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

Found 15,386 cases where Vaccine targets COVID-19 (COVID19) and Patient Died



Case Details

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VAERS ID: 1114040 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Malaise
SMQs:, Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure (according to the clinic, prior to vaccination); Dyspnoea; Hypertension arterial; Tiredness
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272343

Write-up: Feeling sick; uneasy; This is a spontaneous report from a contactable consumer or other non HCP downloaded from the Agency Regulatory Authority FR-AFSSAPS-GR20210526 (Regulatory Authority reference). A 94-year-old female patient received 1st dose BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) intramuscularly on 27Jan2021 at 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension arterial, cardiac degradation, more out of breath from 15Jan2021 and more tired than usual from 15Jan2021. Differential diagnosis was reported as cardiac degradation, according to the clinic, prior to vaccination. There was no more precise cardiac assessment. Concomitant medications were not reported. From 15Jan2021, the patient was more out of breath and more tired than usual. On 17Feb2021, the patient became uneasy at her home. The patient experienced feeling sick on 17Feb2021 with seriousness criteria of death. There was intervention of the firefighters and the Emergencies (emergency room visit) but the patient could not be resuscitated. No hospitalization. The patient died on 17Feb2021. An autopsy was not performed. Outcome of event uneasy was unknown. Dose 2 was not completed (scheduled for 25Feb2021). No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Feeling sick


VAERS ID: 1114041 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-30
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Alzheimer''s disease; Aspiration; Behavioural disorder; Breast cancer female; Cataract; Choked on food; Deglutition disorder; Dementia; Difficulty in walking; Fracture of neck of femur; Hypertension arterial; Insomnia; Malnutrition; Starvation; Swallowing disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272425

Write-up: Death unexplained; This is a spontaneous report. Regulatory Authority FR-AFSSAPS-GR20210565. A contactable physician reported that a 93-year-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection and lot number EM0477) via Intramuscularly in left arm on 14Jan2021 at 30ug single for COVID-19 immunization. Medical history included dementia with behavioral problems, difficulty in walking, atrial fibrillation, hypertension arterial, cataract, starvation, fracture of neck of femur, Alzheimer''s disease, choked on food, deglutition disorder, insomnia, breast cancer, swallowing disorders with recurrent aspirations, malnutrition. Concomitant medications were not reported. The patient died/death unexplained on 30Jan2021. Long-standing treatment were unknown. There was no information available regarding possible symptoms between 14Jan2021 and 30Jan2021, or any biological work-up. Differential diagnosis included age and comorbidities. Outcome of event was fatal. It was unknown if autopsy was performed or not. No follow-up attempts are possible. No further information was provided.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1114042 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Oxygen saturation, Oxygen saturation decreased
SMQs:, Cardiac failure (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Cardiac failure; Choked on food; Deglutition disorder; Disease Parkinson''s; Prostatic adenoma; Starvation
Allergies:
Diagnostic Lab Data: Test Date: 20210116; Test Name: oxygen saturation; Result Unstructured Data: Test Result:arterial oxygen saturation decreased; Comments: sudden oxygen desaturation
CDC Split Type: FRPFIZER INC2021272309

Write-up: Arterial oxygen saturation decreased/ sudden oxygen desaturation; heart failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-GR20210566. An 87-year-old male patient received the first dose of BNT162B2 (COMIRNATY) (Lot Number: EM0477) via intramuscular in arm left on 14Jan2021 at 30 ug, single for COVID-19 immunisation. Medical history included Prostatic adenoma from an unknown date and unknown if ongoing, disease Parkinson''s from an unknown date and unknown if ongoing, Atrial fibrillation from an unknown date and unknown if ongoing, starvation from an unknown date and unknown if ongoing, Deglutition disorder from an unknown date and unknown if ongoing, cardiac failure from an unknown date and unknown if ongoing, Choked on food from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced arterial oxygen saturation decreased and heart failure both on 16Jan2021. The outcome of the events was fatal. Course of the events: On 14Jan2021, the patient received the first vaccination with BNT162B2. On 16Jan2021, the patient experienced sudden oxygen desaturation and rapidly died. Differential diagnosis was heart failure. Oxygen saturation on 16Jan2021 showed arterial oxygen saturation decreased/ sudden oxygen desaturation. The patient died on 16Jan2021. It was unknown if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: heart failure; Arterial oxygen saturation decreased/ sudden oxygen desaturation


VAERS ID: 1114043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-23
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: ARANESP; FUROSEMIDE; DIFFU-K; ELIQUIS; GANFORT; ZYMAD; DOLIPRANE; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; EDUCTYL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Anaemia; Arrhythmia; COVID-19 (in autumn 2020); Deafness bilateral; Heart failure; Low back pain; Macular degeneration; Osteoporosis with fracture; Starvation; Thompson hip prosthesis (Left hip)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272423

Write-up: Decompensation cardiac; This is a spontaneous report received via the Agency and downloaded from the Agency Regulatory Authority-WEB [FR-AFSSAPS- GR20210567]. A contactable physician reported that a 95-year-old female patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: EM0477), intramuscular on arm left on 14Jan2021 at 30 ug, single for COVID-19 immunisation. Medical history included starvation, deafness bilateral, thompson hip prosthesis from Aug2020 (Left hip), anaemia, macular degeneration, osteoporosis with fracture, alzheimer''s disease, COVID-19 from 2020 (in autumn 2020), disabling low back pain, heart failure and rhythm disturbances. Concomitant medication included darbepoetin alfa (ARANESP), furosemide, potassium chloride (DIFFU-K), apixaban (ELIQUIS), bimatoprost, timolol maleate (GANFORT), colecalciferol (ZYMAD), paracetamol (DOLIPRANE), macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) and potassium bitartrate/ sodium bicarbonate (EDUCTYL). No recent biological work-up (the last in Nov2020), no other information. The patient experienced decompensation cardiac on 23Jan2021. The patient died on 23Jan2021 from cardiac decompensation. It was not reported if an autopsy was performed. The outcome of the event was reported as fatal. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1114044 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (NOS); CVA; Dementia; Depressive state; Disease coronary artery; Disorder behavior; Eschar; Hypertension arterial; Osteoporosis; Phlebitis NOS; Ulcer NOS; Vertebral injury
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272311

Write-up: Death unexplained; This is a spontaneous report from a contactable physician from the regulatory authority, downloaded from the regulatory authority-WEB FR-AFSSAPS-GR20210568. A 70-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EJ6796), via intramuscular, on the left arm, on 03Feb2021 (unknown age at time of vaccination) as 30 ug, single for covid-19 immunization. Medical history included osteoporosis, dementia, disorder behavior , arrhythmia (NOS), depressive state, hypertension arterial, disease coronary artery, CVA, phlebitis NOS, ulcers NOS, eschars, and disc pathology, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient experienced death unexplained on 10Feb2021. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1114045 (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: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Loss of consciousness, Tachycardia
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), Dehydration (broad)

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: Medical History/Concurrent Conditions: Arterial hypertension; Cardiac failure (~~~); Heart disease, unspecified; Pacemaker insertion (cardiac); Pulmonary embolism; Stroke
Allergies:
Diagnostic Lab Data: Test Name: Heart rate; Result Unstructured Data: Test Result:130; Comments: Tachycardia at 130 / min
CDC Split Type: FRPFIZER INC2021272327

Write-up: Loss of consciousness; Tachycardia; This is a spontaneous report downloaded from the Regulatory Authority FR-AFSSAPS-LL20210995 (Regulatory Authority reference). A contactable physician reported that a 97-years-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot. EP9598) intramuscularly, in the left arm, at single dose, on 24Feb2021, for COVID-19 immunisation. Relevant medical history included cardiac failure, cardiac pacemaker insertion, arterial hypertension, hypertrophic cardiopathy, stroke in 2011, pulmonary embolism in 1996. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 25Feb2021, the patient experienced tachycardia and loss of consciousness. On 25Feb2021, the patient was found unconscious at around 12:15, stertoral breathing, no response to stimulation, tachycardia at 130 / min, impregnable arterial tension, emergency ambulance service at around 12:30: declaration of death. It was not reported if an autopsy was performed. The patient has not been tested for COVID-19. Clinical outcome of tachycardia and loss of consciousness was reported as fatal. No Follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: tachycardia; Loss of consciousness


VAERS ID: 1114047 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-24
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic calcification; Carotid artery stenosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272381

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-LY20211241. An 87-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot Number: ER0641), intramuscular at right arm on 19Feb2021 (at unknown age) at single dose for COVID-19 immunisation. Medical history included calcified aortic stenosis, Carotid artery stenosis, both were from an unknown date and unknown if ongoing. No previous history of SARS-CoV-2 infection. The patient''s concomitant medications were not reported. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number not provided) for COVID-19 immunisation. No long-standing treatment was reported. On 24Feb2021, the patient developed cardiac arrest requiring emergency intervention. The patient died on 24Feb2021 as a result of the disease (Not otherwise specified). The patient had Emergency room visit. Seriousness criteria of the case was reported as adverse event leading to death. It was unknown if an autopsy was performed. No FU attempts possible. No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1114050 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, Physical examination, SARS-CoV-2 test
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-19
   Days after onset: 20
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia macrocytic; COVID-19; Dementia; Starvation
Allergies:
Diagnostic Lab Data: Test Name: N-terminal prohormone brain natriuretic peptide; Result Unstructured Data: Test Result:increase; Test Date: 20210130; Test Name: oxygen saturation; Result Unstructured Data: Test Result:desaturation; Test Name: crackles heard; Result Unstructured Data: Test Result:increased crackles heard over lower lung fields; Test Date: 20210130; Test Name: tested for COVID-19 on 30Jan2021; Result Unstructured Data: Test Result:COVID-19 aggravation
CDC Split Type: FRPFIZER INC2021272389

Write-up: COVID-19 aggravated; This is a spontaneous report from a contactable physician via Agency downloaded from the Regulatory Authority FR-AFSSAPS-MP20210366 A 97-years-old male patient received the first dose of bnt162b2 (COMIRNATY Batch/Lot Number: EJ6788), intramuscular, administered in Arm Right on 21Jan2021 as single dose for covid-19 immunisation. Medical history included starvation, dementia and anaemia macrocytic all unknown if ongoing. The patient had medical history of COVID-19 and was considered at risk of developing a severe form of COVID-19. The patient''s concomitant medications were not reported. The patient experienced covid-19 aggravated on 30Jan2021 with fatal outcome. The patient died on 19Feb2021. An autopsy was not performed. The clinical course of the events was reported as follows. On 30Jan2021, the patient presented dyspnea, fever and oxygen desaturation which required oxygen therapy was tested for COVID-19 on 30Jan2021 and was diagnosed with COVID-19 aggravation. The patient then presented worsening of confusion and agitation, increased crackles heard over lower lung fields and increase of N-terminal prohormone brain natriuretic peptide, asthenia and anorexia. Outcome: On 19Feb2021, 29 days after vaccination, the patient died due to COVID-19 aggravation. Complete file, no further information available.; Reported Cause(s) of Death: COVID-19 aggravated


VAERS ID: 1114053 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-31
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: Arterial hypertension; Haemorrhagic stroke; Hematoma cerebral; Locked-in syndrome; Percutaneous endoscopic gastrostomy; Tracheostomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272407

Write-up: Sudden death; This is a spontaneous report downloaded from the Regulatory Authority [FR-AFSSAPS- PA20210337] and received via the Agency. A contactable physician reported that a 62-year-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6795) via intramuscular in left arm on 13Jan2021 at 0.3 mL as a single dose for COVID-19 immunisation. The patient''s medical history included haemorrhagic stroke from an unknown date in Jul2019, spontaneous ventilation on tracheostomy, food exclusively on percutaneous endoscopic gastrostomy, hematoma of the posterior fossa with compression of the cerebral trunk on untreated arterial hypertension and severe neuro sequelae with equivalent of a partial locked-in syndrome. The patient had no history of COVID19 infection. Concomitant medications were not reported. On 31Jan2021, around 1:40 a.m. the patient had sudden death without any sign of previous deterioration detected by the medical team where she had been hospitalized for a year. The outcome of the event was fatal. The patient died on 31Jan2021. Cause of death was not reported. It was not reported if an autopsy was performed or not. No follow-up attempts are possible. No further information was expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1114057 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acute on chronic renal failure; Cold type hemolytic anemia; Deep vein thrombosis (bilateral); Diabetes mellitus insulin-dependent; Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: Covid-19 test; Test Result: Negative ; Test Date: 20210212; Test Name: Covid-19 PCR test; Result Unstructured Data: Test Result:highly positive; Comments: PCR
CDC Split Type: FRPFIZER INC2021272321

Write-up: COVID-19 respiratory infection; This is a spontaneous report from a contactable pharmacist downloaded from the Agency Regulatory Authority-WEB. This is a report received from the Agency, Regulatory authority report number FR-AFSSAPS-RE20210613. An 81-year-old male patient received his first dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 05Feb2021 (Lot Number: EJ6788) as single dose for covid-19 immunisation. Medical history included acute on chronic renal failure from Nov2020 to an unknown date, Diabetes mellitus insulin-dependent from an unknown date and unknown if ongoing, Cold type auto-immune hemolytic anemia from an unknown date and unknown if ongoing, obesity from an unknown date and unknown if ongoing, bilateral deep vein thrombosis from Jan2021 to an unknown date. Long-standing treatment included anticoagulant (unspecified). The patient experienced covid-19 respiratory infection with fatal outcome on 12Feb2021. Course of the event: On 21Jan2021, a test was performed and turned out to be negative. On 05Feb2021, the patient received a first injection of bnt162b2. On 12Feb2021, it was reported "Highly positive PCR". The patient experienced an Apathetic confusional state, "respiratory distress could not be corrected". This was due to SARS-CoV-2 infection progression in context of multiple underlying pathologies, it was not an adverse event but a lack of efficacy a week after the injection of the vaccine. The patient was considered at risk of developing a severe form of the disease "because of his medical history". The patient died on 12Feb2021. It was not reported if an autopsy was performed. No FU attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 respiratory infection


VAERS ID: 1114058 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-17
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Cardiac failure, Dyspnoea, Pulmonary embolism, Respiratory distress, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), 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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (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: 2021-02-22
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Ischaemic cardiomyopathy (under pacemaker); Mild neurocognitive disorder (moderate neurocognitive disorder)
Preexisting Conditions: Medical History/Concurrent Conditions: Dysrhythmias; Ischemic heart disease (under pacemaker)
Allergies:
Diagnostic Lab Data: Test Date: 20210218; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021272412

Write-up: Acute respiratory decompensation; Dyspnea; Cardiac decompensation with suspected pulmonary embolism; Cardiac decompensation with suspected pulmonary embolism; Respiratory distress; This is a spontaneous report downloaded from the Agency Regulatory Agency-WEB [FR-AFSSAPS- RN20210588] and received via the Agency . A contactable physician reported that an 89-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6789), intramuscularly in right arm on 05Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history included ongoing mild neurocognitive disorder/ moderate neurocognitive disorder, ongoing heart failure, ongoing ischaemic cardiomyopathy under pacemaker, ischemic heart disease under pacemaker, dysrhythmic. The patient had no history of COVID-19. Concomitant medications were not reported. The patient experienced acute respiratory decompensation, dyspnea, cardiac decompensation with suspected pulmonary embolism, respiratory distress on 17Feb2021. On 18Feb2021, a COVID-19 test was performed, and it was negative. The patient condition required urgent medical intervention. The events acute respiratory decompensation, dyspnea, cardiac decompensation were considered as serious (death) by the physician. The outcome of the events pulmonary embolism, respiratory distress was unknown and fatal for the other events. The patient died on 22Feb2021. It was not reported if an autopsy was performed or not. Comment: Case from a report via the portal (# 20210222150517211), medically confirmed. No follow-up attempts needed. No further information expected.; Reported Cause(s) of Death: Acute respiratory decompensation; Dyspnea; Cardiac decompensation with suspected pulmonary embolism


VAERS ID: 1114063 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Death, Dyspepsia, Feeling hot, Heart rate, Malaise, Oxygen saturation, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-20
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XATRAL; PANTOPRAZOLE; FORLAX; LERCAN; LUMIGAN; CARTEOLOL HYDROCHLORIDE; DOLIPRANE; APIXABAN; LEVETIRACETAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cerebrovascular accident; Epilepsy; Glaucoma; Hypertension arterial; Mixed dementia; Senile macular degeneration; Surdity
Allergies:
Diagnostic Lab Data: Test Date: 20210220; Test Name: blood pressure; Result Unstructured Data: Test Result:13/7; Comments: normal; Test Date: 20210220; Test Name: Body temperature; Result Unstructured Data: Test Result:37; Comments: normal; Test Date: 20210220; Test Name: beats per minute; Result Unstructured Data: Test Result:108; Comments: normal; Test Date: 20210220; Test Name: oxygen saturation; Test Result: 93 %; Comments: normal
CDC Split Type: FRPFIZER INC2021272356

Write-up: vomiting (low volume); feeling unwell; Found dead (cause undetermined); gastric burning; hot sensation without fever; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-TO20211123. A 91-year-old male patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly, administered in Arm Left at single dose on 19Feb2021 (at age of 91-year-old) (Lot Number: EJ6788) for COVID-19 immunization. Medical history included cerebrovascular accident, surdity, epilepsy, mixed dementia, atrial fibrillation, Hypertension arterial, glaucoma, senile macular degeneration. Concomitant medications included alfuzosin hydrochloride (XATRAL LP, 10 mg prolong release tablet), pantoprazole, macrogol 4000 (FORLAX 10 g, powder for oral solution in sachet-dose), lercanidipine hydrochloride (LERCAN 20 mg film-coated tablet), bimatoprost (LUMIGAN); carteolol hydrochloride,paracetamol (DOLIPRANE), apixaban, and levetiracetam. On 19Feb2021, after vaccination, the patient developed a gastric burning and hot sensation without fever. On 20Feb2021 at 3.30 A.M., the patient experienced vomiting (low volume). Vital signs were normal (blood pressure 13/7, oxygen saturation 93%, beats per minute 108 and temperature 37 (units not provided)). On 20Feb2021, upon waking-up, the patient was feeling unwell, had breakfast in common room and then returned to bed. On 20Feb2021 at 10 A.M., the patient was found dead in his bed (unknown cause). The outcome of events ''gastric burning'' , ''hot sensation without fever'' and vomiting was not resolved, of the event ''feeling unwell'' was unknown. The patient died on 20Feb2021. An autopsy was not performed. No follow-up attempts are possible.No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114064 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Blood pressure measurement, Cerebrovascular accident, Hyperhidrosis, Hypertension, Malaise, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypertension (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension arterial (without drug treatment); Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Cognitive disorder (with agitation episodes for few weeks); COVID-19; Diabetes
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021272354

Write-up: Stroke; Sudation increased; Hypertension arterial; Tachycardia; Malaise; agitation; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB [Regulatory Authority number FR-AFSSAPS-TS20210524] from a contactable pharmacist. A 92-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY), intramuscular in right arm, on 17Feb2021 (Lot# ER0641), at single dose, for COVID-19 immunisation. Medical history included ongoing living in nursing home, COVID-19, diabetes, ongoing arterial hypertension (without drug treatment) and cognitive disorders with agitation episodes for few weeks. Concomitant medications were not reported. Previously the patient received the 1st dose of Comirnaty for COVID-19 immunisation. The patient experienced malaise (medically significant) on 18Feb2021 morning with outcome of unknown, agitation (medically significant) on 18Feb2021 morning with outcome of unknown, tachycardia (medically significant) on 18Feb2021 morning with outcome of recovered on 21Feb2021, stroke (death, medically significant) on 20Feb2021, sudation increased (medically significant) on 18Feb2021 morning with outcome of unknown, hypertension arterial (medically significant) on 18Feb2021 with outcome of recovered on 19Feb2021, tachycardia (medically significant) on 18Feb2021 with outcome of unknown. On 20Feb2021 the patient experienced hypotonia of one side and hypertonia of the other side, the physician diagnostic suggested a cerebrovascular accident (CVA). Later the patient was areactive and did not feed. The patient died on 23Feb2021. An autopsy was not performed. Follow-up attempts are completed. No further information in expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1114111 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Cardiac arrest, Head injury, 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), Accidents and injuries (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (only)
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021274770

Write-up: Cardiac arrest; lack of oxygen brain damage; Head injury; This is a spontaneous report from a contactable consumer. This is a report received from the Agency Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103092148547120, Safety Report Unique Identifier GB-MHRA-ADR 24908145. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection); via an unspecified route of administration on 19Feb2021 at a single dose for covid-19 immunisation. Medical history included asthma only. Patient had not had symptoms associated with covid-19. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient experienced death events of cardiac arrest on 20Feb2021 and lack of oxygen brain damage on Feb2021, non serious event of head injury on Feb2021 with outcome of not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test: no - negative covid-19 test on 19Feb2021. The patient died on 23Feb2021. It was not reported if an autopsy was performed. She was reported with cardiac arrest causing head injury and lack of oxygen brain damage. Patient had not tested positive for covid-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cardiac arrest; lack of oxygen brain damage


VAERS ID: 1114115 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocardial infarction, Pain in extremity, Thrombosis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: Parkinson''s disease ((mild and stable) for which she was taking medication)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021274681

Write-up: blood clots; Heart attack; sore arm; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202103102255389050, Safety Report Unique Identifier GB-MHRA-ADR 24915706. This consumer reported similar events for three patients. This is the first of three reports. An 80-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 20Jan2021 (Batch/Lot Number: Not known) as single dose for COVID-19 immunisation. The patient medical history included Parkinson''s (mild and stable) for which she was taking medication. Patient had not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. It was reported that the patient had absolutely no side effects other than a sore arm for a day. She had no signs of any illness or anything of concern. The patient experienced blood clots on an unspecified date, and heart attack on 23Jan2021. The outcome of the events blood clots and heart attack was fatal. The patient died on 23Jan2021. It was not reported if an autopsy was performed and the reported cause of death was thrombosis and myocardial infarction. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021287274 Same reporter/drug, similar events in different patients;GB-PFIZER INC-2021287273 Same reporter/drug, similar events in different patients; Reported Cause(s) of Death: Clot blood; Heart attack


VAERS ID: 1114117 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-23
   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: DOPAMINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease (under control with medication)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021274756

Write-up: Heart attack; This is a spontaneous report from a contactable consumer. This is a report received from the Medicines Healthcare Products Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-WEBCOVID-202103111105393570, Safety Report Unique Identifier GB-MHRA-ADR 24917743. A 78-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 as single dose for COVID-19 immunisation. Medical history included parkinson''s disease: (under control with medication. My mom had parkinsons but was all under control with medication). Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medication(s) included dopamine taken for parkinson''s disease. The patient experienced heart attack (myocardial infarction) on 23Jan2021 and the event was reported as death. "My mother suffered an accute heart attack and passed away 3 days after receiving the vaccine. she had no previous heart problems and there is no history of heart problems in the family. she was fine and well before she had the vaccine and to die 3 days after being given the vaccine was a massive shock to the family. I would like this investigated as this event has obviousely taken its toll on our family, we have lost a very dear mother, wife and nan and our lives have changed forever. No investigations were carried out and in my opinion they should have been!" The patient died on 23Jan2021. It was not reported if an autopsy was performed and the reported cause of death was heart attack. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1114128 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1185 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Diabetes mellitus, Myocardial ischaemia, Pulmonary embolism
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Embolic and thrombotic events, venous (narrow), Other ischaemic heart disease (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
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: Ischaemic heart disease; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021274034

Write-up: pulmonary embolism; ischaemic heart disease; ischaemic heart disease; Diabetes mellitus; This is a spontaneous report from a contactable consumer via the portal. A 69-year-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE, Formulation: Solution for injection, Batch/lot number: EN1185), via an unspecified route of administration in left arm on 31Jan2021 15:15 at single dose for COVID-19 immunization. The patient''s medical history included ischaemic heart disease and type 2 diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The Facility where the most recent COVID-19 vaccine was administered was noted to be the Doctors office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The reporter said Pfizer should ash the GP for a list of any other medications the patient received within 2 weeks of vaccination. A CPR was received a treatment for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Vaccine Facility information was also noted to be available. On an unspecified date, the patient experienced pulmonary embolism, ischaemic heart disease and diabetes mellitus. The events were considered as serious (death) by the consumer. The outcome of the events was fatal. The patient died on 08Mar2021 due to these events. An autopsy was performed that revealed pulmonary embolism, ischaemic heart disease and diabetes mellitus as the causes of death. The consumer said that the autopsy results were available at the time of this report.; Reported Cause(s) of Death: pulmonary embolism; ischaemic heart disease; diabetes mellitus; ischaemic heart disease


VAERS ID: 1114129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Pulmonary oedema, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021287274

Write-up: This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202103102255389050, Safety Report Unique Identifier GB-MHRA-ADR 24915706. This consumer reported similar events for three patients. This is the second of three reports. A 7-decade-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on an unspecified date (Lot Number: unknown) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had the vaccine and then a couple days later had a blood clot that stopped the heart and caused fluid on the lungs and he died. The patient died on unknown date. It was not reported 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) : GB-PFIZER INC-2021274681 Same reporter/drug/events in different patients; GB-PFIZER INC-2021287273 Same reporter/drug/events in different patients; Reported Cause(s) of Death: fluid on the lungs; Clot blood; Heart arrest


VAERS ID: 1114135 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood potassium, Blood uric acid, Death, General physical health deterioration, Haemoglobin, Haemorrhage subcutaneous, Platelet count, Red blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-21
   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: CONCOR; TRITACE; LORSILAN; FURSEMIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Carotid artery stenosis (stenosis ACI bilat.); Cerebral infarction; Chronic renal insufficiency; Depression; Macrocytic anemia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Creatinine; Result Unstructured Data: Test Result:143 umol/l; Test Date: 202101; Test Name: Serum potassium; Result Unstructured Data: Test Result:2.8 mmol/L; Test Date: 202101; Test Name: Urate; Result Unstructured Data: Test Result:920 umol/l; Test Date: 202101; Test Name: Hemoglobin; Result Unstructured Data: Test Result:102 g/l; Test Date: 202101; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:96 x10 9/l; Test Date: 202101; Test Name: Red blood cell count; Result Unstructured Data: Test Result:2.4 x10 12/l
CDC Split Type: HRPFIZER INC2021267331

Write-up: death; deterioration of the general condition; Heavy subcutaneous bleeding; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is HR-HALMED-300044751. A 91-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, lot number: EJ6796) via an unspecified route of administration on 09Jan2021 at 30 ug single for COVID-19 immunisation. Medical history included chronic renal insufficiency (chronic kidney. Insuf.,not ongoing), macrocytic anemia (not ongoing), carotid artery stenosis (not ongoing), arterial hypertension (not ongoing), depression (not ongoing), cerebral infarction (post CVI, I63) from 2007 (not ongoing). Concomitant medications included bisoprolol fumarate (CONCOR), ramipril (TRITACE), lorazepam (LORSILAN), furosemide (FURSEMIDE). The patient experienced heavy subcutaneous bleeding on 14Jan2021, deterioration of the general condition on 14Jan2021, death on 21Jan2021. Treatment of side effects was Oral compensation of K. The patient underwent lab tests and procedures in Jan2021 which included creatinine (ref. 63-107 umol/l): 143, Serum potassium (K, ref. 3.9-5.1 mmol/L): 2.8, urate (ref. 134-337 umol/l): 920, Hemoglobin (119-157 g/l): 102, Thrombocyte count (158- 424 x10 9/l): 96, Red blood cell count (ref. 3.86 - 5.08 x10 12/l): 2.4. It was unknown if autopsy was performed. Outcome of all events was fatal. Seriousness criteria was reported as death and life-threatening. Reporter comment: Reporter relatedness assessment: Possible. Sender Comment: 08Mar2021:Additional data was requested. Relatedness of drug to all events assessed by Regulatory Authority as Unassessable /Unclassifiable (Method of assessment: WHO-UMC Causality) Additional information on drug ADR is adequately labelled: No. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Reporter relatedness assessment: Possible.; Reported Cause(s) of Death: Heavy subcutaneous bleeding; deterioration of the general condition; Unknown cause of death


VAERS ID: 1114146 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood test, Electrocardiogram, Hyperventilation, Malaise, SARS-CoV-2 test, Ultrasound abdomen
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Eosinophilic pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   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: OMEPRAZOLE; TEGRETOL; QUETIAPINE; TIMOPTOL; RIVOTRIL; ZESTORETIC 20; SPIRIVA RESPIMAT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210306; Test Name: blood gas; Result Unstructured Data: Test Result:results not provided; Test Date: 20210306; Test Name: blood test; Result Unstructured Data: Test Result:waiting for results; Test Date: 20210306; Test Name: ECG; Result Unstructured Data: Test Result:results not provided; Test Date: 20210306; Test Name: molecular swab; Test Result: Negative ; Test Date: 20210306; Test Name: abdomen ultrasound; Result Unstructured Data: Test Result:results not provided
CDC Split Type: ITPFIZER INC2021283394

Write-up: general malaise; hyperventilation; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB IT-MINISAL02-694840. A 93-year-old male patient received BNT162B2 (COMIRNATY, lot number: EP9598) second dose intramuscular on 06Mar2021 at 0.3 ml single for COVID-19 immunisation. Medical history was not reported. Concomitant medications included omeprazole tablet, carbamazepine (TEGRETOL) modified-release tablet, quetiapine, timolol maleate (TIMOPTOL) for Glaucoma, clonazepam (RIVOTRIL) Oral solution, hydrochlorothiazide, lisinopril (ZESTORETIC 20) for Hypertension, tiotropium bromide (SPIRIVA RESPIMAT) Inhalation vapour, solution for COPD (Chronic obstructive pulmonary disease). The patient previously took BNT162B2 (COMIRNATY) first dose on 13Feb2021 intramuscular for COVID-19 vaccination and experienced no adverse reactions. The 2nd dose 06Mar2021: the patient showed general malaise and that is why he accessed the hospital emergency room on the same day. Blood tests were performed, waiting for results, the molecular swab was performed with negative results, and Urbason vial 40 mg, paracetamol, hemagel pantoprazole, bicarbonate, lasix intravenously were administered. Subsequently ECG, blood gas before and after hyperventilation, abdomen ultrasound. Patient death on 07Mar2021. On 10Mar2021 the reports of the examinations carried out and the death record were requested from the reporter. It was unknown if autopsy was done or not. No follow-up attempts possible. No information expected.; Reported Cause(s) of Death: General malaise; hyperventilation


VAERS ID: 1114167 (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: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Chills, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; PREDNISOLONE; OMEPRAZOLE; CALCI CHEW D3; QUETIAPINE; TRAMADOL; RIVASTIGMINE; PROLIA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210303; Test Name: body temperature; Result Unstructured Data: Test Result: Fever: 38 to 40.5 degrees Celsius Centigrade; Comments: Fever: 38 to 40.5 degrees Celsius; Test Date: 20210303; Test Name: oxygen saturation; Test Result: 67 %; Comments: decreased.
CDC Split Type: NLPFIZER INC2021267083

Write-up: Fever: 38 to 40.5 degrees Celsius; Cold shivers; saturation decreased; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00463754. A 66-year-old male patient received the second dose of BNT162b2 (COMIRNATY; lot number: EP9598) on 02Mar2021 at single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included acetylsalicylic acid tablet 80mg taken at 80 mg, prednisolone tablet 5mg taken at 5 mg, omeprazole gastro-resistant capsule 40mg taken at 40 mg, calcium carbonate, colecalciferol (CALCI CHEW D3) chewable tablet 2.5g / 800iU taken at 1000mg approximately, quetiapine tablet modified-release tablet 50mg taken at 50 mg, tramadol capsule modified-release 100mg taken at 100 mg, rivastigmine patch 9.5mg taken at 9.5 mg daily (24hrs), denosumab (PROLIA) solution for injection 60mg/ml taken at 60mg/ml. The patient previously took the first dose of BNT162b2 (COMIRNATY) on 01Feb2021 for COVID-19 immunisation with no adverse reaction. On 03Mar2021, the patient experienced saturation decreased, cold shivers and fever: 38 to 40.5 degrees Celsius following administration of BNT162b2. Saturation drop to 67% on 03Mar2021. The patient had not previous COVID-19 infection. No diagnostic procedures were performed. Chills was treated with amoxicilin/clavulanic acid, oxygen saturation decreased was treated with oxygen and pyrexia was treated with amoxicilin/clavulanic acid. The patient died in Mar2021. The outcome of the events was fatal. It was unknown if an autopsy was performed. Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty); past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes; ADRs: no; date: 01Feb2021; saturation additional information ADR: saturation drop to 67%; COVID-19: previous COVID-19 infection: no; other: diagnostic procedures: no. No follow-up attempts possible. No further information expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): yes ADRs: No Date: 01Feb2021 Saturation Additional information ADR: Saturation drop to 67% COVID-19 Previous COVID-19 infection: No. Other diagnostic procedures: No.; Reported Cause(s) of Death: saturation decreased; cold shivers; fever: 38 to 40.5 degrees Celsius


VAERS ID: 1114168 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-04
Onset:2021-01-11
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Oxygen saturation, Rash, Respiratory tract infection
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankle fracture; Asthma; Diabetes mellitus; Living in residential institution; Multimorbidity
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: O2 saturation; Result Unstructured Data: Test Result:frequent falls
CDC Split Type: NOPFIZER INC2021136497

Write-up: suspected respiratory infection; EXANTHEMA; This is a spontaneous report from a contactable physician via Regulatory Authority, downloaded from the Regulatory Authority (NO-NOMAADVRE-FHI-2021-U3ppz, Safety Report Unique Identifier NO-NOMAADVRE-E2B_00014564). An 85-year-old female patient received BNT162B2 (COMIRNATY; Lot number EJ6795) intramuscular on 06Jan2021 at single dose for COVID-19 immunisation and oral amoxicillin/clavulanic acid (AUGMENTIN) from an unspecified date to 04Jan2021 at 1 DF (amoxicillin 500mg/clavulanic acid 125mg) three times a day for respiratory tract infection. Relevant medical history included living in residential institution, ankle fracture, asthma, multimorbidity and diabetes mellitus. Concomitant medications were not reported. On 11Jan2021, the patient experienced exanthema with outcome of recovering and, on an unspecified date, she developed a suspect respiratory infection and she died from it on 22Jan2021. It was unknown if an autopsy as performed. The action taken in response to the events for amoxicillin/clavulanic acid was post-therapy. The Facility assessed the causal relationship between BNT162B2 (COMIRNATY) and amoxicillin/clavulanic acid and the reported event exanthema as possible. Sender''s comment: Background: Woman in her 80''s, lived in a care ward, multimorbid with diabetes, asthma and frequent respiratory infections. Vaccinated with the COVID-19 vaccine COMIRNATY. Prior to vaccination treated with AUGMENTIN (amoxicillin, clavulanic acid, penicillin) due to increasing CRP and decrease in O2 saturation. Good response, and CRP went down nicely. The antibiotic regimen was terminated two days before vaccination. Five days after vaccination, a rash appeared on the lower truncus and extremities. No itching or other ailments, felt in better shape. The rash was about to disappear 4-5 days after debut. The reporter states that the rash is a known side effect of amoxicillin, but is unsure whether the rash can also be due to the vaccine. It is further stated that the patient died two weeks after vaccination. She had been ill in the days before with frequent falls in O2 saturation. According reporter, this was a suspected respiratory infection and she died from it. Comment: The rash that was added is not described in more detail morphologically, only that it was non-itchy and went back spontaneously. The fact that it was non-itchy and came several days after the start of AUGMENTIN and vaccination, speaks against the fact that it was urticaria as part of a type 1 allergic reaction. However, it cannot be ruled out that the rash may have been an expression of a type V allergic reaction, which is cell-mediated and where the rash typically occurs after a few days. 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 (here COMIRNATY and AUGMENTIN), but which can 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: suspected respiratory infection


VAERS ID: 1114169 (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: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure (Stable, moderate.); Gout; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 202006; Test Name: Ejection fraction; Result Unstructured Data: Test Result:40-50 %
CDC Split Type: NOPFIZER INC2021272700

Write-up: Sudden death, unnatural/found dead; This is a spontaneous report downloaded from the regulatory authority NO-NOMAADVRE-FHI-2021-Ujm73 and NO-NOMAADVRE-E2B_00017879. A contactable physician reported that a 72-year-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection and lot number: EP9598) via intramuscularly on 24Feb2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation, cardiac failure (stable, moderate), hypertension arterialis and gout. The patient''s concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (COMIRNATY) for COVID-19 immunization. The patient underwent lab tests and procedures which included ejection fraction 40-50% on an unspecified date in Jun2020. It was reported that, the patient was seldom at check-ups at his GP (general physician), last laboratory tests were performed in Oct2019 (no values stated). The reporter stated that the patient was in good general condition. On 26Feb2021, the patient had sudden death, unnatural/ found dead, outside his home, by his brother. The patient was found next to his scooter, it appeared that he had tried to elevate the scooter with a jack. He was wearing a face mask, which was considered odd by the reporting physician, but the patient''s brother said that it was not unusual, and that the patient often wore a face mask when working outside, for protection. The reporter has stated that based on rigor mortis, the date of death is set to 26Feb2021. The patient''s brother had last seen the patient on the morning of 26Feb2021, when they had breakfast together. The patient had not complained about any symptoms following vaccination, according to his brother. At the time of reporting it was stated that an autopsy was not performed, but that it was planned for 09Mar2021. The patient''s outcome was Fatal, at the time of the report. The case was considered to be Serious. The Regional Pharmacovigilance Center assessed the causal relationship between BNT162B2 (COMIRNATY) and the reported event as Possible. Health Authority Comments: The report concerns a patient in his 70s, who was found dead outside his home a few days after the second dose of the Covid-19 vaccine COMIRNATY. The patient had not complained of any symptoms and was considered to be in his habitual condition before the death occurred. The patient had several underlying diseases. An autopsy was planned, but not carried out, when the report was submitted. When vaccinating patients with underlying diseases, some serious events may occur shortly after vaccination. In the individual case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another random, concurrent cause that has nothing to do with the vaccination 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. Data from use in patients with comorbidity is nevertheless limited, and such lack of information will be obtained in post-marketing studies, among other things. Since the report concerns death and autopsy is scheduled to be performed, we would like you to send us an update when the result of the autopsy report is available. This will provide useful additional information to the report and it''s assessment. Based on the information in the report so far 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 relationship to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is also classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death, unnatural


VAERS ID: 1114173 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease; COVID-19; HIV infection (medicated with antivirals and with stable viral counts); Ischaemic cardiomyopathy; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021272662

Write-up: Fever; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB PT-INFARMED-J202103-818. A contactable physician reported that a 64-year-old male patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, lot/batch number: EP9598), Intramuscular on 19Feb2021 at 0.6 mL, single for COVID-19 immunisation. Medical history included HIV patient medicated with antivirals and with stable viral counts, suffered from chronic obstructive pulmonary disease, with severe ischemic cardiomyopathy, with COVID-19 in Jan2021, with a history of stroke. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (COMIRNATY) for COVID-19 immunization. No adverse reaction on the first dose. A history of ADR for any drug is unknown. Vaccination was scheduled 2 doses with an interval of at least 21 days between each dose. The patient had high fever associated with the use of BNT162B2 on 20Feb2021. The adverse reaction (ADR) started at home, less than 24 hours after taking the second dose of the suspected vaccine and led to the administration of Ben-U-Ron. The administration of the vaccine had taken place the day before, in the hemodialysis unit, without complaints immediately or in the first subsequent hours. The patient death was reported in evolution of ADR. The outcome of event was fatal. There was no autopsy. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever


VAERS ID: 1114178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bundle branch block right, C-reactive protein, Chest pain, Computerised tomogram thorax, Culture, Dyspnoea, Electrocardiogram, Oxygen saturation, Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Conduction defects (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Chronic renal failure; Dementia; Hypertension; Obstipation; Parkinson''s disease; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: DT thorax; Result Unstructured Data: Test Result:bilateral pneumonia; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increasing; Test Date: 202102; Test Name: C-reactive protein; Result Unstructured Data: Test Result:170; Test Date: 202102; Test Name: cultures; Result Unstructured Data: Test Result:unknown results; Test Date: 202102; Test Name: ECG; Result Unstructured Data: Test Result:new bundle branch block right; Test Date: 202102; Test Name: oxygen saturation; Result Unstructured Data: Test Result:70-80 %; Test Date: 202102; Test Name: Covid-19 test; Test Result: Negative
CDC Split Type: SEPFIZER INC2021272667

Write-up: Acute dyspnea/suddenly developed respiratory distress; Chest pain; Oxygen saturation decreased/Saturation between 70-80%; bilateral pneumonia/Abnormal pulmonary status/Increasing CRP; a new bundle branch block right showed at ECG; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, Regulatory authority report number SE-MPA-2021-008936 and additional other number SE-MPA-1614348990521. A 76-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6134), via an unspecified route of administration on Jan2021 at a single dose for COVID-19 immunization. Medical history included chronic renal failure, hypertension, constipation, dementia, type 2 diabetes mellitus, Parkinson''s disease, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Reported suspect adverse events were acute dyspnoea and chest pain with oxygen saturation decreased in Feb2021. The reporter describes that the man about three weeks after the vaccination in Feb2021 suddenly developed respiratory distress and had chest pain. Saturation between 70-80%, a new bundle branch block right showed at ECG. No fever. The man came to hospital. C-reactive protein 170. Abnormal pulmonary status (not further specified in the report). Covid negative. DT thorax shows bilateral pneumonia. Cultures was taken from several locations on the man''s body and he received intravenous antibiotics. Increasing CRP and the man deteriorates. He received infusions and inhalations according to the reporter. The man died after almost a week at the hospital on an unspecified date in 2021. Outcome: Fatal. Report assessed as serious, death. The outcome of the events "Acute dyspnea/suddenly developed respiratory distress", "Chest pain", "Oxygen saturation decreased/Saturation between 70-80%" and "bilateral pneumonia" was fatal. The outcome of other events was unknown. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Acute dyspnea/suddenly developed respiratory distress; Chest pain; Oxygen saturation decreased/Saturation between 70-80%; bilateral pneumonia


VAERS ID: 1114179 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Heart failure class IV (unstable in her heart disease for a couple of months)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021267156

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB (SE-MPA-2021-009772) and case identifier (SE-MPA-1614691187125). A 97-years-old female patient received BNT162B2 (COMIRNATY; lot number EJ6795; expiration date unknown), intramuscular on an unspecified date at 0.3 mL single for covid-19 immunisation. Medical history included ongoing heart failure class IV (unstable in her heart disease for a couple of months). Relevant concomitant medications were not reported. The patient died due to cardiac failure in Jan2021, two days after vaccination. It was not reported if an autopsy was performed. The reporter wrote that the vaccination is assessed not caused the death. No follow-up attempts are possible. No further information expected.; Sender''s Comments: The event cardiac failure considered intercurrent condition and unlikely related to BNT162B2 (COMIRNATY; lot number EJ6795) in this 97 year-old female patient with history of class IV heart failure.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1114180 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve stenosis (dense); Asystole (short); Diabetes; Hospitalization; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021283324

Write-up: Death unexplained; This is a spontaneous report from a contactable physician received from the regulatory authority, downloaded from the Agency Agency-WEB. The regulatory authority report number is SE-MPA-2021-009956. Safety Report Unique Identifier is SE-MPA-1614778385881. An 89-year-old female patient received BNT162B2 (COMIRNATY, batch/lot number: EP2163, expiration date unknown) via intramuscular on an unspecified date in Mar2021 (unknown age at time of vaccination), at single dose, for COVID-19 immunization. The patient medical history included dense aortic valve stenosis, hypertension, and diabetes, all from an unspecified date and unknow if ongoing; short asystole from Jan2021 and unknown if ongoing; hospitalization in Jan2021. Concomitant medications were not reported. Physician reported suspect adverse events were death unexplained. Physician stated that the woman was found dead in her home the morning after the vaccination in Mar2021. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1114558 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-03-02
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPAKENE [VALPROATE SODIUM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy (controlled)
Allergies:
Diagnostic Lab Data:
CDC Split Type: AEPFIZER INC2021257223

Write-up: Death sudden; This is a spontaneous report from a contactable consumer. A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the first dose on 18Jan2021 and the second dose on 06Feb2021, both via an unspecified route of administration at single dose for COVID-19 immunisation. Medical history included epilepsy (controlled). No allergies to medications, food, or other products. Concomitant medication included valproate sodium (DEPAKENE [VALPROATE SODIUM]). The patient experienced death sudden on 02Mar2021. The patient died on 02Mar2021. The event required a visit to the emergency room. An autopsy was performed. Reporter stated that: "I want to report that 3 weeks after receiving the second vaccination a healthy 41 year old male passed away suddenly last week. A post mortem is currently being carried out but this needs to be reported and logged as I am not sure how a post mortem would see if the vaccine had any impact on his death". Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The information on the Lot / Batch number has been requested.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1114592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1491 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Respiratory distress
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Acute central respiratory depression (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dental treatment (general anesthesia)
Preexisting Conditions: Medical History/Concurrent Conditions: Adiposis; Brain damage congenital; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021266936

Write-up: sudden death after corona vaccination, 1 week before death, and general anesthesia for dental treatment on the day of death in the morning, in the afternoon suddenly signs of anaphylaxis; sudden death after corona vaccination, 1 week before death, and general anesthesia for dental treatment on the day of death in the morning, in the afternoon suddenly signs of anaphylaxis; This is a spontaneous report from a non-contactable Consumer downloaded from the Agency Agency-WEB [E2B Authority Number: DE-PEI-CADR2021014664; additional regulatory number: DE-PEI-2021005174]. A 51-year-old male patient received intramuscular BNT162B2 (COMIRNATY) on 20Jan2021 at single dose for COVID-19 immunisation. Lot number was EL 1491. Medical history and concurrent conditions included Diabetes mellitus, Adipositas, brain damage (congenital), dental treatment on 27Jan2021. Concomitant medications were unknown. Sudden death after corona vaccination, 1 week before death, and general anesthesia for dental treatment on the day of death in the morning; in the afternoon suddenly signs of anaphylaxis, reanimation not done. On 27Jan2021, the patient experienced respiratory distress, anaphylaxis. On 27Jan202, the patient died due to respiratory distress and anaphylaxis; no autopsy was performed. Sender Comment: Diabetes mellitus IIb Adipositas mental retardation due to early childhood brain damage. One week after vaccination dental treatment with general anesthesia, on this day in the afternoon anaphylactic shock, death. Follow-up attempts not possible. No further information expected.; Reported Cause(s) of Death: sudden death after corona vaccination, 1 week before death and general anesthesia for dental treatment on the day of death in the morning. In the afternoon suddenly signs of anaphylaxis, reanimation not done; sudden death after corona vaccination, 1


VAERS ID: 1114593 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-02-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension; Dementia; Diabetes mellitus; Multiple vessel coronary artery disease
Preexisting Conditions: Medical History/Concurrent Conditions: Adipositas
Allergies:
Diagnostic Lab Data: Test Date: 20210205; Test Name: COVID-19 virus test; Test Result: Positive ; Comments: 10 days after second Vaccination.
CDC Split Type: DEPFIZER INC2021266978

Write-up: Rapid deterioration of general condition; resp. Insufficiency; Unknown cause of death; COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB with regulatory authority number DE-PEI-CADR2021016372. A 69-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via unknown route of administration on 31Dec2020 at single dose, and received the second dose of BNT162B2, intramuscularly in Jan2021 (Lot Number: EK9788) at single dose, both for COVID-19 immunisation. Medical history included ongoing diabetes mellitus, ongoing arterial hypertension, ongoing dementia, ongoing multiple vessel coronary artery disease, and adipositas. The patient''s concomitant medications were not reported. It was reported ''10 days after second vaccination positive test to Covid 19. Rapid deterioration of general condition and resp. Insufficiency in Feb2021, Hospitalization, ventilation there, died on 10Feb2021''. The patient experienced unknown cause of death on 10Feb2021 and Positive test to Covid 19 on 05Feb2021. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 05Feb2021 (also reported as 10 days after second Vaccination). Therapeutic measures were taken as a result of respiratory insufficiency included treatment with ventilation. The outcome of events ''COVID-19 confirmed by positive COVID-19 test'' was not resolved, of events ''Rapid deterioration of general condition'' and ''resp. Insufficiency'' was unknown. The patient died on 10Feb2021. It was not reported if an autopsy was performed. No follow-up attempts needed, follow-up automatically provided by Regulatory Authority.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1114594 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-02-01
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267027

Write-up: died after massive cerebral hemorrhage; This is a spontaneous report from a non contactable consumer downloaded from the Agency Agency-WEB (DE-PEI-CADR2021018594). A 87-years-old male patient received his second dose of BNT162B2 (COMIRNATY; Batch/Lot Number EK9788, expiration date unknown), intravenous on 25Jan2021 at a single dose for covid-19 immunisation. Medical history included ongoing heart disorder, patient had no allergies; patient received first dose of COMIRNATY for covid-19 immunisation on 28Dec2020 (Batch/Lot Number and expiration date unknown). The patient''s concomitant medications were not reported but it was also mentioned that patient was taking blood thinning medication due to heart disease. The patient previously took comirnaty for immunisation. The patient died after massive cerebral hemorrhage in Feb2021. No treatment administered after vaccination. It was not reported if an autopsy was performed. Causality from Agency: Inconsistent causal association to immunization (as reported). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1114595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267479

Write-up: patient died of unknown reasons; This is a spontaneous report downloaded from the Agency Regulatory Authority-WEB regulatory authority number DE-PEI-CADR2021022893 and DE-PEI-2021013155. A non-contactable consumer reported for an 86-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: Unknown) via intramuscular on 12Feb2021 at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient had no known allergies. The patient historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution for injection) on 21Jan2021 at single dose for COVID-19 immunization. The patient died of unknown reasons on an unspecified date in 2021. It was unknown if an autopsy was performed or not. The event considered serious due to death. The outcome of the event was reported as fatal. The causality of the event was not unclassifiable. Heath Authority Comment: Information regarding risk factors or pre-existing diseases: age / no complaints reported after vaccination, sudden cardiac death, few concomitant diseases despite advanced age, all concomitant diseases were well managed at time of death, therefore no explanation for sudden death. No follow-up attempts needed. Follow-up automatically provided by Regulatory Authority. Lot number cannot be obtained.; Reported Cause(s) of Death: patient died of unknown reasons


VAERS ID: 1114596 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-08
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021267472

Write-up: died with unknown cause; This is a spontaneous report downloaded from the Agency Agency-WEB [DE-PEI-CADR2021023364]. A non-contactable consumer reported that an elderly female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown), intramuscular on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications was not reported. The patient previously took first dose of BNT162B2 (COMIRNATY) for prophylactic vaccination and experienced flu-like symptoms. On 08Feb2021, the patient died with unknown cause. It was unknown if an autopsy was performed. The outcome of the event was reported as fatal. Health Authority Comment: No previous vaccinations, especially vaccination complications (flu), allergies: none. Information on risk factors or previous illnesses. Torasemide intake 5 mg, no significant previous illnesses according to the general practitioner / death in a close temporal context" No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died with unknown cause


VAERS ID: 1114601 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister infected, Death, Pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021262568

Write-up: died; pus blisters on the entire body; gruesome pain; This is a spontaneous report based on information received by Pfizer from Biontech [manufacturer control number: 21589], license party for Comirnaty. A non-contactable consumer reported that a male patient of an unspecified age received BNT162B2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. I had an uncle who was healthy, was riding around on his bike, then he let himself be vaccinated because it was recommended to him and 2 weeks later he had died, got pus blisters on the entire body and had gruesome pain, that was from the poison-syringe. The outcome of event "pus blisters on the entire body" and "gruesome pain" was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: died


VAERS ID: 1114697 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood albumin, Blood bilirubin, Blood potassium, Blood pressure diastolic, Blood pressure systolic, Blood sodium, Body temperature, Cardiac arrest, Death, Dyspnoea, Gamma-glutamyltransferase, Heart rate, Hypoalbuminaemia, Hyponatraemia, N-terminal prohormone brain natriuretic peptide, Oedema peripheral, Oxygen saturation, Pyrexia, Respiratory rate, Respiratory tract infection, Vomiting, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EXFORGE; ZYPREXA; CONCOR; QUEPIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystectomy; Dementia; ERCP; Gallstones (in gallstone diet since then)
Allergies:
Diagnostic Lab Data: Test Date: 20210212; Test Name: Serum albumin; Result Unstructured Data: Test Result:3.2 g/dl; Test Date: 20210212; Test Name: Bilirubin; Test Result: 0.46 mg/dl; Test Date: 20210212; Test Name: Serum potassium; Result Unstructured Data: Test Result:5.5 mEq/l; Test Date: 20210213; Test Name: Diastolic blood pressure; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20210213; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:150 mmHg; Test Date: 20210212; Test Name: Serum sodium; Result Unstructured Data: Test Result:115 mEq/l; Test Date: 20210203; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210204; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210205; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210212; Test Name: Gamma GT; Result Unstructured Data: Test Result:139 IU/l; Test Date: 20210213; Test Name: Pulse rate; Result Unstructured Data: Test Result:75; Test Date: 20210212; Test Name: NT-proBNP; Result Unstructured Data: Test Result:8022 pg/mL; Test Date: 20210209; Test Name: Pulse oximetry; Test Result: 91 %; Test Date: 20210213; Test Name: Pulse oximetry; Test Result: 93 %; Test Date: 20210213; Test Name: Respiratory rate; Result Unstructured Data: Test Result:8; Comments: /min; Test Date: 20210212; Test Name: WBC; Result Unstructured Data: Test Result:16330
CDC Split Type: GRPFIZER INC2021267089

Write-up: Cardiac arrest; Death; respiratory infection; Dyspnea; hyponatremia; hypoalbuminemia; Edema of lower extremities; Vomit; Fever (38 C - 38 C - 37.7 C); This is a spontaneous report downloaded from the Agency WEB [Regulatory Authority number GR-GREOF-20211424] from a contactable other health professional. A 91-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular, on 01Feb2021, as single dose, for COVID-19 immunisation. Medical history included dementia, endoscopic retrograde cholangiopancreatography (ERCP) from 2011, cholecystectomy in 2001, cholelithiasis from 2016 (in gallstone diet since then). Concomitant medications included amlodipine besilate, valsartan (EXFORGE), olanzapine (ZYPREXA), bisoprolol fumarate (CONCOR), quetiapine fumarate (QUEPIN). The patient experienced cardiac arrest (death) on 14Feb2021 with fatal outcome on 14Feb2021, death (death) on 14Feb2021, respiratory infection (medically significant) on 13Feb2021 with outcome of unknown, dyspnea (non-serious) on 13Feb2021 with outcome of not recovered, fever (38 C - 38 C - 37.7 C) (non-serious) on 03Feb2021 with outcome of recovered on 05Feb2021, edema of lower extremities (non-serious) on 09Feb2021 with outcome of not recovered, vomit (non-serious) on 03Feb2021 with outcome of unknown, hyponatremia (non-serious) on 13Feb2021 with outcome of unknown, hypoalbuminemia (non-serious) on 13Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood albumin: 3.2 g/dl on 12Feb2021, blood bilirubin: 0.46 mg/dl on 12Feb2021, blood potassium: 5.5 meq/l on 12Feb2021, blood pressure diastolic: 90 mmhg on 13Feb2021, blood pressure systolic: 150 mmhg on 13Feb2021, blood sodium: 115 meq/l on 12Feb2021, body temperature: 38 centigrade on 03Feb2021, body temperature: 38 centigrade on 04Feb2021, body temperature: 37.7 centigrade on 05Feb2021, gamma-glutamyltransferase: 139 iu/l on 12Feb2021, heart rate: 75 on 13Feb2021, n-terminal prohormone brain natriuretic peptide: 8022 pg/ml on 12Feb2021, oxygen saturation: 91 % on 09Feb2021, oxygen saturation: 93 % on 13Feb2021, respiratory rate: 8/min on 13Feb2021. The patient died on 14Feb2021. It was not reported if an autopsy was performed. Clinical course: On 09Feb2021 the patient experienced low extremities oedema and oxygen saturation 91%. On 12Feb2021 laboratory exams were performed. On 13Feb2021 a physician examined the patient and found respiratory rate 8/min, pulse oximetry 93%, blood pressure 150/90 mmHg, pulse rate 75. The physician diagnosed a possible respiratory infection, hyponatraemia and hypoalbuminemia. He administered N/S 0.9% intravenous (IV) & Fugentin 1000mg x 2. On 14Feb2021 the patient experienced cardiac arrest and died. Sender Comment: Initial report with additional information. On 02Mar2021 the Committee assessment was: unlikely. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Death; Cardiac arrest


VAERS ID: 1114857 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042723 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-23
   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: CARDIRENE; ELIQUIS; LASIX [FUROSEMIDE]; ATORVASTATIN; LANSOPRAZOLE; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Arthrosis; Chronic renal failure; IHD
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20210

Write-up: muscle spasms; Vomiting; A regulatory authority report was received from a healthcare professional concerning a 97-year-old, female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced muscle spasms, vomiting and died. The patient''s medical history was atrial fibrillation, Myocardial ischaemia, Osteoarthritis, Chronic renal failure. Concomitant medications were reported as Cardirine, Eliquis, Lasix, atorvastatin, lorazepalm, lansoprazole. On 23 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 300042723) intramuscularly for prophylaxis of COVID-19 infection. On 23 Feb 2021 patient has experienced muscle spasms and vomiting. The patient died on 23 Feb 2021. The cause of death is unknown. Laboratory details not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. On 23 Feb 2021, outcome of the events muscle spasms and vomiting were FATAL.; Reporter''s Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: cause of death unknown


VAERS ID: 1114863 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Magnetic resonance imaging, Malaise, Pneumonia, Pyrexia, SARS-CoV-2 test, X-ray
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Anemia; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:No results reported; Test Name: MRI; Result Unstructured Data: Test Result:No results reported; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Negative; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Negative; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Negative; Test Name: X-ray pneumothorax; Result Unstructured Data: Test Result:No results reported
CDC Split Type: NLPFIZER INC2021226284

Write-up: Pneumonia; Malaise; Fever; This is a spontaneous report downloaded from the regulatory authority, NL-LRB-00446392 and NL-LRB-00455853. A contactable consumer reported that a 90 years old female patient received BNT162B2 (COMIRNATY, Lot. EJ6134) at single dose, on 01Feb2021, for COVID-19 immunisation. Relevant medical history included anemia and hypertension, both form an unspecified date and ongoing. Patient did not have a previous COVID-19 infection. Concomitant medications were unknown. On 10Feb2021, following administration of vaccine, the patient experienced pneumonia (caused hospitalization and death), fever and malaise. The patient was hospitalized and blood analysis, X-ray pneumothorax and MRI were performed (no results reported). COVID-19 tests (3 times) all negative were performed in the hospital. The patient was treated with antibiotics and two blood transfusions. The patient was transferred to a hospice, on 17Feb2021, seven days after onset of the symptoms. It was reported that the patient died on 24Feb2021 in hospice. The outcome of pneumonia was fatal, while clinical outcome of the other events was unknown at time of patient''s death. Patient was a vital woman before the vaccination with of course problems related to age, she suffered from anemia, high blood pressure, she had medication for that. It was unknown if autopsy was done. Sender''s comments: Since the nature of the reported reaction does not imply seriousness according to one of the CIOMS critera, the reactions fever and malaise were considered as non-serious by the Pharmacovigilance Centre. Reported Cause(s) of Death: Pneumonia


VAERS ID: 1114868 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-20
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 1 LA / OT

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

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021267118

Write-up: Death; This is a spontaneous report from a contactable physician (contactable to HA only) via the Regulatory authority. Regulatory authority report number is PL-URPL-3-283-2021. Report PL-URPL-3-283-2021 was sent to Regulatory authority on 22Feb2021. A 82-year-old patient of an unspecified gender received first dose of BNT162b2 (COMIRNATY; Lot Number: EJ6136; Expiration Date: 30Apr2021) intramuscular in left arm on 29Jan2021 at 18:05 (at 82 years) at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced death on 20Feb2021 at 08:05. The patient died on 20Feb2021. It was not reported if an autopsy was performed. The reporting person classified report as serious. The Regulatory authority also classified the report as serious (death). Sender''s comment:Death more than 3 weeks after vaccination is an unexpected adverse reaction of Comirnaty. There is a temporal relationship between the administration of the vaccine and the occurrence of the reaction. Due to the lack of additional information, a causal relationship between the administration of Comirnaty and death cannot be assessed. The reporting person classified them as serious. Regulatory authority also classified the report as serious (as reported). No follow up attempts needed. No follow up attempts 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 Comirnaty as a cautionary measure and for reporting purposes. The impacts 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: 1115282 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-01-24
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood glucose, Blood potassium, C-reactive protein increased, Cyanosis, Electroencephalogram, Glomerular filtration rate, Magnetic resonance imaging, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: DIPIPERON; ESOMEP [ESOMEPRAZOLE]; EUTHYROX; TRITTICO; VI-DE 3; XARELTO
Current Illness: Acute renal failure
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral ischemia (Evidence of isolated microhemorrhages in the supratentorial medullary bed); Cholecystectomy; Cushing''s syndrome; Deep vein thrombosis (Treated with Xarelto); Dementia aggravated (With partial agitation); Epileptic seizure (Currently seizure-free since summer 2018 without AED.); Hernia; Hypothyroidism (Requiring substitution for status after strumectomy in 1998.); Ileocecal ulcer (With CMV detection under immunosuppression Jan2016.); Immunosuppression (With CMV detection under immunosuppression Jan2016.); Neurogenic bladder; Pneumocystis jiroveci pneumonia; Pulmonary embolism (Treated with Xarelto); Recurrent UTI; Rosacea; Suprapubic catheter insertion; Vasculitis cerebral (Highly suspected, First diagnosis Sep2015)
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: Glucose; Result Unstructured Data: Test Result:12,6 mmol/L; Test Date: 20210124; Test Name: Potassium; Result Unstructured Data: Test Result:6 mmol/L; Test Date: 20210124; Test Name: C-reactive protein; Result Unstructured Data: Test Result:146 mg/l; Comments: acute renal insufficiency; Test Date: 20180912; Test Name: EEG; Result Unstructured Data: Test Result:Moderate general change; Comments: mMderate general change, no phasic suppression of baseline activity and no generalized epileptic activity detectable.; Test Date: 20210124; Test Name: Glomerular Filtration rate; Result Unstructured Data: Test Result:34 ml/min; Test Date: 2016; Test Name: MRI; Result Unstructured Data: Test Result:Disseminated subacute ischemia; Comments: Disseminated subacute ischemia in periventricular and subcortical medullary bed as well as bar, thalamus and cerebellum. Evidence of isolated microhemorrhages in the supratentorial medullary bed.; Test Date: 20210124; Test Name: Covid-19 test; Test Result: Negative
CDC Split Type: CHPFIZER INC2021182556

Write-up: Respiratory insufficiency of unclear etiology; cyanosis; This is a spontaneous report received from a contactable pharmacist via the regulatory authority. Regulatory authority report number CH-SM-2021-10891. A 71-years-old female patient (non-pregnancy) received bnt162b2 (COMIRNATY), intramuscular on 22Jan2021 at single dose for covid-19 immunisation. Medical history included neurogenic bladder dysfunction with recurrent urinary tract infection (UTI), urinary bladder emptying permanently by suprapubic catheter, highly suspected small vessel vasculitis of the brain first diagnosed Sep2015, cerebral ischemia: MRI Neurocranium 2016-2017 (USB): disseminated subacute ischemia in periventricular and subcortical medullary bed as well as bar, thalamus and cerebellum. Evidence of isolated microhemorrhages in the supratentorial medullary bed; suspicion of single, but infection-triggered epileptic seizure Mar2016. EEG control on 12Sep2018: moderate general change, no phasic suppression of baseline activity and no generalized epileptic activity detectable. - Currently seizure-free since summer 2018 without AED; hypothyroidism requiring substitution for status after strumectomy in 1998, level Deep Vein Thrombosis leg right, pulmonary embolism segmental right Jan2016, currently under Xarelto, Ileocecal valve ulcer with CMV detection under immunosuppression Jan2016, status after pneumocystis jirovecli pneumonia Dec2015, status after laparoscopic cholecystectomy, status after mesh insertion for hernia, rosacea face / nasal both sides since 2008, latrogenic Cushing''s syndrome, advanced dementia with partial agitation, kidney disease acute renal failure (ongoing). None known allergies, none smoking, none alcohol, no liver disease. Concomitant medication included pipamperone hydrochloride (DIPIPERON) from 25Jun2020, esomeprazole (ESOMEP [ESOMEPRAZOLE]) from 26Feb2019, levothyroxine sodium (EUTHYROX) from 28May2019, trazodone hydrochloride (TRITTICO) from 26Feb2019, colecalciferol (VI-DE 3) from 10Jan2019, rivaroxaban (XARELTO) from 29Jun2020. The patient experienced respiratory insufficiency of unclear etiology on 24Jan2021. In case of preterminal situation on arrival - Exitus Letalis on 24Jan2021. Emergency referral by paramedics from nursing home on 24Jan2021 for respiratory failure and cyanosis. The paramedics reported that the patient had been found lying in bed cyanotic in the morning. She had received her first covid vaccination on 22Jan2021. In the case of advanced dementia with partial agitation, no vital signs could be recorded by the paramedics, nor could blood or other fluids be collected. According to the nursing center, the patient was in good general condition, especially in the last six months. The acute deterioration and death was surprising. The patient died on 24Jan2021. The patient underwent lab tests on 24Jan2021 included blood glucose was 12,6 mmol/l, blood potassium was 6 mmol/l, c-reactive protein increased was 146 mg/l (acute renal insufficiency), glomerular filtration rate was 34 ml/min, Covid-19 test was negative. An autopsy was refused by the relatives. The outcome of respiratory insufficiency of unclear etiology was fatal, of the other was unknown. A causal relationship between Comirnaty and Acute respiratory failure was assessed as unlikely. This case was reported as serious (fatal and caused/prolonged hospitalization). Reporter comment: According to information from the center for the elderly, the vaccine was administered by Pfizer/BioNTech; not have the vaccination booklet. Sender''s comment: Sudden respiratory failure in an elderly polymorbid patient residing in an elderly home in temporal correlation (2 days before) with the administration of Comirnaty. Unfortunately, an autopsy was not performed, nor were blood samples or other vital signs taken, as the patient was extremely agitated. In the absence of objective data we can only assume an acute pulmonary cardiac event of unknown origin that led to respiratory failure and subsequent death (patient found cyanotic). A thromboembolic event is probably excludable because the patient was anticoagulated with Xarelto. Even a possible anaphylactic shock with bronchoconstriction and subsequent respiratory distress due to the vaccine is unlikely, since these are usually rapid events that occur within seconds-minutes (possibly hours) but not after two days. Given the above, at the current state of knowledge, we do not find a causal correlation between the death of the patient (probable acute cardiopulmonary event) and the Comirnaty vaccine. No follow-up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments: According to information from the center for the elderly, the vaccine was administered by Pfizer/BioNTech; not have the vaccination booklet.; Sender''s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 can be excluded for the reported acute respiratory failure with fatal outcome and cyanosis. The patient polymorbid might have contributed to the onset and severity of the events. This case will be reassessed once additional information becomes available. ; Reported Cause(s) of Death: Acute respiratory failure


VAERS ID: 1115295 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Chest discomfort, Death, Dizziness, Electrocardiogram, Fall, Heart rate, Neuralgia, Oxygen saturation, Vertigo, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Osteoporosis; Prostatic adenoma; Prostatitis
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: Blood pressure; Result Unstructured Data: Test Result:130/80 mmHg; Comments: 7:30 p.m; Test Date: 20210210; Test Name: ECG; Result Unstructured Data: Test Result:unremarkable; Test Date: 20210210; Test Name: pulse; Result Unstructured Data: Test Result:92; Comments: 7:30 p.m; Test Date: 20210210; Test Name: saturation; Test Result: 95 %; Comments: 7:30 p.m
CDC Split Type: FRPFIZER INC2021180628

Write-up: This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MA20210394 This is a report received from the Regulatory Authority. A 94-year-old male patient received bnt162b2 (COMIRNATY) (lot number EJ6788), intramuscular on 09Feb2021 at SINGLE DOSE for covid-19 immunization. Vaccine location was right arm and it was the first dose. Medical history included Alzheimer''s disease from an unknown date and unknown if ongoing, prostatitis from an unknown date and unknown if ongoing, prostatic adenoma from an unknown date and unknown if ongoing, osteoporosis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced death unexplained (death) on 10Feb2021, chest tightness of on 10Feb2021 with outcome of unknown, emesis/vomiting on 10Feb2021 with outcome of unknown, vertigo on 10Feb2021 with outcome of unknown, dizziness on 10Feb2021 with outcome of unknown, vagal discomfort on 10Feb2021 19:00 with outcome of unknown, fell on 09Feb2021 with outcome of unknown. It was reported that during the night of 9 to 10, the patient fell and presented on 10Feb2021 in the morning of dizziness and vomiting with a feeling of chest tightness. Medical consultation, unremarkable ECG, clinical monitoring. At 7:30 p.m., vagal discomfort with blood pressure at 130/80 mmHg, 95 percent saturation, pulse 92. Conscious patient awake and stable. At 8 p.m., the patient was found dead in his room. The patient died on 10Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers already obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1119011 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-10
Onset:2021-03-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK1768 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Death, Influenza like illness, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-19
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: None
Preexisting Conditions: Blindness
Allergies: Soy, fish, shellfish Mycin drugs, sulfa drugs
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu-like symptoms followed by death from suspected heart-attack.


VAERS ID: 1120039 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

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: Adenocarcinoma lung (under chemotherapy); Alcoholic cardiomyopathy; Anemia; Anxiodepressive syndrome; Chemotherapy (long-standing chemotherapy (with no other indication)); COPD (tobacco-induced stage 3); Ex-alcoholic; Femur fracture (right side); Prostatic hypertrophy; Red blood cell count decreased; Tobacco user; Upper gastrointestinal haemorrhage
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272324

Write-up: patient was found dead in his bed with blood in his mouth; Origin of the bleeding is unknown/blood in his mouth; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-GR20210237. A 65-year-old male patient received the first dose of bnt162b2 (COMIRNATY) via intramuscular, administered in right arm on 28Jan2021 (Lot Number: EJ6788) as 30 ug, single for covid-19 immunisation. Medical history included Prostatic hypertrophy, Anxiodepressive syndrome, hemorrhages of upper digestive tract with several idiopathic anemia of blood loss, tobacco-induced stage 3 chronic obstructive pulmonary disease, alcoholic dilated cardiomyopathy, lung adenocarcinoma discovered in Nov2020 and under chemotherapy, right side femur fracture in 2013, weaned alcoholism, tobacco user and Red blood cell count decreased. The patient received long-standing chemotherapy (with no other indication). The patient was found dead in his bed with blood in his mouth on 29Jan2021. It was not reported if an autopsy was performed. The patient had medical history of upper hemorrhages and adenocarcinoma of the lung. Origin of the bleeding is unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: patient was found dead in his bed with blood in his mouth; Bleeding


VAERS ID: 1121340 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 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: 2021-03-06
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FENTANYL; FENTANYL; GEL ONE; OLEOVIT D3; MOLAXOLE; IBUPROFEN; DUTAGLANDIN COMP; PANTOLOC [PANTOPRAZOLE]; CAL D VITA; FENTANYL; SERTRALINE; RIVASTIGMINE; EBRANTIL [URAPIDIL]; MIRTAZAPINE
Current Illness: Arterial hypertension; Asthenia; Chronic lumbago; Degenerative disc disease; Dementia; Gait instability; Insomnia; Parkinson''s disease
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Depressive episode; Effusion pericardial; Inguinal hernia repair; Prostatic hyperplasia; Reflux gastritis; Suicide attempt; Unilateral pleural effusion
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021283083

Write-up: Patient suffers cerebral stroke 14 days after the vaccination -$g death; This is a spontaneous report from a contactable physician. This is a report received from the Medicines Agency. Regulatory authority or other manufacturer number. A 93-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot Number: EJ6790) as single dose for covid-19 immunisation. Medical history included atrial fibrillation from 15Oct2018 to an unknown date (Atrial fibrillation with a tendency to transitioning to tachycardia - first diagnosis), suicide attempt from 18Apr2018 to an unknown date (State after suicide attempt on 18Apr2018 (medication + CO gas) due to grief after spouse''s death on 17Apr2018), ongoing Parkinson''s disease, back pain from 18Feb2016 and ongoing (chronic lumbar pain syndrome with degeneration of the spine, disc prolapse L2-L4, neuroforaminal stenosis L2 to S1, spinal canal stenosis L3/L4, anterolisthesis L4/L5), dementia from 13Feb2020 and ongoing (mild dementia syndrom (especially mixed form), MMSE 20/29), inguinal hernia repair from Apr2017 to an unknown date (state after bilateral inguinal hernia surgery, last re in April 2017), depression episode from 13Feb2020 to an unknown date (severe depression. Episode HAMD 30 points), reflux gastritis from 11May2018 to an unknown date, pleural effusion from 15Oct2018 to an unknown date (narrow pleural effusion left), benign prostatic hyperplasia from 11May2018 to an unknown date (Prostate hyperplasia + incontinence). Concomitant medication(s) included fentanyl taken for an unspecified indication from 05May2020 to an unspecified stop date; fentanyl taken for an unspecified indication, start and stop date were not reported; hyaluronic acid (GEL ONE) taken for an unspecified indication, start and stop date were not reported; colecalciferol (OLEOVIT D3) taken for an unspecified indication, start and stop date were not reported; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOLAXOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen taken for an unspecified indication, start and stop date were not reported; dutasteride, tamsulosin hydrochloride (DUTAGLANDIN COMP) taken for an unspecified indication, start and stop date were not reported; pantoprazole (PANTOLOC [PANTOPRAZOLE]) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CAL D VITA) taken for an unspecified indication, start and stop date were not reported; fentanyl taken for an unspecified indication, start and stop date were not reported; sertraline taken for an unspecified indication, start and stop date were not reported; rivastigmine taken for an unspecified indication, start and stop date were not reported; urapidil (EBRANTIL [URAPIDIL]) taken for an unspecified indication from 02Feb2001 to an unspecified stop date; mirtazapine taken for an unspecified indication, start and stop date were not reported. The patient suffers cerebral stroke 14 days after the vaccination with Comirnaty EJ 6790 on 19Feb2021; dies on 06Mar2021. According to the reporting physician, a stroke was not expected. The patient died on 06Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Patient suffers cerebral stroke 14 days after the vaccination -$g death


VAERS ID: 1121341 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

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

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: Cachexia; Down''s syndrome; Lung fibrosis; Renal insufficiency (NINS)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021283085

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-13188. A 67-year-old male patient received the second dose of BNT162B2 (COMIRNATY, lot number EJ6136) intramuscularly on 09Feb2021 at single dose for COVID-19 immunisation. Ongoing medical history included Down''s syndrome, renal insufficiency ("NNS" as reported), lung fibrosis, and cachexia. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY) intramuscularly on 20Jan2021 for COVID-19 immunisation and experienced reduced general condition on 26Jan2021 with outcome of recovered on 29Jan2021 (duration: 3days). On 19Feb2021, the patient experienced death. 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: death


VAERS ID: 1121345 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ischaemic stroke, Mydriasis
SMQs:, Anticholinergic syndrome (broad), Ischaemic 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021285859

Write-up: ischaemic stroke; Mydriasis; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. The regulatory authority report number is 522391. A female patient of an unspecified age (age: 92, units: not reported) received BNT162B2 (COMIRNATY, lot number and expiry date unknown), via an unspecified route of administration, on 03Mar2021, at a single dose, for covid-19 immunization. Medical history and concomitant medications were not reported. The patient experienced ischaemic stroke and mydriasis on 03Mar2021 with a fatal outcome. Onset time in days (0 days). The patient died on an unspecified date in 2021. It was unknown if an autopsy was performed. Follow-up attempts are not needed; information about the lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Ischaemic stroke; Mydriasis


VAERS ID: 1121346 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-12
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC2021285872

Write-up: cardiac arrest; This is a spontaneous report from a contactable other healthcare professional (HCP), received from the Regulatory Authority. The regulatory authority report number is 522710. An 83-year-old male patient received bnt162b2 (COMIRNATY COVID-19 mRNA Vaccine, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced cardiac arrest on 12Mar2021, which led to death. Onset time was reported as 11 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch/lot number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1121348 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-20
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardiovascular disorder, Dyspnoea, N-terminal prohormone brain natriuretic peptide increased, Respiratory disorder
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-03
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BETMIGA; LETROZOL; LENDORMIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer metastatic
Allergies:
Diagnostic Lab Data: Test Name: NTproBNP; Result Unstructured Data: Test Result:increased
CDC Split Type: BEPFIZER INC2021283186

Write-up: Dyspnoea; Decompensation cardiac; N-terminal prohormone brain natriuretic peptide increased; Respiratory disorder; Cardiovascular disorder; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB BE-FAMHP-DHH-N2021-80173. A 97-year-old female patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at single dose on 18Jan2021 Lot Number: Unknown) for COVID-19 immunisation. Medical history included palliative metastatic breast cancer. Concomitant medications included mirabegron (BETMIGA), letrozol, brotizolam (LENDORMIN), all for an unspecified indication. On 20Jan2021, the patient experienced dyspnoea, decompensation cardiac, N-terminal prohormone brain natriuretic peptide increased, respiratory disorder, cardiovascular disorder. Therapeutic measures were taken as a result of the events included diuretics. The patient died on 03Feb2021. It was not reported if an autopsy was performed. Seriousness criteria of the events was reported as serious due to life threatening and death. Reporter Comment: Treatment - Yes Diuretics Evolution of the ADR - Deceased Examinations - Increased NTproBNP value ADR description - Acute dyspnoea, based on cardiac decompensation. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Treatment - Yes Diuretics Evolution of the ADR - Deceased Examinations - Increased NTproBNP value ADR description - Acute dyspnoea, based on cardiac decompensation; Reported Cause(s) of Death: Dyspnoea; Decompensation cardiac; N-terminal prohormone brain natriuretic peptide increased; Respiratory disorder; Cardiovascular disorder


VAERS ID: 1121360 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-14
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chills, Fatigue, Hypokinesia, Mesenteric vascular insufficiency, Pyrexia, Renal failure, Thermometry
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (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), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 28
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: Atherosclerosis; Myocardial infarction acute
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: Thermometry; Result Unstructured Data: Test Result:37.2 Centigrade
CDC Split Type: CZPFIZER INC2021280967

Write-up: abdominal pain; kidney failure; The large intestine stopped circulating; fatigue; subfebrile temperature 37,2?C; decreased mobility; chills on the back; This is a spontaneous report from a contactable consumer or other non- HCP downloaded from the Regulatory Authority-WEB CZ-CZSUKL-21001646. An 87-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 14Feb2021 (Batch/Lot Number: EJ6790) as single dose for covid-19 immunisation. Medical history included arteriosclerosis from an unknown date and unknown if ongoing, Myocardial infarction acute from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY) for COVID-19 immunisation. The patient experienced abdominal pain (death, hospitalization, medically significant, life threatening) on 23Feb2021, kidney failure (death, hospitalization, medically significant, life threatening) on 23Feb2021, the large intestine stopped circulating (death, hospitalization, medically significant, life threatening) on 23Feb2021, chills on the back on Feb2021 with outcome of unknown, fatigue on an unspecified date with outcome of unknown, decreased mobility on Feb2021 with outcome of unknown, subfebrile temperature 37,2?c on an unspecified date with outcome of unknown. The patient developed a following adverse reaction after the 2nd dose of the COMIRNATY vaccine (14Feb2021). After the vaccination, the patient suffered from fatigue, decreased mobility, subfebrile temperature of 37,2?C, chills. On the 8th day after the vaccination, the patient was hospitalized due to abdominal pain, abdominal surgery was performed due to insufficient blood perfusion of the colon. Patient developed renal failure and died on 01Mar2021. An autopsy will be performed. The reporter sees a possible connection with the administration of the vaccination. The patient underwent lab tests and procedures which included thermometry: 37.2 centigrade on Feb2021. Both physician and the reporter informed us that the patient died on 01Mar2021, according to the reporter, an autopsy will be performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1121362 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-23
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, Pneumonia, Respiratory failure, Septic shock
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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Hyperlipoproteinaemia; Hypertension arterial; Hyperuricaemia; Myocardial decompensation (left cardiac decompensation); Prostatic hyperplasia; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021282957

Write-up: Pneumonia; Respiratory insufficiency; Multiorgan failure; Septic shock; This is a spontaneous report from a contactable Physician downloaded from the Agency Agency-WEB DE-DCGMA-21188309. This report was forwarded via RA, however no RA number was provided. An 86-year-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular on an unspecified date (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing , Hyperlipoproteinaemia from an unknown date and unknown if ongoing, aortic valve replacement from an unknown date and unknown if ongoing, hyperuricaemia from an unknown date and unknown if ongoing , hypertension arterial from an unknown date and unknown if ongoing, Myocardial decompensation from an unknown date and unknown if ongoing (left cardiac decompensation), type 2 diabetes mellitus from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) at single dose for covid-19 immunization. The patient experienced pneumonia (death, hospitalization) on 23Feb2021, respiratory insufficiency (death, hospitalization) on 23Feb2021, multiorgan failure (death, hospitalization) on 23Feb2021, septic shock (death, hospitalization) on 23Feb2021. On 23Feb2021 after vaccination the patient developed Pneumonia and Respiratory insufficiency and Septic shock and Multiorgan failure, lasting for 2 day(s). The patient is dead on 24Feb2021 and was hospitalized. An autopsy was not performed. No follow-up attempts are possible; information on batch/lot# cannot be obtain.; Reported Cause(s) of Death: Pneumonia; Respiratory insufficiency; Multiorgan failure; Septic shock


VAERS ID: 1121365 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac insufficiency; COPD; Hyperkalaemia; Renal insufficiency; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021283002

Write-up: Deterioration in general condition; death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB with regulatory authority number DE-PEI-PEI2021003252. An 82-year-old male patient received the first dose of BNT162B2 (COMIRNATY, lot/batch number: EP2163) intramuscularly on 06Mar2021 at age of 82-year-old at single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), cardiac insufficiency, type II diabetes mellitus, renal insufficiency, and hyperkalaemia, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. After vaccination on 07Mar2021, the patient developed deterioration in general condition, the event was serious with seriousness criteria of death. It also reported the patient experienced death on an unspecified date in Mar2021. The patient was treated with therapy, e.g. antiphlogistic drugs. It was not reported if an autopsy was performed. The events were assessed as Unclassifiable by regulatory authority. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Deterioration in general condition; Unexplained cause of death


VAERS ID: 1121367 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: High temperature (even before vaccination); Sleepy
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021283016

Write-up: Fever; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021003266. A 92-year-old male patient received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 09Feb2021 (Batch/Lot Number: EL8723) as single dose for covid-19 immunisation. Medical history included sleepy, high temperature even before vaccination. The patient''s concomitant medications were not reported. The patient experienced fever (death) on 11Feb2021. The patient died on 11Feb2021. An autopsy was not performed. Relatedness of drug to reaction(s)/event(s) by PEI is: Inconsistent causal association. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever


VAERS ID: 1121370 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Coma, Death, Pyrexia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: Medical History/Concurrent Conditions: Dementia; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210306; Test Name: body temperature; Result Unstructured Data: Test Result:41 Centigrade
CDC Split Type: DEPFIZER INC2021282962

Write-up: Exitus letalis/Death; Fever 41 Centigrade; comatose; This is a spontaneous report from a non-contactable physician from the Agency Regulatory Authority-WEB DE-PEI-PEI2021003289. An 86-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: EP2163), via an unspecified route of administration at the age of 86 years old on 05Mar2021 at single dose for covid-19 immunisation. Medical history included Parkinson''s disease from an unknown date and unknown if ongoing, dementia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (COMIRNATY), via an unspecified route of administration at the age of 86 years old on 12Feb2021 at single dose for covid-19 immunisation and had been tolerated. The patient experienced exitus letalis (as reported) /death on 10Mar2021, fever 41 centigrade on 06Mar2021, comatose on 06Mar2021. 1 day after vaccination on 06Mar2021 the patient developed hyperpyrexia and comatose and then death, lasting for unknown. The patient died on 10Mar2021. An autopsy was performed and results were not provided. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The reported event ''hyperpyrexia'' was confirmed with temperature value below 41.5?C (or 106.7?F, choose the appropriate value), a value which, from a medical point of view is not consistent with ''hyperpyrexia''. The Company therefore coded this event as ''pyrexia''; Reported Cause(s) of Death: Exitus letalis/Death; Fever 41 ? C; Comatose


VAERS ID: 1121371 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-21
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 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: 2021-02-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021282963

Write-up: Sudden death, cause unknown; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency, WEB manufacturer report number DE-PEI-PEI2021003292 . A 70-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 09Feb2021 (Batch/Lot Number: EK9788) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sudden death, cause unknown (death) on 21Feb2021. The patient died on 21Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1121372 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-22
Onset:2021-02-02
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Breast cancer metastatic; Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021282967

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB DE-PEI-PEI2021003293. A 91-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 22Jan2021 at single dose for covid-19 immunisation. Medical history included diabetes mellitus and breast cancer metastatic, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced exitus letalis (death) on 02Feb2021. The patient died on 02Feb2021. It was not reported if an autopsy was performed. Source of assessment: Regulatory Authority, Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected. Batch number unknown, cannot be obtained.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1121375 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Diet refusal, Pyrexia, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-11
   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: Bronchitis (the 2nd vaccination was still carried out on 05Mar2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210306; Test Name: body temperature; Result Unstructured Data: Test Result:up to 39 Centigrade; Comments: up to 39?C
CDC Split Type: DEPFIZER INC2021287478

Write-up: Exitus letalis; Fever up to 39 C; Refusal to eat; cerebral seizure; This is a spontaneous report from a non-contactable physician downloaded from the Agency Regulatory Authority-WEB, Regulatory Authority Report Number: DE-PEI-PEI2021003349. A 68-years-old male patient received the second dose of bnt162b2 (COMIRNATY, lot number: EP2163), via an unspecified route of administration on 05Mar2021 as a single dose for COVID-19 immunization. Medical history included bronchitis from 04Mar2021 to an unknown date and the second vaccination was still carried out on 05Mar2021. The patient''s concomitant medications were not reported. The patient received the first dose of bnt162b2 (COMIRNATY) on 12Feb2021 for COVID-19 immunization and had been tolerated. The patient had a cerebral seizure on 05Mar2021, thereafter, a reduced general condition. The day after the vaccination, on 06Mar2021, the patient developed fever and diet refusal lasting for 6 days. The patient died on 11Mar2021 (reported as ''Exitus letalis''). The patient underwent lab tests and procedures which included body temperature of up to 39 centigrade on 06Mar2021. It was unknown if autopsy was performed. Source of assessment was reported as Regulatory Authority and the result of assessment was reported as indeterminate. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Refusal to eat; Fever up to 39 C


VAERS ID: 1121382 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Kaposi's sarcoma AIDS related, Laboratory test, Oxygen saturation, X-ray
SMQs:, Skin malignant tumours (narrow), Non-haematological malignant tumours (narrow), Opportunistic infections (narrow)

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: QUETIAPINA [QUETIAPINE]; BISOPROLOL; FUROSEMIDE; NOCTAMID; HYDRAPRES; GABAPENTIN; ELIQUIS; ESIDREX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Chronic kidney disease; Congestive heart failure; Decompensated heart failure; Disease progression (in the last 2 months); Dyspnea; Face edema (in the last 3 weeks); Heart failure; Hypertension arterial; Pulmonary hypertension
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:1.5; Test Name: Lab test; Result Unstructured Data: Test Result:microcytic anemia; Comments: microcytic anemia of 9.6 (previous of 10); Test Name: Lab test; Result Unstructured Data: Test Result:chronic renal failure; Comments: chronic renal failure exacerbated to 25 (previous of 33); Test Name: Laboratory tests; Result Unstructured Data: Test Result:AA AMG (alpha-Amylase and Amyloglucosidase) with n; Test Name: Laboratory tests; Result Unstructured Data: Test Result:28/5; Comments: bpm; Test Name: SatO2; Result Unstructured Data: Test Result:96-97 %; Test Name: X-ray; Result Unstructured Data: Test Result:signs of pulmonary congestion; Comments: signs of pulmonary congestion in the context of heart failure
CDC Split Type: ESPFIZER INC2021283056

Write-up: AIDS-associated hemorrhagic sarcoma; This is a spontaneous report from a contactable other healthcare professional downloaded from the WEB ES-AEMPS-782808. An 87-year-old female patient received the second dose of bnt162b2 (COMIRNATY, lot# EK9788), via intramuscular administered in deltoid at arm on 28Jan2021 as 0.3 mL, single for covid-19 immunisation. The patient had CCM (Chronic Care Model - death expected in less than a year-) and CCP (Complex Chronic Patient), with a marked deterioration during the last year and in procedures for institutionalization. Patient''s history: no known medical history or toxic habits, included hypertension arterial, atrial fibrillation, chronic kidney disease, heart failure + pulmonary hypertension, and dyspnea. She suffered from congestive heart failure, recently decompensated and treated in the emergency room on 05Jan2021 due to progressive deterioration of her baseline functional status in the last 2 months, with increased habitual dyspnea, and increased edema of the face in the last 3 weeks. Concomitant medications included quetiapine (QUETIAPINA) 25mg / day, bisoprolol 2.5mg / 12h, furosemide 40mg / 8h, lormetazepam (NOCTAMID) 2mg / day, hydralazine hydrochloride (HYDRAPRES) 25mg (0.5 tab / 8h), gabapentin 600mg / day, apixaban (ELIQUIS) 2.5mg / 12h, hydrochlorothiazide (ESIDREX) 25mg / day and oxygen carrier. The patient received the first dose of bnt162b2 (COMIRNATY) for covid-19 immunization on an unspecified date. The patient experienced AIDS-associated hemorrhagic sarcoma on 29Jan2021. On an unspecified date: X-ray: signs of pulmonary congestion in the context of heart failure. Laboratory tests with microcytic anemia of 9.6 (previous of 10), chronic renal failure exacerbated to 25 (previous of 33; Creatinine 1.5), and an AA AMG (alpha-Amylase and Amyloglucosidase) with normocapnic hypoxemia, with a tendency to metabolic alkalosis. Furosemide was prescribed, 96-97% SatO2 was maintained with VTM (ventilator) 28/5 bpm and improves, maintains diuresis in diapers. The day after vaccination with the second dose, the nursing home staff found her in a situation of cardiac arrest that did not respond to resuscitation maneuvers. Patient had no previous symptoms suggestive of reactogenicity to the vaccine. The patient died on 29Jan2021 due to cardiac arrest and AIDS-associated hemorrhagic sarcoma. No autopsy had been performed. Outcome of event was fatal. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: Cardiac arrest; AIDS-associated hemorrhagic sarcoma


VAERS ID: 1121383 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-02-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Anaphylactic reaction, Blood gases, Depressed level of consciousness, Dyspnoea, Malaise, Oxygen saturation, Oxygen saturation decreased, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Amyotrophic lateral sclerosis
Allergies:
Diagnostic Lab Data: Test Date: 20210224; Test Name: Blood gases; Result Unstructured Data: Test Result:severe hypercapnic respiratory failure; Test Date: 20210224; Test Name: oxygen saturation; Test Result: 80 %
CDC Split Type: ESPFIZER INC2021283155

Write-up: This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB manufacturer report number ES-AEMPS-784368. A 51-year-old male patient received bnt162b2 (COMIRNATY), dose 1 at age of 51-year-old via unspecified route on 24Feb2021 (Lot Number: EP9598) at 0.3 mL, single for covid-19 immunization. Medical history included non-bulbar amyotrophic lateral sclerosis from 2015, under outpatient follow-up, no baseline respiratory involvement or need for non-invasive mechanical ventilation, peripheral muscle involvement. The patient''s concomitant medications were not reported. First dose of bnt162b2 vaccine was administered on 24Feb2021 and 4 hours later, coinciding after dinner, he presented with sudden dyspnoea, with subsequent vomiting, general malaise and decreased level of consciousness. Emergency medical services found desaturation of 80%, respiratory work, no skin alterations. Oxygen and hydrocortisone were administered and he was transferred to hospital emergency. On arrival at the emergency department with low level of consciousness and desaturation. Blood gases showed severe hypercapnic respiratory failure (not present at baseline). Resuscitation and non-invasive ventilation were attempted (patient with a therapeutic ceiling for the underlying disease and the patient''s wishes) and the patient finally succumbed. A causal relationship secondary to vaccine anaphylaxis cannot be ruled out. additional information: Vaccine LOT: EP9598. Tryptase test has not been performed. Patient dependent for all activities of daily living due to muscular deficit, but with no history of dysphagia, bronchial aspiration or dyspnoea. He was not a user of mechanical ventilation. The patient died on 24Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected; Reported Cause(s) of Death: Acute Respiratory failure; Depressed level of consciousness; sudden dyspnoea; vomiting; general malaise; desaturation of 80%; secondary to vaccine anaphylaxis.


VAERS ID: 1121384 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Cerebral infarction, Computerised tomogram head, Cough, Depressed level of consciousness, Fall, General physical health deterioration, Hemiparesis, Hypertension
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypertension (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MIRTAZAPIN ACTAVIS; ORMOX; DIOVAN; SOMAC; FURESIS; SELOKEN ZOC; MAREVAN; VAGIFEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure; Home care; Low vision, both eyes (dry macular degeneration); Pacemaker insertion (cardiac) (pacemaker installed for sick sinus syndrome); Stenosis aortic valve; Vascular disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210214; Test Name: CT head; Result Unstructured Data: Test Result:cerebral infarction, no bleeding in head; Test Date: 20210219; Test Name: CT head; Result Unstructured Data: Test Result:no bleeds, infarction of the thalamus; Test Date: 20210227; Test Name: CT head; Result Unstructured Data: Test Result:unremarkable, no new findings; Test Date: 20210206; Test Name: CRP; Result Unstructured Data: Test Result:27; Test Date: 20210208; Test Name: CRP; Result Unstructured Data: Test Result:40-50; Test Date: 20210227; Test Name: CRP; Result Unstructured Data: Test Result:10
CDC Split Type: FIPFIZER INC2021283198

Write-up: General physical health deterioration; Hypertension; Cough; Muscle weakness right-sided; Fall; Cerebral infarction; Depressed level of consciousness; C-reactive protein increased; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [FI-FIMEA-20211153]. A 93-year-old female patient received BNT162B2 (COMIRNATY) via intramuscular at single dose on 02Feb2021 for COVID-19 immunisation. Medical history included aortic biograft for stenosis from 1999, described as HTA, FA, MCC(CABG), biovalve in aorta due to stenosis; heart failure from 2016, described as heart insufficiency; pacemaker installed in 2016, pacemaker installed for sick sinus syndrome; low vision, dry macular degeneration, described as poor vision, dry fundus degeneration; vascular disease; living at home with home care support. Cerebrovascular disease considered to be the cause of sight and stealing delusions, patient lived at home with the help of home care. Concomitant medications included mirtazapine (MIRTAZAPIN ACTAVIS, film-coated tablet) for sleep disorder; isosorbide mononitrate (ORMOX, tablet) for coronary artery disease; valsartan (DIOVAN, film-coated tablet) for cardiac insufficiency; pantoprazole sodium sesquihydrate (SOMAC, gastro-resistant coated tablet) for gastrooesophageal reflux prophylaxis; furosemide (FURESIS, tablet) for cardiac insufficiency; metoprolol succinate (SELOKEN ZOC, prolonged-release tablet) for atrial fibrillation; warfarin sodium (MAREVAN, tablet) for atrial fibrillation; estradiol (VAGIFEM, vaginal tablet). On 03Feb2021, patient presented general physical health deterioration, hypertension, cough, muscle weakness right-sided, bed ridden patient, fell twice at home, cerebral infarction, depressed level of consciousness and C-reactive protein increased. On 06Feb2021, patient was to visited on-call, CRP 27, mecillinam (SELEXID) started, was admitted. Cough at ward, PLV enterococcus, hypertensive. On 08Feb2021, amoxicillin/clavulanate potassium (AMOXIN COMP) swapped as antibiotic, no fever, CRP around 40-50. On 12Feb2021, patient was released home. On 14Feb2021 morning, producing was abnormal, right sided weakness in the extremities. Findings fitting cerebral infarction found at on-call, no bleeding in head CC, INR 2.7. Symptoms worsened at neurology ward. CT head on 14Feb2021 presented clinical findings in the emergency room consistent with cerebral infarction, no bleeding in head. On 16Feb2021, patient was taken in as bed patient, moved around assisted by a nurse. On 17Feb2021, patient fell went alone to use the restroom without a nurse and rollator. On 18Feb2021, patient fell again. On 19Feb2021, patient had change in the level of consciousness. On-call head CT no bleeds, infarction of the thalamus. Cefuroxime initiated due to elevated inflammatory values iv. On 24Feb2021, patient even went home with the help of her daughter. Planned to be taken to aid home, however, 27Feb2021, neurological situation suddenly worsened. Head CT: unremarkable, no new findings; CRP was 10. Patient moved to symptomatic treatment and 02Mar2021 determined to be in convalescent phase. On 03Mar2021, patient died in the early hours of the morning. It was unknown if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: General physical health deterioration; Hypertension; Cough; Muscle weakness right-sided; Fall; Cerebral infarction; Depressed level of consciousness; C-reactive protein increased


VAERS ID: 1121385 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-08
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Hypertension arterial; Intestinal angioma; Lumbar spinal stenosis; Peripheral arterial occlusive disease; Psoriasis; Psoriatic arthropathy; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021283119

Write-up: Death unexplained/unexpected sudden death; This is a spontaneous report from a contactable physician from the Agency WEB FR-AFSSAPS-BR20210618. A 75-year-old female patient received the first dose of BNT162B2 (COMIRNATY, batch/Lot Number: EP9605), intramuscularly, administered in arm left on 05Mar2021 at single dose for covid-19 immunisation (reported as covid-19 vaccination). Medical history included peripheral arterial occlusive disease from an unknown date and unknown if ongoing, intestinal angioma from an unknown date and unknown if ongoing, anaemia from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, psoriatic arthropathy from an unknown date and unknown if ongoing, hypertension arterial from an unknown date and unknown if ongoing, lumbar spinal stenosis from an unknown date and unknown if ongoing, type 2 diabetes mellitus from an unknown date and unknown if ongoing. The patient had a treatment with 2 immunomodulating treatments Monoclonal Ab. The patient experienced death unexplained/unexpected sudden death on 08Mar2021. The patient died on 08Mar2021. 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: Death unexplained/unexpected sudden death


VAERS ID: 1121386 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cerebral haematoma, Disease recurrence, Embolism, Haemorrhagic transformation stroke, Ischaemic stroke
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KARDEGIC; ATORVASTATIN; DILTIAZEM; LEVOTHYROXINE; DESLORATADINE; MACROGOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of colon; Aphasia (sequelae aphasia); Benign paroxysmal postural vertigo; Hypertension arterial; Hypothyroidism; Ischemic stroke (Left sylvic ischemic stroke)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021272347

Write-up: Embologenic heart disease (atrial fibrillation with complete arrhytmia); Embologenic heart disease (atrial fibrillation with complete arrhytmia); hemorrhagic transformation; deep right sylvic hematoma; Ischemic stroke/severe right sylvian ischemic stroke; Ischemic stroke/severe right sylvian ischemic stroke; This is a spontaneous report from a contactable pharmacist downloaded from the Medicines Agency (MA) WEB FR-AFSSAPS-GR20210525. An 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported) intramuscularly on 15Feb2021 as 0.3 mg, single, for COVID-19 immunisation. Medical history included benign paroxysmal postural vertigo, sequelae aphasia, hypothyroidism all from an unknown date, adenocarcinoma of colon from 2015, hypertension arterial from an unknown date, left sylvic ischemic stroke from Aug2020, all unknown if ongoing. Concomitant medications included acetylsalicylate lysine (KARDEGIC); atorvastatin; diltiazem; levothyroxine; desloratadine; macrogol, all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included dose 1 of bnt162b2 (COMIRNATY, Batch/Lot number was not reported) intramuscularly on 18Jan2021 as 0.3 mg, single for COVID-19 immunisation. The patient experienced ischemic stroke (ischaemic stroke) (death, hospitalization) on 17Feb2021. The patient was hospitalized for ischemic stroke (ischaemic stroke) from 17Feb2021 to an unknown date. Hospitalization for severe right sylvian ischemic stroke, upon discovery of atrial fibrillation with complete arrhythmia. Differential diagnosis: Embologenic heart disease (atrial fibrillation with complete arrhythmia) discovered during this 2nd ischemic stroke. No information on imaging on damage to small or large arteries (atherosclerosis, dissection, arteritis). Evolution: Management of stroke by thrombectomy, complication with hemorrhagic transformation and deep right sylvic hematoma. Therapeutic measures were taken as a result of ischemic stroke, treatment included thrombectomy. The outcome of the events was fatal. The patient died on 28Feb2021. An autopsy was not performed. No FU attempts are possible. No further information is expected.; Reported Cause(s) of Death: Ischemic stroke/severe right sylvian ischemic stroke; Embologenic heart disease (atrial fibrillation with complete arrhytmia); Embologenic heart disease (atrial fibrillation with complete arrhytmia); hemorrhagic transformation; deep right sylvic hema


VAERS ID: 1121387 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-07
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic respiratory failure; COPD; Dyslipidaemia; Lung upper lobectomy; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021283013

Write-up: Hypoxia; Cardio-respiratory arrest; discomfort; Feeling sick; This is a spontaneous report from a contactable physician from the Regulatory Authority Number FR-AFSSAPS-GR20210634. A 77-year-old male patient received second dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EK9788) intramuscularly on 01Feb2021 as 0.3 mL, single for covid-19 immunisation. Medical history included chronic respiratory failure; chronic obstructive pulmonary disease (COPD); upper right lobectomy; type 2 diabetes; dyslipidemia. The patient''s concomitant medications were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY) on an unspecified date for covid-19 immunisation. On 07Feb2021, the patient felt bad at the end of the day, with discomfort. Around 10 p.m., call to the Emergency because of discomfort with hypoxia. Due to cardio-respiratory arrest, beginning of cardiac massage by the neighbors, then his daughter, then the Emergency for 45 minutes. Patient died on 07Feb2021. An autopsy was not performed. The reported cause of death was feeling sick, hypoxia and cardio-respiratory arrest. Outcome of feeling sick, hypoxia and cardio-respiratory arrest was fatal, outcome of discomfort was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest; Feeling sick; Hypoxia


VAERS ID: 1121388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Chronic obstructive pulmonary disease
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KARDEGIC; POTASSIUM CHLORIDE; MIANSERIN; PARACETAMOL; LORAZEPAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Benign prostatic hyperplasia; Cognitive disorders; Ischemic cardiomyopathy; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021283144

Write-up: bronchial superinfection on COPD/ chronic obstructive bronchopneumopathy.; bronchial superinfection on COPD/ chronic obstructive bronchopneumopathy.; This is a spontaneous report from a contactable Pharmacist downloaded from the Agency Agency-WEB FR-AFSSAPS-LL20211080. An 89-year-old male patient received first dose of BNT162B2 (COMIRNATY, Lot EJ6796 and Expiration Date unknown) via Intramuscular on 07Jan2021 at single dose for COVID-19 immunisation. Medical history of arterial hypertension, benign prostatic hyperplasia, osteoporosis, cognitive disorders, ischemic cardiomyopathy with preserved LVEF. Concomitant medications included acetylsalicylate lysine (KARDEGIC) at 75 mg, daily, potassium chloride at 600 mg, 1x/day, Mianserin 10mg 2cp / d, paracetamol 1g X3 if necessary, and lorazepam 1mg. On 11Jan2021 the patient dies, in the course of bronchial superinfection on COPD/ chronic obstructive bronchopneumopathy. It is unknown if autopsy was done. Outcome of the event was fatal. No follow-up attempts are possible, information on batch number already obtained.; Reported Cause(s) of Death: bronchial superinfection on COPD/ chronic obstructive bronchopneumopathy.; bronchial superinfection on COPD/ chronic obstructive bronchopneumopathy.


VAERS ID: 1121389 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aneurysm ruptured, Body mass index, Investigation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:normal; Test Date: 20210222; Test Name: External examination; Result Unstructured Data: Test Result:signs of asphyxia with cyanosis of the toes and fi; Comments: signs of asphyxia with cyanosis of the toes and fingernails. No traumatic elements; Test Date: 20210222; Test Name: Visceral examination; Result Unstructured Data: Test Result:Absence of macroscopic lesions of the cephalic ext; Comments: Absence of macroscopic lesions of the cephalic extremity. Large retroperitoneal hematoma extending from the diaphragmatic dome to the bladder. Secondary to a rupture of an atherosclerotic aneurysm of the abdominal aorta under renal (12.5 cm in circumference). Calcified coronary arteries and diffuse atherosclerosis of the arterial network. Presence of food bolus (death shortly after the meal).
CDC Split Type: FRPFIZER INC2021283134

Write-up: Aneurysm ruptured; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-LM20210484. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 17Feb2021 9:50 a.m (Batch/Lot Number: UNKNOWN) as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient living at home with his wife. Patient BMI was normal. Patient previously received first dose of bnt162b2 on 28Jan2021 10:50 a.m as single dose for covid-19 immunisation, and had no adverse effect. On 18Feb2021 in the morning, patient was fine according to his son, had his daughter on the phone during the day and had lunch with his wife. Lied down to take a nap. Found deceased. Death certificate at 4:40 p.m. by doctor. The patient experienced aneurysm ruptured and sudden death on 18Feb2021. Autopsy on received 22Feb2021. External examination: signs of asphyxia with cyanosis of the toes and fingernails. No traumatic elements. Visceral examination: Absence of macroscopic lesions of the cephalic extremity. Large retroperitoneal hematoma extending from the diaphragmatic dome to the bladder. Secondary to a rupture of an atherosclerotic aneurysm of the abdominal aorta under renal (12.5 cm in circumference). Calcified coronary arteries and diffuse atherosclerosis of the arterial network. Presence of food bolus (death shortly after the meal). Lack of other elements that could explain the death. In conclusion, death appears secondary to a cardiovascular cause, namely a rupture of the aneurysm of abdominal aorta. No follow-up attempts possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Aneurysm ruptured; Autopsy-determined Cause(s) of Death: Aneurysm ruptured


VAERS ID: 1121390 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Asthenia, Bacterial pyelonephritis, Blood bicarbonate, Blood creatinine, Blood potassium, Blood sodium, C-reactive protein, COVID-19, COVID-19 pneumonia, Chills, Coma scale, Computerised tomogram, Cough, Culture urine, General physical health deterioration, Haemoglobin, Klebsiella infection, Liver function test, Microscopy, Oedema peripheral, Physical examination, Platelet count, Pyrexia, SARS-CoV-2 test, Sepsis, Urine analysis, White blood cell count
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BISOPROLOL; ATORVASTATIN; DEPAKOTE; RISPERIDONE; FUROSEMIDE; CANDESARTAN CILEXETIL; RENVELA; LYRIC [PREGABALIN]; MELAXOSE; MIMPARA; LAMALINE [CAFFEINE;PAPAVER SOMNIFERUM LATEX;PARACETAMOL]; NOVORAPID; ABASAGLAR; KARDEGIC; PANTOPRAZOLE; CALC
Current Illness: Chronic renal failure
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Arterial hypertension; Atrioventricular block; Bipolar disorder; Cardiorenal syndrome; Congestive heart failure; Diabetic nephropathy; Heart block atrioventricular; Heart disease, unspecified (with conserved fraction of ejection); Hemodialysis; Hyperparathyroidism secondary; Hyperuricemia; Nephroangiosclerosis; Obesity; Sleep apnea syndrome; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: ALT; Result Unstructured Data: Test Result:195; Comments: increased; Test Date: 20210211; Test Name: AST; Result Unstructured Data: Test Result:250; Comments: increased; Test Date: 20210205; Test Name: bicarbonates; Result Unstructured Data: Test Result:28 mmol/L; Test Date: 20210205; Test Name: creatinine; Result Unstructured Data: Test Result:194 umol/l; Test Date: 20210211; Test Name: creatinine; Result Unstructured Data: Test Result:544 umol/l; Test Date: 20210205; Test Name: potassium; Result Unstructured Data: Test Result:3.2 mmol/L; Test Date: 20210205; Test Name: sodium; Result Unstructured Data: Test Result:139 mmol/L; Test Date: 202102; Test Name: Glasgow score; Result Unstructured Data: Test Result:15; Test Date: 202102; Test Name: thoracic CT; Result Unstructured Data: Test Result:compatible aspect with SARS-cov-2 pneumonia; Comments: with multiple focus of superinfection of pneumonic appearance; Test Date: 20210205; Test Name: C-reactive protein; Result Unstructured Data: Test Result:27 mg/l; Test Date: 202102; Test Name: culture of urine; Result Unstructured Data: Test Result:disclosed infection to Klebsiella Pneumoniae exten; Comments: disclosed infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases; Test Date: 20210205; Test Name: hemoglobin; Result Unstructured Data: Test Result:100 g/l; Test Date: 20210211; Test Name: hemoglobin; Result Unstructured Data: Test Result:87 g/l; Test Date: 20210205; Test Name: liver function; Result Unstructured Data: Test Result:normal; Test Date: 202102; Test Name: microscopy; Result Unstructured Data: Test Result:disclosed infection to Klebsiella Pneumoniae exten; Comments: disclosed infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases; Test Date: 202102; Test Name: cardiac examination; Result Unstructured Data: Test Result:no unusual sign; Test Date: 20210205; Test Name: platelets; Result Unstructured Data: Test Result:152 x10 9/l; Test Date: 20210211; Test Name: platelets; Result Unstructured Data: Test Result:132 x10 9/l; Test Date: 20210206; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Date: 202102; Test Name: culture of urine; Result Unstructured Data: Test Result:infection to Klebsielle Pneumoniae; Test Date: 20210205; Test Name: white blood cells; Result Unstructured Data: Test Result:6 x10 9/l; Test Date: 20210211; Test Name: white blood cells; Result Unstructured Data: Test Result:5.2 x10 9/l
CDC Split Type: FRPFIZER INC2021272353

Write-up: general and respiratory condition deterioration; SARS-CoV-2 (RT-PCR) was positive/COVID-19 aggravated; discreet edema of lower limbs; chills; light dry cough; fever; pneumonia to SARS-Cov-2; bacterial pyelonephritis; infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases; important septic state; important asthenia; This is a spontaneous report from a contactable pharmacist downloaded from the WEB FR-AFSSAPS-LY20211184. A 73-year-old female patient received first dose of bnt162b2 (COMIRNATY), intramuscular on 29Jan2021 (Batch/Lot Number: EJ6788) at single dose for COVID-19 vaccination. Medical history included heart block atrioventricular, anemia, arterial hypertension, type 2 diabetes mellitus, hyperparathyroidism secondary, ongoing chronic renal failure associated with diabetic nephropathy, obesity, bipolar disorder, sleep apnea syndrome, hyperuricemia, nephroangiosclerosis, cardio-renal syndrome, with hemodialysis initiated on 10Apr2019, heart disease with conserved fraction of ejection with multiple episodes of congestive heart failure, atrioventricular block with pacemaker. SARS-Cov-2 history was unknown. Concomitant medications included bisoprolol, atorvastatin, valproate semisodium (DEPAKOTE), risperidone, furosemide, candesartan cilexetil, sevelamer carbonate (RENVELA), pregabalin (LYRIC), lactulose, paraffin, liquid (MELAXOSE), cinacalcet hydrochloride (MIMPARA), caffeine, papaver somniferum latex, paracetamol (LAMALINE), insulin aspart (NOVORAPID), insulin glargine (ABASAGLAR), acetylsalicylate lysine (KARDEGIC), pantoprazole, calcium carbonate (CALCIDOSE), zopiclone (IMOVANE), sodium polystyrene sulfonate (KAYEXALATE). On 29Jan2021 patient received a first injection of COVID-19 mRNA Vaccine (nucleoside modified) (COMIRNATY) for vaccination against SARS-COV-2. On 03Feb2021 patient felt after dialysis. On 05Feb2021 patient experienced chills, but no fever, with light dry cough not noticed before. Hemodynamic state was stable. No clinical evidence of infection was observed, no dysuria, no bowel disorder. No unusual sign on cardiac examination, but discreet edema of lower limbs. No clinical evidence of pneumonia. No bowel disorder. The patient presented with important asthenia, but Glasgow score was 15. Antibiotics by ceftriaxone sodium (unspecified trade name) and gentamicin (unspecified trade name) were started. On 06Feb2021 SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) was positive. Later, pulmonary condition decreased with wheezing and crackles in bases, requiring oxygen therapy. Direct microscopy and culture of urine disclosed infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases, requiring a treatment by imipenem (unspecified trade name) 500mg twice daily. In Feb2021, the patient presented with important septic state with unwell tolerated fever, and covid-19 aggravated. On 16Feb2021 due to general and respiratory condition deterioration it was decided to stop active treatments and to continue comfort care. Patient died on 17Feb2021. In total: complications of pneumonia to SARS-Cov-2 with (bacterial) pyelonephritis to Klebsielle Pneumoniae extended-spectrum beta-lactamases. Laboratory work-up: On 05Feb2021: white blood cells 6 x10^9/L, heamoglobin 100 g/L, platelets 152 x10^9/L, sodium 139 mmol/L, potassium 3.2 mmol/L, bicarbonates 28 mmol/L, creatinine 194 umol/L (usual range not known), liver function was normal, C-reactive-protein 27 mg/L. On 11Feb2021: white blood cells 5.2 x10^9/L, hemoglobin 87 g/L, platelets 132 x10^9/L, creatinine 544 umol/L (usual range not known), increased transaminases (Aspartate aminotransferase 250 and alanine aminotransferase 195 normal ranges not available). Additional examination: In Feb2021 thoracic computed tomography disclosed compatible aspect with SARS-cov-2 pneumonia, with multiple focus of superinfection of pneumonic appearance. The patient died on 17Feb2021. Cause of death was bacterial pyelonephritis and COVID-19 pneumonitis, covid-19, infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases and general and respiratory condition deterioration. 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: infection to Klebsiella Pneumoniae extended-spectrum beta-lactamases; general and respiratory condition deterioration; SARS-CoV-2 (RT-PCR) was positive/COVID-19 aggravated; Bacterial pyelonephritis; COVID-19 pneumonitis


VAERS ID: 1121393 (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: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood lactic acid, Blood potassium, Blood pressure measurement, Coma scale, Death, Heart rate, Oxygen saturation, PCO2, PO2, pH body fluid
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Balance disorder; Dementia Alzheimer''s type; Depression; Humerus fracture; Hypertension arterial; Hysterectomy; Oophorectomy bilateral
Allergies:
Diagnostic Lab Data: Test Date: 20210227; Test Name: bicarbonates; Result Unstructured Data: Test Result:16.8 mmol/L; Test Date: 20210227; Test Name: lactates; Result Unstructured Data: Test Result:13.7 mmol/L; Test Date: 20210227; Test Name: potassium; Result Unstructured Data: Test Result:7.7 mmol/L; Test Date: 20210226; Test Name: blood pressure; Result Unstructured Data: Test Result:14/6 mmHg; Test Date: 20210226; Test Name: blood pressure; Result Unstructured Data: Test Result:12.5 / 5.5 mmHg; Test Date: 20210227; Test Name: Coma Scale; Result Unstructured Data: Test Result:3; Test Date: 20210226; Test Name: pulse; Result Unstructured Data: Test Result:98 bpm; Test Date: 20210226; Test Name: pulse; Result Unstructured Data: Test Result:102 bpm; Test Date: 20210226; Test Name: oxygen saturation; Test Result: 92 %; Test Date: 20210226; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20210227; Test Name: oxygen saturation; Test Result: 70 %; Test Date: 20210227; Test Name: pCO2; Result Unstructured Data: Test Result:74 mmHg; Test Date: 20210227; Test Name: blood gas pH; Result Unstructured Data: Test Result:6.96; Test Date: 20210227; Test Name: pO2; Result Unstructured Data: Test Result:127 mmHg
CDC Split Type: FRPFIZER INC2021283053

Write-up: DEATH; This is a spontaneous report from PHARMACIST downloaded from the Agency WEB FR-AFSSAPS-MP20210380. An 89-year-old female patient received second dose of bnt162b2 (COMIRNATY, Lot Number: EP9598), intramuscular on 26Feb2021 at 9:56 a.m. at single dose for covid-19 immunization. Medical history included balance disorder from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing dementia alzheimer''s type from an unknown date and unknown if ongoing, oophorectomy bilateral from an unknown date and unknown if ongoing , hysterectomy from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, left humeral fracture with elbow to body from 17Feb2021. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) at single dose for covid-19 immunization. The patient experienced death on 27Feb2021. The patient underwent lab tests and procedures which included blood bicarbonate: 16.8 mmol/l on 27Feb2021, blood lactic acid: 13.7 mmol/l on 27Feb2021, blood potassium: 7.7 mmol/l on 27Feb2021, blood pressure measurement: 14/6 mmhg on 26Feb2021, blood pressure measurement: 12.5 / 5.5 mmhg on 26Feb2021, coma scale: 3 on 27Feb2021, heart rate: 98 bpm on 26Feb2021, heart rate: 102 bpm on 26Feb2021, oxygen saturation: 92 % on 26Feb2021, oxygen saturation: 96 % on 26Feb2021, oxygen saturation: 70 % on 27Feb2021, pco2: 74 mmhg on 27Feb2021, ph body fluid: 6.96 on 27Feb2021, po2: 127 mmhg on 27Feb2021. The patient died on 27Feb2021. An autopsy was not performed. History of COVID-19 was unknown. No Person tested. Person vaccinated as part of the COVID-19 vaccination campaign. The clinical course was reported as follows: 27Feb2021: at 11 a.m., tachycardia (value not given) and mottling justifying a call to 15. Emergency room: disturbances of consciousness, patient 3 with reactive mydriasis, generalized mottling, irregular rhythm disturbances at 40 / min , impregnable blood pressure, respiratory distress with a saturation at 70% under 5 liters of oxygen and gasps.Other contributive additional examinations: 27Feb2021: blood gas: pH = 6.96; pCo2 = 74 mmHg (VN = 32-45 mmHg); pO2 = 127 mmHg (VN = 72-103 mmHg), bicarbonates = 16.8 mmol / l; Lactates = 13.7 mmol / L; Potassium = 7.7 mmol / L. Evolution: Decision not to resuscitate given the age and comorbidities, death noted at 2:30 p.m. Brief but complete file, no other information available. No follow-up attempts are possible, information on batch number already obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1121396 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Oxygen saturation decreased
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertensive heart disease NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021283220

Write-up: Breathing difficult; Arterial oxygen saturation decreased; This is a spontaneous report from a contactable other healthcare professional downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-PB20211005, this is a report received from the Regulatory Authority. A 95-year-old (also reported as 96-year-old) female patient received bnt162b2 (COMIRNATY), dose 2 via intramuscular, administered in arm left on 17Feb2021 (Lot Number: EJ6795) at single dose for covid-19 immunization. Medical history included stented hypertensive heart disease, without a medical history of COVID 19. The patient''s concomitant medications were not reported. Appearance on 18Feb2021 in the evening of a desaturation/arterial oxygen saturation decreased and difficulty in breathing/breathing difficult. Call from the Emergency medical services and the Fire Department. Death of the patient on the way to the hospital. The patient died on 18Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained. ; Reported Cause(s) of Death: Arterial oxygen saturation decreased; Breathing difficult


VAERS ID: 1121397 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-18
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pyrexia, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic 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: 2021-02-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210221; Test Name: fever; Result Unstructured Data: Test Result:39 Centigrade; Test Date: 20210218; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: FRPFIZER INC2021283098

Write-up: COVID-19 with symptoms; COVID-19 PCR test positive; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PO20211154. A 93-years-old female patient received bnt162b2 (COMIRNATY) vaccine, dose 2 intramuscular, administered in Arm Right on 10Feb2021 (Batch/Lot Number: EJ6789) as 0.3 mL, single, dose 1 intramuscular on 20Jan2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation . Medical history included hypertension , cardiac failure. The patient''s concomitant medications were not reported. The patient experienced covid-19 PCR test positive on 18Feb2021 , covid-19 with symptoms on 21Feb2021: appearance of fever at 39 ?C, cough, bronchial congestion and desaturation. Treated with 5 L O2 and antibiotic therapy. The patient underwent lab tests and procedures which included pyrexia: 39?C on 21Feb2021 , sars-cov-2 test positive on 18Feb2021. The patient died on 23Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Batch/lot number of the first dose cannot be obtained.; Reported Cause(s) of Death: Covid-19


VAERS ID: 1121402 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-30
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood lactic acid, Blood pressure measurement, Cardio-respiratory arrest, Electrocardiogram, SARS-CoV-2 test, Troponin, pH body fluid
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   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: SEROPLEX; LOXAPAC [LOXAPINE SUCCINATE]; OXAZEPAM; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Hypertension (NOT TREATED STABLE (140/70)); Loss of personal independence in daily activities; Wandering
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: creatinine; Result Unstructured Data: Test Result:360; Test Date: 20210131; Test Name: lactates; Result Unstructured Data: Test Result:20; Test Name: blood pressure; Result Unstructured Data: Test Result:140/70; Test Date: 20210131; Test Name: ECG; Result Unstructured Data: Test Result:negative T waves in the antero-septal; Test Date: 20210131; Test Name: pH; Result Unstructured Data: Test Result:6.9; Test Date: 20210131; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210131; Test Name: troponin; Result Unstructured Data: Test Result:15000
CDC Split Type: FRPFIZER INC2021283026

Write-up: Death NOS/ Cardiopulmonary arrest; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. A 78-years-old male patient received bnt162b2 (COMIRNATY), dose 1, via intramuscular on 18Jan2021 (Lot Number: EM0477) as single dose for COVID-19 immunisation. Medical history included Dementia Alzheimer''s type, autonomy loss, hypertension (not treated stable (140/70)) and wandering from an unknown date and unknown if ongoing. Concomitant medication(s) included escitalopram oxalate (SEROPLEX) taken for an unspecified indication from 12May2020 to 29Jan2021; loxapine succinate (LOXAPAC) taken for an unspecified indication from 29Jan2021 to 31Jan2021; oxazepam taken for an unspecified indication from 04Jan2021 to 09Jan2021 and paracetamol taken for an unspecified indication, start and stop date were not reported. The patient experienced death NOS on 31Jan2021. The clinical course included on 18Jan2021, the patient received first dose vaccination with COMIRNATY at the vaccination center. Pre-vaccination checkup done. 29Jan2021: visit of the attending physician and change of usual treatment: start of LOXAPAC, stop SEROPLEX. Night from 30Jan2021 to 31Jan2021: Cardiopulmonary arrest at home recovered. Transfer to the emergency room and new cardiopulmonary arrest recovered after 3 minutes of ECM. New cardiopulmonary arrest at 4:45 am not recovered: death observed. Biological examinations on 31Jan2021: major metabolic acidosis (lactates 20), troponin 15,000, creatinine 360, pH 6.9. Probable right lung inhalation. Clinical examination on entry. Cardiopulmonary auscultation: probable inhalation of right lung. Recovers during the journey communicates but confused, no neurological deficit, no anisocoria. Additional exams on 31Jan2021: ECG: negative T waves in the antero-septal. Biology: gas measurement: lactates 20, pH 6.9 no hyperkalaemia. COVID-19 virus test: negative on 31Jan2021. Evolution: Patient died on 31Jan2021. It was not reported if an autopsy was performed. The cause of death was reported as cardiopulmonary arrest.; Reported Cause(s) of Death: Cardiopulmonary arrest


VAERS ID: 1121403 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bronchopneumopathy, Oxygen saturation, Oxygen saturation decreased, Respiratory rate
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-26
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Dementia; Parkinsonism; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210224; Test Name: fever; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210224; Test Name: desaturation; Test Result: 87 %; Test Date: 20210224; Test Name: tachypnea; Result Unstructured Data: Test Result:48
CDC Split Type: FRPFIZER INC2021283049

Write-up: Bronchopneumopathy/episode of dyspnea/ Distress respiratory, tachypnea/ supraclavicular indrawing/ outbreak; Oxygen saturation decreased; This is a spontaneous report downloaded from the WEB FR-AFSSAPS-TS20210576. This is a report received from the Regulatory Authority. A contactable Physician reported that a 80 years old male patient received second dose bnt162b2 (COMIRNATY, lot number EK9788), intramuscular on 17-FEB-2021 at single dose for COVID-19 vaccination. The medical history was stroke, parkinsonism complicated by dementia and bedridden state. The concomitant medications were not reported. The Historical Vaccine was first dose COMIRNATY for COVID-19 immunisation. On 24Feb2021, he had an episode of dyspnea with desaturation (87 percent), Distress respiratory ,tachypnea (respiratory rate at 48) and supraclavicular indrawing, without fever (37. 2 Centigrade).Due to a doubt about an outbreak of the left base, he received antibiotic therapy (Augmentin Rovamycin) and morphine (for eupnea).The patient died on 26Feb2021. All in all, severe bronchopneumopathy complicated by desaturation and death on D7 of vaccination in an elderly patient who was bedridden but without a respiratory history.The patient underwent lab tests and procedures, which included fever: 37.2 Centigrade, desaturation 87%,tachypnea 48,all the lab tests on 24-FEB-2021. The patient died on 26-FEB-2021. The autopsy was not performed. The cause of death was bronchopneumopathy and Oxygen saturation decreased. The outcome of events was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Bronchopneumopathy; desaturation


VAERS ID: 1121404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-03-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Superior vena cava syndrome
SMQs:, Embolic and thrombotic events, venous (narrow), Malignancy related conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LERCANIDIPINE; COTRIATEC; ULTIBRO BREEZHALER
Current Illness: Chronic bronchitis; Hypertension arterial
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021283050

Write-up: Death unexplained; hypothesis of superior vena cava syndrome/gasping/Edema in the upper body; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-TS20210597. A 93-year-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not specified), intramuscularly on 26Feb2021 (no information if it was the first or the second dose) at single dose for COVID-19 immunisation. Medical history included Hypertension arterial/high blood pressure and chronic bronchitis, both ongoing. Patient under guardianship living at home. Concomitant medications included lercanidipine; hydrochlorothiazide, ramipril (COTRIATEC); glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER). The patient experienced death unexplained on 01Mar2021. Upon the arrival of the housekeeper and the nurse on the morning of 01Mar2021, patient found on the ground gasping. Edema in the upper body (neck, shoulders, upper torso), purplish in color. The doctor did not suggest an allergic reaction and put forward the hypothesis of superior vena cava syndrome. In total, death following edema of the upper body (superior vena cava syndrome?) In a patient who had been vaccinated 3 days earlier with bnt162b2. The outcome of event superior vena cava syndrome was fatal. The patient died on 01Mar2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: hypothesis of superior vena cava syndrome/gasping/Edema in the upper body; Death unexplained


VAERS ID: 1121405 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-11
Onset:2021-02-08
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Basophil count, Blood albumin, Blood bicarbonate, Blood calcium, Blood creatinine, Blood potassium, Blood sodium, Blood thyroid stimulating hormone, Blood urea, C-reactive protein, Electrocardiogram, Eosinophil count, Glomerular filtration rate, Glycosylated haemoglobin, Haematocrit, Haemoglobin, Lymphocyte count, Mean cell volume, Monocyte count, Neutrophil count, Pemphigoid, Platelet count, Protein total, Red blood cell count, Vitamin B12, Vitamin D, White blood cell count
SMQs:, Severe cutaneous adverse reactions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-27
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CANDESARTAN; L-THYROXINE [LEVOTHYROXINE]; SOTALOL; ZOPICLONE; ALPRAZOLAM; ATORVASTATIN; DUPHALAC [LACTULOSE]; NORMACOL [CALENDULA OFFICINALIS;RHAMNUS FRANGULA]; DOLIPRANE; Venlafaxine HCl
Current Illness: Cerebral microangiopathy (with microbleeds (contraindicating antiaggregants and anticoagulants))
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Carpal tunnel decompression (right and left carpal tunnel surgery); Cesarean section (3 cesarean sections); Cholecystectomy; Foot ulcer; Knee surgery NOS (right and left); Spinal operation (narrow lumbar canal surgery); Thyroidectomy partial; Toe amputation (right 5th toe following ulceration); Total hip replacement; Varicose vein operation (surgery for varicose veins of the lower limb)
Allergies:
Diagnostic Lab Data: Test Date: 20210219; Test Name: basophiles; Result Unstructured Data: Test Result:0,78 g/l; Test Date: 20210223; Test Name: basophiles; Result Unstructured Data: Test Result:0,29 g/l; Test Date: 20210223; Test Name: hypoalbuminemia; Result Unstructured Data: Test Result:30 g/l; Test Date: 20210223; Test Name: alkaline reserve; Result Unstructured Data: Test Result:23 mmol/L; Test Date: 20210223; Test Name: calcium; Result Unstructured Data: Test Result:2,27 mmol/L; Test Date: 20210223; Test Name: corrected calcemia; Result Unstructured Data: Test Result:2,52 mmol/L; Test Date: 20210223; Test Name: creatinine; Result Unstructured Data: Test Result:50 umol/l; Test Date: 20210223; Test Name: hypokalaemia; Result Unstructured Data: Test Result:3,78 mmol/L; Test Date: 20210223; Test Name: hypernatremia; Result Unstructured Data: Test Result:147 mmol/L; Test Date: 20210223; Test Name: TSH; Result Unstructured Data: Test Result:1,29 mU/l; Test Date: 20210223; Test Name: urea; Result Unstructured Data: Test Result:9,96 mmol/L; Test Date: 20210219; Test Name: CRP; Result Unstructured Data: Test Result:3,4 mg/l; Test Date: 20210223; Test Name: CRP; Result Unstructured Data: Test Result:20,4 mg/l; Test Date: 20210223; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm 100/mn, QRS ends, PR 0,16s, some sh; Comments: sinus rhythm 100/mn, QRS ends, PR 0,16s, some shifting premature ventricular contraction (PVC), Q DIII, AQRS 10 degrees, repolarization Nle; Test Date: 20210219; Test Name: hypereosinophilia; Result Unstructured Data: Test Result:1,027 g/l; Test Date: 20210223; Test Name: hypereosinophilia; Result Unstructured Data: Test Result:1,416 g/l; Test Date: 20210223; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:90 ml/min; Test Date: 20210223; Test Name: glycosylated hemoglobin; Result Unstructured Data: Test Result:5,70 %; Test Date: 20210219; Test Name: haematocrit; Result Unstructured Data: Test Result:38,5 %; Test Date: 20210223; Test Name: haematocrit; Result Unstructured Data: Test Result:41,7 %; Test Date: 20210219; Test Name: haemoglobin; Result Unstructured Data: Test Result:12,8 g/dl; Test Date: 20210223; Test Name: haemoglobin; Result Unstructured Data: Test Result:13,9 g/dl; Test Date: 20210219; Test Name: lymphocytes; Result Unstructured Data: Test Result:1,85 g/l; Test Date: 20210223; Test Name: lymphocytes; Result Unstructured Data: Test Result:1,602 g/l; Test Date: 20210219; Test Name: mean cell volume; Result Unstructured Data: Test Result:89; Test Date: 20210223; Test Name: mean cell volume; Result Unstructured Data: Test Result:89; Test Date: 20210219; Test Name: monocytes; Result Unstructured Data: Test Result:0,75 g/l; Test Date: 20210223; Test Name: monocytes; Result Unstructured Data: Test Result:0,729 g/l; Test Date: 20210219; Test Name: neutrophilia; Result Unstructured Data: Test Result:9,36 g/l; Test Date: 20210223; Test Name: neutrophilia; Result Unstructured Data: Test Result:10,525 g/l; Test Date: 20210223; Test Name: platelets; Result Unstructured Data: Test Result:315 g/l; Test Date: 20210223; Test Name: proteins; Result Unstructured Data: Test Result:60 g/l; Test Date: 20210219; Test Name: red cells; Result Unstructured Data: Test Result:4330 g/l; Test Date: 20210223; Test Name: red cells; Result Unstructured Data: Test Result:4710 g/l; Test Date: 20210223; Test Name: vitamin B12; Result Unstructured Data: Test Result:less than 148 pmol/ml; Test Date: 20210223; Test Name: vitamin D2-D3; Result Unstructured Data: Test Result:70,8 nmol/L; Test Date: 20210219; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:13 g/l; Test Date: 20210223; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:14,3 g/l
CDC Split Type: FRPFIZER INC2021283055

Write-up: Bullous pemphigoid; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority FR-AFSSAPS-TS20210610 This is a report received from the Regulatory Authority. A 77-years-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 14Jan2021 (Batch/Lot Number: Unknown) as 0.3 mL, single for covid-19 immunization; venlafaxine hydrochloride (VENLAFAXINE HCL), oral from 11Dec2020 to 16Feb2021, at 37.5 mg, daily for depression. Medical history included cerebral amyloid microangiopathy with microbleeds (contraindicating antiaggregants and anticoagulants); partial thyroidectomy; appendectomy; 3 cesarean sections; total hip replacement (THA); right and left knee surgery; surgery for varicose veins of the lower limb; cholecystectomy; right and left carpal tunnel surgery; narrow lumbar canal surgery; amputation of the right 5th toe following ulceration. Concomitant medication included candesartan, levothyroxine (L-THYROXINE), sotalol; zopiclone; alprazolam (discontinued on 10Dec2020); atorvastatin (dose reduction on 10Dec2020); lactulose (DUPHALAC) if necessary; paracetamol (DOLIPRANE) if needed; calendula officinalis, rhamnus frangula (NORMACOL) if needed. It was reported that in total, probable bullous pemphigoid (onset date 08Feb2021) on D25 of Comirnaty (dose 1) and D59 of venlafaxine leading to death in the patient living in nursing homes. Action taken for venlafaxine was Permanently Withdrawn. The patient died on 27Feb2021. The cause of death was bullous pemphigoid. An autopsy was not performed. Clinical course reported as follow: The patient living in a care home who presented on 12Jan2021 dermatitis of the inguinal folds, the vulva, the intergluteal fold for which treatment with Econazole powder is initiated. On 18Jan2021: discontinuation of Econazole in the face of worsening skin involvement. Discontinuation of atorvastatin (benefit / risk unfavorable). On 25Jan2021 : Econazole relay by CONVEEN cream in thin layers on dermatitis. Prescription of Betadine ovule for 5 days in front of a vulvitis with greenish losses. On 08Feb2021: two identified dermatological damage 1 / dermatitis always intense, purplish at the groin and vulva, with scraping treated Conveen; 2 / appearance of erythematous and itchy plaques on the body (thorax, upper and lower limbs, but not affecting the back). Sensation of grains of sand on palpation, very probable eczema. Initiation of treatment with Flixovate 2 per day. On 16Feb2021. Continuation of eczema with the same intensity. Flixovate relay by Clarelux. Faced with the suspicion of an iatrogenic origin, discontinuation of venlafaxine. On 18Feb2021 : worsening of the skin condition. Erythematous maculopapular rash with multiple small elements, inframillimetric infracentimetric vesicles, producing inflammatory placards in the left knee, left arm (posterior face) and right arm. In the feet, rash with individualized elements, vesicles of more or less large size. On 19Feb2021 : neutrophilic hyperleukocytosis (13 G / L) (9.36 G / L) and hypereosinophilia (1.027 G / L) in the biological assessment. On 22Feb2021 : presence of bubbles in the hands, feet and neck. On 23Feb021 : at 4 p.m., malaise with desaturation cyanosis, polypnea and transient bradycardia. Absence of fever. Auscultation of the deaf heart, movements in the 2 fields. Increase in the number of skin bubbles all over the body. Rapid recovery from 100 percent saturation with high concentration mask and 5 l / min O2. ECG : sinus rhythm 100/mn, QRS ends, PR 0,16s, some shifting premature ventricular contraction (PVC), Q DIII, AQRS 10 degrees, repolarization Nle. Introduction LOVENOX 0.4ml x 1 - SOTALOL reduction. In the biological assessment: CRP increased (20.4 mg/L), hypoalbuminemia 30 g/l, hypernatremia 147 mmol/l, hypokalaemia 3,78 mmol/l, hyperleukocytosis 14,3 G/l ; hypereosinophilia 1,416 G/l ; neutrophilia 10,525 G/L . On 23Feb2021 : dermatological opinion: Bullous pemphigoid probable in front of the appearance of tense bubbles present in the hands and feet. Introduction ADAPTIC on erosive lesions + DERMOVAL 1 to 3 tubes / day as needed on all lesions. Blood assay of anti epidermal membrane antibodies. On 25Feb2021 : extension of the bubbles on the upper limbs, hives on the shoulders +/- scratching lesions. Yesterday 38 bubbles of any diameter were pierced. In the evening, drowsy patient who could not eat or drink, IV infusion impossible because elbow folds under the bandages, subcutaneous infusion not recommended due to skin problems. Still has HC mask, no cyanosis or mottling, RAS ausculation. Twilight state? On 26Feb2021 :Temperature 38 degrees. The injured areas are large, with significant water loss, edema of the right upper limb from the shoulder to the hot hand, less significant edema of the left upper limb, but localized to the hand and elbow. No edema of the lower limbs, just isolated redness and bubbles except on the feet where the lesions are important. Macerated appearance of the hands and feet. Not reactive, auscultation of heart and lungs RAS. Palate: doubt about bubbles on the palate. On 27Feb2021 : death of the patient at 10:30 am. Biology report : On 19Feb2021 : red cells 4330 G/l (normal 3960 to 5120 G/l) ; haemoglobin 12,8 g/dl (normal = 11,7 to 15 g/dl) ; haematocrit 38,5 percent (normal = 34,7 to 44,4 percent) ; mean corpuscular volume (mean cell volume (MCV)) 89 (normal = 78 to 95) ; hyperleukocytosis 13 G/l (normal = 3,9 to 11 G/l) ; neutrophilia 9,36 G/l (normal 2 to 7 G/l) ; hypereosinophilia 1,027 G/l (normal < 5 G/L)) ; basophiles 0,78 G/l (normal < 0,1 G/l) ; lymphocytes 1,85 G/l (normal = 1,5 to 4 G/l) ; monocytes 0,75 G/l (normal = 0,2 to 1 G/l) ; CRP 3,4 mg/l (normal < 5 mg/l). 23Feb2021 : red cells 4710 G/l ; haemoglobin 13,9 g/dL ; haematocrit 41,7 % ; mean corpuscular volume (mean cell volume (MCV)) 89 ; hyperleukocytosis 14,3 G/l ; hypereosinophilia 1,416 G/l ; neutrophilia 10,525 G/L ; basophiles 0,29 G/l ; lymphocytes 1,602 G/l ; monocytes 0,729 G/l ; platelets 315 G/l (normal = 180 to 440 G/l) ; vs 4 mm (normal < 20 mm) ; glycosylated hemoglobin 5,70 % (normal < 6 %) ; urea 9,96 mmol/l (normal = 3,32 to 7,14 mmol/l) ; creatinine 50 umol/l (normal = 50 to 98 umol/l) ; glomerular filtration rate (GFR) 90 ml/min ; chlorine 112 mmol/l (normal = 98 to 175 mmol/l) ; hypernatremia 147 mmol/l (normal = 137 to 145 mmol/l) hypokalaemia 3,78 mmol/l (normal = 4 to 5,30 mmol/l) ; alkaline reserve 23 mmol/l (normal = 22 to 31 mmol/l) ; proteins 60 g/l (normal = 60 to 80 g/l) calcium 2,27 mmol/l (normal = 2,10 to 2,55 mmol/l) ; hypoalbuminemia 30 g/l (normal = 34 to 48 g/l) ; corrected calcemia 2,52 mmol/l (normal = 2,6 to 2,55 mmol/l) ; vitamin B12 < 148 pmol/ml ; folic acid 9,27 nmol/l (normal $g 7,0 nmol/l) ; CRP increased 20,4 mg/l ; TSH 1,29 mU/l (normal = 0,44 mU/l) ; vitamin D2-D3 70,8 nmol/l (normal 15,5 a 124,8 nmol/l). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Bullous pemphigoid


VAERS ID: 1121406 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Blood pressure systolic, Body temperature, Death, Heart rate, Oxygen saturation, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

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: MADOPAR; OMEPRAZOLE; SERESTA; SERETIDE DISKUS
Current Illness: Disease Parkinson''s (Parkinson disease advanced since 2004 (no swallowing disorder))
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (asthma balanced with Seretide Diskus (has Ventoline if needed but in practice does not take it)); Bedridden (for at least 3 years); Bladder neoplasm; Cardiovascular disease, unspecified (no recent cardiovascular problem (stented a long time ago)); Coronary artery disease (no recent cardiovascular problem (stented a long time ago), no history of arrhythmia or thrombosis); Living in nursing home (Patient living in nursing home); Stent insertion NOS (stented a long time ago); Type 2 diabetes mellitus (diabetes mellitus type 2 since 1995 but no longer has treatment for his diabetes)
Allergies:
Diagnostic Lab Data: Test Date: 20210228; Test Name: glycemia; Result Unstructured Data: Test Result:1.3; Comments: dextro at 1.3 on 28Feb; Test Date: 20210304; Test Name: BP; Result Unstructured Data: Test Result:In the suites, no effect (monitoring for 20 min; Comments: of pulse, BP, temperature and SaO2); Test Name: systolic blood pressure; Result Unstructured Data: Test Result:9-10 cmHg; Comments: low BP; Test Date: 20210304; Test Name: temperature; Result Unstructured Data: Test Result:In the suites, no effect (monitoring for 20 min; Comments: of pulse, BP, temperature and SaO2); Test Date: 20210304; Test Name: pulse; Result Unstructured Data: Test Result:In the suites, no effect (monitoring for 20 min; Comments: of pulse, BP, temperature and SaO2); Test Date: 20210304; Test Name: SaO2; Result Unstructured Data: Test Result:In the suites, no effect (monitoring for 20 min; Comments: of pulse, BP, temperature and SaO2); Test Date: 20201224; Test Name: test; Result Unstructured Data: Test Result:unknown result
CDC Split Type: FRPFIZER INC2021283187

Write-up: Death unexplained; This is a spontaneous report from a contactable physician from the Agency Agency-WEB FR-AFSSAPS-TS20210642. Please note that for medicines in active ingredient form, the trade name is not known. Patient history: Parkinson disease advanced since 2004 (no swallowing disorder), coronary artery disease since 1999, no recent cardiovascular problem (stented a long time ago), no history of arrhythmia or thrombosis, diabetes mellitus type 2 since 1995 but no longer has treatment for his diabetes (dextro at 1.3 on 28Feb), asthma balanced with Seretide Diskus (has Ventoline if needed but in practice does not take it), tumor of the bladder (no specific follow-up). Still has a low BP (9-10 cmHg systolic). No allergic history. Patient living in nursing home, GIR 1 for at least 3 years bedridden. Long-term treated with Modopar, omeprazole, Seresta, Seretide Diskus (no recent change in treatment). History of COVID: No. Test carried out on 24Dec2020. 81-year-old patient who received a 1st dose of Comirnaty (batch number not specified), not followed up. 04Mar2021, 2nd injection of Comirnaty (batch ER2659) to the right arm around 3 pm to 4 pm. In the suites, no effect (monitoring for 20 min of pulse, BP, temperature and SaO2). The next morning the patient is fine, has breakfast, has no specific complaints. He was found dead, sitting in his chair, at 11:20 a.m. No trace of vomiting, no edema or rash. In total, unexplained death the day after the 2nd injection of Comirnaty in an 81-year-old patient who did not present any new manifestation between the vaccine and death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1121513 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unsure if patient has had symptoms associated with COVID-19 Not had a COVID-19 test Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021276360

Write-up: Cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202103122150386410, Safety Report Unique Identifier is GB-MHRA-ADR 24930831. A 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; batch/lot number not known and expiration date not provided) via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunisation. Patient''s medical history and concomitant medications were not reported. It was unsure if patient has had symptoms associated with COVID-19. Patient has not had a COVID-19 test. It was unsure if patient is enrolled in clinical trial. The patient experienced cardiac arrest on 28Jan2021 (assessed as serious - Results in Death and Life Threatening). Patient''s clinical course is as follows: Patient had an unwitnessed collapse several hours after his first dose of the COVID 19 vaccination (presumed but not confirmed to be the Pfizer vaccination). Cardiac arrest on arrival to hospital. Patient sadly died without recovering. Unclear if related to vaccination. The patient died on 28Jan2021. It was unknown if an autopsy was performed. No follow-up attempts possible; information regarding batch/lot cannot be obtained; No further information expected.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1121515 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   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: CARVEDILOL; CITALOPRAM; EPLERENONE; LAXIDO; PEPPERMINT OIL [MENTHA X PIPERITA OIL]; PERINDOPRIL ERBUMINE; PRUCALOPRIDE; SENNASID [SENNOSIDE A+B]; SIMETICONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiomyopathy; Duchenne muscular dystrophy; Stress
Allergies:
Diagnostic Lab Data: Test Name: Post mortem; Result Unstructured Data: Test Result:unknown results; Test Date: 20210130; Test Name: ECGs; Result Unstructured Data: Test Result:unknown results
CDC Split Type: GBPFIZER INC2021276226

Write-up: This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103131148536470, Safety Report Unique Identifier GB-MHRA-ADR 24933714. A 37-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number not known; expiration date not provided) via an unspecified route of administration on 28Jan2021 3PM at SINGLE DOSE for COVID-19 immunisation. Patient''s medical history included Duchenne muscular dystrophy, cardiomyopathy, and stress. Patient''s medical history was also reported as ''He had duchenne muscular dystrophy, which caused cardiomyopathy. He was, however, fairly well leading up to the vaccination and our concern is that the vaccination foreshortened his life, e.g. because of the stress on his system. So if the vaccine designed to save him from covid, has instead actually lead to his death, we would be keen for there to be learning from this''. Patient has not had symptoms associated with COVID-19. Patient has not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included carvedilol from 01Jan2004, citalopram from 01Jan2006, eplerenone from 01Jan2015, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (LAXIDO) from 01Jan2010, PEPPERMINT OIL [MENTHA X PIPERITA OIL] from 01Jan2016, perindopril erbumine from 01Jan2002, prucalopride from 01Jan2019, sennoside a+b (SENNASID [SENNOSIDE A+B]) from 01Jan2018, and simethicone from 01Jan2015 all unknown if ongoing. The patient experienced shoulder pain (hospitalization, medically significant, life threatening) and cardiac arrest both on 30Jan2021 (death, hospitalization, medically significant, life threatening). Patient''s clinical course is as follows: On the day of having the vaccine (and in the lead up to this), he was generally bright and well. He received the Pfizer jab at a 3pm appointment on 28th. Later in the evening of receiving the vaccine, he began to feel slightly unwell and this continued on the following day but at that stage it was not serious and seemed like just an ''off day''. But then on the Saturday (30th) he went downhill very rapidly. He had cold sweats and felt very unwell. Around 11am he briefly had left shoulder pain, and although the reporter didn''t realise it at the time, the reporter now recognise that this could have been heart related. He continued to deteriorate. A family member called 111 in the afternoon. An ambulance came, and ECGs were taken (a copy was available if useful). Patient was rushed in to ''Rescus'' at the nearby hospital but died a short time later. It was also reported patient was, however, fairly well leading up to the vaccination and the reporter''s concern is that the vaccination foreshortened his life, e.g. because of the stress on his system. So if the vaccine designed to save him from covid, has instead actually lead to his death, the reporter would be keen for there to be learning from this. The patient died on 30Jan2021. It was reported that ''post mortem was undertaken'' on an unspecified date and ECGs on 30Jan2021 both with unknown results . Cause of death was cardiac arrest. Outcome of the event ''cardiac arrest'' was fatal, outcome of the remaining events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1121517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-03-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Headache, Respiratory arrest, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021275959

Write-up: vomited; headache; stopped breathing; Death/she died of a huge bleed to the brain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103131527333040, Safety Report Unique Identifier GB-MHRA-ADR 24934892. An 87-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not known), via an unspecified route of administration on 09Mar2021 at a single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient has not tested positive for COVID-19 since having the vaccine. Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial. On 09Mar2021, the patient experienced death/she died of a huge bleed to the brain (death and life-threatening). On an unspecified date, the patient vomited, experienced headache, stopped breathing (life-threatening). Additional information: The patient (mother) had the second dose at approximately 1pm on 09Mar2021, the reporter brother (patient son) took her home and they had a cup of tea, without warning she had a severe headache, vomited and stopped breathing, this was within an hour of returning home, the son gave CPR and called the ambulance, para medics got her breathing , but had to work on her for some time outside the house (20mins approximately) she was taken to hospital and placed on a ventilator where she died of a huge bleed to the brain, the reporter was told this is nothing to do with the vaccine, on researching it , the reporter find this "Yellow card system" how can this be an accurate system when nobody knows it exists? The reporter was ill for two days the reporter older brother a whole week, nobody knows has ever heard of this system, so the figures are grossly under estimated, the reporter see all deaths are classed as no evidence they were caused by the vaccine, so by that same logic there is no evidence they were not, they blame it on underlying health conditions & say "They would probably died anyway". The reporter stated that the patient was a healthy active woman yes she had health issues but what 87 year old doesn''t , she would go to town a couple of times a week & to the supermarket every day, just for exercise, she talked of nothing else for three months but her second jab , she just wanted her life back. On Monday, the patient phoned the reporter so excited that she had her date for the following day& IMO it cost her her life. They cannot keep denying there is a huge problem by saying they would have died anyway , many European countries have suspended use on elderly people for exactly the same reasons and eventually people will ask questions here, nobody even knows this yellow card system exists ,just imagine the figures if they did. Outcome of the events of headache, vomited and stopped breathing was unknown. The patient died on 09Mar2021. Cause of death was a huge bleed to the brain. It was not reported if an autopsy was performed. Outcome of the events of headache, vomited and stopped breathing was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Death/she died of a huge bleed to the brain


VAERS ID: 1121522 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Haemorrhage intracranial, Headache, Hypothermia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-14
   Days after onset: 13
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic subdural hematoma; COPD; Hemophilia A; Intracerebral hemorrhage (Prior intracerebral hemorrhage (c2003) with residual hemiplegia); Intracranial hemorrhage (had previously experienced intracranial hemorrhage events during lifetime)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021290384

Write-up: Cerebral haemorrhage; intracranial haemorrhage; non-specific symptoms of ill-health with associated hypothermia; headache; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency. Regulatory authority report number GB-MHRA-WEBCOVID-202103142022555860 and GB-MHRA-ADR 24939703. An 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: not known) via an unspecified route of administration on 13Mar2021 at single dose for COVID-19 immunisation. Medical history included haemophilia A, intracerebral haemorrahge (Prior intracerebral haemorrahge (c2003) with residual hemiplegia), chronic subdural haematoma, COPD (Chronic obstructive pulmonary disease) and the patient has a known diagnosis of haemophilia A and had previously experienced intracranial haemorrhage events during lifetime. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The clinical course was reported as: Following receipt of 2nd vaccine, patient developed non-specific symptoms of ill-health with associated hypothermia in Mar2021. Upon attendance at A and E, reported new onset headache and was found to have suffered a large volume intracranial haemorrhage in Mar2021 and cerebral haemorrhage on 14Mar2021 which was reported as causing death. The patient died on 14Mar2021. It was not reported if an autopsy was performed. The event cerebral haemorrhage was assessed as serious (fatal, life-threatening, disability, medically significant), for intracranial haemorrhage, non-specific symptoms of ill-health with associated hypothermia and headache were assessed as serious (life-threatening, disability, medically significant). The outcome of headache and non-specific symptoms of ill-health with associated hypothermia was reported as unknown, for intracranial haemorrhage was not recovered and outcome of cerebral haemorrhage was reported as fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1121527 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Pulmonary oedema, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment: had not health conditions
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021287273

Write-up: blood clots; stopped the heart; fluid on the lungs; This is a spontaneous report from a contactable consumer. This is the third of three reports. The first report is a report downloaded from from the Regulatory Agency (RA). The MHRA number is GB-MHRA-WEBCOVID-202103102255389050. A 7-decade-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on an unknown date at single dose for COVID-19 immunisation. The patient medical history was none. The patient''s concomitant medication(s) were not provided. Patient had the vaccine and then a couple days later also died suddenly with the same circumstances (a blood clot that stopped the heart and caused fluid on the lungs), he was only in his 60s, had not health conditions and died suddenly. Reporter have serious concerns that the vaccine may be causing blood clots or something that is causing these sudden deaths. Reporter was sure there''s more cases like this and deeply concerned. Reporter only work in an office of 6 people and 3 of they have similar deaths in their family shortly after they took the vaccine. This is too much of a coincidence. The outcome of events was fatal. Patient was currently doing an autopsy. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-2021274681 Same reporter/drug/events in different patients;GB-PFIZER INC-2021287274 Same reporter/drug/events in different patients; Reported Cause(s) of Death: fluid on the lungs; Clot blood; Heart attack


VAERS ID: 1121529 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-11
Onset:2021-01-22
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bradycardia NOS; Hypercholesteraemia (uncontrolled Hypercholesteraemia)
Allergies:
Diagnostic Lab Data: Test Name: coronary angiography; Result Unstructured Data: Test Result:pathological findings
CDC Split Type: GRPFIZER INC2021283254

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician The regulatory authority report number is GR-GREOF-20211470. A 61-year-old male patient received BNT162B2 (COMIRNATY; Lot Number: Unknown), dose 1 via an unspecified route of administration on 11Jan2021 as single dose for covid-19 immunization. Medical history included hypercholesterolaemia from an unknown date, elaborated as uncontrolled hypercholesteremia and bradycardia not otherwise specified from an unknown date. The patient had no concomitant medications. The patient experienced acute myocardial infarction on 22Jan2021, which was serious as it involved hospitalization, was medically significant, and lead to death. Details were as follows: the patient on 22Jan2021, (11 days since the vaccination) presented acute myocardial infarction. The patient underwent CPR as therapeutic measure and was admitted to the hospital (ER). The coronary angiography had pathological findings, date unspecified. The patient died on 07Feb2021. It was not reported if an autopsy was performed.Cardiac arrest was reported as part of the cause of death, with no other details. sender''s comment: initial report with additional information. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: The patient on 22Jan2021 (11 days since the vaccination) presented acute myocardial infarction.undergone cpr and he was admitted to hospital (ER). The coronary angiography had pathological findings.date of death: 07February2021. No concomitant drugs.; Reported Cause(s) of Death: Cardiac arrest; Acute myocardial infarction; Brain death


VAERS ID: 1121533 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Coronavirus test, Pneumonia
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), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 35 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Heart disease, unspecified; Kidney disorder; Liver disorder; Spleen disorder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: ILPFIZER INC2021277215

Write-up: underwent a stroke; pneumonia; This is a spontaneous report from a contactable consumer received. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. Medical history included ongoing liver disorder, ongoing spleen disorder, ongoing cardiac disorder, ongoing renal disorder. The patient''s concomitant medications were not reported. The patient received the vaccine without his knowledge at PRIVACY Hospital where he was hospitalized for rehabilitation. He then had a stroke and pneumonia and died a month after the vaccination. The patient was hospitalized for underwent a stroke and pneumonia for 35 days. The patient underwent lab tests and procedures which included coronavirus test: negative on 11Feb2021. The patient died on Feb2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: pneumonia; stroke


VAERS ID: 1121556 (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: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Malaise, Nausea, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

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: CLOPIDOGREL; SIMVASTATINE; RISEDRONIC ACID; COLECALCIFEROL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021282674

Write-up: Patient died: sudden cardiac death of unknwon cause, possibly due to vaccine.; Patient had difficulty breathing; Nausea; General malaise; This is a spontaneous report from a contactable physician downloaded from the Agency Agency-WEB [NL-LRB-00463585]. A 75-year-old female patient received BNT162b2 (COMIRNATY), via an unspecified route of administration on 02Mar2021 at single dose for Covid-19 immunisation. The patient medical history was not reported. No previous COVID-19 infection. Concomitant medications included clopidogrel tablet; simvastatine tablet; risedronic acid; cholecalciferol capsule. On 04Mar2021 patient experienced sudden death, dyspnoea, nausea, general malaise following administration of Covid-19 Pfizer injectable vaccine with fatal outcome. The clinical course was reported as follow: Two days after vaccination, the patient became dyspnoeic, was nauseous and experienced general malaise. She deceased because of a sudden cardiac death of unknown cause. The patient died on 04Mar2021. It was not unknown if an autopsy was performed. Additional information: Possibly because of vaccine. Cannot be ruled out. Patient was having difficulty breathing, nauseous, general malaise. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no Patient died. Additional information ADR (adverse drug reaction): Sudden cardiac death of unknown cause. Possibly because of vacicne. Can not be ruled out. Patient was having difficulty breathing, nauseous, general malaise. BSN available: yes COVID-19 Previous COVID-19 infection: No.; Sender''s Comments: The limited information provided precludes a full clinical assessment of the case. By close temporal relationship and absence of factors which may provide an alternative cause, the company, as a cautionary measure and for reporting purposes, cannot completely exclude a causal association between the reported events (of note, at the present time all reported with fatal outcome) and Comirnaty administration. The impacts 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: had difficulty breathing; Nausea; General malaise; Sudden cardiac death of unknown cause


VAERS ID: 1121558 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-24
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-03-22
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: 2021-02-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: RIVAROXABAN; MACROGOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021283311

Write-up: Death on 24Feb2021; This is a spontaneous report from a contactable physician from the Regulatory Authority NL-LRB-00465196. A 93-years-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) at 0.3 mL, single for COVID-19 vaccination. The patient medical history was not reported. Concomitant medications included rivaroxaban taken for an unspecified indication, start and stop date were not reported; macrogol taken for an unspecified indication, start and stop date were not reported. The patient experienced death on 24Feb2021. No past drug therapy BioNTech/Pfizer vaccin (Comirnaty). No previous COVID-19 infection. The patient died on 24Feb2021. 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: Death on 24Feb2021


VAERS ID: 1121559 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-27
Onset:2021-03-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: XARELTO; TRIAMCINOLONACETONIDE; PERINDOPRIL; KALIUMCHLORIDE; ALLOPURINOL; FUROSEMIDE; COLECALCIFEROL
Current Illness: Arrhythmia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021283315

Write-up: Cardiac arrest; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority manufacturer report number NL-LRB-00466634. A 83-year-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 27Feb2021 (Batch/Lot Number: EP9598) at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing arrhythmia. Concomitant medications included rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; triamcinolone acetonide (TRIAMCINOLONACETONIDE) taken for an unspecified indication, start and stop date were not reported; perindopril taken for an unspecified indication, start and stop date were not reported; potassium chloride (KALIUMCHLORIDE) taken for an unspecified indication, start and stop date were not reported; allopurinol taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; colecalciferol taken for an unspecified indication, start and stop date were not reported. The patient experienced cardiac arrest (death) on 05Mar2021. The patient died on 05Mar2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1121560 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-07
   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: SPIRONOLACTON; CITALOPRAM; METOPROLOL SUCCINATE; FUROSEMIDE; MACROGOL; ELIQUIS; PERINDOPRIL ERBUMINE; HUMALOG; ABASAGLAR; COLECALCIFEROL
Current Illness: Atrial fibrillation; Dementia; Diabetes mellitus; Hypertension; Kidney failure; Peripheral vascular disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021283274

Write-up: Unexpected death 3 days after administration of the second vaccine.; This is a spontaneous report from a contactable physician downloaded from the Regalatory Authority NL-LRB-00468384. An 87-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 04Mar2021 (batch/Lot Number: EP9598) as single dose for COVID-19 immunisation. Medical history included ongoing hypertension, ongoing peripheral vascular disease, ongoing diabetes mellitus, ongoing kidney failure, ongoing dementia, ongoing atrial fibrillation. Historical vaccine included first dose of bnt162b2 on 03Feb2021 for COVID-19 immunisation. Concomitant medications included spironolactone, citalopram, metoprolol succinate, furosemide, macrogol, apixaban (ELIQUIS), perindopril erbumine, insulin lispro (HUMALOG), insulin glargine (ABASAGLAR) and colecalciferol, all taken for an unspecified indication, start and stop date were not reported. The patient experienced unexpected death 3 days after administration of the second vaccine. Patient was found lifeless in bed on 07Mar2021 at 07:45 am. It was not reported if an autopsy was performed. Outcome of the event was fatal. Reporter comment: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 03Feb2021. Unexpected death 3 days after administration of the second vaccination. Additional information ADR: She was found lifeless in bed on 07Mar at 07:45. Had known hypertension, atrial fibrillation, renal failure, diabetes mellitus and dementia. Additional information ADR: Woman was found lifeless in bed on 07Mar at 07:45 am. She was known with hypertension, atrial fibrillation, renal failure, diabetes mellitus and dementia. She had no side effects such as fever or malaise on 04Mar-07Mar. She had eaten well on the evening of 06Mar and had been nursed to bed in good condition. Confounding factors: Atrial fibrillation, renal insufficiency, peripheral vascular disease, hypertension, diabetes mellitus insulin dependent. Previous COVID-19 infection: No. No follow-up attempts possible. No further information expected.; Sender''s Comments: The event of sudden death is assessed as related until sufficient information is available to confirm an unrelated cause of death.; Reported Cause(s) of Death: unexpected death


VAERS ID: 1121561 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-13
Onset:2021-02-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Magnetic resonance imaging
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: 2021-02-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACENOCOUMAROL; METFORMIN HYDROCHLORIDE; ATENOLOL; LOSEC MUPS; ATORVASTATINE [ATORVASTATIN]; LOSARTAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrhythmia; Deep venous thrombosis arm (low in thrombosis); Diabetes mellitus (mild degree); Erysipelas (just recovered from erysipelas on her legs)
Allergies:
Diagnostic Lab Data: Test Name: MRI scan; Result Unstructured Data: Test Result:severe stroke in her brain stem in her sleep
CDC Split Type: NLPFIZER INC2021283328

Write-up: Stroke; This is a spontaneous report from a contactable consumer from the Regulatory Authority NL-LRB-00468663. Additional identifier is NL-LRB-00470487. An 89-year-old female patient (reporter) received 1st dose of BNT162B2 (COMIRNATY, lot# EJ6789) at single dose on 13Feb2021 via an unknown route for COVID-19 immunisation. Medical history included cardiac arrhythmia, deep venous thrombosis arm (low in thrombosis) for more than 30 years, diabetes (mild degree). The patient had just recovered from erysipelas on her legs. She had received a course of antibiotics for this. However, this treatment had ended about 10 days before the vaccination. Patient had no previous COVID-19 infection. Concomitant drug included acenocoumarol tablet 1mg daily, atenolol, atorvastatin (ATORVASTATINE) tablet 40mg, losartan tablet 50 mg, omeprazole magnesium (LOSEC MUPS) 10mg, and metformine hydrochloride. Patient experienced stroke on 21Feb2021 with seriousness criteria of death "168 hours" (as reported) after administration of covid-19 vaccine. Patient died in hospital. Diagnostic procedure was MRI scan. Confounding factors was cardiac arrhythmia. No autopsy was done. No letter of resignation or autopsy report received. No complaints or side effects immediately after the corona vaccination. The outcome of stroke was fatal. The event clinical course was as follows: patient was still felt fine on Saturday evening. Reporter suspected (but not sure) that the vaccination may have caused the clot in her thrombosis arm (which she had had for more than 30 years) to break loose. It could be a coincidence. But the MRI scan showed that she suffered a severe stroke in her brain stem in her sleep and fell into a coma as a result of this and died later that day from the consequences. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: stroke


VAERS ID: 1121562 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   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: FERROUS FUMARATE; ALENDRONIC ACID; ENALAPRIL; OMEPRAZOL; OXYCODON; RISPERIDON; PREGABALINE; DUROGESIC; FENTANYL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: pyrexia; Result Unstructured Data: Test Result:38 to 40.5 Centigrade
CDC Split Type: NLPFIZER INC2021283305

Write-up: no more food and drink; Fever: 38 to 40.5 degrees Celsius; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB and received via Regulatory Authority NL-LRB-00468895. This case is regarding COMIRNATY(BNT162B2)lot# EP9598. An 85-year old female patient received the second dose of BNT162B2 (COMIRNATY, Lot No. EP9598) at single dose for COVID-19 immunisation on 04Mar2021. Relevant history was unknown. The patient previously received the first dose of Comirnaty for COVID-19 immunisation on 04Feb2021 with no adverse reaction. Relevant concomitant drugs included pregabalin capsule 150mg, enalapril tablet 40mg, risperidone (RISPERIDON) tablet coated 0.5mg, fentanyl patch 50ug / h (generic + DUROGESIC), oxycodone capsule 20mg, ferrous fumarate tablet 200mg, alendronic acid tablet 70mg and omeprazole (OMEPRAZOL) tablet msr 20mg. The patient experienced no more food and drink, pyrexia with 38 to 40.5 centigrade following the vaccination since 04Mar2021, and died on unknown date in Mar2021. It was unknown if the autopsy performed or not. The patient was not infected with COVID-19. The diagnostic procedures was none. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Fever; no more food and drink


VAERS ID: 1121563 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-22
Onset:2021-02-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac monitoring, Chest pain, Death, Electrocardiogram, Hyperhidrosis, Investigation, Laboratory test
SMQs:, Neuroleptic malignant syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-02
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL; APIXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (pacemaker); Cardiac pacemaker insertion; Colon carcinoma (sigmoid resection); Sigmoidectomy
Allergies:
Diagnostic Lab Data: Test Name: rhythm monitoring; Result Unstructured Data: Test Result:result not specified; Test Name: ECG; Result Unstructured Data: Test Result:result not specified; Test Date: 202102; Test Name: cardiological evaluation/extensive cardiological examination; Result Unstructured Data: Test Result:Nothing was found; Comments: Nothing was found in the examination. No ischemia / infarction. No pulmonary embolism. No fever.; Test Name: laboratory research incl troponins etc.; Result Unstructured Data: Test Result:result not specified
CDC Split Type: NLPFIZER INC2021283313

Write-up: Day after discharge on 25/2, same complaint again with spontaneous recovery; Day after discharge on 25/2, same complaint again with spontaneous recovery; Chest pain; heavy sweating duration 20 min; died in his sleep; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00468968. An 84-year-old male patient received BNT162B2 (COMIRNATY, lot number: EJ6790) via an unspecified route of administration on 22Feb2021 at single dose for COVID-19 vaccination. Medical history included atrial fibrillation from May2012 for which pacemaker (inserted) on an unspecified date and colon carcinoma/sigmoid carcinoma from Jun2020 for which sigmoid resection on Jun2020 was performed . No previous COVID-19 infection. Concomitant medications included bisoprolol and apixaban taken for an unspecified indication from an unspecified date. No past drug therapy. On 23Feb2021 (one day after vaccination), the patient developed chest pain and hyperhidrosis (heavy sweating), for which he was admitted to the hospital on 23Feb2021 (it also stated 21.00 o''clock [unknown if it was the event onset time or admission time]). The complaints lasted for 20 minutes. In the hospital they checked for pulmonary embolism, infarction/ischemia, they checked his pacemaker, there was no fever. Nothing was found in the examination. It was also stated that the patient underwent comprehensive cardiological evaluation: no ischemia / infarction. No pulmonary embolism (as reported). The events spontaneous recovered on 23Feb2021 and the patient was sent home after 1 day in hospital (hospitalization end date on 24Feb2021). On 25Feb2021 (the day after discharge from hospital), the patient developed the same symptoms again with spontaneous recovery in Feb2021. Since just examined and found nothing during cardiological evaluation, this time the patient was not submitted. On 26Feb2021 (a day later), there was contact via phone and patient had no complaints anymore. On 02Mar2021, the patient died during sleep at night. It was not reported if an autopsy was performed. Lab tests included extensive cardiological examination in Feb2021 with nothing found. No fever. ECG + rhythm monitoring and laboratory research including troponins etc taken on unspecified date(s) with result not specified (AS REPORTED). Confounding factors reported as follows: atrial fibrillation from May2012 for which pacemaker, after sigmoid carcinoma for which sigmoid resection in Jun2020 (as reported). No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Assuming a plausible drug-events temporal association, as a cautionary measure and for reporting purposes, the company cannot completely exclude a causal association between the reported, serious events and Comirnaty administration. The impacts 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: March 2nd ; died in his sleep at night


VAERS ID: 1121564 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-06
Onset:2021-02-15
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METOPROLOL TARTRATE; BUMETANIDE; MARCOUMAR
Current Illness: Decompensation cardiac
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021283318

Write-up: Decompensation cardiac: Extreme fluid retention, dyspnoea, edema; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB with Regulatory authority report number A 90-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Feb2021 at single dose for covid-19 immunisation. Medical history included ongoing decompensation cardiac. Concomitant medications included metoprolol tartrate; bumetanide; phenprocoumon (MARCOUMAR). The patient experienced decompensation cardiac: extreme fluid retention, dyspnoea, edema (death) on 15Feb2021. Decompensation cardiac was treated with diuretics. The outcome of decompensation cardiac was fatal. The patient died in 2021. It was unknown if an autopsy was performed. Case Summary and Reporter''s Comments: "Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Decompensation cardiac. Additional information ADR: Extreme fluid retention, dyspnoea, edema. confounding factors: pre-existing decompensation. Previous COVID-19 infection: No". No follow-up attempts are possible. Information on batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1121565 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bronchoscopy, Chest X-ray, Dyspnoea, Hyperhidrosis, Presyncope, Pulmonary haemorrhage, SARS-CoV-2 test positive, Ultrasound chest
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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? No
Previous Vaccinations:
Other Medications: TELMISARTAN; SALBUTAMOL; METFORMIN HYDROCHLORIDE; CALCIUM; BICALUTAMIDE; SIMVASTATINE
Current Illness: Dyspnoea
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: bronchoscopy; Result Unstructured Data: Test Result:diffuse bleeding of mucous; Test Date: 2021; Test Name: X-thorax; Result Unstructured Data: Test Result:Chest: abnormalities right; dd infiltrate, haemorr; Test Date: 20210112; Test Name: corona, confirmed with test; Test Result: Positive ; Test Date: 2021; Test Name: Echo cor; Result Unstructured Data: Test Result:no acute infarction with heart
CDC Split Type: NLPFIZER INC2021283272

Write-up: severe dyspnea (condition aggravated vs previous); Sweating; collapses; Pulmonary haemorrhage; This is a spontaneous report from a contactable physician. Regulatory Authority manufacturer report number NL-LRB-00469905. An 88 years old male patient received second dose of bnt162b2 (COMIRNATY, Lot Number EK9788 and Expiration Date unknown) via an unspecified route of administration on 18Feb2021 at single dose for COVID-19 immunisation. Medical history included recent covid-19 infection from 12Jan2021 and ongoing dyspnea. The concomitant drug included bicalutamide tablet 50mg, salbutamol (Inhalation vapour , aerosol) 100ug/do, telmisartan tablet 40mg, simvastatine Film-coated tablet 20mg, metformine hydrochloride, calcium. Three days after vaccination on 21Feb2021, patient experienced severe dyspnea (condition aggravated vs previous), sweating and collaps occurred (presyncope). The patient deceased after resuscitation. Further investigation in hospital showed signs of a pulmonary haemorrhage. Lab test included X-thorax in 2021: abnormalities right, dd infiltrate or haemorrhage. Echo cor in 2021: no acute infarction with heart; Bronschoscopy in 2021: diffuse bleeding of mucous; corona, confirmed with test positive on 12Jan2021. The outcome of all events was fatal after treatment given. Patient die on 21Feb2021 and without autopsy done. Reporters comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Patient already had complaints of dyspnoea. Three days after vaccination sudden severe shortness of breath and death. Additional information ADR: patient already had complaints of dyspnoea. on 12/1 covid test positive. Three days after vaccination, on exertion, she suddenly felt short of breath and collapsed. On examination at hospital, sign of pulmonary haemorrhage, no myocardial infarction. After consultation with the family it was decided that no autopsy would be carried out. COVID19 Previous COVID-19 infection: disease symptoms: quite. Other diagnostic procedures: xthorax right anomalies dd infiltrate or haemorrhage echo cor no active infarct bronchoscopy diffuse bleeding mucosa No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sweating; collaps occurred (presyncope); pulmonary haemorrhage; severe dyspnea (condition aggravated vs previous)


VAERS ID: 1121566 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-04
Onset:2021-03-10
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9598 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   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: FERROUS FUMARATE; AMLODIPINE; ISOSORBIDE DINITRATE; GLICLAZIDE; SORBISTERIT
Current Illness: Anaemia; Renal failure (Progressive renal failure)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021283304

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the WEB and received via Regulatory Authority NL-LRB-00470790. An 85-year-old female patient received second dose of BNT162B2 (COMIRNATY, Lot Number: EM9598) via an unspecified route of administration on 04Mar2021 as single dose for COVID-19 immunisation. Medical history included ongoing years with progressive renal failure and ongoing anaemia. Concomitant medications included ferrous fumarate tablet 200 mg; amlodipine tablet 5mg; isosorbide dinitrate tablet sublingual 5 mg; gliclazide tablet mga 30 mg and mga 80 mg; calcium polystyrene sulfonate (SORBISTERIT) ca pdr susp or / rec 900mg / g. The patient previously received first dose of Comirnaty on 04Feb2021 with no adverse reaction. The patient did not have any symptoms in the days prior to her death. She died 6 days after vaccination in her sleep. Now asleep quietly died 6th day after vaccination. No complaints in days before death. No Previous COVID-19 infection and no diagnostic procedures. The outcome of event was fatal. The patient died on 10Mar2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1121567 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-21
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-03
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SIMVASTATINE; TACAL D3
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ECG; Result Unstructured Data: Test Result:atrial fibrillation 92/min, with LBTB (left bundle; Comments: atrial fibrillation 92/min, with LBTB (left bundle branch block) (neg T''s in I, AVL, V5-6)
CDC Split Type: NLPFIZER INC2021283303

Write-up: cardiac arrest; decompensation cordis; development of atrial fibrillation, leading to shortness of breath (DC), malaise and palpitations, cardiac arrest.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB Regulatory Authority number NL-LRB-00471135. An 80-year-old elderly female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 21Feb2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included simvastatine and calcium carbonate, colecalciferol (TACAL D3). Eight hours after vaccination, the patient experienced atrial fibrillation with dyspnoea (decompensation cordis) resulting in malaise and palpitations, cardiac arrest. Atrial fibrillation is not serious in itself, but in this case it had nevertheless led to the death of this patient. An ECG was performed and showed atrial fibrillation 92/min, with LBTB (left bundle branch block) (neg T''s in I, AVL, V5-6)). The patient was treated with rivaroxaban and diuretics. The patient experienced atrial fibrillation continuously and died 10 days after onset. The suspected cause of death is cardiac arrest. The patient did have a covid 19 infection in the past. The outcome of atrial fibrillation and cardiac arrest was fatal, outcome of other event was unknown. The patient died on 03Mar2021. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Atrial fibrillation; Cardiac arrest


VAERS ID: 1121568 (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: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OMEPRAZOLE; NORTRILEN
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210306; Test Name: pyrexia; Result Unstructured Data: Test Result:38.0-40.5 Centigrade; Comments: Fever: 38 to 40.5 degrees Celcius
CDC Split Type: NLPFIZER INC2021287640

Write-up: Fatigue; Not feeling well; Fever: 38 to 40.5 degrees celcius; This is a spontaneous report from a contactable Physician downloaded from the regulatory authority NL-LRB-00472620. An 88-year-old female patient received the second dose of bnt162b2 (COMIRNATY) lot number: EP9598, via an unspecified route of administration on 05Mar2021 as for COVID-19 immunisation. Medical history included ongoing dementia. Historical vaccine included Comirnaty on 05Feb2021 for COVID-19 immunisation and experienced no adverse reaction. Concomitant medication included omeprazole and nortriptyline hydrochloride (NORTRILEN). On 06Mar2021, the patient experienced fatigue, not feeling well and fever 38 to 40.5 degrees Celsius. It was reported that the event pyrexia is treated with paracetamol. The patient died on 06Mar2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No information expected.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes ADRs: No date: 05Feb2021 confounding factors confounding factors: Dementia Previous COVID-19 infection: No; Reported Cause(s) of Death: Fatigue; Not feeling well; Fever: 38 to 40.5 degrees celcius


VAERS ID: 1121569 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-16
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arterial hypertension (taking medication occasionally, not systematically)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021283349

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number PL-URPL-3-285-2021. An 83-year-old male patient received first dose bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 02Feb2021 13:54 (Lot Number: EJ6136; Expiration Date: 05Feb2021) as single dose (0.3 units not given) for covid-19 immunisation. Medical history included the patient was suffering from arterial hypertension, taking medication occasionally, not systematically. The patient''s concomitant medications were not reported. The date of the reaction on 16Feb2021 at 7.30 am. The following reaction was described in the form sent: sudden death - adverse vaccine reaction notification due to the time relationship. The patient died on 16Feb2021. It was not reported if an autopsy was performed. Sender Comment: Name of the vaccine Comirnaty- COVID-19 vaccine (mRNA). The sudden death of the patient could be related to the inappropriately treated hypertensive disease. There is also a temporal relationship with the administration of the vaccine. However, due to the lack of information on side effects after administration of Comirnaty, the URPL (HA) assessed the reported adverse vaccine reaction as in a temporary coincidence with vaccination. The person reporting adverse vaccine reaction qualified it as serious. HA assessed the adverse vaccine reaction as serious. Comirnaty/ NCA/WHO scale/ Unlikely No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1121570 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure decreased, Blood pressure measurement, Contusion, Diarrhoea, Dyspnoea, Seizure
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Generalised convulsive seizures following immunisation (narrow), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: Blood pressure; Result Unstructured Data: Test Result:dropped
CDC Split Type: PLPFIZER INC2021282721

Write-up: non-febrile convulsions - first episode; limbs bruising; Weakness; blood pressure dropped; Dyspnoea; Diarrhea; This is a spontaneous report from a contactable physician from the Regulatory Authority PL-URPL-3-347-2021. An 80-year-old female patient received the BNT162B2 (COMIRNATY, lot number: EL8723 and expiration date: 31May2021), via an unspecified route of administration, on 08Feb2021 16:06 (at the age of 80-year-old), at single dose, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 10Feb2021, the patient experienced non-febrile convulsions - first episode, diarrhea, limbs bruising, weakness, dyspnoea, blood pressure dropped. Treatment was implemented included drip infusions, antibiotic, dexaven. No improvement was achieved, the patient died on 14Feb2021. Result was death (6 days after vaccination). The reporting person did not classify the severity of vaccine adverse events. Due to the patient''s death, classified the application as severe. The outcome of the events was fatal. It was not reported if an autopsy was performed. Sender Comment: Non-feverish seizures, diarrhea, bruising of the limbs, weakness, shortness of breath, drop in blood pressure is an unexpected side effect, not included in section 4.8 of Comirnaty Summary of Product Characteristics. Given the lack of medical information on the death (autopsy results, medical history, etc.), it cannot be ruled out that the death may have been influenced by factors other than the vaccine administered. The temporal relationship supports a cause and effect relationship (death 6 days post vaccination). The reporting person did not classify the severity of vaccine adverse events. Due to the patient''s death, classified the application as severe. Relatedness the drug to events was classified as unlikely using method. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: non-febrile convulsions - first episode; diarrhea; limbs bruising; weakness; dyspnoea; blood pressure dropped


VAERS ID: 1121572 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

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

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: Dementia; Dialysis; Multimorbidity
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC2021272660

Write-up: death; This is a spontaneous report received from a contactable Physician downloaded from the Regulatory Authority PT-INFARMED-J202103-773. An 80-year-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection and lot number: EP9598) via Intramuscularly on 19Feb2021 at 0.6 ml at single dose for COVID-19 immunization. Patient medical history included Multimorbidity, Dementia and Dialysis from 2015 all are ongoing. Concomitant medications were not reported. Patient previously took COMIRNATY for COVID-19 immunization. Verbatim includes spontaneous case refers to an elderly female of 80 years who died, and death was associated with the use of Comirnaty (batch EP9598), indicated for immunization against COVID-19, with a 2-dose vaccination schedule with an interval of at least 21 days between each dose. Death occurred at home, in less than 24 hours after taking the second dose of the suspected vaccine. According to the family''s report, at dawn, the patient got up, felt unwell and fell, died immediately on 20Feb2021. The administration of the vaccine had taken place the day before, in the hemodialysis unit, without complaints immediately or in the first subsequent hours. Dialysis had been normal and the patient was in good general condition at the end of it. She has been on dialysis since 2015, with significant co-morbidities, including a dementia process. No adverse reaction on the first dose. A history of ADR for any drug is unknown. The patient was cremated and there was no autopsy. Evolution of ADR: death. Outcome of event was fatal.; Reported Cause(s) of Death: Death


VAERS ID: 1121575 (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: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Circulatory collapse
SMQs:, Anaphylactic reaction (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Hypersensitivity (narrow)

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: ATARAX [HYDROXYZINE HYDROCHLORIDE]; BETOLVIDON; CANDEXETIL; CILAXORAL; FOLVIDON; IMPUGAN [FUROSEMIDE]; KALIUMKLORID ORIFARM; LAMICTAL; MORFIN MEDA; OMEPRAZOL; PARACETAMOL NET; PEVARYL [ECONAZOLE NITRATE]; PEVARYL [ECONAZOLE NITRATE]; PEVISO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Breathing difficult (long term); Cardiac failure (suspected but unconfirmed); Depression; Edema; Fungal infection; Gastritis; Hallucinations; Hypokalaemia; Lipids NOS high; Oxygen supplementation (at home); Pain; Pneumonia; Respiratory distress; Rib fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021282921

Write-up: Circulatory failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-007686. A 67-years-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on Jan2021 as single dose for covid-19 immunisation. Medical history included Respiratory distress, anxiety, suspected but unconfirmed cardiac failure, depression, fungal infection, gastritis, hallucination, hypokalaemia, Lipids NOS high, edema, pain, recent pneumonia and rib fracture with long term breathing difficulties and oxygen treatment at home. Concomitant medication included hydroxyzine hydrochloride (ATARAX) taken for an unspecified indication from Jan2021 to an unspecified stop date; cyanocobalamin (BETOLVIDON) taken for an unspecified indication from 17Sep2020 to an unspecified stop date; candesartan cilexetil (CANDEXETIL) taken for an unspecified indication from 22Dec2020 to an unspecified stop date; sodium picosulfate (CILAXORAL) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; folic acid (FOLVIDON) taken for an unspecified indication from 03Sep2020 to an unspecified stop date; furosemide (IMPUGAN) taken for an unspecified indication from 14Apr2020 to an unspecified stop date; potassium chloride (KALIUMKLORID ORIFARM) taken for an unspecified indication from 20Nov2020 to an unspecified stop date; lamotrigine (LAMICTAL) taken for an unspecified indication from 22Dec2020 to an unspecified stop date; morphine hydrochloride (MORFIN MEDA) taken for an unspecified indication from 01Dec2020 to an unspecified stop date; omeprazole taken for an unspecified indication from 14Apr2020 to an unspecified stop date; paracetamol (PARACETAMOL NET) taken for an unspecified indication from 10Dec2020 to an unspecified stop date; econazole nitrate (PEVARYL) taken for an unspecified indication from 29Sep2020 to an unspecified stop date; econazole nitrate (PEVARYL) taken for an unspecified indication from 09Dec2020 to an unspecified stop date; econazole nitrate, triamcinolone acetonide (PEVISONE) taken for an unspecified indication from 12Nov2020 to an unspecified stop date; risperidone (RISPERIDON ACTAVIS) taken for an unspecified indication from 07Jan2021 to an unspecified stop date; simvastatin taken for an unspecified indication from 14Apr2020 to an unspecified stop date; terbinafine hydrochloride (TERBINAFIN) taken for an unspecified indication from 02Dec2020 to an unspecified stop date; venlafaxine hydrochloride (VENLAFAXIN 1A FARMA) taken for an unspecified indication from 26Aug2020 to an unspecified stop date; carbomer (VISCOTEARS) taken for an unspecified indication from 14Apr2020 to an unspecified stop date; diclofenac diethylamine (VOLTAREN) taken for an unspecified indication from 13Oct2020 to an unspecified stop date; zolpidem taken for an unspecified indication from 11Jun2020 to an unspecified stop date; venlafaxine hydrochloride (VENLAFAXIN) taken for an unspecified indication from 10Dec2020 to an unspecified stop date; paracetamol taken for an unspecified indication from 07Oct2020 to an unspecified stop date. The patient experienced circulatory failure an unknown date on an unknown date in Jan2021. The patient died on an unknown date in Jan2021. An autopsy was performed that revealed circulatory failure. The outcome of the events was fatal. The clinical course was reported as follows: Vaccinated in January 2021 with the first dose. Four days later he used the alarm notifying home care he was in need of assistance. When they arrived an hour later, the man was found dead. The death was very unexpected. According to the preliminary autopsy result the man had suffered circulatory failure. The Agency has requested that the reporter send us relevant information from the finalized autopsy report. Additional Information: The reporter writes 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 writes that each individual case can be explained by concomitant illness, medication and so on, but that the number of patients affected at a similar time 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. No follow-up attempts are possible, information on batch number cannot be obtained.; Reported Cause(s) of Death: circulatory failure; Autopsy-determined Cause(s) of Death: circulatory failure


VAERS ID: 1121576 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Drug ineffective, Hypotension, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (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: Alzheimer''s disease; COVID-19 (Covid-19 diagnosed/lab verified); Hypertension; Renal failure
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:38,5 Centigrade; Test Name: oxygen saturation; Test Result: 95 %; Comments: stable throughout the course.; Test Name: oxygen saturation; Test Result: 80 %; Test Date: 202102; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:positive; Comments: Covid-19 diagnosed/lab verified
CDC Split Type: SEPFIZER INC2021283321

Write-up: drug ineffective; COVID-19 aggravated; Blood pressure low; Oxygen saturation decreased; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, one authority number SE-MPA-2021-009784. Other case identifier number SE-MPA-1614696293216. This is one of 2 reports. A 94-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY), via an unspecified route of administration as single dose in Feb2021 around 8:00 for COVID-19 immunisation. Medical history included hypertension, Alzheimer''s disease, have had a relatively mild course of COVID-19 diagnosed/lab verified in Feb2021, renal failure. The patient''s concomitant medications were not reported. The patient previously received the 1st dose of bnt162b2 (COMIRNATY) on an unknown date for COVID-19 immunisation. In Feb2021 the patient experienced COVID-19 aggravated, blood pressure low, oxygen saturation decreased, drug ineffective. The patient underwent lab tests and procedures which included: body temperature: 38,5 centigrade, oxygen saturation: 95% stable throughout the course, oxygen saturation: 80%, Sars-cov-2 test: positive in Feb2021. The patient died on an unspecified date in 2021. The events had outcome fatal. It was not reported if an autopsy was performed. Course of events was as follow: She have had a relatively mild course of Covid-19, max temp 38,5 degrees and O2 saturation around 95% stable throughout the course. After 11 days the patient was free from fever and relatively recovered in Feb2021. The next day the woman received her second dose of Comirnaty around 8:00 a clock in the morning. Between 10-11, the woman deteriorates sharply with saturation of 80%. The woman died two days later. Report assessed as serious, death.; Sender''s Comments: Linked Report(s) : SE-PFIZER INC-2021288142 Different dose and events.; Reported Cause(s) of Death: COVID-19 aggravated; blood pressure low; oxygen saturation decreased; drug ineffective


VAERS ID: 1121578 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes; Myocardial infarct; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: COVID 19 test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021283335

Write-up: drug ineffective/diagnosed with Covid 13 days after vaccination of dose 2; COVID-19; This is a spontaneous report from a contactable physician downloaded from the Agency-WEB, regulatory authority number SE-MPA-2021-011683. Other Case identifier number: SE-MPA-1614952941111. An 87-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on an unknown date in Feb2021 (Batch/Lot Number: EL0725) as 0.3 mL, single; and dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: unknown) as a single dose for COVID-19 immunisation. Medical history included previous myocardial infarction, previous stroke, diabetes mellitus and dementia, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Reported suspect adverse event was death. The patient experienced death, covid-19 and drug ineffective. The patient was vaccinated at his nursing home with COMIRNATY dose 2 in February 2021. Then fell ill with Covid-19 on an unspecified date in Mar2021. He was diagnosed with Covid 13 days after vaccination of dose 2. He died in the aftermath of the disease in early March, three weeks after dose 2 of Comirnaty. Outcome: Fatal. Report assessed as serious, death. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive in Mar2021. The patient died on Mar2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: COVID-19; drug ineffective/diagnosed with Covid 13 days after vaccination of dose 2


VAERS ID: 1121579 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC2021283331

Write-up: dead; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-012965. Other Case identifier number: SE-MPA-1615191743107. A 77-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot Number: EP2166), intramuscularly on Mar2021 at 0.3 mL, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported, no known underlying diseases. The patient received vaccine in Mar2021 in the afternoon, felt well at least until the next morning. Alone at home in the forenoon the next day. The patient was found dead early in the afternoon the day after the vaccination. Probably died before 12 o''clock. Report assessed as serious, death. 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: death


VAERS ID: 1121732 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Decreased appetite, Dehydration, Dyspnoea, Fatigue, Feeling abnormal, Heart rate, Mobility decreased, Oxygen saturation, Pulmonary embolism, Pupil dilation procedure
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Dementia (broad), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Dehydration (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-05
   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: AERIUS [DESLORATADINE]; ATORVASTATIN; MILURIT; LETROX; PRESTANCE; HYDROCORTISON [HYDROCORTISONE ACETATE]; MINIRIN MELT
Current Illness: Cholecystolithiasis (asymptomatic); Diabetes insipidus; Dyslipidemia; Gonarthrosis; Hypertension arterial (mild on therapy); Hyperuricemia; Overweight; Panhypopituitarism; Pollen allergy (polinosis); Renal cyst (bilateral); Unilateral blindness (of the left eye); Vertebrogenic pain syndrome (of lumbosacral spine, mild discopathy)
Preexisting Conditions: Medical History/Concurrent Conditions: Malignant melanoma excision (extirpation of malignant melanoma under the right ankle 2014); Melanoma malignant (under right ankle); Pituitary cyst; Pituitary gland operation (pituitary cyst surgery)
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: Blood pressure; Result Unstructured Data: Test Result:0 mmHg; Test Date: 20210305; Test Name: Pulse rate; Result Unstructured Data: Test Result:0/min; Test Date: 20210305; Test Name: O2 saturation; Test Result: 0 %; Test Date: 20210305; Test Name: Pupil dilation procedure; Result Unstructured Data: Test Result:Left 5, right 5
CDC Split Type: CZPFIZER INC2021287801

Write-up: pulmonary embolism; Dehydration; reduced mobility; Breathlessness; Decreased appetite; did not feel good; tired; This is a spontaneous report from a contactable physician and a contactable consumer downloaded from the CZ-CZSUKL-21002036. A 77-year-old female patient received first dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), intramuscular on 03Mar2021 18:00 as single dose for COVID-19 immunisation. Medical history included ongoing bilateral renal cysts, ongoing vertebrogenic pain syndrome (of lumbosacral spine, mild discopathy), ongoing asymptomatic cholecystolithiasis, ongoing hyperuricemia, ongoing unilateral blindness (of the left eye), ongoing pollen allergy (polinosis), ongoing dyslipidemia, malignant melanoma (under right ankle) from an unknown date to 2014, ongoing hypertension arterial (mild on therapy), pituitary cyst from an unknown date to 1989, ongoing diabetes insipidus, gonarthrosis from 2015 and ongoing, ongoing overweight, pituitary gland operation from 1989 and not ongoing (pituitary cyst surgery), ongoing panhypopituitarism, malignant melanoma excision from 2014 and not ongoing (extirpation of malignant melanoma under the right ankle 2014). Concomitant medications included desloratadine (AERIUS) taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; allopurinol (MILURIT) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LETROX) taken for an unspecified indication, start and stop date were not reported; amlodipine besilate, perindopril arginine (PRESTANCE) taken for an unspecified indication, start and stop date were not reported; hydrocortisone acetate (HYDROCORTISON) taken for an unspecified indication, start and stop date were not reported; desmopressin acetate (MINIRIN MELT) taken for an unspecified indication, start and stop date were not reported. The patient previously took tetanus vaccine for immunization in Jun2017. The patient experienced pulmonary embolism (death, medically significant, life threatening) on 05Mar2021 16:00, dehydration on 04Mar2021, reduced mobility on 04Mar2021, breathlessness on 04Mar2021, decreased appetite on 04Mar2021, did not feel good on 04Mar2021, tired on 04Mar2021. The patient underwent lab tests and procedures which included blood pressure measurement: 0 mmhg on 05Mar2021, heart rate: 0/min on 05Mar2021, oxygen saturation: 0 % on 05Mar2021, pupil dilation procedure: left 5, right 5 on 05Mar2021. The patient died on 05Mar2021. An autopsy was not performed. The outcome of event pulmonary embolism was fatal. The outcome of events did not feel good and tired was unknown. The outcome of other events was not recovered. To reaction(s)/event: Source of assessment - reporter (consumer), result of assessment -related; to reaction(s)/event: Source of assessment - physician, result of assessment -unrelated. The clinical course was reported as follows:A COMIRNATY vaccination of a 77-year-old female patient was complicated by a fatal pulmonary embolism.On 03Mar2021 at 6PM the patient was vaccinated with COMIRNATY. Before the vaccination, the reporter last saw the patient on 28Feb2021 and she seemed perfectly healthy, able to do long walks. She suffered from no health problems.After the vaccination, she talked with the reporter and still seemed content and fine. The morning of 04Mar2021 she did not feel good, would not get out of bed, was growling, would not eat. She was dehydrated. Having been alerted to the possibility of not feeling good after the vaccination, the reporter and patient thought this is the reason and that it would go away. During the night from 04Mar2021 to 05Mar2021 the patient died in her sleep.The physician from an ambulance said the cause of death was a pulmonary embolism. She did not see the vaccination as the cause of death or embolism. But according to the reporter, it would be a very improbable coincidence, that her state had worsened so fast just a few hours after the vaccination. Report of the physician who performed the Found by her husband lying on her stomach unconscious. He commenced a phone-assisted first-aid. When the ambulance arrived, the doctor has already diagnosed death. There already were some signs of death (postmortem stiffness of the face, limbs. Asystole, breathlessness, without stem reflexes). Exitus lethalis 05Mar2021 at 4 o''clock. According to her husband, the patient was vaccinated on Wednesday. From 04Mar2021 she was dyspnoic, tired, perhaps she was gargling during the night, she had defecated themselves. The husband tried to put the patient back to bed, it didn''t work, so he let the patient sleep on the floor. It was around 4 p.m. He woke up in the morning and found the patient lying on his stomach. Objective finding: No signs of life - certain signs of death - no stem reflexes, asystole, breathless, postmortem spots - on the underside of the body, postmortem stiffness-advanced-face, limbs; cyanosis of the head, defecated. Vital values ??at 7:52: Pressure 0mmHg, frequency 0 / min, Saturation 0%, Pupil L5, P5 Diagnosis: Other unspecified and unspecified causes of death, pulmonary embolism.The diagnosis of pulmonary embolism was made only on the basis of information from a relative, it cannot be taken as a certain diagnosis. The emergency service doctor stated the cause of death as described by the husband, the autopsy was not performed and the embolism was not verified, the patient was dehydrated.To reaction(s)/event: Source of assessment - reporter , result of assessment -related; to reaction(s)/event: Source of assessment - physician, result of assessment -unrelated. Information about lot/batch number cannot be obtained. No further information expected.; Reported Cause(s) of Death: The diagnosis of pulmonary embolism was made only on the basis of information from a relative, it cannot be taken as a certain diagnosis.


VAERS ID: 1121813 (history)  
Form: Version 2.0  
Age: 100.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-16
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fracture bone; Pain
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUMODERNATX, INC.MOD20210

Write-up: Inappetence; harder to drink, drank; A regulatory report was received from a 100-year-old, female patient, who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced inappetence and difficulty to drink that led to death. The patients medical history included current illness of bone fracture and pain which started from 04-JAN-2021. The relevant concomitant medications were not provided. On 16-JAN-2021, prior to the onset of the events, the patient received their unknown dose of two planned doses of mRNA (Lot number: 300042698) through intramuscular route of administration for prophylaxis of COVID-19 infection. On unknown date on JAN-2021, patient experienced inappetence and difficulty to drink. No laboratory data was provided. Action taken with mRNA-1273 in response to the events was not applicable. The reporter indicated that the causal relationship between the suspected drug and the event is considered unlikely. The outcome of the event inappetite was Fatal on 28-JAN-2021. The details of autopsy done was unknown. No treatment information was provided.; Reporter''s Comments: Based on reporter''s causality, the advanced patient''s age and the prior medical history, the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: death due to Inappetence


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