronic heart failure, COPD, Alzheimer''s. The patient''s concomitant medications were not reported. One day after receiving the vaccine, breathing problems and a drop in blood pressure, after a few days breathing problems worsened and was transferred to [PRIVACY] emergency room due to worsening of COPD, in the emergency room one black vomit and then asystole in the monitor, resuscitation was performed for 50 min, the patient died. The events black vomit and asystole was assessed as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: drop. The patient died due to the event Brought to the emergency room due to worsening of COPD on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events black vomit, asystole in the monitor, and drop in blood pressure was unknown. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the temporal association, a causal relationship between the events worsening of COPD, black vomit, asystole and blood pressure decreased and BNT162B2 cannot be completely excluded. Other risk factors to be considered may include the patient''s underlying atrial fibrillation, diabetes, hypertension, chronic heart failure, and COPD. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Brought to the emergency room due to worsening of COPD


VAERS ID: 1152877 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac death, Death
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypertension (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: Congestive heart failure; COPD; Diabetes; Smoker
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:one-time rise in blood pressure
CDC Split Type: ILPFIZER INC2021330475

Write-up: She was found dead in the nursing home in her room; cardiac event; A one-time rise in blood pressure; This is a spontaneous report from a contactable other HCP received via the regulatory authority. A 79 -year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK4242) on an unknown date at single dose for COVID-19 immunization. The first dose of vaccine was done on an unknown date. medical history included congestive heart failure, COPD, diabetes, smoking. Concomitant drugs were unknown. She was found dead in the nursing home in her room 5 days from the vaccine administration, coronary event. On the day of her death, a one-time rise in blood pressure. No follow-up attempts possible. No further information expected. Batch/lot number already provided.; Sender''s Comments: The event death is unexpected with this 79 year old female living in a nursing home. Her significant medical history of congestive heart failure, COPD, diabetes and smoking are confounding factors to her demise. This case will be updated when new information becomes available including which concomitant medications were used for her medical illnesses and if autopsy report is available.,Linked Report(s) : IL-PFIZER INC-2020517122 same source, different patient; Reported Cause(s) of Death: cardiac event; Found dead in her room


VAERS ID: 1152878 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Schizophrenia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330486

Write-up: died in the institution he was hospitalized in; This is a spontaneous report from a contactable Healthcare Professional received via the regulatory authority. The report was received in the epidemiology department division by medical staff for patient. A 58-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4238) at single dose for COVID-19 immunization. Medical history included schizophrenia, hypertension and diabetes mellitus, all from an unknown date. The patient''s concomitant medications were not reported. On an unspecified date the patient died in the institution he was hospitalized in for an unknown reason. The cause of death was unknown and it was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2020517122 master case-patient 1; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1152879 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ALS
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330530

Write-up: died at home; This is a spontaneous report from a contactable other hcp. A 67-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Batch/Lot Number: EK4240), via an unspecified route of administration as single dose on an unspecified date (at 67-year-old) for COVID-19 immunisation. Medical history included ongoing amyotrophic lateral sclerosis (ALS). There was no information on heart disease. The patient''s concomitant medications were not reported. The patient experienced died at home on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 master case; Reported Cause(s) of Death: Unknown Cause of Death


VAERS ID: 1152881 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021328274

Write-up: Died; Unconscious; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB IS-IMA-2072. An 89-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 02Mar2021 (batch/lot number: unknown) as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient did not have any complaints immediately following the vaccination. She stated that she did not have any soreness after the needle. In the evening of 06Mar2021, the patient was found found unconscious. She never regained consciousness and died on the eve of Wednesday, 10Mar2021. The outcome of the event was fatal. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: died


VAERS ID: 1152908 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm ruptured, Gastrointestinal haemorrhage, Haematemesis, Haemoperitoneum
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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: ALPRAZOLAM; BISOPROLOL FUMARATE; SERTRALINE; STILNOX; TALOFEN; LIXIANA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial aneurysm; Depression; Hypertensive heart disease; Insomnia; Sedative therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021322987

Write-up: Hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report: diagnosis of digestive haemorrhage.; Hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report: diagnosis of digestive haemorrhage.; Hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report: diagnosis of digestive haemorrhage.; Hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report: diagnosis of digestive haemorrhage.; This is a spontaneous report downloaded from the Agency Agency-WEB, IT-MINISAL02-697430. This report was received from a contactable physician via the Regulatory Authority. A 90-year-old female patient received the first dose of BNT162B2 (COMIRNATY; batch/lot number: EJ6790 and expiry date unknown), intramuscular on 18Feb2021 as a SINGLE DOSE for COVID-19 immunisation; and edoxaban tosilate (LIXIANA; batch/lot number was not reported), oral from an unspecified date to an unspecified date, at 1 DF, 1x/day for AFib (atrial fibrillation). The patient''s medical history included arterial aneurysm, sedative therapy/ sedation, hypertensive heart disease, depression, and insomnia, all from an unknown date and unknown if ongoing. Concomitant medications included alprazolam for sedative therapy; bisoprolol fumarate for hypertensive heart disease; sertraline for depression; zolpidem tartrate (STILNOX) for insomnia; and promazine hydrochloride (TALOFEN for sedation; therapy dates for all were not reported. On 19Feb2021, the patient experienced hematemesis and haemoperitoneum from ruptured gastroduodenal artery aneurysm. From clinical report, diagnosis of digestive haemorrhage. The patient died on 23Feb2021. The cause of death was not reported. It was not reported if an autopsy was performed. Reporter comment: There is a temporal link, I don''t think about the causal link of the bleeding with vaccination. I don''t know the type of vaccine. Lixiana contributed. The aneurysm was not known. Sender comment: 12Mar2021 Local agency center: request for follow-up information from the reporter regarding clinical report. Waiting. 18Mar2021 Local agency center: the form is updated with the additional information provided by the reporter and the clinical report is attached. No follow-up attempts are possible. No further information is expected. Information on the batch/lot number of Comirnaty was already obtained.; Reporter''s Comments: There is a temporal link, I don''t think about the causal link of the bleeding with vaccination. I don''t know the type of vaccine. Lixiana contributed. The aneurysm was not known.; Reported Cause(s) of Death: The patient died


VAERS ID: 1152909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 RA / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Disorientation, Epilepsy, Hallucination
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   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: LEVOPRAID [LEVOSULPIRIDE]; TORVAST; DIBASE; LUVION [CANRENONE]; PANTORC; LANTUS; SEROQUEL; KCL-RETARD; METFORAL; APIDRA; COUMADIN; THEO-DUR; ZYLORIC; LORTAAN; LASIX [FUROSEMIDE]; DULOXETINE HYDROCHLORIDE; RANEXA; CONGESCOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Diabetic metabolic decompensation; Fractured femur (excl neck); Gross obesity; Respiration failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021302772

Write-up: Allucinazioni, disorientamento, crisi comiziale; Hallucinations, disorientation, seizure; Hallucinations, disorientation, seizure; Hallucinations, disorientation, seizure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-697877. A 75-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Deltoid Right on 01Mar2021 13:00 (Batch/Lot Number: EP9598; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. The patient received dose 1 on 08Feb2021 (1st dose, lot EL0725 exp. Mar2021). Medical history included respiratory failure, diabetic metabolic decompensation, atrial fibrillation, Fractured femur (excl neck), Gross obesity. Concomitant medications included levosulpiride (LEVOPRAID); atorvastatin calcium (TORVAST); colecalciferol (DIBASE); canrenone (LUVION; pantoprazole sodium sesquihydrate (PANTORC); insulin glargine (LANTUS); quetiapine fumarate (SEROQUEL); potassium chloride (KCL-RETARD); metformin hydrochloride (METFORAL); insulin glulisine (APIDRA); warfarin sodium (COUMADIN); theophylline (THEO-DUR); allopurinol (ZYLORIC); losartan potassium (LORTAAN); furosemide (LASIX); duloxetine hydrochloride; ranolazine (RANEXA); bisoprolol fumarate (CONGESCOR), all were taken for an unspecified indication, start and stop date were not reported. On 02March2021 the patient experienced Disorientation, Hallucinations, Disorder aggravation, and Epileptic fit. The event caused hospitalization. The events were assessed as fatal. The patient died on 03Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Patient institutionalized for femur fracture, the lady presented with glycometabolic decompensation, severe obesity, chronic respiratory insufficiency for bpco requiring 02 3l / min, hyperlipidemia, high frequency AF, hyperuricemia. From 15Feb2021 she had persistent nausea with episodes of vomiting after the ingestion of food, with improvement after taking levopraid before the meal.; Reported Cause(s) of Death: Disorientation; Hallucinations; Disorder aggravation; Epileptic fit


VAERS ID: 1152911 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 8
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: DONEPEZIL; CARDICOR; ACETYLSALICYLIC ACID; EUTIROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive deterioration; Ischaemic heart disease; Thyroidectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021322984

Write-up: bridging ischaemic stroke; This is a spontaneous report received from a contactable physician downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-701388. An 82-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, batch/lot number: EP2166), intramuscular on 05Mar2021 at 11:41 at 0.3 mL, single for SARS-CoV-2 vaccination. The patient''s medical history included thyroidectomy, ischaemic heart disease, and cognitive deterioration; all from an unknown date and unknown if ongoing. Concomitant medications included donepezil, bisoprolol fumarate (CARDICOR), acetylsalicylic acid, and levothyroxine sodium (EUTIROX); all taken for an unspecified indication, start and stop date were not reported. The patient experienced bridging ischaemic stroke on 06Mar2021, reported as the patient arrived at the emergency department on 06Mar2021 in a sleepy state. She was admitted to the emergency medicine ward on 11Mar2021 for coma in acute cerebral ischaemia. Her family reported that the patient had undergone the Pfizer vaccine on 05Mar2021. The patient died on 14Mar2021 due to the bridging ischaemic stroke. It was not reported if an autopsy was performed. Sender''s comment: Comirnaty vaccine batch EP2166 carried out on 05Mar2021 at 11.41. The report of the referring physician and the vaccination card always sent by the referring physician are attached. Requested additional data on previous pathologies or drugs taken by the patient and awaiting a reply. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bridging ischaemic stroke


VAERS ID: 1152956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-09
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC2021328359

Write-up: Lung edema; Death; This is a spontaneous report from a contactable consumer (patient) downloaded from the Agency Regulatory Authority-WEB LT-SMCA-1551. This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number LT-SMCA-1551. A 69-years-old male patient received BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine (COMIRNATY), suspension for injection, intramuscular on an unknown date in 2021 (Batch/Lot Number: EN6200) at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 09Mar2021 lungs edemas was observed. The outcome was fatal. It was also reported that the date of death and cause of death were not submitted. The patient died in Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Lung edemas


VAERS ID: 1152971 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 30042721 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hypophagia, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOSINOPRIL; METFORMINE [METFORMIN]; NITROFURANTOINE; COMBIGAN; OXAZEPAM; CLOPIDOGREL; NORTRIPTYLINE; CALCIUM CARBONATE; AMLODIPINE; PARACETAMOL; HYDROXOCOBALAMINE; CLOBETASOL
Current Illness: Alzheimer''s disease; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Multiple myeloma; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: corona sneltest; Test Result: Negative ; Result Unstructured Data: Negative
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: A Regulatory Authority report was received from a pharmacist for a 78 year old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and who experienced fatigue, nausea, vomiting, and decreased oral intake (hypophagia). The patient''s medical history included cerebrovascular accident, type 2 diabetes mellitus, urinary tract infection, alzheimer''s dementia, and plasma cell myeloma. The concomitant medications included clopidogrel, nortriptyline, calcium carbonate, amlodipine, paracetamol, hydroxocobalamine, clobetasol, fosinopril, metformine [metformin], nitrofurantoine, brimonidine tartrate timolol maleate and oxazepam. On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 30042721) intramuscularly for prophylaxis of COVID-19 infection. On 12-Feb-2021, one day after receiving the vaccine, the patient experienced fatigue, nausea and vomiting. A SARS-CoV-2 test was performed which was negative. On a date not reported, the patient experienced decreased oral intake. The patient died on 18 Feb 2021. The cause of death was reported as nausea and decreased oral intake. No autopsy was performed. Treatment information was not applicable. Action taken with mRNA-1273 was not applicable. The outcome of the events nausea, vomiting, and decreased oral intake was fatal and the outcome for the event of fatigue was unknown. On 11Mar2021, follow up information was received which provided cause of death as decreased oral intake with no autopsy performed. A SARS-CoV-2 test was performed on 12Feb2021 which was negative.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient''s comorbidities may confound causality assessment. This case concerns a 78-year-old female who experienced serious unexpected events of fatigue, nausea, vomiting. The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcomes fatal. As above, a causal relationship cannot be excluded.


VAERS ID: 1152975 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-03-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Death, Malaise, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; FUROSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: Oxygen saturation; Result Unstructured Data: Decreased; Test Date: 20210305; Test Name: COVID-19 PCR test; Test Result: Negative ; Result Unstructured Data: Covid PCR test; Test Date: 20210304; Test Name: COVID-19 rapid POC test; Test Result: Negative ; Result Unstructured Data: Covid test
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; oxygen saturation decreased; A regulatory authority report was received from a physician, concerning an 81 year-old male patient, who was administered Moderna''s COVID-19 vaccine (mRNA-1273), and experienced oxygen saturation decreased, malaise (malaise), asthenia, and pyrexia and subsequently died (Death). The patient''s medical history was not reported. Concomitant medications reported included clopidogrel, and furosemide. On 25 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 300042722), intramuscularly for the prophylaxis of COVID-19 infection. On 04 Mar 2021, the patient experienced oxygen saturation decreased, malaise, asthenia and pyrexia. On the same day, the patient underwent COVID-19 rapid point-of care (POC) test which was negative. On 05 Mar 2021, the patient underwent COVID-19 polymerase chain reaction (PCR) test which was negative. On 07 Mar 2021, the patient died. Cause of death was not reported. Plans for an autopsy were unknown. No treatment information was reported. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcomes of the events, oxygen saturation decreased, malaise, asthenia and pyrexia, were unknown.; Reporter''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (oxygen saturation decreased, malaise, asthenia and pyrexia), a causal relationship cannot be excluded. Very limited information regarding this patient''s death has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1152976 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Chills, Death, Headache, Hyperpyrexia, Malaise, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   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: INSULINE ASPARTATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No adverse event history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Death; A regulatory authority report was received from a consumer concerning a 87-year-old, male patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced generalized joint pain, malaise, hyperpyrexia, pain, chills, headache and died. The patient''s medical history was not provided. Concomitant products known to have been used by patient, within two weeks prior to the event, included Insulin Aspartate. On 12-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 12-FEB-2021, after receiving mRNA-1273, the patient began experiencing generalized joint pain, malaise, hyperpyrexia, pain, chills and headache and finally resulted in death of patient. The patient died on 12FEB2021. The cause of death is unknown. Treatments of these events were not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, generalized joint pain, malaise, hyperpyrexia, pain, chills and headache were not provided.; Reporter''s Comments: This is a case of death in a 87-year-old male subject with unknown medical history, who died same day after receiving the first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1152977 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-27
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, Cardiac murmur, Chest pain, Dyspnoea, Oxygen saturation, Troponin
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: COPD; Dementia; Diabetes mellitus; Heart failure; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: Souffle grade 3; Result Unstructured Data: Test Result:souffle grade 3; Test Name: CRP; Result Unstructured Data: Test Result:50; Test Name: saturatie; Test Result: 95 %; Test Name: troponine; Result Unstructured Data: Test Result:366
CDC Split Type: NLPFIZER INC2021311622

Write-up: Dyspnoea; Chest pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number NL-LRB-00474154. A 90-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Feb2021 as a single dose (at the age of 90-years-old) for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), dementia, heart failure, diabetes mellitus, and hypertension; all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 27Feb2021, the patient experienced chest pain and dyspnoea. The patient was admitted to the hospital for his dyspnoea and they could not find the cause of his dyspnoea. No diagnosis was made. The patient underwent lab tests and procedures which included cardiac murmur: souffle grade 3, c-reactive protein: 50, oxygen saturation: 95 %, and troponin: 366; all on an unspecified date. The outcome of the events was fatal. The cause of death was chest pain and dyspnoea. The patient died on 28Feb2021. It was unknown if an autopsy was performed. Case Summary and Reporter''s Comments Text: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Additional information ADR: the patient became increasingly dyspnoeic. Demented gentleman, copd, smoker, tendency to the cordis. Admission: PRIVACY 27Feb21. work diagnosis; copd, / dec cordis / pneumonia / acs ?? no exact diagnosis has been established. 28fb died No follow-up attempts are possible, information about lot number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no Additional information ADR: the patient became increasingly dyspnoeic. Demented gentleman, copd, smoker, tendency to the cordis. Admission: PRIVACY 27Feb21. work diagnosis; copd, / dec cordis / pneumonia / acs ?? no exact diagnosis has been established. 28fb died; Reported Cause(s) of Death: Chest pain; Dyspnoea


VAERS ID: 1152978 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-08
Onset:2021-02-17
   Days after vaccination:437
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Chills, Drug ineffective, Hernia pain, Malaise, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test, Vaccination site pain
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (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: 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: DUROGESIC; HYDROCHLOORTHIAZIDE; DEXAMETHASON [DEXAMETHASONE]; REMDESIVIR; CODEINE; DIAZEPAM; CLINDAMYCINE [CLINDAMYCIN]; ENZALUTAMIDE; AMLODIPINE; COLECALCIFEROL; ZOLADEX [GOSERELIN]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Prostatic cancer metastatic
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade; Test Date: 20210301; Test Name: Covid culture; Result Unstructured Data: Test Result:positive
CDC Split Type: NLPFIZER INC2021323064

Write-up: COVID-19 infection; COVID-19 infection; Fever: 38 to 40.5 degrees Celsius; Hernia pain/back pain due to hernia; Cold shivers; Not feeling well; Muscle strain/Myalgia; Nausea; Reaction at or around the injection site: pain; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB, regulatory authority number NL-LRB-00480709. An 87-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: EJ6789) as single dose for COVID-19 vaccination; and goserelin (ZOLADEX), via an unspecified route of administration from 08Dec2019 to an unspecified date, at 10.8 mg, every 3 months for prostate cancer metastatic. Medical history included prostate cancer metastatic from an unknown date. Concomitant medications included fentanyl (DUROGESIC); hydrochloorthiazide (HYDROCHLOORTHIAZIDE); dexamethasone (DEXAMETHASON); remdesivir; codeine; diazepam; clindamycin (CLINDAMYCINE); enzalutamide; amlodipine; and colecalciferol. The patient was reported to have hernia pain/ back pain due to hernia on 23Feb2021, cold shivers on 23Feb2021 reported as cause of death, not feeling well on 23Feb2021 reported as cause of death, Muscle strain/myalgia on 23Feb2021 reported as cause of death, nausea on 23Feb2021 reported as cause of death, reaction at or around the injection site: pain on 17Feb2021, fever: 38 to 40.5 degrees Celsius on 01Mar2021 reported as cause of death, and COVID-19 infection on 01Mar2021 reported as cause of death following administration of Pfizer COVID-19 vaccine for COVID -19 immunization and gosereline implant for prostatic cancer metastatic. Chills was treated with dexamethasone, remdesivir and O2; and injection site pain, malaise, pyrexia and COVID-19 were treated with dexamethasone and remdesivir. The patient died on an unspecified date. It was unknown if an autopsy was performed. The outcome of the events hernia pain and reaction at or around the injection site: pain was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: COVID-19 infection; Cold shivers; muscle strain; Not feeling well; Nausea; Fever: 38 to 40.5 degrees Celsius


VAERS ID: 1152979 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-14
Onset:2021-03-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature, Cardiac failure, Erysipelas, Erythema, Fluid retention, Peripheral swelling, Pyrexia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Arthritis (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210315; Test Name: fever; Result Unstructured Data: Test Result:38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC2021328267

Write-up: Fluid retention; Renal failure/kidney failure; Erysipelas; Generalized joint pain; very thick inflamed legs; Fever: 38 to 40.5 degrees Celsius; Cardiac failure/heart failure; erythema; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB. The regulatory authority report number is NL-LRB-00481336. An 89-year-old female patient received the first dose of BNT162B2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration, on 14Mar2021, at a single dose, for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no previous covid-19 infection. The patient experienced the following adverse events on 15Mar2021: fluid retention, renal failure/kidney failure, erysipelas, generalized joint pain, very thick inflamed legs, fever: 38 to 40.5 degrees Celsius, cardiac failure/heart failure, and erythema. The outcome of the events was fatal. The patient died on an unspecified date in Mar2021. It was unknown if an autopsy was performed. Reporter''s comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Kidney failure. Additional information ADR: Fluid retention, very thick legs, inflamed legs, erythema, heart failure. BSN available: Yes. COVID-19. Previous COVID-19 infection: No. Other: diagnostic procedures: No was no more. No follow-up attempts are possible; information on the lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): No. Kidney failure. Additional information ADR: Fluid retention, very thick legs, inflamed legs, erythema, heart failure. BSN available: Yes. COVID-19. Previous COVID-19 infection: No. Other: diagnostic procedures: No was no more.; Reported Cause(s) of Death: fluid retention; renal failure/kidney failure; erysipelas; generalized joint pain; very thick inflamed legs; fever: 38 to 40.5 degrees Celsius; cardiac failure/heart failure; erythema


VAERS ID: 1152980 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-03-04
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: positive after 9 days; Test Result: Positive
CDC Split Type: NLPFIZER INC2021333751

Write-up: vaccination failure/COVID-19 confirmed by positive COVID-19 test 9 days after start; COVID-19 confirmed by positive COVID-19 test 9 days after start; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB, regulatory authority number NL-LRB-00482557. An 87-year-old female patient received the first dose of bnt162b2 (COMIRNATY), on 26Jan2021 and then received the second dose on 23Feb2021 both via an unspecified route of administration as a single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. On 04Mar2021, the patient experienced vaccination failure/covid-19 confirmed by positive covid-19 test 9 days after start. The outcome of the events was fatal. Cause of death was vaccination failure/covid-19 confirmed by positive covid-19 test 9 days after start. The patient died on an unspecified date. 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: COVID-19 confirmed by positive COVID-19 test 9 days after start; vaccination failure/COVID-19 confirmed by positive COVID-19 test 9 days after start


VAERS ID: 1152983 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-02-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram abdomen, Diarrhoea, Disease recurrence, Fall, Gastrointestinal necrosis, Gastrointestinal surgery, General physical health deterioration, Intestinal ischaemia, Mesenteric artery embolism, Sepsis
SMQs:, Pseudomembranous colitis (broad), Embolic and thrombotic events, arterial (narrow), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Noninfectious diarrhoea (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Mesenteric ischemia
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: abdominal CT; Result Unstructured Data: Test Result:Acute on chronic mesenteric ischemia; Comments: acute on chronic mesenteric ischemia with necrosis of the small intestine; Test Date: 202103; Test Name: Gastrointestinal surgery; Result Unstructured Data: Test Result:only 40 cm of viable intestines were found; Comments: and this was not compatible with life
CDC Split Type: NOPFIZER INC2021328319

Write-up: SEPSIS; EMBOLISM MESENTERIC; MESENTERIC ISCHEMIA/acute on chronic mesenteric ischemia with necrosis of the small intestine; MESENTERIC ISCHEMIA/acute on chronic mesenteric ischemia with necrosis of the small intestine; acute on chronic mesenteric ischemia with necrosis of the small intestine; DIARRHEA; REDUCED GENERAL CONDITION; FALLING DOWN; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory authority report number NO-NOMAADVRE-FHI-2021-Uj3g9z, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00022624. An 86-years-old female patient received the second dose of BNT162B2 (COMIRNATY; lot number: EP2166), via unspecified route of administration on 26Feb2021 at a single dose for COVID-19 immunization. Medical history included Chronic Mesenteric Ischemia. The patient''s concomitant medications were not reported. On 27Feb2021, the patient experienced diarrhea, reduced general condition, and ''falling down''. On 01Mar2021, the patient developed sepsis, embolism mesenteric, mesenteric ischemia. On the same day, abdominal CT confirmed acute on chronic mesenteric ischemia with necrosis of the small intestine. The patient was admitted to hospital from 01Mar2021 to an unspecified date due to sepsis, embolism mesenteric, mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. On an unspecified date in Mar2021, gastrointestinal surgery was performed and only 40 cm of viable intestines were found and this was not compatible with life. The patient died in Mar2021 due to sepsis, embolism mesenteric, and mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. The outcome of the other events was unknown. It was not reported if an autopsy was performed. Sender Comment: The report applies to a patient who got diarrhea, reduced general condition and fell at home the day after the second dose of COMIRNATY. On 01Mar2021, the patient was hospitalized due to sepsis, embolism mesenteric, mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine. Abdominal CT showed acute on chronic mesenteric ischemia with necrosis of the small intestine. The reported reactions are not among the known side effects of this vaccine. As of today, we know a lot about side effects that occur in the days and weeks after vaccination, but we cannot rule out rare side effects or whether there should be side effects that only appear long after the vaccination. In each case, it is difficult to know whether the symptoms are due to the vaccine or another, random simultaneous cause that has nothing to do with the vaccine in question. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease and / or habitual condition and thus is disposed of in the relevant case. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis; Embolism mesenteric; mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine; mesenteric ischemia/acute on chronic mesenteric ischemia with necrosis of the small intestine; mesenteric ischemia/acute on ch


VAERS ID: 1152992 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-03-07
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   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: Arterial hypertension (hypertonia arterialis); Epidural hematoma (Chronic epidural hematoma); Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021323083

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB PL-URPL-3-367-2021. An 81-years-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EP9598; Expiration Date: 30Jun2021), intramuscular, administered in left arm on 18Feb2021 11:45 at a single dose for COVID-19 immunisation. Medical history included ongoing chronic extradural haematoma, ongoing arterial hypertension (hypertonia arterialis), and ongoing Type 2 diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced death on 07Mar2021 07:30, 3 weeks after vaccination of Comirnaty. The cause of death was unknown. It was unknown if an autopsy was performed. The reporter commented that death was not related to vaccination. Sender comments: In the submitted report, no post-vaccination symptoms preceding the patient death were described. Agency has only knowledge about comorbidities in the patient, i.e. arterial hypertension, non-insulin-dependent diabetes mellitus, chronic epidural hematoma. There is a time relationship between vaccine administration and death. Due to the above information, Agency assessed the reported death as occurring in a temporary coincidence with vaccination. The reporting doctor, in the description of the reaction, also did not link the death with the administration of the Comirnaty vaccine. The person reporting vaccine adverse event qualified it as severe. Due to the health result - death, Agency assessed the vaccine adverse event as severe. Death /WHO scale, Agency/ Unlikely. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Death not related to vaccination; Sender''s Comments: Event unknown cause of death is assessed as Related by the company until sufficient information is available to confirm an unrelated cause of death. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1152993 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Oxygen saturation decreased
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), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021328338

Write-up: Cardiac arrest; Oxygen saturation decreased; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB. The regulatory authority number is PL-URPL-DML-MLP.4401.1.180.2021. An 89-year-old male patient received his second dose of BNT162B2 (COMIRNATY, lot number: EP9598), via an unspecified route of administration on 19Feb2021 at 0.3 mL, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient received his first dose of BNT162B2 (COMIRNATY, lot number and expiration date were not reported) at the age of 89-years-old, via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunisation without side effects. On 25Feb2021 at 18:30, the patient experienced a decrease in saturation and on 26Feb2021, the patient experienced cardiac arrest. The patient died on 26Feb2021. The causes of death were cardiac arrest and oxygen saturation decreased. An autopsy was not performed. The physician reported that the second dose was fatal and assessed the side effect as severe (death). The reporting physician assessed the side effect as severe (death). URPL classified the application as serious. The data contained in the electronic report is all at the disposal of URPL - in the case of obtaining additional information, another version will be sent. Causality assessment for the events and the suspect drug was reported as unlikely. Sender''s Comment: The fall in saturation (which resulted in cardiac arrest) is an unexpected adverse reaction, not included in section 4.8 of Comirnaty''s Summary of Product Characteristics. There is a time relationship between the administration of the drug and the occurrence of the side effect. Due to the lack of detailed information (autopsy results, health history, comorbidities, medications taken, etc.), it cannot be ruled out that a factor other than the administered vaccine may have contributed to the death. The reporting physician assessed the side effect as severe (death). URPL classified the application as serious. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: ICD-10 I46 Cardiac arrest; Oxygen saturation decreased


VAERS ID: 1153022 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Infection, Pneumonia, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOXALOLE; EBIXA; CYKLOKAPRON; PARACETAMOL NET; RISPERIDON ACTAVIS; OXASCAND; MIRTAZAPIN ACTAVIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Dementia; Depressed mood; Pain; Renal failure
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: blood pressure; Result Unstructured Data: Test Result:95/47 mmHg; Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021282922

Write-up: Fainted; Blood pressure 95/47; Suspected infection/pneumonia; Suspected infection/pneumonia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB (Regulatory Authority report number: SE-MPA-2021-007688). A 95-year-old male patient received BNT162B2 (COMIRNATY, Lot number and expiration date were not reported) in Jan2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included pain, dementia, anxiety, depressed mood and renal failure; all unknown if ongoing. Concomitant medications included macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOXALOLE) from 19Nov2020 to an unspecified date; memantine hydrochloride (EBIXA) from Jan2021 to an unspecified date; tranexamic acid (CYKLOKAPRON) from 19Nov2020 to an unspecified date; paracetamol (PARACETAMOL NET) from 19Nov2020 to an unspecified date; risperidone (RISPERIDON ACTAVIS) from 19Nov2020 to an unspecified date; oxazepam (OXASCAND) from 05Nov2020 to an unspecified date; and mirtazapine (MIRTAZAPIN ACTAVIS) from 19Nov2020 to an unspecified date. In Jan2021, 22 days after the vaccination, the patient had fainted while sitting on a chair; and blood pressure was at 95/47 mmHg. The events were reported to be serious (medically significant). The patient''s COVID-19 virus test in Jan2021 came back negative. A few days later, on an unspecified date in 2021, the patient had died, and the cause of death was suspected infection/pneumonia according to the death certificate. No autopsy was performed. The outcome of the events, ''fainted'' and ''blood pressure was at 95/47 mmHg'', was unknown. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Suspected infection/pneumonia; Suspected infection/pneumonia


VAERS ID: 1153028 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, General physical health deterioration, Pyrexia, Respiratory arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (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), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic surgery; Aortic valve stenosis; Atrial fibrillation; Cardiovascular disorder; Chronic obstructive pulmonary disease; Diabetes mellitus; Hypertension; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021311839

Write-up: cardiac arrest; respiratory arrest; Fever; Reduced general condition; This is a spontaneous report from the regulatory authority-WEB, regulatory authority number SE-MPA-2021-012281 and SE-MPA-1614936640058. A contactable physician reported that an 85-year-old female patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Lot Number: EJ6795), via an unspecified route of administration on Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included atrial fibrillation, cardiovascular disorder, aortic surgery chronic obstructive pulmonary disease, diabetes mellitus and hypertension, previous aortic valve stenosis surgery and stroke. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number: EJ6795) on Dec2020 at 0.3 ml, single for COVID-19 immunisation and approximately 2 weeks after the first dose, the woman developed a fever and had a CRP of $g160, treatment with DOXYFERM was initiated due to infection with unclear focus. The woman recovered. In late January, 9 days after the vaccination with dose 2, the woman developed reduced general health and a fever. There was a previous decision to initiate palliative care in case of deterioration. There was no CRP taken, COVID-test was negative (Jan2021). The woman died 15 days after the second dose (Jan2021). No autopsy has been performed. The reporter had never met the patient and on her death certificate he has submitted cardiac arrest and respiratory arrest as causes of death, alongside previous illnesses as contributing factors. However, he clearly states that he cannot know for certain what the cause of death was without an autopsy. He submitted what he thought was most likely. The outcome of the events was reported as fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Fever; Reduced general condition; cardiac arrest; respiratory arrest


VAERS ID: 1153587 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-03-06
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 626761A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Myocardial infarction
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Myocardial infarction (narrow), Haemorrhagic central nervous system vascular conditions (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: Autoimmune hepatitis; Cachexia; Calcinosis; Cirrhosis of liver; CREST syndrome; Enteroparesis; Gastroparesis; Hydrops fetalis; Large intestine angiodysplasia; Malnutrition; Peripheral artery occlusion; Portal hypertension; Sigmoid diverticulosis; Sjoegren''s syndrome
Preexisting Conditions: Medical History/Concurrent Conditions: Finger amputation; Gastrooesophageal varices ; Oesophageal variceal ligation; Pleural cavity drainage; Procedural pneumothorax; Upper gastrointestinal bleeding; Upper gastrointestinal bleeding; Comments:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20210

Write-up: A regulatory authority report was received from a physician concerning, a 60-year-old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced myocardial infarction and cerebral hemorrhage. The patient''s medical history included finger amputation, large intestine angiodysplasia, cachexia, autoimmune hepatitis, portal hypertension, peripheral artery occlusion, upper gastrointestinal bleeding, esophageal variceal ligation, cirrhosis of liver, enteroparesis, pleural cavity drainage, sigmoid diverticulosis, procedural pneumothorax, gastroesophageal varices, malnutrition, CREST syndrome, gastroparesis, sjogren''s syndrome, hydrops fetalis, calcinosis and drug intolerance to ilomedin and rivotril . No concomitant medications were reported. On 12 Feb 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 626761A) for prophylaxis of COVID-19 infection. On 6 Mar 2021, the patient experienced myocardial infarction and cerebral hemorrhage and subsequently died. No treatment information were provided. Cause of death was unknown. Plans for an autopsy were unknown. Action taken with mRNA-1273 in response to the events was not applicable.; Reporter''s Comments: Very limited information regarding circumstances leading to fatal myocardial infarction and fatal cerebral hemorrhage has been provided at this time.


VAERS ID: 1153614 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Bronchiolitis, Decreased appetite, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Rarely was conscious; Could not eat and drink; Bronchiolitis; A regulatory authority report was received concerning a 100-year-old, female patient who experienced bronchiolitis, could not eat and drink/decreased appetite and rarely was conscious/ depressed level of consciousness. The patient''s medical history included COVID-19 in Oct 2021. Concomitant product use was not provided by the reporter. On 15 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route for prophylaxis of COVID-19 infection. On 17 Feb 2021, the patient experienced reduced level of consciousness with difficulty in eating and drinking by mouth. On an unknown date,the patient was hospitalized. On 27 Feb 2021, the patient died with a diagnosis of bronchiolitis, with no accompanying fever. Treatment for the event included oxygen, buscopan as needed and morphine for pain and discomfort as well as temesta for sedation. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, could not eat and drink/decreased appetite and rarely was conscious/ depressed level of consciousness was unknown. The Patient died on 27 Feb 2021. Cause of death was reported as bronchiolitis. Plans for autopsy was not reported.; Reporter''s Comments: This case concerns a 100-year-old, female patient who experienced fatal event of bronchiolitis, decreased appetite and depressed level of consciousness. Very limited information regarding this event has been provided at this time. The patient''s advanced age and previous COVID-19 infection remains a risk factor. Cause of death was reported as bronchiolitis. Plans for autopsy was not reported.; Reported Cause(s) of Death: Bronchiolitis


VAERS ID: 1153633 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Lymphocytic infiltration, Pulmonary artery thrombosis, Pulmonary vasculitis
SMQs:, Interstitial lung disease (narrow), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (narrow), Vasculitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021328303

Write-up: ; This is as spontaneous report received from a non-contactable physician downloaded from there regulatory authority. The regulatory authority report number is DE-PEI-PEI2021003643. A 75-years-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 19Feb2021 first/ second or other dose (Batch/Lot Number: EL8723) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 20Feb2021 after vaccination the patient developed Thrombosis pulmonary artery and Lymphocytic infiltration and Pulmonary vasculitis, lasting for unknown. The patient was dead. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events was fatal. No follow-up attempts possible. No further information expected. Information on lot/batch number already obtained.; Reporter''s Comments: Autopsy follows; Reported Cause(s) of Death: Fulminant thrombosis of the pulmonary arteries bds; Lymphocytic infiltration of the right ventricular myocardium; Microvascular inflammatory reaction of the pulmonary end-stream pathway


VAERS ID: 1153647 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal heart rate abnormal, Maternal exposure during pregnancy
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021348584

Write-up: lack of fetal heartbeat; Maternal exposure during pregnancy, first trimester; This is a spontaneous report from a contactable other healthcare professional reporting mother and fetus cases. This is second of two reports. The first report was downloaded from regulatory authority, The regulatory authority report number ES-AEMPS-784906. A 38-year-old female (mother) received BNT162B2 (COMIRNATY, Solution for injection, lot number: EJ6796), via an unspecified route of administration, 08Jan2021 at a single dose for COVID-19 immunization. Date of LMP (last menstrual period) was 16Dec2021. Gestation Period at Exposure was at 3 weeks. Concomitant medications was not reported. The patient with fertility problems was vaccinated with BNT162B2 on 08Jan2021 without knowing she was pregnant. The fetus patient experienced Maternal exposure during pregnancy first trimester on 08Jan2021 and lack of fetal heartbeat (foetal heart rate abnormal) (death) on an unspecified date. Outcome is fatal as the mother suffered an induced abortion due to lack of fetal heartbeat on 24Feb2021, at 10 weeks of gestation. No follow-up attempts are possible, no information is expected.; Sender''s Comments: Linked Report(s) : ES-PFIZER INC-2021283153 mother and fetus cases; Reported Cause(s) of Death: Fetal heartbeat absent


VAERS ID: 1153649 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Hypopnoea, Increased upper airway secretion
SMQs:, Acute central respiratory depression (narrow), Respiratory failure (narrow)

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: PRIMASPAN; AVODART; PANADOL FORTE [PARACETAMOL]; MEMANTIN ORION; GALVUS; TAMSULOSINE HCL SANDOZ; ANORO ELLIPTA; GABAPENTIN RATIOPHARM; DONEPEZIL ORION; SPESICOR DOS; CARDACE [RAMIPRIL]; KALCIPOS-D; MULTIVITAMINS [VITAMINS NOS]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC2021328220

Write-up: Death; Shallow breathing; Increased upper airway secretion; This is a spontaneous report from a contactable consumer via Regulatory Authority, downloaded from the regulatory authority A male patient of an unspecified age received BNT162B2 (COMIRNATY) via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications included acetylsalicylic acid (PRIMASPAN) at 100 mg daily, dutasteride (AVODART) at 0.5 mg daily, paracetamol (PANADOL FORTE), memantine hydrochloride (MEMANTIN ORION) at 10 mg daily, vildagliptin (GALVUS) at 50 mg daily, tamsulosin hydrochloride (TAMSULOSINE HCL SANDOZ) at 0.4 mg daily, umeclidinium bromide/vilanterol trifenatate (ANORO ELLIPTA) at 1 DF daily, gabapentin (GABAPENTIN RATIOPHARM) at 900 mg daily, donepezil hydrochloride (DONEPEZIL ORION) at 10 mg daily, metoprolol succinate (SPESICOR DOS), ramipril (CARDACE) at 5 mg daily, calcium carbonate/colecalciferol (KALCIPOS-D) at 2 DF daily and multivitamins (MULTIVITAMINS [VITAMINS NOS]), 1x1, all taken for unspecified indications, start and stop dates were not reported. On 26Feb2021, the patient experienced increased upper airway secretion and shallow breathing and he died on 26Feb2021 (cause of death was unknown). On 26Feb2021, the patient became very mucous and his breathing was superficial. On 26Feb2021 he passed away. It was unknown if an autopsy was performed. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1153652 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-31
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ9795 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: Arrhythmia supraventricular; Cognitive disturbance; Hypertension arterial; Ischaemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021311540

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authorian. This is a report received from the Regulatory Authority. An 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscular on 27Jan2021 (lot number: EJ9795) as single dose for COVID-19 vaccination. The patient''s medical history included ischaemic heart disease, arrhythmia supraventricular, cognitive disturbance, and hypertension arterial. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY) on 06Jan2021 for COVID-19 immunisation. The patient died due to cardio-respiratory arrest on 31Jan2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1153657 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke, SARS-CoV-2 test
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cancer of prostate (Hormonal therapy); Ketosis-prone diabetes mellitus (insulin-dependent diabetes)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201022; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021333492

Write-up: Ischemic stroke; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. An 83-year-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: EP9598), intramuscular administered in left arm on 01Mar2021 as SINGLE DOSE for COVID-19 immunisation. Medical history included ongoing ketosis-prone diabetes mellitus (insulin-dependent diabetes), COVID-19 history (positive test date 22Oct2020, form presented not provided) from 22Oct2020, and ongoing cancer of prostate (on hormonal therapy). The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY) on an unspecified date for COVID-19 immunisation. On 01Mar2021, the patient experienced ischemic stroke leading to the death of the patient on the same day. The patient died on 01Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Ischemic stroke


VAERS ID: 1153707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-23
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4243 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Brain injury, Cardiac arrest, Computerised tomogram head, Congestive cardiomyopathy, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 7
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: H hernia
Allergies:
Diagnostic Lab Data: Test Name: Coronary Angiogram; Result Unstructured Data: Test Result:Clear; Test Name: CT Head; Result Unstructured Data: Test Result:Normal; Test Date: 20210227; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021319627

Write-up: Hypoxic Brain Injury; Dilated cardiomyopathy; Cardiac arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Safety Report Unique Identifier GB-MHRA-ADR 25000301. A 67-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4243, expiration date was not reported), via an unspecified route of administration on 13Feb2021 at single dose for covid-19 immunization. Medical history included H hernia. It was reported that patient has no major medical issues other than H hernia. Patient has not had symptoms associated with COVID-19, and was not enrolled in clinical trial. Concomitant medication included lansoprazole for hiatus hernia. The patient experienced cardiac arrest on 23Feb2021 (also reported as 23Mar2021). The clinical course was reported as follows: patient was taken to A&E (accident and emergency) with an out of hospital cardiac arrest on 23Feb2021 (also reported as 23Mar2021) 10 days after vaccination, patient was admitted to ITU (Intensive Therapy Unit). Coronary angiogram was clear, CT head normal. Death reported as due to hypoxic brain injury, cardiac arrest, and dilated cardiomyopathy. Patient had no prior cardiac history. This may of course be unrelated to the vaccine. The patient underwent lab tests and procedures which included COVID-19 virus test: negative (no - negative covid-19 test) on 27Feb2021. The patient died on 02Mar2021. It was not reported if an autopsy was performed. Patient had not tested positive for COVID-19 since having the vaccine. Follow-up attempts are completed. No further information is expected.; Sender''s Comments: In concurrence with the reporting investigator, the Company deems the reported cardiac arrest occurred 10 days after the administration of COVID19 vaccine, BNT162N2, unlikely related to the suspect. Similarly, hypoxic brain injury and dilated cardiomyopathy are unrelated to the suspect.; Reported Cause(s) of Death: Hypoxic Brain Injury; Dilated Cardiomyopathy; Cardiac arrest


VAERS ID: 1153708 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-02-01
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia (advanced)
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210201; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021327159

Write-up: SARS-CoV-2 infection/ Vaccine breakthrough infection; This is a spontaneous report from a contactable healthcare professional. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103231343284950, Safety Report Unique Identifier GB-MHRA-ADR 25005895. An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at a single dose for COVID-19 immunisation. Medical history included ongoing dementia (advanced). Unsure if patient has had symptoms associated with COVID-19. She was not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced SARS-CoV-2 infection and vaccine breakthrough infection on 01Feb2021. The events were assessed as serious by HA (fatal and medically significant). Case narrative: The patient received COVID vaccination 19Jan2021, confirmed COVID positive 01Feb2021. Treated with antibiotics. Chest x-ray unremarkable. Died 13Feb2021. Cause of death 1) advanced dementia and 2) COVID-19. An autopsy was not performed. The patient underwent lab tests and procedures which included COVID-19 virus test: yes - positive COVID-19 test on 01Feb2021. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Dementia; SARS-CoV-2 infection/ Vaccine breakthrough infection


VAERS ID: 1153718 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-03-19
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NORVASC; RAMIPRIL; METFORMIN; JARDIANCE; ZOCOR
Current Illness: Cardiovascular disorder; COVID-19 immunization; Diabetes mellitus; Hyperlipidemia; Hypertension; Smoker
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HKPFIZER INC2021339609

Write-up: FEELING DIZZINESS; FAINT OUT DURING DRIVING; This is a spontaneous report from a non-contactable other healthcare professional and contactable consumer via Regulatory authority- (regulatory authority number: not reported), based on information received by Pfizer from BioNtech SE (manufacturer control number: 2021FOS000452), license party for bnt162b2 (COMIRNATY). This is a spontaneous report received from the department of health. The regulatory authority report number is unknown. A non-contactable HCP reported events for a 66-year-old male patient. Patient started to receive COVID-19 VACCINE (COMIRNATY) injection on 16-Mar-2021 at unspecified dosing frequency for COVID-19 immunization. Medical history included hypertension, diabetes mellitus, hyperlipidemia, cardiovascular disease and smoking history. Concomitant medication(s) included Norvasc(AMLODIPINE BESILATE), Ramipril(RAMIPRIL), Metformin(METFORMIN), Jardiance(EMPAGLIFLOZIN) and Zocor(SIMVASTATIN). Past drug not reported. The patient experienced FEELING DIZZINESS, FAINT OUT DURING DRIVING 19-Mar-2021. Clinical course as follow: patient had no discomfort during vaccination observation. On 19-Mar-2021, patient was feeling dizziness in the morning walking around in the park, then he was faint out in the car during driving, he was admitted to hospital immediately, but passed away eventually. No lab test was provided. Expert Committee on Clinical Event Evaluation of COVID-19 Vaccine claimed that the patient has chronic diseases, "three highs" and other problems, as well as smoking habits, possibly related to cardiovascular diseases. It is preliminarily considered that it has little direct relationship with the vaccine. A government expert consultant and professor of respiratory lecture said that the patient had a number of cardiovascular problems, all of which were high risk factors. It was not excluded that natural death was caused by acute myocardial infarction, and the cause of death may not be directly related to the vaccine. Many countries have received a total of more than 100 million doses of nucleic acid vaccine, and there is no report shows it will increase the risk of cardiovascular disease. The action taken for COVID-19 VACCINE (COMIRNATY) was not applicable. The patient died on 19-Mar-2021. It is unknown if an autopsy was performed. Follow-up (20-Mar-2021, 21-Mar-2021, 22-Mar-2021, 23-Mar-2021 and 25-Mar-2021): New information reported from a non-contactable consumer includes: medical history, new reporter, patient status during vaccination observation. Follow-up closed, no further information is possible. Causality Assessment: The reporter and manufacturer considered the causality of events dizziness and faint out during driving with the vaccine as possible.; Reported Cause(s) of Death: FEELING DIZZINESS; FAINT OUT DURING DRIVING


VAERS ID: 1153725 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4238 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dialysis; Renal insufficiency
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330123

Write-up: collapsed at home; This is a spontaneous report from a contactable other healthcare professional via Agency Regulatory Authority. A 75-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4238), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included ongoing dialysis patient and ongoing renal insufficiency both from an unknown date. It was unknown if the patient was pregnant at the time of vaccination. The patient''s concomitant medications were not reported. It was reported that the patient collapsed at home on an unspecified date. Emergency medical services performed, resuscitation. The outcome of collapsed at home was fatal. The patient died on an unspecified date. Cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 same correspondence reporter, same product, other patient, other events (master case); Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1153726 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Cardiac failure congestive; Cardiac pacemaker insertion; Lipids NOS
Allergies:
Diagnostic Lab Data: Test Name: Coronavirus test; Result Unstructured Data: Test Result:found positive for Corona
CDC Split Type: ILPFIZER INC2021330257

Write-up: Cardiac arrest and breathing; Cardiac arrest and breathing; Was found positive for Corona the day prior death; Was found positive for Corona the day prior death; This is a spontaneous report received from a contactable other HCP. A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route on unknown date for COVID-19 immunization. Medical history included Cardiac failure congestive, Cardiac pacemaker insertion and Lipid disorder. Concomitant medications were not reported. On unknown date the patient experienced Cardiac arrest and breathing and he was found positive for Corona the day prior death. No follow-up attempts are possible, information about batch /lot number cannot be obtained; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 cannot be totally excluded. Cardiac arrest and Breathing difficult are most likely related to an intercurrent or underlying condition which is not related to the suspected drug. The case will be reassessed if additional information becomes available. 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: breathing difficult; Cardiac arrest and breathing


VAERS ID: 1153727 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4175 / 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: Medical History/Concurrent Conditions: Blood pressure high (Medically treated)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330263

Write-up: Was found lifeless in her home; This is a spontaneous report received from a non-contactable other health care professional via regulatory authorities. A 68-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EK4175), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included high blood pressure, medically treated. Concomitant medications were not reported. The patient was found lifeless in her home on an unspecified date. Time range between the vaccination and adverse event was 10 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, "death cause unknown" is processed as "related" until sufficient information becomes available to exclude a reasonable possibility of relatedness to BNT162B2. Case will be reassessed when follow-up information is received. 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: found lifeless in her home


VAERS ID: 1153728 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4175 / 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: ILPFIZER INC2021330274

Write-up: was found dead at home; This is a spontonues report received from Health Care Professional via regulatory authority. A 64 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EK4175), on an unknown date at single dose for COVID-19 immunization. The patient had a lot of background diseases (not reported). Concomitant drugs were unknown. The patient was found dead in his home 60 hours after vaccination. No follow up attempts are possible , no further information is expected.; Sender''s Comments: Based on the information currently available, the underlying diseases might have contributed to patient''s demise. However, unless further information regarding specific cause of death is provided, at present, the reported event death of unknown cause is assessed as possibly related to suspect drug, as a cautionary measure and for reporting purposes. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 Same source,similar event,diffrent paitent; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1153729 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330310

Write-up: was found dead in his car; This is a spontaneous report received from other healthcare professional. A 41-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), second dose via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4242) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) for COVID-19 immunization at unspecified date. It was reported that the patient was found dead in his car (reported as Time range: 3 days). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 master; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1153730 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4240 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Myocarditis, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypercholesterolemia; Hypertension; Hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330432

Write-up: Brought to the emergency room due to myocarditis; cough; difficulty breathing mainly when lying down; fever for three days; This is a spontaneous report from a contactable other healthcare professional via Agency Regulatory Authority. A 47-year-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: EK4240) as SINGLE DOSE for COVID-19 immunisation. Medical history included Hypertension, hypercholesterolemia, hypothyroidism, diabetes with target organ damage. The patient received first dose of vaccine on unspecified date. The patient''s concomitant medications were not reported. The patient was brought to emergency room due to myocarditis, fever for three days, cough and difficulty breathing mainly when lying down. He was anesthetized and resuscitated due to his rapidly deteriorating condition. The patient died due to myocarditis. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Batch/lot number already provided.; Sender''s Comments: Linked Report(s) : IL-PFIZER INC-2020517122 same reporter/vaccine, reporting similar events in different patients; Reported Cause(s) of Death: myocarditis


VAERS ID: 1153731 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial disorder (heart diseases and arteries including heart failure); Diabetes; Disorder lung; Heart disorder (heart diseases and arteries including heart failure); Heart failure; Hypertension; Kidney disorder; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330457

Write-up: was found dead in his home; This is a spontaneous report from a non-contactable other healthcare professional (HCP) via regulatory authority. A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (batch/lot number: EK4242) as a single dose for COVID-19 immunisation. Medical history included hypertension, heart diseases and arteries including heart failure, lung diseases, kidney diseases, diabetes, obesity. The patient''s concomitant medications were not reported. The patient was found dead in his home on an unspecified date. Time range reported as 3 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. Medical history of hypertension, heart diseases and arteries including heart failure, lung diseases, kidney diseases, diabetes, obesity may provide plausible explanations for the event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : IL-PFIZER INC-2020517122 same drug and event, different patient; Reported Cause(s) of Death: was found dead in his home


VAERS ID: 1153732 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anemia; Diabetes; Hepatitis C; Hypertension; Hypoalbuminemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330464

Write-up: Died in the emergency room; Fever raised; Wheezing in lungs; This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4242; Expiration date was not reported) as a single dose, with route of administration and therapy date unspecified for COVID-19 immunization. Medical history included hepatitis C, Alzheimer''s, hypertension, diabetes, hypoalbuminemia and anemia. The patient''s concomitant medications were not reported. On an unspecified date, days after the vaccination, the patient had fever raised and wheezing in the lungs. The events resulted into an emergency room visit, and the patient was treated with antibiotics. On an unspecified date, the patient had died in the emergency room. The outcome of the events, ''fever'' and ''wheezing in the lungs'', was unknown. It was unknown if an autopsy was performed, and the cause of death was not reported. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The information provided is very limited and does not allow for a complete medical assessment. Based on current convention, the case of death is assessed as related to BNT162B2 until sufficient information is available to confirm an unrelated cause of death. The patient had multiple comorbidities that may have contributed to patient''s demise. Additional information is needed to better assess this report. 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 in the emergency room


VAERS ID: 1153733 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aneurysm aortic; Hypertension; Stenosis aortic valve
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021330520

Write-up: death; This is a spontaneous report from a contactable other healthcare professional (hcp) received from Agency Regulatory Authority. Regulatory report number was not reported. A 61-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EK4242, expiry date not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Medical history included aortic valve aneurysm, hypertension, and valve stenosis, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death on an unspecified date. The cause of death was unknown. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1153736 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-30
Onset:2021-01-10
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Dyspnoea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-10
   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: Dementia; Diabetes
Allergies:
Diagnostic Lab Data:
CDC Split Type: ISPFIZER INC2021328271

Write-up: Sudden death 11 days after injection; Shortness of breath; aphasia; This is a spontaneous report from a contactable consumer and physician downloaded from the regulatory authority. The case was received via regulatory authority. An 80-year-old female patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 30Dec2020 (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included diabetes and dementia. The patient''s concomitant medications were not reported. According to the HCPs at the nursing home, she did not experience any adverse events directly after the vaccination or changes to her condition. According to the reporting relative, she experienced aphasia after the vaccination when he spoke to her on the phone. In the morning of 10Jan2021, it was reported that the patient felt breathlessness when she walked to the toilet. She was found dead in her bed about 30 minutes later. The doctor on duty confirmed the death. Went through the medical records and there was no indication of a reaction to the vaccination, both during review of the medical records and in conversations with staff. Sudden death 11 days after injection. The patient died on 10Jan2021. Autopsy was performed on 12Jan2021 and the conclusion was as follows: Acute closure of the right coronary artery is considered to fully explain unexpected cardiac death. The connection between this event and the vaccination 11 days earlier would be judged to be non-existent or unlikely. Sender Comment: This case was received via the e-reporting system from a relative. Follow-up information was received from the treating physician. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: Sudden death; Autopsy-determined Cause(s) of Death: Acute closure of the right coronary artery is considered to fully explain unexpected cardiac death


VAERS ID: 1153762 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin, Blood bilirubin, Blood creatinine, Bradykinesia, C-reactive protein, Computerised tomogram, Decreased appetite, Dyspnoea, Echocardiogram, Fall, Haemoglobin, Haemoglobin decreased, Hypotension, Jaundice, Lumbar puncture, Lung disorder, Lymphadenopathy, Metabolic acidosis, Procalcitonin, Renal impairment, Respiratory failure, Serratia test positive, Stenotrophomonas test positive, Thrombocytopenia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Lactic acidosis (broad), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Parkinson-like events (narrow), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-17
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LASIX [FUROSEMIDE]; ZYLORIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal failure; Diabetes mellitus; Hypertension arterial; Hyperuricemia; MGUS; Prostatic hypertrophy (benign) (declared "prostatic hypertrophy")
Allergies:
Diagnostic Lab Data: Test Name: albuminemia; Test Result: 2.1 [iU]; Comments: 2.1 INTERNATIONAL UNIT(S)-(UNDER 100); Test Name: Bilirubin; Test Result: 10.38 [iU]; Comments: 10,38 INTERNATIONAL UNIT(S)-(UNDER 1000); Test Name: creatininemia; Test Result: 6 [iU]; Comments: 6 INTERNATIONAL UNIT(S)-(UNDER 100); Test Name: Whole body CAT; Result Unstructured Data: Test Result:multiple polydistrict lymphadenopathies; Comments: multiple polydistrict lymphadenopathies, right supleural lung lesion of 2 cm ndd, right renal expansion; Test Name: C-reactive protein; Test Result: 150 [iU]; Comments: 150 INTERNATIONAL UNIT(S)-(UNDER 1000); Test Name: Transesophageal echocardiogram; Result Unstructured Data: Test Result:negative; Test Name: Haemoglobin; Test Result: 8.4 [iU]; Comments: 8.4 INTERNATIONAL UNIT(S)-(UNDER 100); Test Name: Spinal tap; Result Unstructured Data: Test Result:Negative; Test Name: Procalcitonin; Test Result: 4.88 [iU]; Comments: 4.88 INTERNATIONAL UNIT(S)-(UNDER 100); Test Name: Serratia test positive; Result Unstructured Data: Test Result:positive; Test Name: Stenotrophomonas test positive; Result Unstructured Data: Test Result:positive; Test Name: Thrombopenia; Test Result: 19000 k[iU]
CDC Split Type: ITPFIZER INC2021323049

Write-up: stenotrophomonas test positive; serratia test positive; haemoglobin: 8.4 IU; thrombocytopenia: 19000 kiu; multiple polydistrict lymphadenopathies; right supleural lung lesion; ideomotor slowdown; Dyspnea; loss of appetite appears; worsening jaundice; metabolic acidosis; fell to the ground; worsening of renal function; arterial hypotension; severe respiratory insufficiency; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-701777. A 82-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EP9598, Expiry date: Unknown) via intramuscularly on 02Mar2021 as single dose for covid-19 immunisation. Medical history included hypertension, hyperuricaemia, diabetes mellitus, benign prostatic hyperplasia declared (prostatic hypertrophy), chronic kidney disease, hypergammaglobulinaemia benign monoclonal. Concomitant medications included Furosemide (LASIX) and Allopurinol (ZYLORIC) taken for an unspecified indication. On 02Mar2021, the patient experienced ideomotor slowdown, dyspnea, loss of appetite appears, worsening jaundice, metabolic acidosis, fell to the ground, worsening of renal function, arterial hypotension and severe respiratory insufficiency. The patient arrived in the Emergency Room in on 07Mar2021 and was hospitalized in the Emergency Room from which he was transferred to the Hospital on 09Mar due to lack of beds. The patient underwent lab tests and procedures which included blood albumin: 2.1 IU (international units) (under 100) , blood bilirubin: 10.38 IU (under 1000), blood creatinine: 6 IU (under 100), computerised tomogram: multiple polydistrict lymphadenopathies, right supleural lung lesion of 2 cm ndd, right renal expansion, c-reactive protein: 150 IU (under 1000), echocardiogram: negative, haemoglobin: 8.4 IU (under 100), lumbar puncture: negative, procalcitonin: 4.88 IU (under 100), serratia test positive: positive, stenotrophomonas test positive: positive, thrombocytopenia: 19000 kiu. Therapeutic measures were taken with tracheal intubation and mechanical intubation, antibiotic therapy, vasopressors, CVVH (renal replacement therapy). The patient died on 17Mar2021. It was not reported if an autopsy was performed. The outcome of the event was fatal.; Reporter''s Comments: Initial information dated 18Mar2021: - concomitant use of other products: ''no'';; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1153782 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-03-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Body temperature, Brain compression, Brain neoplasm, Cardio-respiratory arrest, Cerebral haemorrhage, Subarachnoid haemorrhage
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Non-haematological tumours of unspecified malignancy (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: AI (Autopsy imaging); Result Unstructured Data: Test Result:cerebral hemorrhage (cerebellum); Test Date: 20210319; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021326145

Write-up: Cerebral haemorrhage; brain stem compression; subarachnoid hemorrhage; cardiopulmonary arrest; Brain tumor; This is a spontaneous report from received from the regulatory authority. The regulatory authority report number is v20101958. A contactable physician reported that a 26-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EP9605; Expiration Date: 30Jun2021), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that On 23Mar2021 (4 days after the vaccination), she did not show up for the night shift, and her family visited her home and found her in cardiopulmonary arrest, around 11.00 Autopsy imaging (AI) showed findings including cerebral hemorrhage (cerebellum), brain stem compression and subarachnoid hemorrhage. Suspicion of brain tumor was also suggested. The patient underwent lab tests and procedures which included body temperature: 36.0 centigrade on 19Mar2021 before vaccination, imaging procedure: cerebral hemorrhage on 23Mar2021, findings included: cerebral hemorrhage, brain stem compression and subarachnoid hemorrhage. Suspicion of brain tumor was also suggested. The patient underwent lab tests and procedures which included body temperature: 36.0 centigrade on 19Mar2021 before vaccination, imaging procedure: cerebral hemorrhage (Cerebellum) on 23Mar2021. Findings included: cerebral hemorrhage, brain stem compression and subarachnoid hemorrhage. Suspicion of brain tumor was also suggested. The outcome of events cardiopulmonary arrest, brain tumor was unknown. The patient died on 23Mar2021. Autopsy was performed. The reporting physician classified the event as serious (Death) and assessed that the causality between the event and BNT162B2 as un-assessable. Other possible causes of the event such as any other diseases were cerebral hemorrhage (cerebellum) and subarachnoid hemorrhage. No further follow-up is possible. No information is required. Health authority comment: The AI showed the above findings and they were determined to be the direct causes of death. The causal relationship between the vaccination and the death could not be evaluated.; Reported Cause(s) of Death: brain stem compression; subarachnoid hemorrhage; Cerebral haemorrhage


VAERS ID: 1153788 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MTPFIZER INC2021338126

Write-up: covid-19; covid-19; This is a spontaneous report from a contactable physician through a sales representative. This is the 1st report out of 6 from the same reporter reporting similar events for 6 different patients. An over 80 years old elderly patient of an unspecified gender received first and second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiration date were not reported) as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had died from COVID-19 (despite being fully vaccinated) within 14 days of taking the second dose. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Drug causality cannot be excluded for suspect medication BNT162B2 in onset of the reported events. It was noted that patient had died from COVID-19 (despite being fully vaccinated) within 14 days of taking the second dose. Case will be reassessed upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.; Reported Cause(s) of Death: Drug ineffective; COVID-19


VAERS ID: 1153790 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Myocardial infarction, Seizure, Vaccination site pain
SMQs:, Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-21
   Days after onset: 17
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: Angioplasty; Heart attack
Allergies:
Diagnostic Lab Data:
CDC Split Type: MYPFIZER INC2021315230

Write-up: cause of death was due to a heart attack/complained of chest pain and had difficulty breathing/ became unconscious.; seizure; feeling ache of hand at the vaccination site; dizziness; This is a spontaneous report from press release by regulatory authority from a non-contactable healthcare professional which identified by a sales representative. A 42-year-old male patient received first dose of bnt162b2 (COMIRNATY) on 02Mar2021 morning at single dose for COVID-19 immunisation. Medical history included heart attack from unspecified date and undergone an angioplasty procedure in 2013. Concomitant medications were not reported. The patient showed no contraindications and did not have any side effects when he was observed at the Vaccine Centre. A day after vaccination (on 03Mar2021), he had only complained of feeling ache of hand at the vaccination site and symptoms of dizziness but was able to continue working as usual. On the second day of vaccination, there were no problems and he had carried on with his daily duties as usual until 19Mar2021. Early morning on 21Mar2021, the patient''s wife who is a specialist doctor said he had complained of chest pain and had difficulty breathing, then suffered a seizure and became unconscious. The patient''s wife made an emergency call and performed cardiopulmonary resuscitation (CPR) at home. He was rushed to a hospital''s emergency and trauma department where an active resuscitation was done but failed to be rescued. Based on the symptoms, clinical signs and case presentation, the emergency specialist confirmed that the cause of death was due to a heart attack and there was no link to the Covid-19 vaccination. Outcome of other events was unknown. The patient died on 21Mar2021. It was unknown if autopsy was performed. No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The events heart attack and seizure were considered as intercurrent conditions and unrelated to the use of bnt162b2. Seizure could be secondary to heart attack. 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: cause of death was due to a heart attack/complained of chest pain and had difficulty breathing/ became unconscious.


VAERS ID: 1153800 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-02
Onset:2021-03-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000042722 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test positive, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: COVID-19
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210104; Test Name: corona, bevestigd met test; Test Result: Positive ; Result Unstructured Data: Positive
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Sudden death; A Agency Regulatory Authority report was received by a healthcare professional, concerning a female patient of 81 years of age, who received Moderna''s COVID-19 vaccine on 02 Mar 2021 and later suddenly died on 04 Mar 2021. The patient''s medical history included Covid-19. Concomitant product use was not provided by the reporter. On 02 Mar 2021, prior to the onset of events, the patient received a dose of mRNA-1273 (lot number - 3000042722) via an unknown route for COVID-19 infection prophylaxis. On 04 Mar 2021, after dose of vaccine, the patient suddenly died. Treatment medication was not reported by the reporter . Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event, Sudden death was considered to be fatal at the time of this report.; Reporter''s Comments: This is a case of sudden death in a 81-year-old female subject with unknown medical history except recent history of Covid infection, who died 2 days after receiving Moderna''s COVID-19 vaccine. Very limited information has been provided at this time. Further information has been requested. No follow up is possible.; Reported Cause(s) of Death: morbus subitum


VAERS ID: 1153802 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042722 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Herpes zoster, Malaise, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No reported medical history)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Drowsiness/waardoor suf worden en uiteindelijk overlijden; Decreased appetite/verminderde intake; Malaise/algehele malaise zonder koorts; Herpes zoster; A regulatory report was received from a physician concerning a 101-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced drowsiness/waardoor suf worden en uiteindelijk overlijden, decreased appetite/verminderde intake, malaise/algehele malaise zonder koorts and herpes zoster. The patient''s medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. On 1 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 300042722) intramuscularly for prophylaxis of COVID-19 infection. On 1 Mar 2021, the patient experienced drowsiness, decreased appetite, malaise and herpes zoster. As per the report, drowsiness, decreased appetite, malaise and herpes zoster resulted in patient death. The patient died on 10 Mar 2021. Autopsy information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome for the events, drowsiness, decreased appetite, malaise and herpes zoster, were considered fatal.; Reporter''s Comments: This fatal case concerns a 101 Y/O F with serious unexpected events of somnolence, malaise, decreased appetite, and herpes zoster. Event onset 4 days after first dose mRNA-1273. Event outcome death. Autopsy information not provided. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Reported Cause(s) of Death: algehele malaise zonder koorts; waardoor suf worden; verminderde intake; herpes zoster


VAERS ID: 1157293 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-02-22
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   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: Condrosulf; COVERAM; INVOKANA [CANAGLIFLOZIN]; JANUMET; PLAVIX
Current Illness: Arterial hypertension; Lumbo-sacral pain; Obesity; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial stent insertion (mesenteric artery and celiac trunk); Mesenteric ischemia; Percutaneous coronary intervention (mesenteric artery and celiac trunk)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death; A regulatory report, was received from a physician concerning a 76-year-old male patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced death. The patient''s medical history included type 2 diabetes mellitus, arterial hypertension, obesity, mesenteric ischemia, lumbovertebral syndrome, and PTCA and stenting of the mesenteric artery and celiac trunk. Concomitant medications included chondroitin sulfate sodium, amlodipine besilate/perindopril arginine, canagliflozin, metformin hydrochloride/sitagliptin phosphate, and clopidogrel bisulfate. On 23 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch: 300042460) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 20 FEB 2021, the patient received their second of two planned doses of mRNA-1273 (Batch: 300042723) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 22 FEB 2021, the patient died. Cause of death was unknown. Plans for an autopsy was not provided. The action taken with mRNA-1273 in response to the event was not applicable. The reporter considered the death unlikely related to mRNA-1273.; Reporter''s Comments: This case concerns a 76-year-old, male, with multiple comorbidities, who experienced a serious (fatal) unexpected event of death (unknown cause). Death occurred 2 days after receiving 2nd dose of mRNA-1273 (Lot# 300042723). Based on the current available information, the event was considered unrelated to the study medication in agreement with the reporter''s assessment. The advance age and multiple co-morbidities may remain as risk factors. No further information has been requested.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1157379 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Fatigue, Malaise, Nausea, Pneumonia, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atrial fibrillation; Dementia
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: A regulatory authority report was received from a physician concerning a 90- year old-female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced pneumonia, malaise, dyspnea,f atigue, vomiting, nausea, fever and died. The patient''s medical history included Covid-19, dementia and atrial fibrillation. No relevant concomitant medications were reported. On 23-Feb-2021, prior to the onset of the events, the patient received their first of two doses of mRNA-1273 (lot/batch unknown) intramuscularly for prophylaxis of COVID-19 infection. On 24-Feb-2021, the patient experienced fatigue. On 26 Feb 2021,t he patient experienced pneumonia, malaise, dyspnea, vomiting, nausea and fever. Treatment information was not provided. The date and the cause of the death was not provided. Autopsy details were not provided. Action taken with mRNA-1273 in response to the events was not applicable. On an unknown date,t he outcome of the events, pneumonia, malaise, dyspnea, fatigue, vomiting, nausea and fever were considered fatal.; Reporter''s Comments: A case of death of a 90- year old-female (date and cause unknown). Patient experienced fatigued 1-day post mRNA-1273, pneumonia, malaise, dyspnea, vomiting, nausea and fever 2-day post mRNA-1273. With pneumonia being of an infective origin and the patient''s advanced age. The other events are assessed as symptoms of pneumonia, Hence, the reported events with fatal outcome is assessed as unlikely related to mRNA-1273; Reported Cause(s) of Death: unknown


VAERS ID: 1157383 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-03-04
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-04-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Plasma cell myeloma
SMQs:, Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Multiple myeloma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Multiple myeloma progression; death; A regulatory authority report was received from a physician concerning a female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and died. The patient''s medical history included multiple myeloma. Concomitant product use was not provided by the reporter. On 26-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 23-FEB-2021 the patient received the second dose of two planned doses of mRNA-1273 (Batch number: unknown) for prophylaxis of COVID-19 infection. On 04 March 2021, the patient died. No other details were reported. Treatment information was unknown. Action taken with the drug in response to the event was unknown. The patient died on 04 March 2021. The cause of death was multiple myeloma progression. Plans for an autopsy were unknown.; Reporter''s Comments: This is a case of death in a female subject of unknown age with a medical history of multiple myeloma, who died 9 days after receiving second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death:


VAERS ID: 1158404 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-29
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042460 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood pressure measurement, Death, Heart rate
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history reported.)
Allergies:
Diagnostic Lab Data: Test Date: 20210127; Test Name: Blood pressure; Result Unstructured Data: normal; Test Date: 20210127; Test Name: pulse; Result Unstructured Data: normal
CDC Split Type: CHMODERNATX, INC.MOD20210

Write-up: Death NOS; A regulatory authority report was received from a health care professional concerning a 75-year-old male patient who after the administration of Moderna''s COVID-19 vaccine (mRNA-1273) died (Death). The patient''s medical history was not provided. Concomitant product use was not provided. On 27 Jan 2021, the patient received first dose of two planned doses of mRNA-1273 (Batch number: 300042460) intramuscularly for prophylaxis of COVID-19 infection. On 27 Jan 2021, approximately 15 minutes after receiving the vaccination, the patient''s pulse (73/ min) and pressure (117/80 mmHg) were taken. Results were normal. On 29 Jan 2021, the patient was found dead by his relatives in his apartment. The patient died on 29 Jan 2021. The cause of death was not reported. Plans for autopsy was not provided. Action taken with the mRNA-1273 was not applicable.; Reporter''s Comments: Very limited information regarding this elderly patient''s death has been provided at this time.; Reported Cause(s) of Death: unknown cause of death


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