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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: 1055850 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021196678

Write-up: patient died; This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech (manufacturer control number 17268), license party for BNT162B2. This physician reported similar events for seven patients. This is the third of seven reports. A patient of unspecified age and gender received first dose of BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated in a nursing home in the period from 31Dec2020 to 05Feb2021. The patient died on day 16 after the first dose 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.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021195319 same reporter/drug/event, different patients; Reported Cause(s) of Death: patient died


VAERS ID: 1055851 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021196679

Write-up: Patient died; This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech (manufacturer control number 17268), license party for BNT162B2. This physician reported similar events for seven patients. This is the fourth of seven reports. A patient of unspecified age and gender received first dose of BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated in a nursing home in the period from 31Dec2020 to 05Feb2021. The patient died on day 22 after the first dose 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.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021195319 same reporter/drug/event, different patients; Reported Cause(s) of Death: Patient died


VAERS ID: 1055869 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Malaise, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   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: Chronic liver disease; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESPFIZER INC2021181693

Write-up: Diarrhea; Malaise; Muscular weakness; This is a spontaneous report from a contactable physician downloaded from the Agency ES-AEMPS-750879. A 68-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 11Feb2021 at single dose for COVID-19 immunisation. Medical history included neuro-psychiatric disorders and chronic liver disease. Concomitant medications were unknown. The patient experienced diarrhea, malaise, muscular weakness on 11Feb2021. The patient was stable but 4 hours after vaccination he begins to complain, muscle weakness, at 6 hours there were 4 liquid stools until he died on 12Feb2021 at 18 hours after vaccination. It was unknown if autopsy was performed. Outcome of all events was fatal. No follow-up attempts are possible, information on lot/batch number cannot be obtained.; Reported Cause(s) of Death: diarrhea; malaise; muscular weakness


VAERS ID: 1055874 (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: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood pressure systolic, Body temperature, Cognitive disorder, Computerised tomogram thorax, Dysphagia, Hyperthermia, Lung disorder, Oxygen saturation, Oxygen saturation decreased, Pneumonia, SARS-CoV-2 test positive, Somnolence, Tongue oedema
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Deep vein thrombosis; Dementia Alzheimer''s type; Hypertension arterial; Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:99 mmHg; Test Date: 20210120; Test Name: body temperature; Result Unstructured Data: Test Result:38.7 Centigrade; Test Date: 20210121; Test Name: body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Test Date: 20210122; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210129; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Date: 20210121; Test Name: thoracic scanner; Result Unstructured Data: Test Result:pneumonia; Test Date: 20210120; Test Name: o2 saturation; Test Result: 95 %; Test Date: 20210201; Test Name: o2 saturation; Test Result: 65 %; Comments: desaturation; Test Date: 20210122; Test Name: SARS-CoV-2 test positive; Test Result: Negative ; Test Date: 20210129; Test Name: SARS-CoV-2 test positive; Result Unstructured Data: Test Result:POSITIVE COVID-19 PCR test.
CDC Split Type: FRPFIZER INC2021181407

Write-up: Pneumopathy; Edema tongue; ARRHYTHMIA; Oxygen saturation decreased/ respiratory degradation with 65% O2 desaturation; positive COVID-19 PCR test; deterioration of cognitive function; difficulty swallowing; pneumonia; slight drowsiness; hyperthermia at 38.7 C; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-CF20210161. A 90-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot# EM0477), intramuscular on 18Jan2021 at single dose for covid-19 immunisation. Medical history included dementia alzheimer''s type, deep vein thrombosis, hypertension arterial, living in nursing home from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced oxygen saturation decreased on 01Feb2021, pneumopathy on 21Jan2021, edema tongue on 20Jan2021. Clinical course reported as: On 20Jan2021, she presented with hyperthermia at 38.7 C which will persist throughout the day with slight drowsiness. No respiratory distress (SpO2 95%), no mottling. Put on antibiotic therapy and solumedrol. 21Jan2021: eupneic patient, T ? at 37.5 ? C, appearance of edema of the tongue with difficulty in swallowing =$g realization of a thoracic scanner objectifying pneumonia (inhalation?). From Jan22 to 28Jan2021: hospitalization of the patient, initiation of antibiotic therapy + corticosteroid therapy + polaramine. Temperature at 37 ? C but persistence of edema of the tongue. Covid test negative. Return to nursing home on 29Jan2021: deterioration of cognitive functions. Recurrence of fever at 38.5 C. positive COVID-19 PCR test. 31Jan2021: comfort care for the patient =$g put on morphine. 01Feb2021: respiratory degradation with 65% O2 desaturation and evidence of an arrhythmia associated with systolic BP of 99 mmHg =$g taken in charge by the Emergency medical services, death observed two hours after this treatment. The patient died on 01Feb2021. It was not reported if an autopsy was performed. Events oxygen saturation decreased, pneumopathy, edema tongue were reported as serious fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Oxygen saturation decreased; Pneumopathy; Edema tongue


VAERS ID: 1055875 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-25
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-25
   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: Arteriopathic disease; Cardiac failure; Diabetes; Diabetic nephropathy; Diabetic neuropathy; General physical health deterioration (for several months before the vaccination)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021180550

Write-up: Respiration labored; Feeling sick; This is a spontaneous report from a contactable physician downloaded from the WEB FR-AFSSAPS-GR20210284 This is a report received from the Regulatory Authority. A 90-year-old (also reported as 93 years old, pending clarification) female patient was received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795) Intramuscular at left arm on 12Jan2021 at single dose for COVID-19 vaccination. Medical history included diabetes with multiple complications: Nephropathy (diabetic nephropathy), Neuropathy (diabetic Neuropathy), Arteriopathy (Arteriopathic disease), Heart failure (Cardiac failure), all from unknown date and unknown if ongoing. Long-term treatment was not specified. The patient has had a deterioration in her general condition for several months before the vaccination. Concomitant medication was not reported. The deterioration in the patient''s general condition continues in the weeks following vaccination. The patient has no other side effects from the vaccine. On25Jan2021, the patient is unwell and has difficulty breathing. differential diagnosis was very poor general condition. Patient was died on 25Jan2021 for respiration labored and feeling sick. Cause of death was also reported as reduced general condition. The autopsy was not done. No follow-up attempts possible. No further information expected. Information on lot and batch numbers already obtained. ; Reported Cause(s) of Death: Reduced general condition; Respiration labored; Feeling sick


VAERS ID: 1055876 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: SERESTA; LEVOTHYROXINE SODIQUE; NICARDIPINE HYDROCHLORIDE; XARELTO; GAVISCON [ALUMINIUM HYDROXIDE;CALCIUM CARBONATE;SODIUM ALGINATE;SODIUM BICARBONATE]; PARACETAMOL; INSULINE GLARGINE; DIGOXINE; INSULINE GLULISINE; HYDROCHLOROTHIAZIDE; EUPR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acetabulum fracture; AFib; Arrhythmia; Fall; Heart murmur; Hypertension arterial; Hypothyroidism; Ketosis-prone diabetes mellitus; Radius fracture
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021181381

Write-up: Sudden death; Asthenia; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB [FR-AFSSAPS-LM20210183]. An 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Lot/Batch number EJ6788) via intramuscular at single dose in right deltoid on 04Feb2021 for COVID-19 immunisation. First dose was on 14Jan2021. Medical history included atrial fibrillation (AFib) and arrhythmia, complete arrhythmia by atrial fibrillation treated with fluindione (PREVISCAN) 1/day; hypertension arterial (high blood pressure); hypothyroidism; Ketosis-prone diabetes mellitus; aortic heart murmur. Patient had a fall at home on 10Oct2020 and had fracture of the lower end of his right radius and a fracture of the roof of the left acetabulum, both in orthopedic treatment from 10 to 19Oct2020. Then convalescence in follow-up care and rehabilitation geriatric. Single suite with rehabilitation, released 04Jan2021. Patient had well-healed stage 1 right heel ulcer upon release. The decision was to stop his AVK (Vitamin K antagonist) treatment, and switch to rivaroxaban (XARELTO) 20 mg /day due to the lability of INRs (international normalized ratio) with overdose. Concomitant medications included oxazepam (SERESTA); levothyroxine sodique; nicardipine hydrochloride; rivaroxaban (XARELTO, film-coated tablet); aluminium hydroxide/calcium carbonate/sodium alginate/sodium bicarbonate (GAVISCON); paracetamol; insuline glargine; digoxine; insuline glulisine; hydrochlorothiazide; urapidil hydrochloride (EUPRESSYL); irbesartan. There was no complications after vaccination. There was no symptoms suggestive of COVID when it was released on 05Feb2021. Patient experienced asthenia on 04Feb2021 with outcome of recovered on 05Feb2021. Patient had sudden death at home on 06Feb2021 with outcome of fatal. Autopsy was not done. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1056105 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-31
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Chest X-ray, Electrocardiogram, Fatigue, Feeding disorder, Heart rate, Oxygen saturation, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: RIPEDON; CHINOTAL; ACETYLSALICYLIC ACID; SERMION [NICERGOLINE]; GERODORM; XANAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cachexia; Dementia; Hypertension; Ischaemic heart disease; Melanoma; Psychiatric disorder NOS
Allergies:
Diagnostic Lab Data: Test Date: 20210201; Test Name: Blood pressure; Result Unstructured Data: Test Result:113/62 mmHg mmHg; Test Date: 20210201; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 degrees Celsius Centigrade; Test Date: 20210202; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pneumonia right side; Test Date: 20210201; Test Name: EKG; Result Unstructured Data: Test Result:atrial fibrillation,; Comments: atrial fibrillation, HR:152/min, aVF negative T waves, V4-V6 ascending ST depression; Test Date: 20210201; Test Name: Heart rate; Result Unstructured Data: Test Result:152/min; Test Date: 20210201; Test Name: Oxygen saturation; Test Result: 89 %; Test Date: 20210202; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210204; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210201; Test Name: COVID-19 rapid POC test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021183051

Write-up: could not be fed; weakness; Prostration; fever; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authorityHU-OGYI-050421. An 83-year-old male patient received first dose of bnt162b2 (COMIRNATY, Lot#: EJ6134), intramuscular on 28Jan2021 19:14 at 0.3 mL, single for covid-19 immunisation. Medical history included dementia from an unknown date and unknown if ongoing , cachexia from an unknown date and unknown if ongoing , ischaemic heart disease from an unknown date and unknown if ongoing , melanoma from an unknown date and unknown if ongoing , psychiatric disorders NOS from an unknown date and unknown if ongoing , hypertension from an unknown date and unknown if ongoing. Concomitant medication included risperidone (RIPEDON) 1 film-coated tablet (twice a day), pentoxifylline (CHINOTAL) (unknown dose, three times a day), unknown acetylsalicylic acid (100 mg once daily), nicergoline (SERMION [NICERGOLINE]) 30 mg film-coated tablet (once daily), cinolazepam (GERODORM) (once daily), alprazolam (XANAX) 0,25 mg tablet (three times a day). The occurence of weakness, prostration and feeding disorder resulting in death after the administration of Comirnaty concentrate for dispersion for injection (30 micrograms of COVID-19 mRNA Vaccine: BioNTech Manufacturing GmbH/ Pfizer). On 28Jan2021 at 19:14, the patient received the first dose of Comirnaty (COVID-19 mRNA Vaccine (nucleoside modified)/ Tozinameran) concentrate for dispersion for injection (strength: 1 dose (0.3 mL) contains 30 micrograms of COVID-19 mRNA Vaccine, intramuscularly, left arm, batch number: EJ 6134) for COVID-19 immunisation. On 31Jan2021, the patient experienced fever, weakness, prostration, and feeding disorder (could not be fed). On 01Feb2021 the patient was taken to the emergency, where EKG, COVID-19 PCR and chest X-ray was performed. X-ray showed right sided pneumonia. He received 1500 ml saline solution due to dehydratation and 1 ampoule Algopyrin (metamizole sodium), unknown Ceftriaxon (intravenously, 2 gr), and Fragmin injection (dalteparin sodium, 2500 NE daily). The patient died on 04Feb2021 at 5:45 am silently. Autopy was done, cause of death was subtotal pulmonary embolism caused by deep vein thrombosis, and poor general condition. Established diagnoses: Atherosclerosis generalized, Ventricular hypertrophy hypertrophia, Pulmonary oedema, Bronchopneumonia, Embolism pulmonary. The reporter physician did not consider the events to be related to vaccination. Tests included On 01Feb2021, EKG: atrial fibrillation, HR:152/min, aVF negative T waves, V4-V6 ascending ST depression, Oxygen saturation: 89 percent, COVID-19 rapid test: negative, Blood pressure: 113/62, Body temperature: 38.4 degrees Celsius. On 02Feb2021, COVID-19 PCR test: negative, Chest X-ray: pneumonia right side. On 04Feb2021, COVID-19 PCR test: negative. Sender Comment: 83-year-old patient died 6 days after vaccination with Comirnaty. Cause of death was pulmonary embolism according to the autopsy. The causal relationship between the events and Comirnaty is considered unlikely. The case is serious due to the fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: pulmonary embolism


VAERS ID: 1056106 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-02-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure immeasurable, Blood pressure measurement, Blood sodium, C-reactive protein, Chest X-ray, Diarrhoea, Electrocardiogram, Fibrin D dimer, Oxygen saturation, Oxygen saturation decreased, Renal function test, SARS-CoV-2 test negative, SARS-CoV-2 test positive
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: AMLODIPIN TEVA; CITALOPRAM ZENTIVA; FRONTIN; LAVESTRA; BETALOC [METOPROLOL SUCCINATE]; ATORIS
Current Illness: Dementia; Encephalopathy; Hypertension; Ischaemic heart disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Blood pressure; Result Unstructured Data: Test Result:96/70 mmHg; Comments: 96/70; Test Date: 20210204; Test Name: sodium; Result Unstructured Data: Test Result:hyponatraemia; Test Date: 20210204; Test Name: Chest X-ray; Result Unstructured Data: Test Result:bilateral infiltrates unchanged; Test Date: 20210204; Test Name: CRP; Result Unstructured Data: Test Result:high; Test Date: 20210204; Test Name: EKG; Result Unstructured Data: Test Result:tachycardia; Test Date: 20210204; Test Name: D-dimer; Result Unstructured Data: Test Result:high; Test Date: 20210204; Test Name: Oxygen saturation; Test Result: 80 %; Test Date: 20210204; Test Name: renal function; Result Unstructured Data: Test Result:decreased; Test Date: 20210126; Test Name: COVID-19 antigen test negative; Test Result: Negative ; Test Date: 20210111; Test Name: COVID-19 PCR test positive; Test Result: Positive
CDC Split Type: HUPFIZER INC2021183089

Write-up: blood pressure immeasurable; low oxygen saturation, around 80%; Diarrhoea; This is a spontaneous report from a contactable physician downloaded from the Agency HU-OGYI-050521. A 77-years-old female patient received the first dose of bnt162b2 (COMIRNATY, lot# EJ6134), intramuscular 0.3 mL single on 30Jan2021 at 09:26 for covid-19 immunisation. Medical history included ongoing encephalopathy, ongoing myocardial ischaemia, ongoing dementia, ongoing hypertension. Concomitant medications included amlodipine besilate (AMLODIPIN TEVA), citalopram hydrobromide (CITALOPRAM ZENTIVA), alprazolam (FRONTIN), losartan potassium (LAVESTRA), metoprolol succinate (BETALOC), atorvastatin calcium (ATORIS). The patient experienced diarrhoea on 01Feb2021, blood pressure immeasurable on 04Feb2021, low oxygen saturation, around 80% on 04Feb2021. On 04Feb2021, the patient was taken to the emergency due to 2-day-long diarrhoea, low oxygen saturation around 80%, and immeasurably low blood pressure. EKG and chest X-ray were performed. X-ray showed bilateral infiltrations which were unchanged since the previous scan. Decreased renal function, hyponatraemia, high CRP levels, and high D-dimer values showed in the patient''s laboratory tests. The patient underwent lab tests and procedures which included blood pressure measurement: 96/70 mmhg on 04Feb2021, chest x-ray: bilateral infiltrates unchanged on 04Feb2021, electrocardiogram: tachycardia on 04Feb2021, oxygen saturation: 80 % on 04Feb2021, sars-cov-2 test negative on 26Jan2021, sars-cov-2 test positive: positive on 11Jan2021. She received unknown infusion and dopamine perfursor was started. Sodium supplementation, oxygen supplementation, Solu-medrol (methylprednisolone, intravenously), ceftriaxon therapy, and low-dose LMWH prophylaxis was used in unknown dosages. On the day of admission, the patient was tachycard in the afternoon, her breathing was rapid, and metabolic acidosis was shown on the Astrup device. Bicarbonate was replaced. Her blood pressure was again immeasurably low, and the dose of vasopressor was increased. Later, her circulation collapsed, despite all of the efforts, the patient died on 04Feb2021 at 17:40. Autopsy was done, cause of death was left heart failure caused by ischaemic heart disease and generalised atherosclerosis. The lungs did not indicate possible COVID infection according to the pathological examination. Following diagnosis were reported: atherosclerosis generalized, ventricular hypertrophy hypertrophia, pulmonary oedema, hepatic steatosis, colelitiasis, arteriolosclerotic nephrosclerosis. The reporter physican did not consider the events to be related to vaccination. Sender Comment: 77-year-old patient died 5 days after vaccination with Comirnaty. Cause of death was left heart failure according to the autopsy. The causal relationship between the events and Comirnaty is considered unlikely. The case is serious due to the fatal outcome. No follow-up attempts are possible. No further information is expected; Sender''s Comments: Based on the clinical course description and the autopsy result, which revealed the cause of death was left heart failure caused by ischaemic heart disease and generalised atherosclerosis. The lungs did not indicate possible COVID infection according to the pathological examination, the Company, in concurrence with the sender, the events are unrelated to COVID-19 vaccine, BNT162B2, administration.; Reported Cause(s) of Death: diarrhea; Blood pressure immeasurable; Oxygen saturation decreased; Left heart failure


VAERS ID: 1056152 (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: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: covid quick test; Test Result: Negative
CDC Split Type: ITPFIZER INC2021180666

Write-up: on 02Feb2021 the 2nd dose of the COVID 19 Pfizer vaccine was administered - in the morning the lady was not responding to stimuli (coma) and began to have fever (negative COVID rapid test).; on 02Feb2021 the 2nd dose of the COVID 19 Pfizer vaccine was administered - in the morning the lady was not responding to stimuli (coma) and began to have fever (negative COVID rapid test).; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency. An patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular at single dose in left arm (left shoulder) on 02Feb2021 13:00 for COVID-19 immunisation. Medical history and concomitant medication were not reported. On 02Feb2021, the 2nd dose of the COVID 19 Pfizer vaccine was administered. In the morning the lady was not responding to stimuli (coma) and began to have fever (negative COVID rapid test) on 03Feb2021. The events resulted death, in Feb2021. Cause of death was fever and coma. The outcome of events was fatal. It was unknown if an autopsy was performed or not. Reporter comment: The patient presented several co-morbidities, including one, possibly responsible for the stroke and the outcome. On 02Feb2021 the 2nd dose of the COVID 19 Pfizer vaccine was administered - in the morning the lady did not respond to stimuli (coma) and started having fever (negative COVID rapid test). Sender Comment: 15Feb2021 drug database: request for follow-up information to the reporter regarding the medical documentation of the case and further information. Waiting for an answer. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: The patient presented several co-morbidities, including one, possibly responsible for the stroke and the outcome. On 02Feb2021 the 2nd dose of the COVID 19 Pfizer vaccine was administered - in the morning the lady did not respond to stimuli (coma) and started having fever (negative COVID rapid test).; Reported Cause(s) of Death: Coma; Fever


VAERS ID: 1056153 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-02-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Blood culture, COVID-19, Chest X-ray, Multiple organ dysfunction syndrome, Pneumonia bacterial, Respiratory viral panel, SARS-CoV-2 test, Septic shock, Ultrasound chest, Vaccination failure, Viral test
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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUTIROX; RETACRIT [EPOETIN ZETA]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency (undergoing dialysis treatment); Closed fracture of multiple cervical vertebrae (C1-C2 fracture (September 2020) with atlantoaxial sub-dislocation and compression at bulb passage); Dialysis; Hypertension arterial; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: Blood culture; Result Unstructured Data: Test Result:positive for Acinetobacter Calcoaceticus-baumanni; Comments: positive for Acinetobacter Calcoaceticus-baumannii complex; Test Date: 20210210; Test Name: CXR; Result Unstructured Data: Test Result:complete opacification of the left hemithorax is d; Comments: complete opacification of the left hemithorax is documented as per lung atelectasis. Other more circumscribed parenchymal thickenings are noticeable on the right; Test Date: 20210210; Test Name: Respiratory viral panel; Result Unstructured Data: Test Result:positive for SARS-COV 2; Test Date: 20210211; Test Name: SARS-CoV-2 PCR test; Test Result: Positive ; Test Date: 20210210; Test Name: Lung ultrasound; Result Unstructured Data: Test Result:diffuse pattern of B lines bilaterally (left hemi; Comments: diffuse pattern of B lines bilaterally (left hemithorax greater than right hemithorax), presence of bilateral pleural sliding without macroscopic signs of pleural effusion; Test Date: 20210210; Test Name: rapid swab for Sars-Cov2; Test Result: Positive
CDC Split Type: ITPFIZER INC2021180724

Write-up: septic shock; multi-organ failure; SARS-CoV 2 infection; acute respiratory failure caused by untyped bacterial pneumonia; acute respiratory failure caused by untyped bacterial pneumonia; vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority manufacturer report number IT-MINISAL02-678359. A 63-year-old female patient received the second dose of BNT162B2 (Comirnaty, Lot No. EJ6797) intramuscularly on 27Jan2021, the first dose (Lot No. EL1484) was received on 05Jan2021, both at single dose for COVID-19 immunisation. Relevant history induced Type 2 diabetes mellitus, arterial hypertension, Chronic renal failure under dialysis treatment, closed fracture of multiple cervical vertebrae since 01Sep2020 (C1-C2 fracture (September 2020) with diver - atlanto-axial flux and compression at the bulb-medullary passage and on the cervical cord, without neurosurgical indication due to the high risk-benefit ratio. The patient had Long-term hospitalization. Relevant concomitant drug included levothyroxine sodium (EUTIROX) 50mcg tablet and epoetin zeta (RETACRIT) 4000 IU / 0.4 ML solution for injection for Chronic renal failure. Therapy administered in a nursing home included: Eutirox 50mcg, Humalog 6 UI for Diabetes mellitus, Lobivon 5 mg for Hypertension arterial, catapresan CRTT for Hypertension arterial, Nitrodem 10 mg, Calcium 1cpr, retacrit 4,000 for Chronic renal failure, Rocaltrol 0.25mcg, Omeprazen 20mg, Adalat crono 30 mg for Hypertension arterial, Lantus 12U.I for Diabetes mellitus. 15 days after the Covid-19 vaccination (II dose), the patient was found to have positive SARS-CoV 2 infection, and arrived in emergency room and then in Intensive T. on 10Feb2021 for acute respiratory failure caused by untyped bacterial pneumonia, died within 24 hours of septic shock and multi-organ failure (chest x-ray not suggestive of Covid pneumonia), with onset of respiratory symptoms on 05Feb2021 (reported by doctor). Treatment therapy included: Resuscitation treatment of the picture Respiratory, Hemodynamic and Renal (Invasive ventilation, amine-vasoactive, broad spectrum antibiotic therapy, CVVHDF dialysis treatment). Examinations performed on admission: Chest x-ray (on 10Feb2021): "complete opacification of the left hemithorax is documented as per lung atelectasis. Other more circumscribed parenchymal thickenings are noticeable on the right. ECHO-lung: diffuse pattern of B lines bilaterally (left hemithorax greater than right hemithorax), presence of bilateral pleural sliding without macroscopic signs of pleural effusion. Rapid swab positive for SARS CoV-2 performed by 118 crew (on 10Feb2021). Upper respiratory panel filmarray (nasopharyngeal swab) (on 10Feb2021): positive for SARS-COV 2. SARS CoV 2 PCR rt Positive (nasopharyngeal swab) (on 11Feb2021). FILMARRAY blood culture panel on 10Feb2021 positive for Acinetobacter Calcoaceticus-baumannii complex (on 10Feb2021, culture tests are in progress). FILMARRAY blood culture panel on 10Feb2021 positive for Acinetobacter Calcoaceticus-baumannii complex (on 10Feb2021, culture tests are in progress); complete opacification of the left hemithorax is documented as from pulmonary atelectasis. Other more circumscribed parenchymal thickenings are noticeable on the right; SUCCESSFUL; upper respiratory panel filmarray (nasopharyngeal swab) (10Feb2021): positive for SARS-COV 2; diffuse pattern of B lines bilaterally (left hemithorax greater than right hemithorax), presence of bilateral pleural sliding without macroscopic signs of pleural effusion.; Reported Cause(s) of Death: untyped bacterial pneumonia; acute respiratory failure; SARS-CoV 2 infection; vaccination failure; septic shock; multiorgan failure


VAERS ID: 1056156 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Body temperature increased, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210204; Test Name: Body temperature increased; Result Unstructured Data: Test Result:38.3 Centigrade; Comments: acme
CDC Split Type: ITPFIZER INC2021180663

Write-up: Vomiting; fever (acme 38.3 ? c); Acute respiratory insufficiency/respiratory failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority- IT-MINISAL02-678861. An 83-year-old male patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, batch/lot number: EL0725, expiration date: 31Mar2021), intramuscular on 04Feb2021 at single dose (1 dose form) in left arm (reported as "left shoulder") for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 04Feb2021, the patient experienced Fever (acme 38.3 Centigrade), Vomiting, Acute respiratory insufficiency. The adverse reaction was severe and the outcome was patient was death. The patient died on 07Feb2021. It was unknown if an autopsy was performed. Reporter comment: Hyperpyrexia and vomiting appeared about 5 hours after the administration of the anti-SARS-Cov2 vaccine. After about 36 hours, respiratory failure with the need for oxygen therapy. The outcome of the events was fatal.; Reporter''s Comments: Hyperpyrexia and vomiting appeared about 5 hours after the administration of the anti-SARS-Cov2 vaccine . After about 36 hours, respiratory failure with the need for oxygen therapy.; Reported Cause(s) of Death: Acute respiratory insufficiency/respiratory failure; Fever (acme 38.3 Centigrade); Vomiting


VAERS ID: 1056208 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-13
Onset:2021-01-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiovascular disorder, Cerebrovascular accident, Computerised tomogram head
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), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Late effects of head trauma; Type II diabetes mellitus; Vogt-Koyanagi-Harada disease
Allergies:
Diagnostic Lab Data: Test Name: CT scan cerebral; Result Unstructured Data: Test Result: unknown results.
CDC Split Type: BEPFIZER INC2021192137

Write-up: Arrhythmogenic ventricular cardiomyopathy; Cardiovascular disorder; This is a spontaneous report from contactable physician received from the Regulatory Authority and downloaded from the Regulatory Authority -WEB (Regulatory Authority number BE-FAMHP-DHH-N2021-76542). An 82 years old female patient received the first single dose of BNT162B2 (COMIRNATY; lot EM0477) on 13Jan2021, for COVID-19 immunisation. Medical history included VKF (Vogt-Koyanagi-Harada disease), DM2 and abusive head trauma. Concomitant medications were not reported. On 18Jan2021 the patient experienced arrhythmogenic ventricular cardiomyopathy (stroke), cardiovascular disorder. The patient died on 29Jan2021. Cause of death was not specified, anyway arrhythmogenic ventricular cardiomyopathy and cardiovascular disorder were reported as fatal. It was unknown if an autopsy was done. Examinations: CT scan cerebral (unknown results). Relationship with vaccination was unclear. Assessment of relatedness: unclassified method for both events. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatment - Evolution of the ADR - Died Situations - Other: relationship with vaccination is unclear Examinations - CT SCAN CEREBRAL; Reported Cause(s) of Death: Arrhythmogenic ventricular cardiomyopathy; cardiovascular disorder


VAERS ID: 1056209 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-02-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 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: 2021-02-08
   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: SIPRALEXA; PROLOPA; FLUDROCORTISONE ACETATE; NESTROLAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia with Lewy bodies ((mental deterioration)); Parkinson''s disease; Walking aid user (walked with walker)
Allergies:
Diagnostic Lab Data:
CDC Split Type: BEPFIZER INC2021192190

Write-up: Unexpected death; This is a spontaneous report from a contactable physician downloaded from the WEB BE-FAMHP-DHH-N2021-76862. An 84-year-old male patient received second dose of BNT162B2 (COMIRNATY, lot number: EK9788), via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. Medical history included Parkinson''s disease, Lewy body dementia (mental deterioration) and walked with walker, all from an unknown date to an unknown date. Concomitant medication included escitalopram oxalate (SIPRALEXA, strength: 10 mg), benserazide hydrochloride/levodopa (PROLOPA), fludrocortisone acetate and trazodone hydrochloride (NESTROLAN, strength: 100 mg). The patient previously received first dose of BNT162B2 (COMIRNATY) on an unspecified date and experienced no adverse effect. The patient''s unexpected death occurred on 08Feb2021, unknown cause of death. An autopsy was not performed. Reporter''s Comment: No Evolution of the ADR - Died no signs of reaction after second vaccination nor after first vaccination. No follow-up attempts possible. No further information expected.; Reporter''s Comments: No Evolution of the ADR - Died no signs of reaction after second vaccination nor after first vaccination; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1056210 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood lactic acid, Blood urea, C-reactive protein increased, Coma, Dyspnoea, Fibrin D dimer increased, Headache, Investigation, Leukocytosis, Malaise, Oxygen saturation, Oxygen saturation decreased, Peripheral coldness, Platelet count decreased, Pulse abnormal, Renal disorder, Respiratory disorder, SARS-CoV-2 test, Thrombocytopenia, Troponin
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLEXANE; BISOPROLOL; PANTOMED [DEXPANTHENOL]; LORAMET; BEFACT [CYANOCOBALAMIN;PYRIDOXINE;THIAMINE]; MIRCERA; FOLAVIT; D-CURE; DAFALGAN FORTE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Anuria; Atrial fibrillation; Dialysis (dialysis patient (3x / week)); Heart failure; Hypoalbuminemia; Malnutrition; Pneumonia; Pulmonary edema; Renal failure; Respiratory failure; Ventricular tachycardia.
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Test Result: 3.07 mg/dl; Test Date: 20201229; Test Name: lactate; Result Unstructured Data: Test Result: increased; Test Name: Urea; Result Unstructured Data: Test Result:82.7; Test Name: crp; Result Unstructured Data: Test Result:333.3 mg/l; Test Name: dimers; Result Unstructured Data: Test Result:13600 ng/ml; Test Date: 20201229; Test Name: BD; Result Unstructured Data: Test Result:77/58; Test Name: leukocytosis; Result Unstructured Data: Test Result:16890/uL; Test Date: 20201229; Test Name: saturation; Result Unstructured Data: Test Result:84; Test Date: 20201229; Test Name: decreased platelet; Result Unstructured Data: Test Result:61000/ul; Test Date: 20201229; Test Name: pulse; Result Unstructured Data: Test Result:94; Test Date: 20201229; Test Name: Covid test; Result Unstructured Data: Test Result: negative; Test Date: 20201229; Test Name: troponin; Result Unstructured Data: Test Result:107 ng/L; Comments: increased; Test Date: 20201229; Test Name: HA; Result Unstructured Data: Test Result:25.
CDC Split Type: BEPFIZER INC2021192197

Write-up: he desatured; Cold extremities; Problem with breathing; short of breath; Thrombopenia ++; 30 min after vaccination unwell, headache; 30 min after vaccination unwell, headache; Comatose; Renal problem; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB, regulatory authority number BE-FAMHP-DHH-N2021-77530. A 73-year-old male patient received the second dose of BNT162B2 (COMIRNATY), from lot EK9788 on 06Feb2021 at single dose, via unknown route for COVID-19 immunization. The patient had received the first dose of the same vaccine on 16Jan2021 and no adverse event occurred. Relevant medical history included renal failure, dialysis patient (3x/week), heart failure and atrial fibrillation. The patient was hospitalized in Nov2020 for severe acute anuria, renal failure, heart failure, respiratory failure in the context of pulmonary edema, ventricular tachycardia, anemia, pneumonia, atrial fibrillation, malnutrition and hypo-albuminemia, socially precarious situation. Concomitant medications included enoxaparin sodium (CLEXANE), bisoprolol, dexpanthenol (PANTOMED), lormetazepam (LORAMET), cyanocobalamin, pyridoxine, thiamine (BEFACT), methoxy polyethylene glycol-epoetin beta (MIRCERA), folic acid (FOLAVIT), colecalciferol (D-CURE), paracetamol (DAFALGAN FORTE). On unknown date the patient experienced short of breath, Renal disorder, Respiratory disorder, 30 min after vaccination unwell, headache, Oxygen saturation decreased, Cold extremities, Comatose, Thrombopenia. The patient died on 07Feb2021 of the events. It was unknown if an autopsy was performed. The patient had not fever, no signs of acute infection not even the morning of vaccination. The patient underwent lab data that included Covid test on 29Dec2020: negative. Lab examination in the hospital (emergency) showed a leukocytosis of 16890/uL, a CRP of 333.3 mg/L and MDRD clearance of 20 mL/min, Urea of 82.7 and Creatinine of 3.07mg/dL. lab: increased dimers (13600ng/ml), increased troponin (107ng / l), decreased platelets (61000/ul), thrombopenia, increased lactate. BD 77/58, pulse 94, saturation 84, AH 25. He was given oxygen but did not get better. He was admitted at 2:47 pm . Intensive care and resuscitation were of no avail and the patient died in the night from 06Feb to 07Feb (exact time not known). The death was determined at 3:40 AM. The doctor did not think there was a causal relationship. Headache, malaise/ possible by FAMHP, all other events: unclassifiable by FAMHP No follow-up attempts possible. No further information expected.; Reporter''s Comments: hospitalization Nov2020: severe acute anure renal failure, heart failure, respiratory failure in the context of pulmonary edema, ventricular tachycardia, anemia, pneumonia, atrial fibrillation, malnutrition and hypo-albuminemia, socially precarious situation. frailty score: 7. no COVID infection, Covid test on 29Dec2020: negative. no reactions after first vaccination on 16Jan. poor health condition at 2nd vaccination but no fever, no signs of acute infection not even the morning of vaccination. study hospital: comatose, dyspnea, BD 77/58, pulse 94, saturation 84, AH 25. Lab examination in the hospital (emergency) showed a leukocytosis of 16890 / uL, a crp of 333.3 mg / L! and MDRD clearance of 20 mL / min, Urea of ??82.7 and Creatinine of 3.07mg / dL.. lab: increased dimers (13600ng / ml), increased troponin (107ng / l), decreased platelets (61000 / ul), thrombopenia, increased lactate. He was given oxygen but did not get better. He was admitted at 2:47 pm .; Intensive care and resuscitation were of no avail and the patient died in the night from 06Feb to 07Feb (exact time not known to me), The death was determined at 3:40 AM. doctor does not think there is a causal relationship.; Sender''s Comments: Based on the current available information, the events are most likely related to an intercurrent or underlying condition which is not related to the suspected drug BNT162B2. The case will be reassessed if additional information becomes available.; Reported Cause(s) of Death: Oxygen saturation decreased; Cold extremities; Respiratory disorder; Shortness of breath; Thrombopenia; malaise; Headache; coma; renal disorder


VAERS ID: 1056225 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-26
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Arrhythmia, Aspartate aminotransferase, Asthenia, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood glucose, Blood pH, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, Body temperature, Bradycardia, C-reactive protein, COVID-19 pneumonia, Chest pain, Chills, Cough, Decreased appetite, Delirium, Dyspnoea, Fibrin D dimer, Gamma-glutamyltransferase, Haematocrit, Haemoglobin, Heart rate, Hypokalaemia, Hypoxia, International normalised ratio, Investigation, Jaundice, Lymphocyte count, Multiple organ dysfunction syndrome, N-terminal prohormone brain natriuretic peptide, Nervousness, Neutrophil count, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Platelet count, Procalcitonin, Pyrexia, Respiratory acidosis, Respiratory failure, Restlessness, SARS-CoV-2 test, Sepsis, Troponin, Ventricular tachycardia, White blood cell count
SMQs:, Torsade de pointes/QT prolongation (narrow), Cholestasis and jaundice of hepatic origin (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Akathisia (broad), Acute central respiratory depression (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PRESTARIUM NEO; ANOPYRIN; TAMSULOSIN; APO-CITALOPRAM; SORTIS
Current Illness: Ex-smoker (until age of 60years, 20cig/day); Hypercholesteraemia (on therapy); Hypertension arterial; Ischemic heart disease; Prostatic hypertrophy (on therapy)
Preexisting Conditions: Medical History/Concurrent Conditions: Hemorrhoid operation; Transurethral bladder resection (for benign bladder polyps); Vertebrobasilar insufficiency (St.p. collapse state in Nov2000); Vesical polyp (benign)
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: APTT; Result Unstructured Data: Test Result:32.9; Test Date: 20210208; Test Name: GPT; Result Unstructured Data: Test Result:1.05 IU/l; Test Date: 20210208; Test Name: Blood glutamic-oxaloacetic transferase; Result Unstructured Data: Test Result:1.06 IU/l; Test Date: 20210208; Test Name: Alk phos; Result Unstructured Data: Test Result:1.2 IU/l; Test Date: 20210209; Test Name: Bicarbonate; Result Unstructured Data: Test Result:30.8 mmol/L; Test Date: 20210209; Test Name: Bicarbonate; Result Unstructured Data: Test Result:29.9 mmol/L; Test Date: 20210212; Test Name: Bicarbonate; Result Unstructured Data: Test Result:24.7 mmol/L; Test Date: 20210212; Test Name: Bicarbonate; Result Unstructured Data: Test Result:29.8 mmol/L; Test Date: 20210210; Test Name: Bilirubin; Result Unstructured Data: Test Result:21 umol/l; Test Date: 20210206; Test Name: Chloride; Result Unstructured Data: Test Result:88 mmol/L; Test Date: 20210208; Test Name: Creatinine; Result Unstructured Data: Test Result:77 umol/l; Test Date: 20210212; Test Name: Creatinine; Result Unstructured Data: Test Result:180 umol/l; Test Date: 20210206; Test Name: Glucose; Result Unstructured Data: Test Result:6.6 mmol/L; Test Date: 20210210; Test Name: Glucose; Result Unstructured Data: Test Result:9.1 mmol/L; Test Date: 20210212; Test Name: Glucose; Result Unstructured Data: Test Result:8.3 mmol/L; Test Date: 20210209; Test Name: Blood pH; Result Unstructured Data: Test Result:7,528; Test Date: 20210210; Test Name: Blood pH; Result Unstructured Data: Test Result:7,498; Test Date: 20210212; Test Name: Blood pH; Result Unstructured Data: Test Result:7,267; Test Date: 20210208; Test Name: Potassium; Result Unstructured Data: Test Result:2.9 mmol/L; Test Date: 20210212; Test Name: Potassium; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210206; Test Name: Potassium; Result Unstructured Data: Test Result:3.7 mol/L; Test Date: 20210206; Test Name: Blood pressure; Result Unstructured Data: Test Result:120/80 mmHg; Test Date: 20210206; Test Name: Sodium; Result Unstructured Data: Test Result:136 mmol/L; Test Date: 20210212; Test Name: Sodium; Result Unstructured Data: Test Result:151 mmol/L; Test Date: 20210208; Test Name: Urea; Result Unstructured Data: Test Result:11.7 mmol/L; Test Date: 20210212; Test Name: Urea; Result Unstructured Data: Test Result:15.2 mmol/L; Test Date: 20210126; Test Name: Body temperature; Result Unstructured Data: Test Result:<=39 Centigrade; Test Date: 20210206; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Test Date: 20210206; Test Name: C-reactive protein; Result Unstructured Data: Test Result:160 mg/l; Test Date: 20210208; Test Name: C-reactive protein; Result Unstructured Data: Test Result:88.8 mg/l; Test Date: 20210210; Test Name: C-reactive protein; Result Unstructured Data: Test Result:199.5 mg/l; Test Date: 20210210; Test Name: C-reactive protein; Result Unstructured Data: Test Result:262.2 mg/l; Test Date: 20210212; Test Name: C-reactive protein; Result Unstructured Data: Test Result:222.5 mg/l; Test Date: 20210206; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:1890 mg/l; Test Date: 20210208; Test Name: GGTP; Result Unstructured Data: Test Result:1.32 IU/l; Test Date: 20210206; Test Name: Hematocrit; Result Unstructured Data: Test Result:0.44; Test Date: 20210206; Test Name: Hemoglobin; Result Unstructured Data: Test Result:149 g/l; Test Date: 20210212; Test Name: Hemoglobin; Result Unstructured Data: Test Result:124 g/l; Test Date: 20210206; Test Name: Pulse rate; Result Unstructured Data: Test Result:58; Comments: Units/min; Test Date: 20210206; Test Name: International normalised ratio; Result Unstructured Data: Test Result:0.99; Test Name: microbiological examination of Legionella + Penumococcus; Test Result: Negative ; Test Date: 20210212; Test Name: Lymphocytes; Result Unstructured Data: Test Result:2.8%; Test Date: 20210206; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.61 x10 9/l; Test Date: 20210208; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.6 x10 9/l; Test Date: 20210212; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.43 x10 9/l; Test Date: 20210212; Test Name: Netrophils absolutely; Result Unstructured Data: Test Result:14.56; Test Date: 20210212; Test Name: Neutrophils; Result Unstructured Data: Test Result:94.7%; Test Date: 20210208; Test Name: Neutrophils; Result Unstructured Data: Test Result:9.79 x10 9/l; Test Date: 20210212; Test Name: Neutrophils; Result Unstructured Data: Test Result:14.56 x10 9/l; Test Date: 20210210; Test Name: NT-proBNP; Result Unstructured Data: Test Result:4583 pg/mL; Test Date: 20210206; Test Name: O2 saturation; Test Result: 75 %; Test Date: 20210206; Test Name: O2 saturation; Test Result: 94 %; Comments: 8l/min; Test Date: 20210212; Test Name: O2 saturation; Test Result: 69.5 %; Test Date: 20210209; Test Name: Partial pressure CO2; Result Unstructured Data: Test Result:12; Test Date: 20210212; Test Name: Partial pressure CO2; Result Unstructured Data: Test Result:9; Comments: kPa; Test Date: 20210206; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:221 x10 9/l; Test Date: 20210212; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:271 x10 9/l; Test Date: 20210209; Test Name: Partial pressure O2; Result Unstructured Data: Test Result:12; Test Date: 20210212; Test Name: Partial pressure O2; Result Unstructured Data: Test Result:6.1; Comments: kPa; Test Date: 20210210; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.24 ug/L; Test Date: 20210210; Test Name: Ag-SARS-Cov2; Test Result: Positive ; Test Date: 20210206; Test Name: PCR SARS-CoV2; Test Result: Positive ; Test Date: 20210206; Test Name: Troponin; Result Unstructured Data: Test Result:60 ng/L; Test Date: 20210212; Test Name: Leukocytes; Result Unstructured Data: Test Result:15.38; Test Date: 20210206; Test Name: WBC; Result Unstructured Data: Test Result:7.92 x10 9/l; Test Date: 20210208; Test Name: WBC; Result Unstructured Data: Test Result:10.67 x10 9/l; Test Date: 20210212; Test Name: WBC; Result Unstructured Data: Test Result:15.38 x10 9/l.
CDC Split Type: CZPFIZER INC2021180818

Write-up: Respiratory failure; COVID-19 pneumonia; dyspnoea; bronchial pain; restlessness; hyposaturation; Jaundice; Nervous; respiratory acidosis; hypokalaemia; Septic condition; delirium; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority CZ-CZSUKL-21000604. An 88-year-old male patient received the first dose of bnt162b2 (COMIRNATY), intramuscularly on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included arterial hypertension on therapy since 1988, ischemic heart disease, st.p. selective coronagraphy in Sep2005, 2x stent into the right coronary artery, normal kinetics and left ventricular ejection fraction, St.p. collapse state in Nov2000, insufficiency in the vertebrobasilar basin, hypercholesterolemia on therapy, St.p. transurethral resection, perhaps benign small bladder polyps, vesical polyp, hypertrophy of the prostate on therapy, St.p. haemorrhoid surgery in 1983, ex-smoker from about 60 years, previously 20 cig/d, alcohol occasionally, and without allergies. Family history was insignificant. Concomitant medications included perindopril arginine (PRESTARIUM NEO), acetylsalicylic acid (ANOPYRIN), tamsulosin, citalopram hydrobromide (APO-CITALOPRAM), and atorvastatin calcium (SORTIS). The patient experienced respiratory failure in Feb2021, COVID-19 pneumonia on 26Jan2021, and fever 38 ?c to 39 ?c on 26Jan2021. The patient died on the 13Feb2021 because of respiratory failure. Since the 5th day after the vaccination on 26Jan2021, the patient developed increasing body temperature up to fever 39?C, rigoring, inappetence, weakness and cough. From the general practitioner, he received a prescription for erdosteine (ERDOMED). Next dyspnoea and bronchial pain during coughing added. In the beginning, he was in the care of his family. On 06Feb2021 he was hospitalized via ambulance for bilateral COVID pneumonia. On 06Feb2021 on receipt, he had saturation 75% with the need of the oxygen therapy by half mask with a reservoir. Antiviral therapy was not started. Laboratory mild lymphopenia - administered Isoprinosine, hypokalaemia, CRP elevation, no leukocytosis, elevated D-dimers. Initiated therapy with systemic corticosteroids, therapeutic dose with low molecular weight heparins. For mask intolerance, on 09Feb2021 was initiated HFNO (high-flow oxygen therapy). For significant restlessness and numerous episodes of hyposaturation the patient was transferred to the ICU. Ventilation and circulation stable during transport. Admission to the ICU was ventilating sufficient to support O2 goggles at a dose of 6 l/min, a continuation of potassium correction and set therapy. On 10Feb2021, persistent deliriant state, the necessity of pharmacological sedation with dexmetonidine, the tendency to bradycardia at higher doses, a single administration of atropine. Furthermore, runs of transient ventricular tachycardia, administered amiodarone with effect. Due to progressive respiratory insufficiency continued HFNO. Tazobactam + amikacin was empirically administered for the elevation of inflammatory parameters (from 11Feb2021 only tazobactam monotherapy). On 11Feb2021, progressive respiratory insufficiency, laboratory elevation of inflammatory parameters. For significant discomfort, pain and dyspnea of the patient, continuous opiates were started. The patient died on the 13Feb2021. An autopsy was not indicated. New or worsening symptoms during Covid-19 disease: Multiorgan failure, respiratory, dyspnea, hypoxemia, COVID pneumonia, respiratory failure, cardiovascular, arrhythmia-transient ventricular tachycardia, tendency to bradycardia, gastrointestinal/hepatic, jaundice-laboratory and icteric materials, slightly elevated Urea and Creatinine, nervous, altered state of consciousness-delirium, septic condition, respiratory acidosis, and hypokalaemia. Treatment for Covid-19: Corticosteroids (stop 11Feb2021 in sepsis), antibiotherapy (tazobactam + amikacin 10Feb2021, from 11Feb2021 only tazobactam), isoprenosine from 06Feb2021, Erdomed - from a general practitioner, atropine-10Feb2021 once for bradycardia, cordaorne-for runs of transient ventricular tachycardia from 10Feb2021, morphine-continuously from 11Feb2021, and infusion therapy and supportive therapy. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 32.9 on 06Feb2021, alanine aminotransferase: 1.05 iu/l on 08Feb2021, aspartate aminotransferase: 1.06 iu/l on 08Feb2021, blood alkaline phosphatase: 1.2 iu/l on 08Feb2021, blood bicarbonate: 30.8 mmol/l on 09Feb2021, blood bicarbonate: 29.9 mmol/l on 09Feb2021, blood bicarbonate: 24.7 mmol/l on 12Feb2021, blood bicarbonate: 29.8 mmol/l on 12Feb2021, blood bilirubin: 21 umol/l on 10Feb2021, blood chloride: 88 mmol/l on 06Feb2021, blood creatinine: 77 umol/l on 08Feb2021, blood creatinine: 180 umol/l on 12Feb2021, blood glucose: 6.6 mmol/l on 06Feb2021, blood glucose: 9.1 mmol/l on 10Feb2021, blood glucose: 8.3 mmol/l on 12Feb2021, Blood pH: 7,528 on 09Feb2021, 7,498 on 10Feb2021, 7,267 on 12Feb2021, Potassium: 2.9 mmol/L on 08Feb2021, 4.3 mmol/L on 12Feb2021, Potassium: 3.7 mol/L on 06Feb2021, Blood pressure: 120/80 mmHg on 06Feb2021, Sodium: 136 mmol/L 06Feb2021, 151 mmol/L 12Feb2021, Urea: 11.7 mmol/L on 08Feb2021, 15.2 mmol/L on 12Feb2021, Body temperature: <=39 Centigrade on 26Jan2021, 36.3 Centigrade on 06Feb2021, C-reactive protein: 160 mg/l on 06Feb2021, 88.8 mg/l on 08Feb2021, 199.5 mg/l on 10Feb2021, 262.2 mg/l on 10Feb2021, 222.5 mg/l on 12Feb2021, Fibrin D dimer: 1890 mg/l on 06Feb2021, GGTP: 1.32 IU/l on 08Feb2021, Hematocrit: 0.44 on 06Feb2021, Hemoglobin: 149 g/l on 06Feb2021, 124 g/l on 12Feb2021, Pulse rate: 58 Units/min on 06Feb2021, International normalised ratio: 0.99 on 06Feb2021, Lymphocytes: 2.8% on 12Feb2021, Lymphocytes: 0.61 x10 9/l on 06Feb2021, 0.6 x10 9/l on 08Feb2021, 0.43 x10 9/l on 12Feb2021, Netrophils absolutely: 14.56 on 12Feb2021, Neutrophils: 94.7% on 12Feb2021, Neutrophils: 9.79 x10 9/l on 08Feb2021, 14.56 x10 9/l on 12Feb2021, NT-proBNP: 4583 pg/mL on 10Feb2021, O2 saturation: 75% on 06Feb2021, 94% 8l/min on 06Feb2021, 69.5% on 12Feb2021, Partial pressure CO2: 12 on 09Feb2021, 9 kPa on 12Feb2021, Thrombocyte count: 221 x10 9/l on 06Feb2021, 271 x10 9/l on 12Feb2021, Partial pressure O2: 12 on 09Feb2021, 6.1 kPa on 12Feb2021, Procalcitonin: 0.24 ug/L on 10Feb2021, Ag-SARS-Cov2: positive on 10Feb2021, PCR SARS-CoV2: positive on 06Feb2021, Troponin: 60 ng/L on 06Feb2021, Leukocytes: 15.38 on 12Feb2021, WBC: 7.92 x10 9/l on 06Feb2021, 10.67 x10 9/l on 08Feb2021, and 15.38 x10 9/l on 12Feb2021. Other relevant examinations: microbiological examination of Legionella + Penumococcus negative on an unspecified date. The patient died on 13Feb2021. An autopsy was not performed. No follow-up attempts possible. No further information expected. Batch/Lot number cannot be obtained.; Reported Cause(s) of Death: COVID-19 pneumonia; Respiratory failure.


VAERS ID: 1056228 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021191544

Write-up: Exitus letalis; This is a spontaneous report downloaded from the Regulatory Authority -WEB DE-PEI-PEI2021002689. This is a report received from the Regulatory Authority. A female patient of an unspecified age received the first dose of bnt162b2 (COMIRNATY, lot no.: EM0477), via an unspecified route of administration single dose on 28Jan2021 for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced exitus letalis on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1056229 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021191543

Write-up: Ischemic cerebral infarction; This is a spontaneous report from a non-contactable physician downloaded from the Regularity Authority -WEB DE-PEI-PEI2021002702. A 92-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration (at age of 92-year-old) on 08Feb2021 as a single dose for covid-19 immunisation, lot number: Unknown. Medical history included dementia. Concomitant medications were not reported. On 12Feb2021 after vaccination the patient developed Ischaemic cerebral infarction, lasting for unknown (as reported). On 13Feb2021 the patient was dead, death cause was reported as Ischaemic cerebral infarction. It was unknown if an autopsy was performed. Inconsistent causal association (as reported). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ischaemic cerebral infarction


VAERS ID: 1056230 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Heart rate, Laboratory test, Liver function test, Multiple organ dysfunction syndrome, Oxygen saturation, Renal function test
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-17
   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:
Allergies:
Diagnostic Lab Data: Test Name: body temperature; Result Unstructured Data: Test Result:no fever; Test Name: Heart rate; Result Unstructured Data: Test Result:sinus rhythm; Test Name: infection parameters; Result Unstructured Data: Test Result:increased infection parameters; Test Name: Laboratory test; Result Unstructured Data: Test Result:no infiltration; Test Name: liver function test; Result Unstructured Data: Test Result:liver failure; Test Name: O2 saturation; Test Result: 92 %; Test Name: kidney function test; Result Unstructured Data: Test Result:kidney failure
CDC Split Type: DEPFIZER INC2021191549

Write-up: Multiorgan failure; This is a spontaneous report from physician downloaded from the regulatory authority-WEB DE-PEI-PEI2021002719 and received via Regulatory Authority. An 89-year-old female patient received the second dose bnt162b2 (COMIRNATY) (Lot no. was not reported), via an unspecified route of administration at single dose on 12Feb2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of Comirnaty on an unspecified date for covid-19 immunisation. On 16Feb2021, the patient developed multiorgan failure. The patient was hospitalized and condition was life threatening. The patient died on 17Feb2021. It was not reported if an autopsy was performed. Death cause was reported as multiorgan failure. The patient underwent lab tests and procedures which included on an unspecified date body temperature: no fever; heart rate: sinus rhythm; laboratory test: increased infection parameters; laboratory test: no infiltration; liver function test: liver failure; oxygen saturation: 92 %; renal function test: kidney failure. Reporter''s comments: In the laboratory: liver and kidney failure, increased infection parameters, no fever, no inflation rate, sinus rhythm. No follow-up attempts are possible. No further information expected; Information about batch/lot number cannot be obtained.; Reporter''s Comments: In the laboratory: liver and kidney failure, increased infection parameters, no fever, no inflation rate, sinus rhythm; Reported Cause(s) of Death: Multiorgan failure


VAERS ID: 1056234 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021196680

Write-up: Patient died; This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech (manufacturer control number 17268), license party for BNT162B2. This physician reported similar events for seven patients. This is the fifth of the seven reports. A patient of unspecified age and gender received the second dose of BNT162B2 (COMIRNATY; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The physician reported that the patient was vaccinated in a nursing home in the period from 31Dec2020 to 05Feb2021. The patient died on day 4 after the second dose on an unknown date. It was unknown if an autopsy was performed. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The information currently available is limited and does not allow a meaningful case assessment. However, based solely on event-vaccine chronological association, contributory role of BNT162B2 (COMIRNATY) to event Death (unknown cause) cannot be completely excluded. The case will be reevaluated should additional information including patient''s age, medical history, underlying medical conditions etc become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : DE-PFIZER INC-2021195319 same reporter/drug/event, different patients; Reported Cause(s) of Death: Patient died.


VAERS ID: 1056237 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, Pneumonia, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: COVID-19 virus test; Test Result: Positive; Comments: The test was positive when the patient died.
CDC Split Type: DKPFIZER INC2021189936

Write-up: COVID-19 virus test was positive; COVID-19 virus test was positive; Patient died on 04Feb2021 with pneumonia; This is a spontaneous report downloaded from the Regulatory Authority -WEB DK-DKMA-WBS-0032249. The case was received from a contactable physician via The Regulatory Authority. An 81-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection; lot number; EJ679) via Intramuscular route on 03Jan2021 and second dose (lot number; EJ6136, expiry date; 30Apr2021) via intramuscular route, on 24Jan2021, and both were at single dose for COVID-19 immunisation. Medical history included ongoing dementia. Concomitant medications were not reported. The patient underwent COVID-19 virus test on 26Jan2021 and resulted as positive. On an unknown date in 2021, patient had pneumonia. On 04Feb2021 the patient died due to pneumonia. There are no other ADRs to COMIRNATY. An autopsy has not been performed. The test was positive when the patient died. No treatment or medical procedure due to the ADRs was reported. Seriousness of the event pneumonia was fatal. Outcome of the event pneumonia was fatal and for other events it was unknown. Causality: The hospital believes that the patient has died from Pneumonia. The reporting physician does not believe that there is a causal relationship between pneumonia and COMIRNATY, but he sticks to reporting the case due to the temporal correlation. No follow-up attempts are possible, batch number already obtained.; Sender''s Comments: The association between the event fatal pneumonia and lack of effect (COVID-19 virus test positive) with COMIRNATY use can not be fully excluded.; Reported Cause(s) of Death: Patient died on 04Feb2021 with pneumonia


VAERS ID: 1056238 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SERETIDE; SPIRIVA RESPIMAT; PAMOL; PANTOPRAZOL ACTAVIS; CALCIUM +D [CALCIUM;ERGOCALCIFEROL]; VENTOLINE [SALBUTAMOL SULFATE]; PAROXETIN HEXAL
Current Illness: Anxiety; Asthenia (The patient was in general weakened and fragile prior to his death); Bronchospasm; Calcium supplementation; Living in nursing home (SARS-COV-2 was found at the nursing home 30Dec2020); Pain; Prophylaxis against gastrointestinal ulcer; Psychosomatic disease; Pulmonary disorder; Renal impairment; Vitamin D supplementation
Preexisting Conditions: Medical History/Concurrent Conditions: Dyspepsia (Dyspepsia in the 1980''s); Hip fracture; Laryngeal cancer (Treated with X-ray); Myocardial reinfarction; Pulmonary contusion (Car accident. Life support machine treatment due to Pulmonary contusion); Renal cyst
Allergies:
Diagnostic Lab Data: Test Date: 20210101; Test Name: Respiratory rate; Result Unstructured Data: Test Result:44; Comments: Unit not specified; Test Date: 20210101; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: DKPFIZER INC2021189943

Write-up: Respiratory insufficiency; Very unwell; Fever; SARS-CoV-2 test was positive; This is a spontaneous report downloaded from the regulatory authority DK-DKMA-WBS-0032363 and via telephone before transmitting version 001. A contactable physician (ID: AECS_010833_D040221_1331) reported that an 87-year-old male patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6797, Expiration date: 30Apr2021), intramuscularly on 31Dec2020 at single dose for COVID-19 immunisation. The patient''s medical history included hip fracture from an unspecified date in 2016 to an unspecified date, ongoing renal impairment from an unspecified date in 2010, ongoing living in nursing home (SARS-COV-2 was found at the nursing home 30Dec2020), ongoing asthenia (the patient was in general weakened and fragile prior to his death), renal cyst from an unspecified date in 2010, dyspepsia (in the 1980''s), laryngeal cancer from an unspecified date in 1997 to an unspecified date in 2002 (treated with X-ray), myocardial reinfarction from an unspecified date in 2007 to an unspecified date, ongoing psychosomatic disease from an unspecified date in 1972, pulmonary contusion from an unspecified date in 2005 to an unspecified date (car accident. Life support machine treatment due to pulmonary contusion), ongoing pain, ongoing gastrointestinal ulcer prophylaxis, ongoing anxiety, ongoing pulmonary disorder, ongoing bronchospasm, ongoing calcium supplementation, ongoing vitamin-D supplementation. Concomitant medication included fluticasone propionate/salmeterol xinafoate (SERETIDE) via resp inhalation from 09Nov2016 at 4DF (Dosage Form), once a day (Strength: 25+250 ?g/dose) for pulmonary disorder, tiotropium bromide (SPIRIVA RESPIMAT, Strength: 2.5ug) via resp inhalation from 09Nov2016 at 5ug, once a day (Strength: 2.5 mikrogram) for pulmonary disorder, paracetamol (PAMOL) via oral from 24Nov2016 at 1000mg as needed for pain, pantoprazole sodium sesquihydrate (PANTOPRAZOL ACTAVIS, Strength: 40mg) via oral from 09Dec2019 at 40mg, once a day for prophylaxis against gastrointestinal ulcer, calcium/ergocalciferol (CALCIUM+D) via oral from 31Oct2016 at 1 DF (Dosage Form), once a day (Strength: 400mg Ca+ & 19mikg D-vitamin) for calcium supplementation, salbutamol sulfate (VENTOLINE, Strength: 0.2mg) via resp inhalation from 06Dec2016 at 0.2 mg, as needed for bronchospasm and paroxetine hydrocholoride (PAROXETIN HEXAL, Strength: 20mg), via oral from 11Sep2020 at 20mg, once a day for anxiety. The patient previously took pneumococcal vaccine, 23-valent (PNEUMOVAX, Batch number: S014391) on 11May2020 at single dose for pneumococcal immunisation and influenza vaccine (TRIVALENT INFLUENZA VACCINE HIGH DOSE, Batch number: UJ459AB) on 20Oct2020 at single dose for influenza immunisation; the patient did not experience any adverse drug reaction on both vaccines. On 01Jan2021, the patient experienced COVID-19. On 01Jan2021, the patient underwent lab tests and procedures includes SARS-CoV-2 test: Positive and respiratory rate: 44 (unit not specified). On 01Jan2021, the day after the vaccination, the patient experienced respiratory insufficiency, fever and unwell. Respiratory insufficiency was by the physician reported as causing hospitalisation from 01Jan2021 until he died (07Jan2021) and being fatal (patient died on 07Jan2021). The patient was at the hospital treated at the utmost (Remdesivir, unknown antibiotics, Oxygen and Dexavit (DEXAMETHASONE SODIUM PHOSPHATE)). Respiratory insufficiency did not recover. The outcome of the event respiratory insufficiency was fatal and unknown for the other events. The patient died on 07Jan2021. The cause of death was respiratory insufficiency. The event has been reported to the police, but no inquest has and would be performed. Autopsy has not been performed. Causality: The physician states that the patient in general was weakened and fragile prior to his death. She also states that the patient was diagnosed with COVID-19 the same date (31Dec2020) as he was vaccinated with COMIRNATY, and that this all in all possibly has been fatal for the patient. The physician believes that there is a very small probability that COMIRNATY has worsened the course. The patient had a lot of comorbidities. If the agency receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Respiratory insufficiency


VAERS ID: 1056241 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-24
Onset:2021-01-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chronic obstructive pulmonary disease, SARS-CoV-2 test
SMQs:, COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Alzheimer''s disease; Chronic obstructive airways disease (Hospitalised several times earlier due to exacerbations); Dementia; Ischaemic heart disease (Chronic); Kidney tumor (presumably malignant. No further diagnostic); Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Lung embolism
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:negativ
CDC Split Type: DKPFIZER INC2021189945

Write-up: Chronic obstructive airways disease exacerbated with CO2 accumulation; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority -WEB DK-DKMA-WBS-0033361. The case was received from a contactable physician via the Medicines Agency (KMA). A 99-year-old male patient received second dose of BNT162B2 (COMIRNATY, lot no: EJ6136, Expiration date: 30Apr2021), intramuscular on 24Jan2021 at a single dose for covid-19 immunisation. Ongoing medical history included chronic obstructive airways disease (Hospitalised several times earlier due to exacerbations), Alzheimer''s disease, Dementia, Chronic Ischaemic heart disease, Kidney tumor (presumably malignant. No further diagnostic) and the patient was Living in nursing home and Lung embolism. The patient''s concomitant medications were not reported. The patient previously received first dose of COMIRNATY (Batch number: EJ6797), on 02Jan2021 for COVID-19 immunisation. On 25Jan2021, the patient developed Chronic obstructive airways disease exacerbated (Chronic obstructive airways disease exacerbated with CO2 accumulation). The event was considered as serious by reporter with seriousness criteria (hospitalisation and fatal, the patient died on 28jan2021). No treatment due to the ADRs was reported. There was no information regarding test results. The outcome of the event was fatal. Causality: The reporter states that they find a relation between COMIRNATY and Chronic obstructive airways disease exacerbated less likely, but the case is reported because the aggravation starts the day after 2nd vaccination. By the requested follow-up the reporter states that no autopsy will be performed and that there is no suspicion that there is a link between the death and Comirnaty. If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Chronic obstructive airways disease exacerbated


VAERS ID: 1056257 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-03
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Auscultation, Blood alkaline phosphatase, Blood bilirubin, Blood lactate dehydrogenase, Blood thyroid stimulating hormone, C-reactive protein, Chest X-ray, Coagulation test, Fibrin D dimer, Gamma-glutamyltransferase, Haemoglobin, Hepatitis acute, Investigation, Physical examination, Platelet count, Prothrombin level, Prothrombin time, Red blood cell count, SARS-CoV-2 test, Serum ferritin, White blood cell count
SMQs:, Hepatitis, non-infectious (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   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: PRISDAL [CITALOPRAM HYDROBROMIDE]; FEROGRADUMET; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Senile dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:2023 IU/l; Test Date: 20210204; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:6780 IU/l; Test Date: 20210203; Test Name: ASAT; Result Unstructured Data: Test Result:2377 IU/l; Test Date: 20210204; Test Name: ASAT; Result Unstructured Data: Test Result:4413 IU/l; Test Name: auscultation; Result Unstructured Data: Test Result:Generalized bilateral rhonchi were identified; Test Date: 20210203; Test Name: ALK phosph; Result Unstructured Data: Test Result:165 IU/l; Test Date: 20210204; Test Name: ALK phosph; Result Unstructured Data: Test Result:167 IU/l; Test Date: 20210203; Test Name: Bilirubin total; Test Result: 0.4 mg/dl; Test Date: 20210204; Test Name: Bilirubin total; Test Result: 0.8 mg/dl; Test Date: 20210203; Test Name: LDH; Result Unstructured Data: Test Result:2419 IU/l; Test Date: 20210204; Test Name: LDH; Result Unstructured Data: Test Result:2830 IU/l; Test Date: 20210203; Test Name: TSH; Result Unstructured Data: Test Result:2.71; Comments: 2.71 mU/L; Test Date: 20210203; Test Name: Thorax X-ray; Result Unstructured Data: Test Result:No apparent consolidative infiltrates; Test Date: 20210203; Test Name: Coagulation test; Result Unstructured Data: Test Result:Basic Study of Pathological Coagulation; Test Date: 20210203; Test Name: C-reactive protein; Test Result: 3 mg/dl; Test Date: 20210204; Test Name: C-reactive protein; Test Result: 5.3 mg/dl; Test Date: 20210203; Test Name: Fragment D dimer; Result Unstructured Data: Test Result:12038 ng/ml; Test Date: 20210203; Test Name: Gamma GT; Result Unstructured Data: Test Result:51 IU/l; Test Date: 20210204; Test Name: Gamma GT; Result Unstructured Data: Test Result:56 IU/l; Test Date: 20210203; Test Name: Haemoglobin; Result Unstructured Data: Test Result:10.3 g/dl; Test Name: ABD; Result Unstructured Data: Test Result:Soft, depressible, not distended or tympanic; Comments: Soft, depressible, not distended or tympanic, no gesture of pain; Test Name: ACP; Result Unstructured Data: Test Result:Rhythmic heart tones, tachycardia; Comments: Rhythmic heart tones, tachycardia, no apparent murmurs; Test Name: Physical examination; Result Unstructured Data: Test Result:Frank sarcopenia, mutism, uncooperative; Test Date: 20210203; Test Name: Platelet count; Result Unstructured Data: Test Result:152 x10 3/mm3; Test Date: 20210204; Test Name: Prothrombin activity; Test Result: 50 %; Test Date: 20210204; Test Name: Pro-thrombin time; Test Result: 18.4 s; Test Date: 20210203; Test Name: RBC count; Result Unstructured Data: Test Result:3.21 10*6/uL; Test Date: 20201229; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210114; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210201; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210203; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210205; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210203; Test Name: Ferritin; Result Unstructured Data: Test Result:1027 ng/ml; Test Date: 20210203; Test Name: WBC; Result Unstructured Data: Test Result:8.4 x10 3/mm3
CDC Split Type: ESPFIZER INC2021193571

Write-up: This is a spontaneous report downloaded from the Regulatory Agency ES-AEMPS-756791. A contactable physician reported that a 97-year-old female patient received the second dose of BNT162B2 (COMIRNATY) intramuscularly, at 0.3 mL, single dose, on 31Jan2021, for COVID-19 immunisation. Relevant medical history included advanced senile dementia, form an unspecified date. No hospital admissions in the last 10 years. The patient previously, on 10Jan2021, received the first dose of BNT162B2 (COMIRNATY) intramuscularly, at 0.3 mL, single dose, for COVID-19 immunisation. Concomitant medications included citalopram hydrobromide (PRISDAL) 20 mg, ferrous sulfate (FEROGRADUMET), dietary supplement 2 daily, and paracetamol as needed. On 03Feb2021, the patient experienced hepatitis acute. Laboratory tests, performed on 03Feb2021, showed the following value: alanine aminotransferase (ALT) 2023 IU/l, aspartate aminotransferase (AST) 2377 IU/l, blood alkaline phosphatase 165 IU/l, total bilirubin 0.4 mg/dl, blood lactate dehydrogenase (LDH) 2419 IU/l, blood thyroid stimulating hormone (TSH) 2.71 mU/L, thorax X-ray no apparent consolidative infiltrates, C-reactive protein 3 mg/dl, Fragment D dimer 12038 ng/ml, gamma-glutamyltransferase (GGT) 51 IU/l, haemoglobin 10.3 g/dl, platelet count 152 x10 3/mm3, red blood cell count (RBC count) 3.21 10*6/uL, ferritin 1027 ng/ml, and white blood cell count (WBC) 8.4 x10 3/mm3. Abdominal ultrasound was not requested. Acute hepatitis that worsened in laboratory analysis of day 04Feb2021. Laboratory tests, performed on 04Feb2021, showed the following value: alanine aminotransferase (ALT) 6780 IU/l, aspartate aminotransferase (AST) 4413 IU/l, blood alkaline phosphatase 167 IU/l, total bilirubin 0.8 mg/dl, blood lactate dehydrogenase (LDH) 2830 IU/l, C-reactive protein 5.3 mg/dl, gamma-glutamyltransferase (GGT) 56 IU/l, prothrombin activity 50 %, and prothrombin time 18.4 seconds. PCR tests performed for COVID-19: on 29Dec2020: Negative, on 14Jan2021: Negative, on 01Feb2021: Negative, on 03Feb2021: Negative (PCR influenza virus A, B and Coronavirus Sars-Cov2-negative antigen) and on 05Feb2021: Negative. Patient''s clinical course: derived by general malaise, in the form of diaphoresis and tachycardia, without fever or low-grade fever, for less than 24 hours. On auscultation, generalized bilateral rhonchi were identified. Physical examination: frank sarcopenia, mutism, uncooperative. ACP: rhythmic heart tones, tachycardia, no apparent murmurs. ABD: soft, depressible, not distended or tympanic, no gesture of pain. Diagnosis: Acute cytolytic hepatitis. Etiology unknown, in context of recent SARS-Cov vaccine. Antibiotic treatment was added. She died on 06Feb2021. No autopsy was done. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Hepatitis acute


VAERS ID: 1056261 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, C-reactive protein, Glomerular filtration rate, Liver function test, N-terminal prohormone brain natriuretic peptide, Pulmonary congestion
SMQs:, Cardiac failure (broad), Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   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: Advanced lung cancer (Untreated, known for 2 years); Chronic respiratory failure
Allergies:
Diagnostic Lab Data: Test Name: C reactive protein; Result Unstructured Data: Test Result:norm; Test Name: glomerular filtration rate; Result Unstructured Data: Test Result:59 ml/min; Test Name: disturbed liver function test; Result Unstructured Data: Test Result:usual for the patient; Test Name: NT ProBNP; Result Unstructured Data: Test Result:1300 ng/L
CDC Split Type: FRPFIZER INC2021181389

Write-up: Fatal evolution was done following acute respiratory distress with pulmonary congestion.; Fatal evolution was done following acute respiratory distress with pulmonary congestion.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency FR-AFSSAPS-GR20210280. This is a report received from the Regulatory Authority. E2B Authority Number was FR-AFSSAPS-GR20210280 An 82-year-old female patient received her 1st dose of BNT162B2 (COMIRNATY, lot EJ6795) at 30 ug single dose on 14Jan2021 intramuscular in left arm for COVID-19 vaccination. Medical history included chronic respiratory failure, and advanced lung cancer (untreated which was known for 2 years as of 19Feb2021). Concomitant drug was not provided. Patient experienced distress respiratory on 28Jan2021. Patient died on 02Feb2021. No autopsy was performed. Fatal evolution was done following acute respiratory distress with pulmonary congestion. The event clinical course was as follows: degradation of the patient''s general condition for several weeks before vaccination, patient was vaccinated on 14Jan2021. From 28Jan2021, patient experienced rapid worsening at the respiratory level. Differential diagnosis included severe respiratory failure and lung cancer. NT ProBNP (Brain Natriuretic Peptide) at 1300 ng / L and disturbed liver function test (usual for the patient). blood count and C reactive protein was within the norm, glomerular filtration rate at 59 mL / min. Patient was implemented of comfort care. Outcome of distress respiratory was fatal. No follow-up attempts are possible; No further information is expected.; Sender''s Comments: A contributory role of Comirnaty administration in the occurrence of the reported events cannot be completely excluded, due to a positive drug-events temporal association, however, medical history of chronic respiratory failure and advanced lung cancer, cannot be also excluded as important factors related to the fatal events that occurred two weeks after the vaccination, in the setting of degradation of the patient''s general condition for several weeks before vaccination. 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: pulmonary congestion; severe respiratory failure; Distress respiratory/acute respiratory distress


VAERS ID: 1056295 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 0724 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19, COVID-19 pneumonia, Confusional state, Heart rate, Hypertension, Malaise, Oxygen saturation, Respiratory rate, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-29
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ADIZEM-XL; ACETYLSALICYLIC ACID; ATORVASTATIN; RAMIPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 pneumonia; Ex-smoker (Ex-smoker (stopped 2015, unable to establish pack years from notes)); Hypertension; Peripheral arterial disease; Comments: HTN, Ex-smoker (stopped 2015, unable to establish pack years from notes), IGR, PAD. Unsure if patient is enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:160/80; Test Name: Body temperature; Result Unstructured Data: Test Result:39.7; Test Name: Heart rate; Result Unstructured Data: Test Result:90; Test Name: Oxygen saturation; Test Result: 90 %; Test Name: Oxygen saturation; Result Unstructured Data: Test Result:less than 90 %; Test Name: Respiratory rate; Result Unstructured Data: Test Result:28; Test Date: 20210111; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC2021185944

Write-up: hypertension; unwell; confused state; SARS-CoV-2 infection; COVID-19 pneumonia; This is a spontaneous report from a contactable other healthcare professional (other HCP) received from the MHRA. Regulatory authority report number is GB-MHRA-WEBCOVID-202102180927046120, Safety Report Unique Identifier is GB-MHRA-ADR 24784988. A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ 0724) via an unspecified route of administration on 31Dec2020 at a single dose for covid-19 immunisation. Medical history included covid-19 pneumonia, hypertension, ex-smoker (stopped 2015, unable to establish pack years from notes), IGR, and peripheral arterial disease (PAD). Unsure if patient was enrolled in clinical trial. Concomitant medication included diltiazem hydrochloride (ADIZEM-XL) from 12May2017, acetylsalicylic acid from 11Mar2017 for prophylaxis, atorvastatin from 17Sep2015 for prophylaxis, and ramipril from 12Mar2016 for hypertension. The patient experienced covid-19 pneumonia (death) on 05Jan2021, hypertension (death) on an unspecified date, unwell (non-serious) on an unspecified date with outcome of unknown, confused state (non-serious) on an unspecified date with outcome of unknown, sars-cov-2 infection (non-serious) on 11Jan2021 with outcome of not recovered. Details reported as found on the floor at his home address on 07Jan2021, had been on floor for 2 days. In confused state and had not used alarm system to summons assistance. Ambulance crew used OOH for assessment ad patient. Refused admission to hospital. Obs then, RR28, Hr 90, SpO2 90%oa, BP 160/80, T 39.7c BM6.5. It was attempted to follow up the next working day. Unable to make contact. Ambulance called again on 10Jan2021. SpO2 less than 90%, now too unwell to refuse admission. Admitted to local hospital on 10Jan2021. Patient tested positive Covid-19 on 11Jan2021 in hospital. Onto CPAP. Never recovers. The patient died on 29Jan2021. Cause of death given as Covid pneumonia and hypterension. It was unknown if an autopsy was performed. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Covid Pneumonia; Hypertension


VAERS ID: 1056296 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / UNK - / -

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

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XANAX
Current Illness: Suspected COVID-19 (Unsure when symptoms started)
Preexisting Conditions: Comments: Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021186753

Write-up: Death; This is a spontaneous report received from a contactable other HCP from the Medicines and Healthcare products Regulatory Agency (MHRA). The regulatory authority report number is GB-MHRA-WEBCOVID-202102181513058660. Sender''s (Case) Safety Report Unique Identifier: GB-MHRA-ADR 24789067. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: Not known) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included ongoing suspected covid-19, unsure when symptoms started. Concomitant medication included alprazolam (XANAX). The patient experienced death (death, hospitalization, disability, medically significant, life threatening, congenital anomaly) on an unspecified date. Not had a COVID-19 test. Patient is not enrolled in clinical trial. Unknown if autopsy was performed. Cause of death not reported. The outcome of the event was fatal. No follow up attempts are possible; information about batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1056299 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-01-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diplegia
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-28
   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: Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021186874

Write-up: Paralysis legs; This is a spontaneous report from a contactable consumer. This is a report received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102191115265950, Safety Report Unique Identifier GB-MHRA-ADR 24791698. An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced paralysis legs on 26Jan2021. The patient died on 28Jan2021. Patient remained bedridden and ill till death three days after vaccine. It was not reported 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: Paralysis legs


VAERS ID: 1056333 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-09
Onset:2021-01-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1484 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral haemorrhage, Facial paralysis, Monoplegia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-15
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021181279

Write-up: Upper limb paralysis and buccal rim deviation + gaze deviation. Death caused by cerebral haemorrhagic spread; Upper limb paralysis and buccal rim deviation + gaze deviation. Death caused by cerebral haemorrhagic spread; Upper limb paralysis and buccal rim deviation + gaze deviation. Death caused by cerebral haemorrhagic spread; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority- IT-MINISAL02-675199. A 99 years old female patient received 1st dose of bnt162b2 (COMIRNATY, lot EL1484, expiration date 01Apr2021) at 0.3ml single dose on 09Jan2021 intramuscular at left shoulder for COVID-19 immunisation. Medical history and concomitant drugs were not provided. The patient experienced Upper limb paralysis and buccal rim deviation + gaze deviation, spontaneous cerebral haemorrhagic spread occurred the day after the administration of the first dose of vaccine on 10Jan2021. The patient died on 15Jan2021. It was unknown whether autopsy was done. The reporter did not consider the event to be correlated with vaccination. The outcome of the events was fatal. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Spontaneous cerebral haemorrhagic spread occurred the day after the administration of the first dose of vaccine. The reporter does not consider the event to be correlated with vaccination.; Sender''s Comments: Based on event-vaccine chronological association, contributory role of BNT162B2 (COMIRNATY) vaccine to onset of facial paralysis cannot be excluded. Events upper limb paralysis and cerebral haemorrhagic spread are attributed to intercurrent medical conditions and assessed Unrelated to BNT162B2 (COMIRNATY) vaccine.; Reported Cause(s) of Death: Upper limb paralysis and buccal rim deviation + gaze deviation. Death caused by cerebral haemorrhagic spread; Upper limb paralysis and buccal rim deviation + gaze deviation. Death caused by cerebral haemorrhagic spread; Upper limb paralysis and bucca


VAERS ID: 1056334 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 0725 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Diabetes mellitus management, Heart rate, Investigation, Oxygen saturation, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   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: TRIATEC [RAMIPRIL]; CARDIOASPIRIN; LANSOPRAZOLE; SODIUM CHLORIDE; SEREPRILE; LACTULOSE; SERENASE [LORAZEPAM]; DUROGESIC; SEQUACOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Arthrosis; Bicuspid aortic valve (1st degree); Breast cancer (quadrantectomy and radiotherapy); Chronic sinusitis; Cognitive impairment; Femur fracture; Hip fracture; Ischemic heart disease; Osteoporosis; Renal cysts; Scoliosis; Sepsis; Subclinical hypothyroidism; Thalassemia minor; Vertebral collapse
Allergies:
Diagnostic Lab Data: Test Name: Blood pressure; Result Unstructured Data: Test Result:120/60 mmHg; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/80 mmHg; Test Date: 20210125; Test Name: Blood pressure; Result Unstructured Data: Test Result:unknown results mmHg; Test Date: 20210210; Test Name: Blood pressure; Result Unstructured Data: Test Result:140/80 mmHg; Test Date: 20210210; Test Name: Blood pressure; Result Unstructured Data: Test Result:55/38 mmHg; Test Date: 20210210; Test Name: Glycaemia control; Result Unstructured Data: Test Result:unknown results; Test Name: Heart rate; Result Unstructured Data: Test Result:73 bpm; Test Date: 20210125; Test Name: Heart rate; Result Unstructured Data: Test Result:unknown results; Test Date: 20210210; Test Name: Heart rate; Result Unstructured Data: Test Result:not detectable in peripheral; Test Date: 20210210; Test Name: DTX; Test Result: 201 mg/dl; Test Name: O2 saturation; Test Result: 96 %; Test Date: 20210125; Test Name: O2 saturation; Result Unstructured Data: Test Result:unknown results %; Test Date: 20210210; Test Name: O2 saturation; Test Result: 96 %; Test Date: 20210210; Test Name: O2 saturation; Test Result: 99 %
CDC Split Type: ITPFIZER INC2021180549

Write-up: syncope after injection of second vaccine dose for COVID Pfizer vaccine; FARO This is a non-interventional study report from contactable physician downloaded from the Regulatory Authority-WEB regulatory authority IT-MINISAL02-679162. ANAMNESIS: the guest entered the structure on 25Sep2020. In history of post-infarct ischemic heart disease, aortic valve insufficiency, thalassemia minor, chronic sinusitis, bilateral renal cysts, outcomes of quadrantectomy and radiotherapy for breast cancer, scoliosis, arthrosis, multiple vertebral collapses, osteoporosis, left femur fracture (2014), subclinical hypothyroidism, Bicuspid aortic valv I degree, severe cognitive impairment, hip fracture, sepsis on 10Feb2021. Last multidimensional evaluation (Dec2020): Daily life activity = 1/6; Instrumental Activity of Daily Living= 0/8; Barthel Index = 2/100; Mini-Mental State Examination= not executable; Clinical dementia rating = 3; Frailty Index = 0.57; Clinical Frailty scale = 8/9; Karnofsky Performance Status = 30%. CASE DESCRIPTION: An 85-year-old female subject received second dose of bnt162b2 (COMIRNATY, lot number: EL0725, expiry date: 31Mar2021), intramuscularly on 10Feb2021 15:25 at 0.3 mL, single for COVID-19 immunization. Bnt162b2 composed of 195FL 0.45ML. The patient presented acute symptoms approximately 40 minutes after administration (time of administration: 15:25) of the second dose of bnt162b2 (COMIRNATY) with patient exitus in the following hours. Concomitant medication included ramipril (TRIATEC), acetylsalicylic acid (CARDIOASPIRIN), lansoprazole, sodium chloride for fluid replacement, tiapride hydrochloride (SEREPRILE, strength: 100 mg), lactulose, lorazepam (SERENASE), fentanyl (DUROGESIC), bisoprolol fumarate (SEQUACOR). The subject experienced syncope after injection of second vaccine dose for COVID Pfizer vaccine on 10Feb2021. The subject died on 10Feb2021 around 20:00. The action taken in response to the event for bnt162b2 was not applicable. It was not reported if an autopsy was performed. Clinical course: At approximately 16:00 the host was reported by the nursing staff of a second episode of loss of consciousness (first episode occurred at 14:40 before vaccine administration). The subject appeared pale, skin cold at the extremities and wet with sweat, unresponsive to verbal and painful stimuli, in the absence of side signs (vital signs: Blood Pressure 140/80mmHg; SpO2 96%; Heart Rate not detectable in peripheral; DTX 201 mg/dl). When the rescuers arrived, O2 therapy was set at 2L/min, bringing SpO2 to 99%; Flebocortid 500mg was also administered following the collapse of the BP at 55/38 mmHg with partial benefit. The patient was taken to the Hospital, where she died around 20:00. Information taken from a clinical report drawn up on 12Feb2021. Actions taken (IV cortisone, liquids, access to emergency room). On unspecified date, 120/60 mmHg; 73 bpm; 96% in AA; 140/80 mmHg. Lab tests also included Glycaemia control on 10Feb2021, Heart rate on 25Jan2021, Blood pressure on 25Jan2021, O2 saturation on 25Jan2021, all with unknown results. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on event-vaccine chronological association causality between event syncope and BNT162B2 vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: syncope after injection of second vaccine dose for COVID Pfizer vaccine


VAERS ID: 1056336 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-22
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Heart failure; Hypotension; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021193843

Write-up: Worsening of heart failure after vaccination; Worsening of heart failure after vaccination; worsening of hypotension after vaccination; Sudden cardiocirculatory arrest; This is a spontaneous report downloaded from the Medicines Agency (MA) Regulatory Authority-WEB [Ministero Della Salute (MINISAL02)IT-MINISAL02-680104] from a contactable pharmacist. A 92-year-old male patient received the 1st dose of bnt162b2 (COMIRNATY) (lot# EJ6797), intramuscular in left deltoid, on 19Jan2021 at 17:32, at single dose, for COVID-19 immunisation. Medical history included ongoing hypotension, ongoing cardiac failure and ongoing living in residential institution. Concomitant medications were not reported. Clinical picture worsened after vaccination. The patient experienced worsening of heart failure after vaccination on 19Jan2021, worsening of hypotension after vaccination on 19Jan2021, sudden cardiocirculatory arrest on 22Jan2021. The patient was hospitalized in Jan2021 for worsening of heart failure after vaccination and worsening of hypotension after vaccination. The events had fatal outcome on 22Jan2021, as the patient died. An autopsy was not performed.; Reported Cause(s) of Death: Sudden cardiocirculatory arrest; Worsening of hypotension; Worsening of heart failure after vaccination; Worsening of heart failure after vaccination


VAERS ID: 1056347 (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: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral ischaemia, Computerised tomogram head, Electrocardiogram, Heart rate, Ischaemic cerebral infarction
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial insufficiency peripheral; Hypertension; Venous insufficiency
Allergies:
Diagnostic Lab Data: Test Name: CT scan brain; Result Unstructured Data: Test Result:no bleeding and no demarcation visible CTa scan br; Comments: White matter abnormalities; no bleeding and no demarcation visible; Test Name: CT scan brain; Result Unstructured Data: Test Result:No stop; Test Name: ECG; Result Unstructured Data: Test Result:sinus rhythm: 81/min., intermediate axis, PR 234ms; Comments: sinus rhythm: 81/min., intermediate axis, PR 234ms, beyond norm all conduction times, no ST elevation or depression C / 1st degree AV block, otherwise ECG compliant (compared to ECG 06Jun2019).; Test Date: 20190606; Test Name: ECG; Result Unstructured Data: Test Result:unknown results; Test Name: heart rate; Result Unstructured Data: Test Result:81; Comments: /min
CDC Split Type: NLPFIZER INC2021180693

Write-up: Ischaemic cerebrovascular incident: Expressed in lowering legs, aphasia and hemi-paresis; Ischaemic cerebrovascular incident: Expressed in lowering legs, aphasia and hemi-paresis; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency NL-LRB-00443166. E2B Authority Number was NL-LRB-00443166. An 86-year-old female patient received her 1st dose of BNT162B2 (COMIRNATY) at single dose on 28Jan2021 via an unknow route for COVID-19 immunisation. Medical history included hypertension, peripheral arterial insufficiency, venous insufficiency. Concomitant drug was not provided. Patient had no past drug therapy BioNTech / Pfizer vaccine (COMIRNATY); No Previous COVID-19 infection. Patient experienced ischemic cerebrovascular incident: expressed in lowering legs, aphasia and hemi-paresis on 29Jan2021. The seriousness criteria for this event were hospitalization, disability, life-threatening and death. Drugs and latency between covid-19 vaccine Pfizer injection and fluid ischaemic cerebral infarction was 12 hours after start. During in terminal phase due to CVA Hospitalization , patient was submitted on suspicion of iCVA, only eligible for preventive medication. Confounding factors: Hypertension, peripheral arterial insufficiency, venous insufficiency. Diagnostic procedures included: CT brain: white matter abnormalities, no bleeding, no demarking, no demarcation visible. Brain CTa (Computerised tomogram angiography): No stop; ECG: sinus rhythm: 81/min., intermediate axis, PR 234ms, beyond norm all conduction times, no ST elevation or depression C / 1st degree AV block, otherwise ECG compliant (compared to ECG 06Jun2019). Outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Ischaemic cerebrovascular incident: Expressed in lowering legs, aphasia and hemi-paresis; Ischaemic cerebrovascular incident: Expressed in lowering legs, aphasia and hemi-paresis


VAERS ID: 1056348 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiopulmonary failure, Conjunctival oedema, Lip swelling, Malaise, Mouth swelling, Peripheral swelling, Pyrexia, Swelling face, Swollen tongue
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conjunctival disorders (narrow), Hypersensitivity (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HALDOL; OMEPRAZOLE; MACROGOL; AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]; MORFINE; PRIMPERAN; SALBUTAMOL; COLECALCIFEROL
Current Illness: Aspiration pneumonia; Delirium
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: fever; Result Unstructured Data: Test Result:no fever
CDC Split Type: NLPFIZER INC2021191257

Write-up: swelling mouth; left arm; breathing and circulation were insufficient; Swelling face; Conjunctival swelling; increasing illness; complaints of the tongue, seemed a bit thick; complaints of the lip, seemed a bit thick; This is a spontaneous report from a contactable physician via the pharmacovigilance center (LAREB) downloaded from the Medicines Agency (MA) Regulatory Authority-WEB NL-LRB-00443834 A 74-years-old male patient received the second dose of bnt162b2 (COMIRNATY, lot EJ6795), via an unspecified route of administration on 09Feb2021 at single dose for covid-19 immunisation. Medical history included delirium and pneumonia aspiration both from 08Feb2021 and ongoing (were suspected). The patient had no previous COVID-19 infection. Concomitant medication included haloperidol (HALDOL), omeprazole (unknown manufacturer), macrogol (unknown manufacturer), amoxicillin, clavulanic acid (AUGMENTIN), morfine (unknown manufacturer), metoclopramide hydrochloride (PRIMPERAN), salbutamol (unknown manufacturer), colecalciferol (unknown manufacturer). The patient experienced swelling mouth, left arm, breathing and circulation were insufficient, swelling face, conjunctival swelling, increasing illness on 12Feb2021; complaints of the lip, seemed a bit thick and complaints of the tongue, seemed a bit thick on 10Feb2021. Cause of death was reported as unknown, anyway fatal outcome was reported for all the events. The patient died on 12Feb2021. It was not reported if an autopsy was performed. The reporter described that the day before vaccination an aspiration pneumonia with a delirium were suspected, for which amoxicillin/clavulanic acid and haloperidol were started. One day later, on the day of vaccination, the patient had no pyrexia. One day after vaccination, the patients tongue and lip seemed sligthly swollen. The next evening, the same events were reported again. A candida infection was suspected due to the use of amoxicillin/clavulanic acid and examination by the physician would follow the next day. The next morning, 3 days after vaccination, the patient did not react and his whole face, mouth, tongue, conjunctivae and left arm where swollen and there was cardiopulmonary insufficiency. Palliative policy followed after which the patient deceased several hours later. Differential diagnostic was thought of the aspiration pneumonia, sepsis, lupus erythemathosus and vena cava superior syndrome. The influence of the coronavaccination is unknown.; Reported Cause(s) of Death: swelling mouth; swelling left arm; breathing and circulation were insufficient; complaints of the lip, seemed a bit thick; Swelling face; Conjunctival swelling; increasing illness; complaints of the tongue, seemed a bit thick; Unknown cause of death


VAERS ID: 1056349 (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: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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: MACROGOL; PARACETAMOL; CYANOCOBALAMINE; CALCIUMCARBONAAT; BUMETANIDE; CLOPIDOGREL; COLECALCIFEROL; LOSARTAN; PANTOPRAZOLE
Current Illness: Heart failure
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021191256

Write-up: Death; This is a spontaneous report received from a contactable other health professional downloaded from the Regulatory Agency NL-LRB-00444824. A 93-year-old male patient received BNT162B2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 28Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing severe heart failure. Concomitant medication included macrogol at one dose form, paracetamol (formulation: tablet, strength: 1000 mg) at 1000 mg, cyanocobalamine (formulation: tablet) at 1000 ug, calciumcarbonaat (formulation: chewable tablet) at one dose form (680/80 mg), bumetanide (formulation: tablet) at 0.5 mg , clopidogrel (formulation: tablet) at 75 mg, colecalciferol (formulation: capsule) at 5600 iU, losartan (formulation: film-coated tablet) at 25 mg and pantoprazole (formulation: gastro-resistant tablet) at 40 mg. The patient death occurred on 30Jan2021, unknown cause of death. 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: 1056350 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chills, Cystitis, Fatigue, Hepatic failure, Malaise, Urine analysis
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood test; Result Unstructured Data: Test Result:unknown; Test Name: urine test; Result Unstructured Data: Test Result:unknown
CDC Split Type: NLPFIZER INC2021191261

Write-up: liver failure leading to death; Cystitis; occur general malaise; Fatigue; Cold shivers; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency NL-LRB-00444927. A 95-year-old female patient received first dose of BNT162B2 (COMIRNATY, lot number: EM0477), via an unspecified route of administration on 04Feb2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fatigue and cold shivers on 04Feb2021; liver failure leading to death, cystitis and general malaise, all on 07Feb2021. The patient underwent lab tests and procedures which included blood test and urine analysis: both results were unknown on an unspecified date. The patient died on an unspecified date, unknown cause of death. 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: 1056377 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: VISCOTEARS; MORFIN ABCUR; ALVEDON; HEMINEVRIN [CLOMETHIAZOLE EDISILATE]; PARACETAMOL EVOLAN; HERACILLIN [FLUCLOXACILLIN MAGNESIUM]; MINIDERM [GLYCEROL]; OMNILAX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; COVID-19; Dementia; Femur fracture; Hypertension; Ischemic heart disease; Skin necrosis; Wound infection
Allergies:
Diagnostic Lab Data: Test Date: 20201112; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: SEPFIZER INC2021191792

Write-up: Sudden cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB, regulatory authority number SE-MPA-2021-002257. A 94-years-old female patient received bnt162b2 (COMIRNATY; Lot # EJ6796) , intramuscular on Jan2021 at 0.3 mL, single for Covid-19 immunisation . Medical history included dementia from , myocardial ischaemia, cardiac failure, skin necrosis , wound infection, femur fracture on Jul2020 , covid-19 from Jan2021 , hypertension . Concomitant medication included carbomer (VISCOTEARS), morphine hydrochloride (MORFIN ABCUR), paracetamol (ALVEDON), clomethiazole edisilate (HEMINEVRIN [CLOMETHIAZOLE EDISILATE]), paracetamol (PARACETAMOL EVOLAN) , flucloxacillin magnesium (HERACILLIN [FLUCLOXACILLIN MAGNESIUM]), glycerol (MINIDERM [GLYCEROL]), macrogol (OMNILAX). The patient experienced sudden cardiac arrest on Jan2021 with outcome fatal. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 12Nov2020 . The patient died on an unspecified date. It was not reported if an autopsy was performed. The MPA will request more information.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1057541 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Chronic obstructive pulmonary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEMODERNATX, INC.MOD20210

Write-up: AVLIDEN; A spontaneous report was received from a consumer (SWEDEN) concerning a 70 year old, female patient who was pronounced dead on ??-JAN-2021. The patient''s medical history included Chronic obstructive pulmonary disease. Concomitant product use was not provided/unknown by the reporter. The patient received the mRNA-1273 vaccine (Batch number not provided) on ??-JAN-2021. The dosage is unknown. The patient was pronounced dead on ??-JAN-2021. Treatment information was nor provided/unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The patient died on ??-JAN-2021. The cause of death was not provided/unknown. Plans for an autopsy were unknown/not provided.; Reporter''s Comments: Very limited information regarding this events has been provided at this time. The cause of death was not provided. Plan for an autopsy was not provided. Company assessed the events to be unlikely related to company product.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1057579 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia, Death, Electrocardiogram, Face oedema, Oedema peripheral, Pulmonary arterial hypertension
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Arrhythmia related investigations, signs and symptoms (broad), Pulmonary hypertension (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-17
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BETMIGA; AMLODIPIN ACCORD; HYDREA; SERTRALIN ACCORD; GAVISCON FORTE [ALGELDRATE;ALGINIC ACID;CALCIUM CARBONATE;MAGNESIUM TRISILICATE;SODIUM BICARBONATE]; PANTOPRAZOLE 2CARE4; MAGNESIA MEDIC; LAXOBERAL; PREGABALIN ACCORD; OXAPAX; RAMIPRIL HE
Current Illness: Anaemia (Diagnosed in 2020); Anxiety; Cerebral palsy; Depression; Dyspepsia; Gallbladder stone (2 cm gallbladder stone found in december. No surgery performed.); Hypertension; Incontinence; Insomnia; Myeloproliferative disorder; Non-smoker; Obstipation; Polycythaemia; Reflux gastritis; Spasticity; Wheelchair user
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia (Multiple hospitalisation in 2020 due to pneumonia)
Allergies:
Diagnostic Lab Data: Test Name: Electrocardiogram; Result Unstructured Data: Test Result:Decreased function of right ventricle.
CDC Split Type: DKPFIZER INC2021158676

Write-up: Bradycardia; Pulmonary arterial hypertension; Edema extremities; Edema face; The patient died on 17Jan2021; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the European Medicines Agency DK-DKMA-WBS-0029225. A 74-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EM0477), intramuscular on 05Jan2021 at single dose for covid-19 immunization. Medical history included multiple hospitalization in 2020 due to pneumonia from 2020, ongoing wheelchair user, ongoing spasticity, ongoing cerebral palsy, ongoing polycythaemia, ongoing anaemia diagnosed in 2020. The patient was a non-smoker. Concurrent condition also included hypertension, incontinence, reflux gastritis, myeloproliferative disorder, insomnia, obstipation, anxiety, dyspepsia and depression, 2 cm gallbladder stone found in December in an unknown year. No surgery performed for the cholelithiasis. Concomitant medication included mirabegron (BETMIGA) from 16Feb2018 to 17Jan2021 for Incontinence, amlodipine besilate (AMLODIPIN ACCORD) from an unknown date to 17Jan2021 for hypertension, hydroxycarbamide (HYDREA) from 01Jan2011 to 17Jan2021 for Myeloproliferative disorder, sertraline hydrochloride (SERTRALIN ACCORD) from 16Feb2018 to 17Jan2021 for depression, algeldrate, alginic acid, calcium carbonate, magnesium trisilicate, sodium bicarbonate (GAVISCON) from 16Feb2018 to 17Jan2021 for Reflux gastritis, pantoprazole (PANTOPRAZOLE 2CARE4) from 09Jan2021 to 17Jan2021 for Dyspepsia, magnesium hydroxide (MAGNESIA MEDIC) for obstipation, sodium picosulfate (LAXOBERAL) from an unknown date to 17Jan2021 for Obstipation, pregabalin (PREGABALIN ACCORD) from 01Jan2011 to 17Jan2021 for Anxiety, oxazepam (OXAPAX) from 16Feb2018 to 17Jan2021 for Anxiety, ramipril (RAMIPRIL HEXAL) from 16Feb2018 to 17Jan2021 for hypertension, zopiclone (IMOZOP) from 16Feb2018 to 17Jan2021 for Insomnia, folic acid (FOLIMET) from 04Jan2021 to 17Jan2021 for Anaemia. There was no information regarding past medication. On 05Jan2021 the patient developed edema extremities and edema face. On 09Jan2021 the patient developed Bradycardia and Pulmonary arterial hypertension. The ADRs were by the physician reported as resulting in hospitalization. The patient was treated with Xarelto (Rivaroxaban). The patient was treated with high-spectrum antibiotics during hospitalization, after which an increase in white blood cells was seen. However, it was not known if the patient could have had an underlying infection, which suddenly manifested itself and was the cause of death. Cause of death was reported as unknown cause of death. The patient underwent lab tests and procedures which included electrocardiogram with result of decreased function of right ventricle. Bradycardia recovered on 13Jan2021. Edema extremities and Edema face recovered on 15Jan2021. Pulmonary arterial hypertension was not recovered. The patient died on 17Jan2021. The physician assumed that there was no causality between the vaccine and the cause of death. However, the physician cannot state the cause of death.; Sender''s Comments: Based solely on event-vaccine chronological association, contributory role of BNT162B2 (COMIRNATY) to event Death (unknown cause) cannot be completely excluded. The case will be reevaluated should additional information including the cause of death become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1057626 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-20
Onset:2020-12-01
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ0553 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2020-12-25
   Days after onset: 24
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: Costochondritis; Joint prosthesis replacement; Knee osteoarthritis; Megaloblastic anaemia NOS; Osteoarthritis; Comments: Megaloblastic anaemia NOS TKR -Total prosthetic replacement of knee joint using cement TKR -Total prosthetic replacement of knee joint using cement TKR - Other total prosthetic replacement of knee joint Knee osteoarthritis NOS Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021177037

Write-up: chest pain / left sided chest pain; costochondritis; cardiac arrest; back pain; This is a spontaneous report from a contactable physician received from the MHRA. Regulatory authority report number GB-MHRA-WEBCOVID-202102170858432420, Safety Report Unique Identifier GB-MHRA-ADR 24778572. An 83-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EJ0553) on 20Dec2020 at single dose, for COVID-19 immunisation. Medical history included osteoarthritis, costochondritis, megaloblastic anaemia NOS, TKR -total prosthetic replacement of knee joint using cement, knee osteoarthritis NOS. The patient had not had symptoms associated with COVID-19, had no COVID-19 test and was not enrolled in clinical trial. Concomitant medications were not reported. Since 24Dec2020 the patient attended A&E four days after having had vaccine with left sided chest pain. He was discharged home with a diagnosis of costochondritis. He collapsed at home the following day in Dec2020 after complaining of back pain, cardiac arrest. The patient died on 25Dec2020. It was unknown if an autopsy was done. Cause of death was reported as death unexplained. Awaiting Post Mortem and Coroners. Chest pain, back pain, cardiac arrest were reported to have a fatal outcome. The outcome of the event costochondritis was unknwon.The reporter was advised to report, due to the frame, but believed the death was unrelated to vaccine. No follow-up activities are possible. No further information is expected. Follow-up (21Feb2021) New information received from a contactable physician via the UK-MHRA includes: Chest pain, back pain, cardiac arrest were reported to have a fatal outcome. No follow-up activities are possible. No further information is expected.; Reported Cause(s) of Death: Chest pain; back pain; cardiac arrest


VAERS ID: 1058058 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2020-12-27
Submitted: 0000-00-00
Entered: 2021-02-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Off label use, Oxygen saturation decreased, Product use issue, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Medication errors (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-31
   Days after onset: 35
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: Aspiration; Chronic respiratory failure; Dysphagia; Oxygen therapy (for years for chronic respiratory failure); Parkinsonism; Polymyalgia rheumatica (Chronic treatment with corticosteroids); Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210124; Test Name: desaturation; Result Unstructured Data: Test Result:desaturation; Test Date: 20210115; Test Name: PCR; Test Result: Negative ; Test Date: 20210120; Test Name: PCR; Test Result: Negative ; Test Date: 20210124; Test Name: PCR; Test Result: Positive
CDC Split Type: ESPFIZER INC2021098153

Write-up: Drug ineffective/COVID-19 respiratory infection; COVID-19 respiratory infection; polymyalgia rheumatica on chronic treatment with corticosteroids; polymyalgia rheumatica on chronic treatment with corticosteroids; This is a spontaneous from a contactable physician downloaded from the Regulatory Authority-WEB ES-AEMPS-729768. A 98-year-old female patient received first dose of BNT162B2 (COMIRNATY) Solution for injection, intramuscular on 27Dec2020 as a single dose (lot number: EJ6796), second dose intramuscular on 17Jan2021 as a single dose (lot number/batch number: EM0477) for covid-19 vaccination. Medical history included chronic respiratory failure, parkinsonism, vascular dementia, polymyalgia rheumatica on chronic treatment with corticosteroids, nocturnal oxygen therapy for years for chronic respiratory failure, possible microaspirations due to dysphagia. Concomitant medications were not reported. As per verbatim: The patient''s (Institutionalized person) (AP) past antecedent included vascular dementia, parkinsonism, polymyalgia rheumatica on chronic treatment with corticosteroids, nocturnal oxygen therapy for years for chronic respiratory failure, possible microaspirations due to dysphagia. On 27Dec2020 she received the 1st dose of Comirnaty. On 17Jan2021 she received the 2nd dose (batch EM0477). Since 15Jan2021, she was confined by close contact in her module. Polymerase chain reaction (PCR) on 15Jan2021 and 20Jan2021 were negative. On 24Jan2021 he presented fever and desaturation. PCR was positive for COVID. Covid-19 infection. On 24Jan2021, the patient experienced COVID-19 respiratory infection (medically significant), drug ineffective (medically significant). The patient underwent laboratory tests and procedures which included SARS-CoV-2 PCR test: negative on 15Jan2021 and 20Jan2021, positive on 24Jan2021 and desaturation on 24Jan2021. It was further reported that the evolution was unfavorable and she died on 31Jan2021, no autopsy was performed. Follow-up (23Feb2021): New information from the same contactable physician, downloaded from the Regulatory Authority-WEB ES-AEMPS-729768 includes updated outcome for events vaccination failure and COVID-19 respiratory infection to fatal, death date provided, autopsy details reported, seriousness criterion (death) added for events vaccination failure and COVID-19 respiratory infection. Follow-up attempt are not possible. No expected further information.; Reported Cause(s) of Death: Vaccination failure; COVID-19 respiratory infection


VAERS ID: 1061110 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-02-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-02-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK AR / IM

Administered by: Private       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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Not known
Current Illness: Not known
Preexisting Conditions: Mental disability
Allergies: Not known
Diagnostic Lab Data: Not known
CDC Split Type:

Write-up: Death


VAERS ID: 1061467 (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: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Body temperature increased, Death, Heart rate, Heart rate decreased, Oxygen saturation, Respiratory rate, Respiratory rate decreased
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZOREEDA; DILATREND; LASIX [FUROSEMIDE]; DULOXETINE; SPIROBENE; NEUPRO; ESOMEPRAZOLE; SINTROM; GABAPENTIN
Current Illness: Cor pulmonale; Multimorbidity; Pulmonary arterial hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Name: body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Name: HR; Result Unstructured Data: Test Result:drop (less than 40); Test Name: O2 saturation; Result Unstructured Data: Test Result:greater than 90 %; Test Name: RR; Result Unstructured Data: Test Result:drop
CDC Split Type: ATPFIZER INC2021190062

Write-up: O2 saturation; Body temperature increased; Heart rate decreased; Blood pressure decreased; Respiratory rate decreased; Death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority (AT-BASGAGES-2021-01408). An 86-year-old female patient received the second dose of BNT162B2 (COMIRNATY; Lot number: EJ6134), via an unspecified route of administration, on 02Feb2021 at a single dose for COVID-19 immunisation. Medical history included ongoing multimorbidity, ongoing cor pulmonale, and ongoing pulmonary arterial hypertension. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ZOREEDA), carvedilol (DILATREND), furosemide (LASIX), duloxetine (MANUFACTURER UNKNOWN), spironolactone (SPIROBENE), rotigotine (NEUPRO), esomeprazole (MANUFACTURER UNKNOWN), acenocoumarol (SINTROM), and gabapentin (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunization. The patient experienced oxygen (O2) saturation, body temperature increased, heart rate decreased, blood pressure decreased, and respiratory rate decreased on 03Feb2021 at 09:00, which all caused hospitalization. The patient also experienced death on 09Feb2021, which was reported as fatal. The patient underwent lab tests and procedures, all on an unspecified date, which included respiratory rate (RR): drop, body temperature: 38.5 centigrade, heart rate (HR): drop (less than 40), O2 saturation: greater than 90%, and blood pressure: decreased. The clinical outcome of oxygen (O2) saturation, body temperature increased, heart rate decreased, blood pressure decreased, and respiratory rate decreased was not recovered. The patient died on 09Feb2021. The cause of death was reported as unknown. An autopsy was performed, and results were not provided. It was reported that: The autopsy revealed a different cause of death than the vaccination. From the point of view of the pathologist, the contribution of the vaccination to the cause of death cannot be objectified. At the time of the vaccination there were no signs of infection. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : AT-BASGAGES-2021-00233; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1061476 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Carotid occlusion (occlusion of the internal carotid artery, left); Dependence on renal dialysis (kidney failure requiring dialysis); Fundus hypertonicus; Hypertension arterial; Kidney failure; Vascular encephalopathy
Preexisting Conditions: Medical History/Concurrent Conditions: Ischaemic cerebral infarction (St.p. multiple (embolically configured) ischemic cerebral infarcts in the flow area of the left cerebral artery)
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC2021190501

Write-up: unexplained death; Found dead at home; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (Regulatory Authority number AT-BASGAGES-2021-03550). A 73 years old male patient received the first single dose of BNT162B2 (COMIRNATY; lot EJ6797) intramuscular, on 10Feb2021, for COVID-19 immunisation. Medical history included ongoing fundus hypertonicus, ongoing dependence on renal dialysis, ongoing kidney failure requiring dialysis, ongoing cerebral arterial occlusive disease (occlusion of the internal carotid artery, left), ongoing hypertension arterial, ischaemic cerebral infarction from Dec2012 (st.p. multiple (embolically configured) ischemic cerebral infarcts in the flow area of the left cerebral artery), ongoing vascular encephalopathy. He had numerous unspecified multiple concomitant medications. At noon on 12Feb2021 the patient was seen on dialysis since he was symptom-free. On 14Feb2021 the patient experienced unexplained death; found dead at home. It was unknown if an autopsy was done. There were no signs of infection at the time of vaccination. There was no positive test result for SARS-CoV2 and he had no SARS-CoV2 antibodies at the time of vaccination. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: unexplained death; Found dead at home


VAERS ID: 1061492 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; FUROSEMID; RAMILICH; METAMIZOLE; FENTANYL; TAMSULOSIN; PREGABALIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021191546

Write-up: Death; Vomiting; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-DCGMA-21188000. An 81-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (Lot no.: EM0477), via an unspecified route of administration at single dose on 14Jan2021 for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included apixaban, furosemide (FUROSEMID), ramipril (RAMILICH), metamizole, fentanyl, tamsulosin, pregabalin. On 14Jan20, the patient developed vomiting and death. The patient died on 14Jan2021. An autopsy was not performed. Reporter comments: UAW: The patient vomited in the evening after the Covid vaccination and was then found dead. No follow-up attempts are needed. No further information is expected.; Reporter''s Comments: UAW: The patient vomited in the evening after the Covid vaccination and was then found dead.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1061506 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BEL8723 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute abdomen, Intestinal ischaemia, Respiratory failure, Septic shock
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (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), Ischaemic colitis (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; COPD; Dementia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021191550

Write-up: Acute abdomen; Septic shock; Mesenteric ischaemia; Respiratory failure; This is a spontaneous report from a non-contactable physician via Regulatory Authority. An 81-year-old male patient received the first dose of bnt162b2 (COMIRNATY) (Lot no. BEL8723), intramuscular at single dose on 12Feb2021 for covid-19 immunisation. Medical history included atrial fibrillation, dementia, hypertension arterial, chronic obstructive pulmonary disease (COPD). Concomitant medications were not reported. On 13Feb2021, the patient developed acute abdomen, septic shock, mesenteric ischaemia, respiratory failure. The patient was hospitalized and condition was life threatening. The patient died on 13Feb2021. It was not reported if an autopsy was performed. Death cause was reported as mesenteric ischaemia. Comirnaty/to all events/C. Inconsistent causal association. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Mesenteric ischaemia


VAERS ID: 1061507 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021191679

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-PEI-PEI2021002723. A 85-years-old female patient received the first dose of bnt162b2 (COMIRNATY; Lot # EJ6796) vaccine , via an unspecified route of administration on 31Dec2020 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. The patient died from unknown cause on 01Jan2021. It was not reported if an autopsy was performed. Result of Assessment : C. Inconsistent causal association Lot number already obtained. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event of death from unknown cause. The reported event may likely be associated with underlying medical conditions in this elderly 85 year old patient. There is very limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1061508 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-02-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021191681

Write-up: the fatal outcome; This is a spontaneous report from a non- contactable physician downloaded from the regulatory authority- DE-PEI-PEI2021002724 A female patient of an unspecified received the second dose of bnt162b2 (COMIRNATY; Lot # EL1491) vaccine, via an unspecified route of administration on 23Jan2021 at single dose for Covid-19 immunisation . The patient medical history and concomitant medications were not reported. On 31Dec2020, the patient received the first dose of COMIRNATY. The patient died on 04Feb2021. The cause of death was unknown. It was not reported if an autopsy was performed. Relatedness of drug to reaction(s)/event(s) assessed Inconsistent causal association by regulatory authority. No follow-up attempts possible. No further information expected. COMIRNATY batch already obtained.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1061519 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-31
Onset:2021-02-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, General physical health deterioration, Pulmonary oedema
SMQs:, Cardiac failure (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: KALIUMKLORID ORIFARM; CONTALGIN; BERODUAL; SCOPODERM [HYOSCINE]; LAXOBERAL; FURIX [CEFUROXIME]; PREGABALIN KRKA; PARACETAMOL ORIFARM; XARELTO
Current Illness: ALS (Terminal state. Able to speech, swallow and move both index fingers); Apnoea; Constipation; Pain; Phlegm (Increasing in the months close to vaccination)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021189957

Write-up: The physician can not exclude that the vaccination had an additive effect on already worsening state of health resulting in death/ exacerbation of disease; The physician can not exclude that the vaccination had an additive effect on already worsening state of health resulting in death.; lung edema; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (DK-DKMA-WBS-0034363). A 71-year-old male patient received the second dose of BNT162B2 (COMIRNATY; Lot number: EK9788; Expiration date: 31May2021), via an unspecified route of administration, on 31Jan2021 at a single dose for COVID-19 immunisation. Medical history included amyotrophic lateral sclerosis (ALS) (terminal state; able to speech, swallow and move both index fingers) from 2019 and ongoing, ongoing phlegm (increasing in the months close to vaccination), ongoing apnoea, ongoing pain, and ongoing constipation. Concomitant medication included potassium chloride (KALIUMKLORID ORIFARM) taken as potassium supplementation from 18Nov2020, morphine sulfate (CONTALGIN) taken for pain from 07Jan2021, fenoterol hydrobromide, ipratropium bromide (BERODUAL) taken for drug use for unknown indication, hyoscine (SCOPODERM) taken as prophylaxis of nausea and vomiting from 29Jan2021, sodium picosulfate (LAXOBERAL) taken for constipation from 15Jan2020, cefuroxime (FURIX) taken as diuretic therapy from 24Aug2020, pregabalin (MANUFACTURED BY: KRKA) taken for pain, paracetamol (MANUFACTURED BY: ORIFARM) taken for pain from 22Apr2020, and rivaroxaban (XARELTO) taken for thrombosis prophylaxis from 17Nov2020. The patient previously received the first dose of BNT162B2 (COMIRNATY; Lot number: EM0477) on 06Jan2021 for COVID-19 immunisation. In Feb2021, the physician can not exclude that the vaccination had an additive effect on already worsening state of health resulting in death. The patient also experienced lung edema in Feb2021. The events were reported as fatal. The patient was treated with furosemide and fenoterol and ipratropium bromide with some effect, but the patient died relatively sudden on 11Feb2021. Therapeutic measures were taken as a result of the events as aforementioned. The patient died on 11Feb2021. The cause of death was reported as exacerbation of disease and lung edema, as well as worsening state of health resulting in death. An autopsy was not performed. The reporter stated that he could not exclude that the vaccination had an additive effect on already worsening state of health resulting in death. He did not suspect that the vaccination caused death. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: The physician can not exclude that the vaccination had an additive effect on already worsening state of health resulting in death; The physician can not exclude that the vaccination had an additive effect on already worsening state of health resultin


VAERS ID: 1061520 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, General physical health deterioration
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

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: MORFIN DAK; MATRIFEN; PREDNISOLON ACTAVIS; MIDAZOLAM ACCORD
Current Illness: Difficulty breathing (worsening breathing difficulty); Lung cancer recurrent; Reduced general condition (Slowly deteriorating)
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer (surgery 2001); Surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021189953

Write-up: Dyspnea. Hospitalised 03feb2021 due to exacerbated dyspnea.; The 03Feb2021 the patient was hospitalised due to worsening general condition; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB. This is a report received from the Medicines Agency (KA). The regulatory authority report number is MA-WBS-0034367. A 79-year-old male patient received the second dose of the bnt162b2 (COMIRNATY; Lot Number: EK9788 and Expiration Date: 31May2021), intramuscularly on 01Feb2021 at a single dose for COVID-19 immunization. Medical history included lung cancer recurrent from Dec2020 and ongoing, lung cancer from an unknown date to 2001 (surgery 2001), reduced general condition from Dec2020 and ongoing (slowly deteriorating), difficulty breathing from 2020 and ongoing (worsening breathing difficulty), surgery in 2001. Concomitant medications included morphine hydrochloride (MORFIN DAK) taken for an shortness of breath from 05Feb2021 to an unspecified date, fentanyl (MATRIFEN) taken for an unspecified indication from an unspecified date to an unspecified date, prednisolone (PREDNISOLON ACTAVIS) taken for steroid therapy from 29Dec2020 to an unspecified date, midazolam hydrochloride (MIDAZOLAM ACCORD) taken for an unspecified indication from an unspecified date to an unspecified date. The patient previously received the first dose of the of the bnt162b2 (COMIRNATY; Lot Number: EM0477) COVID-19 immunization on 08Jan2021. On an unspecified date in Feb2021, the patient experienced: dyspnea. hospitalised 03Feb2021 due to exacerbated dyspnea, and "the 03Feb2021 the patient was hospitalised due to worsening general condition"; which required hospitalization and resulted in death. The patient was hospitalized from 03Feb2021 to an unknown date. There was no information regarding test results. The clinical outcome of the events was fatal. The patient died on 10Feb2021 due to dyspnea exacerbated and reduced general condition. An autopsy was not performed. The physician did not suspect any causal relationship between the vaccination and death but could not rule out that the vaccine had further facilitated the already deteriorating breathing and general condition. Sender Comment: If the Medicines Agency receives supplemental significant information regarding this case the case will be re-submitted. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Reduced general condition; Dyspnea exacerbated


VAERS ID: 1061584 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood bicarbonate, Blood calcium, Blood creatinine, Blood lactic acid, Blood magnesium, Blood potassium, C-reactive protein, Cardiac failure, Echocardiogram, Electrophoresis protein, Oxygen saturation, PCO2, PO2, Renal impairment, SARS-CoV-2 antibody test, SARS-CoV-2 test, Sudden death, Troponin, White blood cell count, X-ray, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-07
   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: Alzheimer''s disease; Auricular fibrillation; Chronic renal failure (Moderate); Cognitive disturbance (such as Alzheimers); Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: HCO3-; Result Unstructured Data: Test Result:23; Test Date: 20210207; Test Name: calcium; Result Unstructured Data: Test Result:25; Test Date: 20210207; Test Name: creatinine; Result Unstructured Data: Test Result:200; Comments: Renal failure with a creatinine of 200; Test Date: 20210207; Test Name: lactate; Result Unstructured Data: Test Result:3.8; Comments: Blood gas with venous lactates at 3.8; Test Date: 20210207; Test Name: magnesium; Result Unstructured Data: Test Result:0.84; Test Date: 20210207; Test Name: potassium; Result Unstructured Data: Test Result:4.8; Test Date: 20210207; Test Name: c-reactive protein; Result Unstructured Data: Test Result:113; Test Date: 20210207; Test Name: transthoracic echocardiography; Result Unstructured Data: Test Result:Did not show pericarditis and heart failure; Comments: did not show pericarditis and heart failure with preserved LVEF (hypertensive, hypervolemic and rhythmic a priori) was observed.; Test Date: 20210207; Test Name: plasma protein electrophoresis; Result Unstructured Data: Test Result:Alveolointerstitial syndrome; Test Date: 20210207; Test Name: oxygen desaturation; Result Unstructured Data: Test Result:Desaturation; Comments: Desaturation motivating a putting under 6L of O2.; Test Date: 20210207; Test Name: pCO2; Result Unstructured Data: Test Result:37; Test Date: 20210207; Test Name: pH; Result Unstructured Data: Test Result:Normal; Test Date: 20210207; Test Name: pAO2; Result Unstructured Data: Test Result:98 under 6L; Test Date: 20210207; Test Name: COVID-19 serology test; Result Unstructured Data: Test Result:8.6; Test Date: 20210207; Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:Negative; Test Date: 20210207; Test Name: troponin; Result Unstructured Data: Test Result:100; Test Date: 20210207; Test Name: leucocytes; Result Unstructured Data: Test Result:8990; Comments: No hyperleukocytosis; Test Date: 20210207; Test Name: x-ray; Result Unstructured Data: Test Result:Overload and apical atelectasis without focus; Comments: Overload and apical atelectasis without focus were observed
CDC Split Type: FRPFIZER INC2021193007

Write-up: Sudden death; Decompensation cardiac; Cardio-renal decompensation; This is a spontaneous report downloaded from the Regulatory Authority-WEB, regulatory authority FR-AFSSAPS-PC20210241. A contactable physician reported that an 87-year-old female patient received the second dose of BNT162B2 (COMIRNATY) intramuscularly, at single dose, on 05Feb2021, for COVID-19 immunisation. Relevant medical history included moderate cognitive disturbance such as Alzheimer, hypertension arterial, moderate chronic renal failure and chronic auricular fibrillation all from an unspecified date, and unknown if ongoing. The patient was described as being very fit despite her comorbidities, with no respiratory signs. The patient previously, on 15Jan2021, received the first dose of BNT162B2 (COMIRNATY), for COVID-19 immunisation. Concomitant medications were unknown. From 06Feb2021 to 07Feb2021, rapid onset of respiratory signs and deterioration of general condition were observed. The patient did not have a fever. From 07Feb2021, the patient was hospitalized in the emergency room in short-term hospitalization unit. They presented a sudden desaturation motivating a putting under 6L of O2. Relevant laboratory test performed on 07Feb2021, showed the following value: blood bicarbonate (HCO3) 23, blood calcium 25, blood creatinine 200 (renal failure with a creatinine of 200), blood lactic acid 3.8 (blood gas with venous lactates at 3.8), blood magnesium 0.84, blood potassium 4.8, C-reactive protein 113, PCO2 37, pH body fluid normal, pAO2 98 under 6L, troponin stable at 100 and white blood cell count (leucocytes) 8990, no hyperleukocytosis. The PPE (plasma protein electrophoresis) showed alveolointerstitial syndrome. TTE (transthoracic echocardiography) did not show pericarditis and heart failure with preserved LVEF (hypertensive, hypervolemic and rhythmic a priori) was observed.The patient was afebrile and normocardic and she did not present with polypnea. On the X-ray, overload and apical atelectasis without focus were observed. Six hours later (approximately 48 hours after the second injection), in the middle of the night, the patient died suddenly. Specialized resuscitation was carried out from the outset by the teams with support from the SMUR. Note that the constants were normal a few hours earlier. She had no vomiting, bleeding, or cyanosis. It was concluded that it was about a sudden death on a cardio-renal decompensation with a context of inflammatory syndrome of cause not discovered before the death. Cardiac decompensation 24 hours after the second injection, prompting hospitalization 48 hours after the second injection. The notifier specified that the causal link is very uncertain but that the temporal concordance justified the declaration. After the second dose, on 07Feb2021: negative PCR and positive serology at 8.6. It was unknown if autopsy was done. No follow-up attempts are possible, information about lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death; Decompensation cardiac; Renal function aggravated


VAERS ID: 1061810 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-19
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN1185 / UNK LA / 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:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021192607

Write-up: Patient died; This is a spontaneous report from a contactable physician. A 91-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EN1185), intramuscular at single dose on 17Feb2021 for covid-19 immunisation. Medical history included Alzheimer''s disease. Concomitant medications were not reported. The patient died on 19Feb2021 14:45. No treatment required. An autopsy was not performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: patient died


VAERS ID: 1061811 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: GBPFIZER INC2021208647

Write-up: anaphylactic reaction, passed away; This is a spontaneous report from a contactable pharmacist who reported for four patients. This is the fourth of 4 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced anaphylactic reaction, and passed away on an unspecified date. It was unknown if an autopsy was performed. Information on the batch/lot number has been requested.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported fatal event of anaphylactic reaction due to temporal relationship and current known drug safety profile. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-2021169283 Same reporter, same drug, different event; Reported Cause(s) of Death: Anaphylactic reaction


VAERS ID: 1061816 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-01-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Fibromyalgia, 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: 2021-01-19
   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: RIVOTRIL; PIOGLITAZON; CONTROLOC [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; ALOPURINOL; ATORIS; AMLOPIN [AMLODIPINE BESILATE]; SORTIS; AMYZOL [AMITRIPTYLINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia; Cerebrovascular infarction (St. post CVI); Diabetes mellitus; Penicillin allergy; Recurrent urinary tract infection; Tetraplegia
Allergies:
Diagnostic Lab Data: Test Date: 202101; Test Name: Body temperature; Result Unstructured Data: Test Result:38.0-38.3 Centigrade
CDC Split Type: HRPFIZER INC2021190007

Write-up: Death; Fibromyalgia; Fever 38.0 ? C - 38.3 ? C for three days; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. This is a report received from the regulatory authority. The regulatory authority report number is HR-HALMED-300043964. A 57-year-old male patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EL1491), intramuscularly on 07Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included recurrent urinary tract infection from an unknown date and unknown if ongoing, penicillin allergy from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, tetraplegia from an unknown date and unknown if ongoing, cerebrovascular infarction from an unknown date and unknown if ongoing (status post CVI), anaemia from an unknown date and unknown if ongoing. Concomitant medications included clonazepam (RIVOTRIL), pioglitazone hydrochloride (MANUFACTURER UNKNOWN), pantoprazole sodium sesquihydrate (CONTROLOC [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), alopurinol (MANUFACTURER UNKNOWN), atorvastatin calcium (ATORIS) , amlodipine besilate (MANUFACTURER UNKNOWN), atorvastatin calcium (SORTIS), amitriptyline hydrochloride (AMYZOL [AMITRIPTYLINE HYDROCHLORIDE]); all taken for an unspecified indication from an unspecified date to an unspecified date. On 08Jan2021, the patient experienced: fibromyalgia, and fever 38.0 ? C - 38.3 ? C for three days; both of which caused death. On 19Jan2021, the patient experienced: death (death, medically significant). The patient underwent lab tests and procedures which included body temperature: 38.0-38.3 Centigrade in Jan2021. The clinical outcome of the events was fatal. The patient died on 19Jan2021, in a hospital, due to unknown cause of death (as reported), fibromyalgia and fever. It was unknown if an autopsy was performed. Sender comments: 18Feb2021: Despite several contact attempts with the reporter, additional medicinal documentation has not been received. Based on the currently available information, it is not possible to assess causal relationship between fatal outcome and vaccine administration. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Fibromyalgia; Fever; Unknown cause of death


VAERS ID: 1061818 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, C-reactive protein, Chest X-ray, Cough, Fibrin D dimer, Pneumonia, Pyrexia, Renal function test, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), 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: 2021-02-05
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PAROGEN; PARNASSAN; KEMADRIN; GERODORM; MIRZATEN; RILEX [LORAZEPAM]; KEMADRIN
Current Illness: Alzheimer''s disease; Bipolar affective disorder; Cachexia; COPD; Secondary parkinsonism
Preexisting Conditions: Medical History/Concurrent Conditions: Myelomatosis multiple (treated from 2017)
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: Body temperature; Result Unstructured Data: Test Result:39.4 Centigrade; Test Date: 20210131; Test Name: Chest X-ray; Result Unstructured Data: Test Result:pneumonia; Test Date: 20210131; Test Name: CRP; Result Unstructured Data: Test Result:high; Test Date: 20210131; Test Name: d-dimer; Result Unstructured Data: Test Result:high; Test Date: 20210131; Test Name: renal function; Result Unstructured Data: Test Result:impaired; Test Date: 20210202; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210204; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021190187

Write-up: cough; fever at 39.4 degrees Celcius; Bronchopneumonia; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB HU-OGYI-052721 A 75-year-old male patient received first dose of bnt162b2 (COMIRNATY; expiry date: Apr2021, lot/batch EJ6134) intramuscularly in left arm on 29Jan2021 at 13:30 at 0.3 mL single for covid-19 immunisation. Medical history included ongoing Secondary parkinsonism , ongoing Bipolar affective disorder, ongoing cachexia, ongoing Alzheimer''s disease, ongoing chronic obstructive pulmonary disease (COPD) and myelomatosis multiple treated from 2017. Concomitant medication included paroxetine hydrochloride (PAROGEN), olanzapine (PARNASSAN), procyclidine hydrochloride (KEMADRIN), cinolazepam (GERODORM), mirtazapine (MIRZATEN) , lorazepam (RILEX and procyclidine hydrochloride (KEMADRIN (IE)). On 31Jan2021 at 15:29 the patient experienced cough and fever, both serious due to hospitalization in 2021; fever and coughing also resulted in death. On 31Jan2021, the patient experienced 39.4 degrees Celcius fever and coughing, he was taken to the emergency. No medical history could be obtained from the patient (as reported), COVID-19 PCR test and chest X-ray were performed: X-ray showed pneumonia on 31Jan2021; COVID-19 PCR test was negative on 02Feb2021 and also negative on 04Feb2021. Laboratory test on 31Jan2021 revealed high C-reactive protein (CRP), high d-dimer, impaired renal function. He received infusion due to dehydratation, unknown ceftriaxon intravenously 2 gr, dalteparin sodium (FRAGMIN 2500 NE injection, Pfizer Kft) once daily subcutaneously, methylprednisolone (SOLU-MEDROL 40 mg, Pfizer Kft.) twice daily intravenously,and salbutamol (VENTOLIN EVOHALER pressurized inhalation suspension, GlaxoSmithKline Kft.) as treatments. The patient was transferred to the internal medicine department, where he died on 05Feb2021 at 04:15 am. Autopsy was done, cause of death was bronchopneumonia. Established diagnoses reported as follows: Atherosclerosis generalized,Ventricular hypertrophy,Pulmonary oedema,Bronchopneumonia, Myeloma multiplex.The reporter physican did not consider the events to be related to vaccination. Sender Comment: 75-year-old patient died 7 days after vaccination with Comirnaty. Cause of death was bronchopneumonia according to the autopsy. The causal relationship between the events and Comirnaty is considered unlikely. The case is serious due to the fatal outcome. No follow-up attempts possible. No further information expected.; Sender''s Comments: There is no reasonable possibility that the fatal events cough, fever and bronchopneumonia were related to COMIRNATY use. These are more likely associated with intercurrent bronchopneumonia confirmed by diagnosis.; Reported Cause(s) of Death: Bronchopneumonia; fever; cough


VAERS ID: 1061821 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-01
Onset:2021-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 34
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OPSUMIT; UPTRAVI
Current Illness: Mechanical ventilation
Preexisting Conditions: Medical History/Concurrent Conditions: Intubation
Allergies:
Diagnostic Lab Data: Test Name: COVID-19; Result Unstructured Data: Test Result:positive
CDC Split Type: ILPFIZER INC2021188701

Write-up: COVID-19; general deterioration in her health status; Drug ineffective; This is a spontaneous report from contactable consumers and nurse via other company. A 53-year-old female patient received bnt162b2 (Formulation: Solution for injection), via an unspecified route of administration on an unknown date in Jan2021 at single dose for COVID-19 immunisation. Medical history included endotracheal intubation and ongoing mechanical ventilation. Concomitant medication included macitentan (OPSUMIT) at 10mg once a day for pulmonary arterial hypertension, selexipag (UPTRAVI, Strength: 800 ug) at 800 ug, twice a day for pulmonary arterial hypertension. It was reported that patient was vaccinated with the first dose of COVID-19 vaccine and one week after that began general deterioration in her health status on an unknown date in Jan2021. The patient was hospitalised and diagnosed with COVID-19 on 29Jan2021 and shortly after that had severe dyspnea on an unknown date in Jan2021. The patient was intubated and sedated on MV(mechanical ventilation). It was reported that patient was hospitalized since 29Jan2021 until death. The patient died on 04Feb2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible, information on batch number cannot be obtained.; Sender''s Comments: Based on the temporal relationship, the association between the event lack of effect (fatal COVID19) with BNT162b2 can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: general deterioration in her health status; COVID-19; severe dyspnea


VAERS ID: 1061849 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hyperpyrexia
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: 2021-02-01
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210207; Test Name: Body temperature; Result Unstructured Data: Test Result:40.5 to 42 Centigrade
CDC Split Type: NLPFIZER INC2021191179

Write-up: Hyperpyrexia (body temperature from 40.5 to 42 degrees Celsius); This is a spontaneous report downloaded from the Regulatory Authority-WEB, Authority number: NL-LRB-00443764. A contactable consumer reported that an 83 years old male patient received the first dose of BNT162B2 (COMIRNATY) at single dose, on 05Feb2021, for COVID-19 immunisation. Relevant medical history was unknown. Concomitant medications included non-specified blood thinner. On 07Feb2021, the patient experienced hyperpyrexia (body temperature from 40.5 to 42 degrees Celsius). The patient died on an unspecified date, in Feb2021.Clinical outcome of the event was fatal. It was unknown if autopsy was done. Case Summary and Reporter''s Comments: BioNTech / Pfizer vaccine (COMIRNATY). Past drug therapy BioNTech / Pfizer vaccine (COMIRNATY): no Previous COVID-19 infection: No Diagnostic procedures: No No follow-up attempts are possible, information about lot number cannot be obtained.; Reporter''s Comments: BioNTech / Pfizer vaccine (COMIRNATY). Past drug therapy BioNTech / Pfizer vaccine (COMIRNATY): no Previous COVID-19 infection: No Diagnostic procedures: No; Reported Cause(s) of Death: Hyperpyrexia (body temperature from 40.5 to 42 degrees Celsius)


VAERS ID: 1061850 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Malaise, Nausea, SARS-CoV-2 test positive
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   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: CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Seizure; Vascular dementia
Allergies:
Diagnostic Lab Data: Test Date: 20201021; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021191182

Write-up: Nausea; Malaise; This is a spontaneous report downloaded from the Medicines Agency regulatory authority-WEB [Lareb (LRB) number NL-LRB-00443788] from a contactable physician. An 84-year-old male patient received bnt162b2 (COMIRNATY) (lot# EM0477), via an unspecified route of administration, on 04Feb2021, at single dose, for COVID-19 immunisation. Medical history included vascular dementia from Sep2019, seizure from 12Jan2021, COVID-19 from 21Oct2020. Concomitant medication included citalopram (unknown manufacturer). The patient experienced nausea and malaise both on 04Feb2021 with fatal outcome in Feb2021 (within 8 days after vaccination). The patient underwent lab tests and procedures which included COVID-19 virus test: positive on 21Oct2020. 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: Malaise; nausea


VAERS ID: 1061851 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-07
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Apallic syndrome, Aphasia, Cerebrovascular accident, Dysphagia, Gaze palsy, Hemiparesis, Muscle twitching, Respiration abnormal, Seizure
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUTICASONE PROPRIONATE; BECLOMETASONE; PANTOPRAZOLE; CLOPIDOGREL; AMLODIPINE; HYDROCHLOORTHIAZIDE; COLECALCIFEROL; MACROGOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Coronary artery bypass graft; Dementia vascular; Ischemic heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021191264

Write-up: Seizure; Cerebrovascular accident; Twitching; Blowing breathing; Vegetative state; right hemiparesis; forced position of the eyes to the left; No more speech; No more swallowing function; This is a spontaneous report downloaded from the regulatory authority [number NL-LRB-00444787] from a contactable physician. A 91-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, on 28Jan2021, at single dose, for COVID-19 immunisation. Medical history included myocardial ischaemia, vascular dementia, coronary artery bypass. Patient did not have previous COVID-19 infection. Concomitant medications included fluticasone propionate (unknown manufacturer), beclometasone (unknown manufacturer), pantoprazole (unknown manufacturer), clopidogrel (unknown manufacturer), amlodipine (unknown manufacturer), hydrochloorthiazide (unknown manufacturer), colecalciferol (unknown manufacturer), macrogol (unknown manufacturer). The patient experienced seizure, cerebrovascular accident, twitching, blowing breathing, vegetative state, right hemiparesis, forced position of the eyes to the left, no more speech, no more swallowing function all on 07Feb2021 with fatal outcome the same day. It was not reported if an autopsy was performed. Case summary and Reporter Comment: Cerebrovascular accident (CVA) after which seizure occurs. Woman suddenly had a seizure with twitching and blowing breathing, after which she was in a vegetative state with right hemiparesis, forced position of the eyes to the left and no more speech or swallowing function; all this very probably after a CVA, ischemic or bloody. Confounding factors: extensive cardiac ischemia wv, coronary artery bypass graft (CABG), dementia vascular; highly stressed cardiovascular risk profile. Previous COVID-19 infection: no. Diagnostic procedures: no. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: Cerebrovascular accident (CVA) after which seizure occurs. Woman suddenly had a seizure with twitching and blowing breathing, after which she was in a vegetative state with right hemiparesis, forced position of the eyes to the left and no more speech or swallowing function; all this very probably after a CVA, ischemic or bloody. Confounding factors: extensive cardiac ischemia wv, coronary artery bypass graft (CABG), dementia vascular; highly stressed cardiovascular risk profile.; Reported Cause(s) of Death: Twitching; Blowing breathing; Vegetative state; right hemiparesis; forced position of the eyes to the left; No more speech; No more swallowing function; Seizure; Cerebrovascular accident


VAERS ID: 1061852 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-01
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Respiratory disorder, SARS-CoV-2 test
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-02
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210131; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021191346

Write-up: Diagnised by pathologist with COVID-19 but negative test; Respiratory dysfunction; This is a spontaneous report downloaded from the Regulatory Authority-WEB [Lareb (LRB) number NL-LRB-00445009] from a contactable consumer (patient''s daughter or son). An elderly male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration, on 28Jan2021, at single dose, for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient was diagnosed by a pathologist with COVID-19 in Jan2021 but test was negative on 31Jan2021, and experienced respiratory dysfunction in Jan2021. After events onset the patient underwent lab tests and procedures which included COVID-19 virus test: negative on 31Jan2021. The patient died on 02Feb2021. An autopsy was performed and results were not available. Case summary and Reporter comment: My father was vaccinated on 28Jan2021. Sadly died on 02Feb2021 from the effects of the vaccine, he was chronically short of oxygen and his lungs stopped functioning. I have come into conflict with the pathologist who diagnosed COVID-19. What the pathologist didn''t know was that my father had been tested for COVID-19 after the symptoms started. COVID-19 negative test result was on 31Jan2021. The pathologist, after initial doubts, stayed with his diagnosis of COVID-19 and said it was not contagious (unbelievable), I myself warned the nursing home to take measures, but that was according to not need the pathologist. The pathologist himself reported to the nursing home that the investigation was still ongoing (various signals, miscommunication). No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reporter''s Comments: My father was vaccinated on 28Jan2021. Sadly died on 02Feb2021 from the effects of the vaccine, he was chronically short of oxygen and his lungs stopped functioning. I have come into conflict with the pathologist who diagnosed COVID-19. What the pathologist didn''t know was that my father had been tested for COVID-19 after the symptoms started.; Reported Cause(s) of Death: Respiratory dysfunction; Diagnised by pathologist with COVID-19 but negative test


VAERS ID: 1061853 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   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: IMODIUM; IPRAMOL; ITRACONAZOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autism; Mental disability
Allergies:
Diagnostic Lab Data: Test Name: CT-scan; Result Unstructured Data: Test Result:showed a major ischemic stroke; Test Date: 20210201; Test Name: COVID-19 test; Test Result: Negative
CDC Split Type: NLPFIZER INC2021191170

Write-up: Received 1st vaccination on 04Feb. Found on 07Feb morning with ischemic cardiovascular accidennt, died of it; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [NL-LRB-00445065 ]. A 65-years-old male patient received the first dose of bnt162b2 (COMIRNATY; Lot # EM0477) vaccine , via an unspecified route of administration on 04Feb2021 at single dose for covid-19 immunisation . Medical history included autism spectrum disorder, mental disability. Concomitant medication included loperamide hydrochloride (IMODIUM), ipratropium bromide, salbutamol sulfate (IPRAMOL), itraconazol (ITRACONAZOL). The patient received 1st vaccination on 04Feb2020. found on 07Feb2020 morning with ischemic cardiovascular accidennt, on 07Feb2021. The patient underwent lab tests and procedures which included computerised tomogram: showed a major ischemic stroke, sars-cov-2 test: negative on 01Feb2021. The patient died on 08Feb2021 because of the event. It was not reported if an autopsy was performed. Course of the event Hemiparesis on the left with among other things compulsive head. Large ischemic CVA on CT on the right. Unable to eat and died in hospital on 08Feb2021. Patient was severely mentally disabled with autism. One month before, Covid had prevailed in his group home, the patient himself was not infected. He had a fever on the evening of 01Feb2021, was then tested for Covid, was negative. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: large ischemic stroke


VAERS ID: 1061855 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial sepsis, Body temperature, C-reactive protein, Chest X-ray, Echocardiogram, Heart rate, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Respiratory rate, SARS-CoV-2 test, Tachycardia, Unresponsive to stimuli, Urinary tract infection, Urine analysis
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bedridden; Brain infarction; Brain stem bleeding; Frailty (Clinical Frailty Scale (CFS): 7); Multimorbidity; Speech loss; Swallowing difficult; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210203; Test Name: Body temperature; Result Unstructured Data: Test Result:38.6 Centigrade; Test Date: 20210203; Test Name: Chest X-ray; Result Unstructured Data: Test Result:Without obvious pathology; Test Date: 20210203; Test Name: C-reactive protein; Result Unstructured Data: Test Result:21 mg/l; Test Date: 20210208; Test Name: C-reactive protein; Result Unstructured Data: Test Result:123 mg/l; Test Date: 20210203; Test Name: Cardiac ultrasound; Result Unstructured Data: Test Result:Severe valve pathology; Comments: not available for intervention and very dilated left atrium; Test Date: 20210203; Test Name: Heart rate; Result Unstructured Data: Test Result:Increased; Test Date: 202001; Test Name: Oxygen saturation; Test Result: 92 %; Test Date: 20210203; Test Name: Oxygen saturation; Test Result: 80 %; Test Date: 20210203; Test Name: Respiratory rate; Result Unstructured Data: Test Result:Increased; Test Date: 20210203; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210203; Test Name: Urine analysis; Result Unstructured Data: Test Result:UTI
CDC Split Type: NOPFIZER INC2021191034

Write-up: Oxygen saturation decreased; Unresponsive to stimuli; Fever 38.6 C; Tachycardia; Bacterial sepsis; UTI; This is a spontaneous report downloaded from the Medicines Agency (MA) regulatory authority -WEB [Regulatory Authority number NO-NOMAADVRE-FHI-2021-U7mgw] from a contactable physician. Other case identifier NO-NOMAADVRE-E2B_00015407. An 80-year-old male patient received the 2nd dose of bnt162b2 (COMIRNATY) (lot# EM0477), intramuscular, on 02Feb2021 at 11:30, for COVID-19 immunisation. Medical history included atrial fibrillation, frailty (Clinical Frailty Scale (CFS): 7), swallowing difficult, wheelchair user, speech loss from 2017, brain stem bleeding in 2010, brain infarction in 2017, multimorbidity, bedridden. Concomitant medication included apixaban (ELIQUIS) for atrial fibrillation. Previously the patient received the 1st dose of bnt162b2 (COMIRNATY) for COVID-19 immunisation with no adverse effect. The patient experienced oxygen saturation decreased, unresponsive to stimuli, fever 38.6 C, tachycardia, bacterial sepsis on 03Feb2021 all with fatal outcome on 11Feb2021. Also the patient experienced urinary tract infection (UTI) on 03Feb2021 with outcome of unknown. It was unknown if an autopsy was performed. The patient underwent lab tests and procedures which included body temperature: 38.6 C on 03Feb2021, heart rate: increased on 03Feb2021, respiratory rate: increased on 03Feb2021, oxygen saturation: 80% on 03Feb2021, 92% in Jan2020, urine analysis: urinary tract infection (UTI) on 03Feb2021, chest x-ray: without obvious pathology on 03Feb2021, COVID-19 virus test: negative on 03Feb2021, cardiac ultrasound: severe valve pathology, not available for intervention and very dilated left atrium on 03Feb2021, c-reactive protein: 21 on 03Feb2021, 123 on 08Feb2021. Regulatory Authority comment: The report concerns an 80-year-old patient who died just over a week after the second dose of the Covid-19 vaccine Comirnaty. The patient was generally frail. More and additional information about the patient''s condition is registered in anonymous form in the adverse reaction database. The patient''s course of illness and death were compatible with bacterial sepsis, which the reporter states as a probable cause. On the basis of the information in the report, only the reporter''s causality assessment is registered. Reporter has stated that there was no suspicion of a connection with vaccination, and therefore a causal connection with vaccination was considered unlikely. Since the patient died, the report was classified as serious. Event assessment: Reporter/Comirnaty/ Oxygen saturation decreased, Unresponsive to stimuli, fever, tachycardia, sepsis: unlikely. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Tachycardia; Fever 38.6 C; Unresponsive to stimuli; Oxygen saturation decreased; Bacterial sepsis


VAERS ID: 1061858 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-02-09
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac valve disease; Cardiovascular disorder; Heart failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021191021

Write-up: DEATH; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Umng1 and NO-NOMAADVRE-E2B_00015344. A 92-year-old female patient received first dose of BNT162B2 (COMIRNATY), intramuscular on 05Feb2021 at single dose for COVID-19 immunization. Medical history included cardiovascular disorder, heart failure and cardiac valve disease, all from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient''s death occurred on 09Feb2021, unknown cause of death. It was not reported if an autopsy was performed. Reporter''s comment: 12Feb2021 RELIS: Additional information requested by telephone. Updated following data fields: Product. As the reporter originally had written that she was unsure whether the patient had received MODERNA or COMIRNATY, the reporter was contacted. At that time the reporter stated that the patient was given COMIRNATY, but due to technical issues she did not manage to initially register this vaccine up on submission of the report. Batch no was unknown. Sender''s Comments (TRANSLATION): The report concerns a patient in her 90s, who was found dead in bed in the morning, four days after the first dose of the Covid-19 vaccine COMIRNATY. The patient had been in a habitual state the night before. The patient had heart failure, heart valve disease and vascular disease. Normally, between 300 and 400 people die per week in nursing homes and similar institutions in Norway. In a Norwegian study of patients on long-term stays, a high degree of comorbidity, severe dementia and the need for assistance in daily activities, as well as lower BMI were among the factors associated with higher mortality. International, retrospective studies have similar findings and show, among other things, that the risk of death is increased in the first four months after admission to nursing home, and that patients who have recently been hospitalized have a particularly increased risk. Other diseases or factors that increase the risk of death, regardless of dementia or level of function, are cancer, cardiovascular disease (including heart failure and arrhythmia), kidney failure, chronic lung disease and weight loss. In general, the cause of death in nursing home patients is often multifactorial and difficult to establish with certainty. The cause of death is usually considered to be a chronic, underlying disease, which ultimately leads to a sequence of fatal complications. In a recently published cohort study that analyzed the causes of death in nursing home patients on long-term stays, cardio- and cerebrovascular diseases were accounted for 1 in 4 registered deaths. Other common causes of death in the population were neurodegenerative disease (including dementia) (about 20%), respiratory and infectious diseases (including pneumonia and sepsis) (about 15%), and cancer (about 10%). When vaccinating vulnerable / frail, multi-diseased elderly patients, some serious events, including death, may occur shortly after vaccination. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or something else accidental, at the same time a 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. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. No follow-up attempts possible, batch/lot number cannot be obtained. No further information expected.; Reporter''s Comments: 12Feb2021 RELIS: Additional information requested by telephone. Updated following data fields: Product. As the reporter originally had written that she was unsure whether the patient had received Moderna or Comirnaty, the reporter was contacted. At that time the reporter stated that the patient was given Comirnaty, but due to technical issues she did not manage to initially register this vaccine up on submission of the report. Batch no was unknown.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1061859 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-12
Onset:2021-01-20
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, C-reactive protein, Death, Heart rate, N-terminal prohormone brain natriuretic peptide, Oedema peripheral, Oxygen saturation, Physical examination
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-01
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FURIX [FUROSEMIDE]; PARACET [PARACETAMOL]; QUETIAPIN AMNEAL; NORSPAN [BUPRENORPHINE]; BISOPROLOL SANDOZ
Current Illness: Dementia; Essential hypertension; Living in nursing home; Multimorbidity; Osteoporosis; Wheelchair user
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210120; Test Name: Blood pressure; Result Unstructured Data: Test Result:100/71; Test Date: 20210127; Test Name: Blood pressure; Result Unstructured Data: Test Result:106/75; Test Date: 20210201; Test Name: C-reactive protein; Result Unstructured Data: Test Result:160; Test Date: 20210120; Test Name: Pulse rate; Result Unstructured Data: Test Result:103; Test Date: 20210127; Test Name: Pulse rate; Result Unstructured Data: Test Result:107; Test Date: 202003; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1617; Test Date: 20210120; Test Name: Oxygen saturation; Test Result: 94 %; Test Date: 20210120; Test Name: Physical examination; Result Unstructured Data: Test Result: edematous area; Comments: Examined by doctor due to reported edema around left arm. There was an edematous area around the left elbow 5cm x 5cm. The patient sits very crooked in her wheelchair, and her elbow hangs low.; Test Date: 20210127; Test Name: Physical examination; Result Unstructured Data: Test Result: No changes; Comments: No changes in the patient''s general condition, no increased in wheezing or edema.
CDC Split Type: NOPFIZER INC2021191020

Write-up: DEATH; edematous area around the left elbow 5cm x 5cm.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB [NO-NOMAADVRE-FHI-2021-Uqper]. Other case identifier number: NO-NOMAADVRE-E2B_00015189. A 80-years-old female patient received the first dose of bnt162b2 (COMIRNATY; Lot EJ6795) , intramuscular on 12Jan2021 at single dose for covid-19 immunisation. Medical history included living in residential institution, ongoing multimorbidity, ongoing osteoporosis, ongoing wheelchair user, ongoing dementia, ongoing essential hypertension. Concomitant medication included furosemide (FURIX [FUROSEMIDE]), paracetamol (PARACET [PARACETAMOL]), quetiapine fumarate (QUETIAPIN AMNEAL), buprenorphine (NORSPAN [BUPRENORPHINE]), bisoprolol fumarate (BISOPROLOL SANDOZ). On 20Jan2021, the patient showed an edematous area around the left elbow 5cm x 5cm. with outcome of unknown. The patient died on 01Feb2021 of unknown cause. The patient underwent lab tests and procedures which included blood pressure measurement: 100/71 on 20Jan2021, blood pressure measurement: 106/75 on 27Jan2021, c-reactive protein: 160 on 01Feb2021, heart rate: 103 on 20Jan2021, heart rate: 107 on 27Jan2021, n-terminal prohormone brain natriuretic peptide: 16:17 on Mar2020, oxygen saturation: 94 % on 20Jan2021, physical examination: edematous area on 20Jan2021. It was not reported if an autopsy was performed. Reporter''s comment: Multimorbid long-term resident at a nursing home with dementia, essential hypertension and unspecified osteoporosis. proBNP from March 2020: 1617. In June and July 2020, the patient was assessed by the previous nursing home doctor as being a preterminal. However, the patient returned to habitual. Likewise, the staff asked if the patient was terminal in November 2020, but the patient was not in terminal phase. 12Jan2021: The patient received Covid-19 vaccine. No side effects were reported after vaccination. After the vaccine, she was in a habitual state, until her death. Ate and drank as usual. Been up in a wheelchair and awake. 20Jan2021: supervision by doctor due to reported edema around left arm. There was an edematous area around the left elbow 5cm x 5cm. The patient sits very crooked in her wheelchair, and her elbow hangs low. Otherwise no edema. vitalia: BT: 100 / 71mmHg p: 103 O2: 94%. A review of the patient''s medicines done: Furix 20mg was discontinued due to little / no edema. No symptoms of stasis. Low fluid intake. Likewise, bisoprolol 1.25 mg was discontinued. Quetiapine 25mg was also discontinued due to no anxiety or restlessness. 27Jan2021: Physical examination: After the above medication changes; no changes in the patient''s general condition, no increased in wheezing or edema. Vitalia unchanged. Blood pressure: 106/75, pulse rate: 107. 01Feb2021: The patient died. Journal note 01Feb2021: Supervision by nurse in the morning due to distended and tender when palpated abdomen. She was a little pale but otherwise dry and warm skin. Appears as in habitual state, but constipation was suspects due clinical examination and no documented stool since 25Jan2021. Nurse is contacted again at about 11:30 due to deterioration of patient''s status. Unable to measure BT as the patient is very tense throughout the body. Difficult to speak, breathing superficially. CRP is measured at 160. In a few minutes her condition worsened and she is no longer contactable or respond to pain stimuli. Even more superficial respiration. The patient is suspect to be in terminal state. Then the patient had Cheyne-Stokes respiration. Morphine was not given as the patient appears peaceful and very short remaining life is suspect. The patient dies 11:55. No signs of external trauma. Do not suspect a clear link between vaccine and death. Reports for good measure. Sender''s Comments (TRANSLATION): When vaccinating patients with frailty who are ill with many underlying diseases, some serious events, including death, may occur shortly after vaccination without any connection to vaccination. However, it cannot be ruled out that the vaccine has contributed to the worsening of the patient''s underlying disease. In each case, it is difficult to know whether the death is due to the vaccine, the patient''s underlying disease or another, random, simultaneous cause that has nothing to do with the vaccination in question. The reporter has stated that there is no suspected clear connection between the vaccine and the death, and that it is reported for good measure. On the basis of the information in the report, it is difficult to assess this in more detail, and we therefore register in this case a causal connection with vaccination as uncertain. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established.; Reported Cause(s) of Death: DEATH.


VAERS ID: 1061860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness
SMQs:

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: Atrial fibrillation; Falling down (Tendency of falling down); Hypertension; Living in care (Multimorbid patient, living home with visits from community care 3 times daily, help from relatives)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NOPFIZER INC2021191028

Write-up: Flu symptoms from the morning off. Found dead by relatives on the evening of 11Feb2021; This is a spontaneous report from a contactable physician via The Medicines Agency (NOMA) downloaded from the Regulatory Authority-WEB NO-NOMAADVRE-FHI-2021-Uzpj9, NO-NOMAADVRE-E2B_00015511. A 94-years-old male patient received the second dose of bnt162b2 (COMIRNATY Batch/lot no: EJ6789), intramuscular on 09Feb2021 at single dose for covid-19 immunisation. Medical history included fall (Tendency of falling down), hypertension, living in residential institution (Multimorbid patient, living at home with visits from community care three times daily and help from relatives) and atrial fibrillation. The patient''s concomitant medications were not reported. The patient experienced Influenza-like symptoms from the morning on 11Feb2021 and found dead by relatives on the evening of 11Feb2021. The patient died on 11Feb2021. It was not reported if an autopsy was performed. This was a multimorbid patient still living at home, and the reporter states that is uncertain whether the death was directly caused by the vaccine. The cause of death was reported as unknown anyway the event of influenza like syndrome was reported as fatal. Health Authority Comment: Symptoms such as fever, headache and general malaise (flu-like symptoms) occur in the first days after vaccination with all vaccines. A large proportion of those who were vaccinated reported fatigue, joint and muscle pain, and a small proportion developed fever and chills after Comirnaty. Fever and malaise occurred more often after the second dose. Due to time correlation, the reported flu-like symptoms could represent a reaction to the vaccine. Whether these are the causes of the death is temporarily unclear. When vaccinating marginal patients with underlying diseases and risk factors for disease, some serious events, including acute illness and / or death, may occur relatively soon after vaccination, without necessarily being related to vaccination. On the basis of the information in the report and in accordance with international criteria, the causal link with vaccination is assessed as possible. A possible causal relationship is defined as a reaction, including pathological laboratory tests, which occurs in a temporal relation to the use of a drug, but which may also be due to an underlying disease, other drugs or chemicals. Since the patient died, the report is classified as serious, even though no causal link between the vaccine and the death has been established. Additional information: J07BX - Other virus vaccines No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death; Influenza-like symptoms


VAERS ID: 1061868 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-02-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER0641 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chest pain, Dyspnoea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-11
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021190657

Write-up: Fainting; Weakness; Dyspnoea; Chest pain; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (Regulatory authority number PL-URPL-3-200-2021). A 59 years old patient of unspecified gender received BNT162B2 (COMIRNATY; lot ER0641) on 10Feb2021 at 14:00 (at the age of 59 years old), at single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 10Feb2021 in the afternoon and on the next day the patient experienced of breath, chest pain, weakness. On 11Feb2021 he fainted in the evening hours, an ambulance was called. These events were reported with a fatal outcome. The patient died on 11Feb2021 at 19:15. It was unknown if an autopsy was done. Sender Comment: Weakness (fatigue) is an expected side effect following the administration of Comirnaty. Dyspnoea, chest pain, and feeling faint are unexpected symptoms. URPL has no information on any additional circumstances (medications used, chronic diseases) that could result in the occurrence of the described side effects. Up to 16Feb2021, the EVDAS database recorded 230 deaths, 981 dyspnoea cases, 348 chest pain cases. The temporal relationship speaks for a cause-and-effect relationship. The person reporting NOP qualified it as severe. URPL assessed the undesirable post-vaccination reaction as severe due to the assessment of the reporting person and the health result-death. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: chest pain; fainting; weakness; dysponea


VAERS ID: 1062304 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042698 / 1 - / OT

Administered by: Unknown       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: No adverse event (No adverse event history.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLMODERNATX, INC.MOD20210

Write-up: Pyrexia; A regulatory authority report was received from a health care professional concerning a 90 years old female patient who received Moderna''s COVID-19 vaccine (mRNA-1273) and experienced pyrexia. The patient''s medical history was not provided. No relevant concomitant medications were reported. On 02 Feb 2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch/Lot number: 300042698) for prophylaxis of COVID-19 infection. On 05 Feb 2021, pyrexia has started, which was confirmed by conducting pyrexia lab test with test result as: 38 tot 40.5 degrees Celsius. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, pyrexia, was fatal.; Reporter''s Comments: Very limited information regarding the fatal event of pyrexia in this elderly patient has been provided at this time. Based on the limited information available, it is difficult to assess a cause and effect relationship.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1064458 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-20
Onset:2021-01-29
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, Pulmonary infarction, SARS-CoV-2 test
SMQs:, Embolic and thrombotic events, 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: 2021-01-29
   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: SUPRASORB A + AG; ULTRASICC; QUETIALAN; OLEOVIT D3; PREGABALIN; ALNA; DELPRAL; FINASTERID; MIRTAZEP; NOVALGIN [METAMIZOLE SODIUM]; PANTOLOC [PANTOPRAZOLE]; SEROQUEL; VENLAFAXIN
Current Illness: Acathisia (Akathisia); Chronic renal failure (acute to chronic kidney failure); Marasmus (Marasmus senilis); Prostatic hyperplasia; Steatosis hepatic (Hepatis steatosis)
Preexisting Conditions: Medical History/Concurrent Conditions: Acute renal failure (acute to chronic kidney failure); Bacterial pneumonia, unspecified; Bullous pemphigoid (bullous pemphigoid soles and abdomen); Chorea (chronic choral movement disorder); Intervertebral disc prolapse (Disc prolapse L4/5); Tetraparesis (Tetraspastic)
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: ATPFIZER INC2021190439

Write-up: Bronchopneumonia; Infarct pulmonary; This is a spontaneous report from a contactable other healthcare professional downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-03375. An 89-years-old male patient receive bnt162b2 (COMIRNATY, Lot#EL1491), via an unspecified route of administration on 20Jan2021 16:45 at SINGLE DOSE for covid-19 immunisation. Medical history included ongoing Prostatic hyperplasia, Bacterial pneumonia, unspecified from Oct2020 to an unknown date (no ongoing), intervertebral disc protrusion from an unknown date and unknown if ongoing (Disc prolapse L4/5), ongoing Steatosis hepatic (Hepatis steatosis), ongoing Chronic renal failure (acute to chronic kidney failure), chorea from an unknown date and unknown if ongoing (chronic choral movement disorder), Tetraparesis from an unknown date and unknown if ongoing (Tetraspastic), ongoing Acathisia (Akathisia), Acute renal failure from Oct2020 to an unknown date no ongoing (acute to chronic kidney failure), Bullous pemphigoid from Mar2019 to an unknown date, not ongoing (bullous pemphigoid soles and abdomen), ongoing marasmus (marasmus senilis). Concomitant medication included calcium alginate, silver (SUPRASORB A + AG) from 26Jan2021, paraffin/liquid/white soft paraffin (ULTRASICC) since 23Sep2019, quetiapine fumarate (QUETIALAN) since 26Jan2021, colecalciferol (OLEOVIT D3) since 15Oct2018, pregabalin (PREGABALIN) since 26Sep2020, tamsulosin hydrochloride (ALNA) since 08Apr2019, tiapride hydrochloride (DELPRAL), finasteride (FINASTERID) since 15Oct2018, mirtazapine (MIRTAZEP) since 27Nov2020, metamizole sodium (NOVALGIN [METAMIZOLE SODIUM]) since 15Jan2021, pantoprazole (PANTOLOC [PANTOPRAZOLE]) since 12Aug2019, quetiapine fumarate (SEROQUEL) since 15Jan2021, venlafaxine hydrochloride (VENLAFAXIN) since 26Sep2020. On 29Jan2021 04:00 the patient experienced Infarct pulmonary and Bronchopneumonia. The patient died on 29Jan2021 from Bronchopneumonia, Infarct pulmonary. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative on 29Jan2021. The patient died on 29Jan2021. An autopsy was performed and results were not provided. The autopsy determined cause of death was reported to be: "English summary (full translation available upon request)". The patient did not show any symptoms shortly after the vaccination. No signs of infection at the time point of vaccination. Sender Comment: Confounding factors: missing info. The available information was considered inadequate to fully assess the case. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. The topic will be monitored closely. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Bronchopneumonia and infarct pneumonia in the right lower and upper lobes; Bronchopneumonia and infarct pneumonia in the right lower and upper lobes


VAERS ID: 1064459 (history)  
Form: Version 2.0  
Age: 98.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-29
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL 1491 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Emphysema, Pneumonia, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: 2021-01-29
   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: FENTANYL; INHIXA; OLEOVIT D3; VENDAL [MORPHINE SULFATE]; BIATAIN; PRONTOSAN [POLIHEXANIDE]; QUETIALAN
Current Illness: Arterial hypertension; Arteriosclerotic cardiovascular disease (Sclerosis of the basal cerebral arteries); Atrial fibrillation; Cardiac dilatation (Right heart dilation); Decubitus (Gluteal decubitus); Dementia; Depression; Heart insufficiency; Hypercholesteraemia; Immobile (Immobility (bedridden for months)); Incontinence urinary; Knee prosthesis user; Marasmus (Marasmus senilis); Osteoporosis; Renal cyst; Renal insufficiency (Renal insufficiency IIIb); Steatosis hepatic; Thyroid adenoma (regressive follicle. Adenoma in the right lower lobe of the thyroid); Umbilical hernia
Preexisting Conditions: Medical History/Concurrent Conditions: Atrioventricular block first degree (1st degree AV block); Femur fracture (status post pertrochanteric OSCH fracture left op 1/17)
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: COVID-19 rapid test; Test Result: Negative
CDC Split Type: ATPFIZER INC2021190656

Write-up: Bronchopneumonia in the context of chronic bullous pulmonary emphysema and cor scleroticum decompensatum; Bronchopneumonia in the context of chronic bullous pulmonary emphysema and cor scleroticum decompensatum; Bronchopneumonia in the context of chronic bullous pulmonary emphysema and cor scleroticum decompensatum; This is a spontaneous report from other healthcare professional downloaded from the regulatory authority AT-BASGAGES-2021-03383 and received via Regulatory Authority. A 98-year-old female patient received BNT162B2 (COMIRNATY, batch/lot number: EL 1491) first dose on 19Jan2021 15:45 at single dose for COVID-19 immunization. The patient''s medical history and concurrent conditions included: Dementia (continuing), Depression (continuing), Knee prosthesis user (continuing), Umbilical hernia (continuing), Heart insufficiency (continuing), Arterial hypertension (continuing), Immobile (continuing, Immobility (bedridden for months)), Incontinence urinary (continuing), Renal insufficiency (from Oct2013 and continuing), Osteoporosis (continuing), Femur fracture from Jan2017 and not ongoing (status post pertrochanteric OSCH fracture left op 1/17), Atrial fibrillation (continuing), Marasmus (continuing, Marasmus senilis), Decubitus (continuing, Gluteal decubitus), Thyroid adenoma (continuing, regressive follicle. Adenoma in the right lower lobe of the thyroid), Arteriosclerotic cardiovascular disease (continuing, Sclerosis of the basal cerebral arteries), Steatosis hepatic (continuing), Renal cyst (continuing), Cardiac dilatation (continuing, Right heart dilation), Atrioventricular block first degree (1st degree AV block) from unspecified date and unknown if ongoing, Hypercholesteraemia (continuing). Concomitant medicaitons included Fentanyl Gen 25 ?g patch from 29Dec2020, enoxaparin sodium (INHIXA), colecalciferol (OLEOVIT D3) drops, morphine sulfate (VENDAL AMP) on 29Jan2021 because of pain, shortness of breath, restlessness, fear, polyurethane (BIATAIN) silicone plaster since 21Jan2021, Biaitain Alginate Gel local since 21Jan2021, polihexanide (PRONTOSAN) solution, locally since 06Nov2020, Tegaderm Roll plaster since 26Nov2020, quetiapine fumarate (QUETIALAN) Ftbl 28since Dec2020. The patient died on 29Jan2021 16:00 from Bronchopneumonia, Bullous emphysema, Decompensated heart failure. The autopsy determined cause of death was reported to be: ronchopneumonia, Bullous emphysema, Decompensated heart failure. The Covid rapid test was negative on 29Jan2021. Autopsy findings from 03Feb2021: Since the connection between death and vaccination cannot be safely ruled out -$g autopsy. The autopsy died with bronchopneumonia in the context of chron. bullous emphysema and cor scleroticum decompensatum. A connection to the recent COVID-19 vaccination cannot be made with the means of an anatomical section, as immunological. Processes in the field of physiological or biochem. Structural levels cannot be captured by it. Thus, no evidence of any accelerations of underlying diseases resulting in death by this method is possible. No evidence of a communicable infectious disease - negative COVID-19 test before autopsy. Agency follow-up from 17Feb2021: No causal connection with the Comirnaty vaccination suspected, No symptoms occurred when (date, possibly time) after the vaccination, there were no signs of infection at the time of vaccination - apart from the underlying diseases, Sender Comment: Confounding factors: missing info The available information was considered inadequate to fully assess the case. The information provided in this individual case does not warrant a change in the product information or other measures. The case will be closed at this time. The topic will be monitored closely. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Bronchopneumonia in the context of chronic bullous pulmonary emphysema and cor scleroticum decompensatum; Bronchopneumonia in the context of chronic bullous pulmonary emphysema and cor scleroticum decompensatum; Bronchopneumonia in the context of chr


VAERS ID: 1064472 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Dyspnoea, General physical health deterioration, Oxygen saturation decreased, Pyrexia, Respiratory disorder
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PERINDOPRIL; XARELTO; AMLODIPIN [AMLODIPINE BESILATE]; ESCITALOPRAM; FOLIC ACID; D-VITAL CALCIUM; PANTOPRAZOLE; ATORVASTATIN; CITALOPRAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Coronavirus infection; CVA; Degenerative aortic valve disease; Frailty (frailty 7: Completely dependent for personal care regardless of the cause (physical or cognitive)); Hypercholesterolemia; Liver metastases; Living in nursing home (living in Inpatient care center); Nephrectomy (before 2004); Osteoarthritis; Pacemaker insertion (cardiac)
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:decreased; Test Name: body temperature; Result Unstructured Data: Test Result:fever Centigrade; Test Date: 20210205; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210205; Test Name: oxygen saturation low; Result Unstructured Data: Test Result:58
CDC Split Type: BEPFIZER INC2021192192

Write-up: Problem with the breathing; oxygen saturation decreased/saturation remained okay /saturation 58; very short of breath; Fever 38 centigrade; her condition deteriorated sharply during the day after vaccination; This is a spontaneous report from a contactable other healthcare professional downloaded from the Medicines Agency (MA) regulatory authority-WEB BE-FAMHP-DHH-N2021-77547, received from Regulatory Authority. An 84-year-old female patient received bnt162b2 (COMIRNATY, Batch/lot number: EM0477) at single dose, the 1st dose on an unknown date and the 2nd dose on 04Feb2021 for covid-19 immunisation. Medical history included coronavirus infection from Nov2020 to an unknown date, nephrectomy before 2004, poly osteoarthritis, arterial hypertension, hypercholesterolaemia, cardiac pacemaker insertion due to recurrent syncopes in 2004, ischemic stroke (CVA) in 2017 to an unknown date, degenerative valve disease, metastases to liver, living in Inpatient care center, frailty 7: Completely dependent for personal care regardless of the cause (physical or cognitive). Concomitant medication included perindopril (manufacturer unknown) 1 DF, 1x/day, rivaroxaban (XARELTO) 15 mg, 1x/day, amlodipine besilate (AMLODIPIN) 1 DF, 1x/day, escitalopram (manufacturer unknown) 1 DF, 1x/day, folic acid (manufacturer unknown), ascorbic acid, calcium carbonate, colecalciferol, ergocalciferol (D-VITAL CALCIUM), pantoprazole (PANTOPRAZOL) 1 DF, 1x/day, atorvastatin (manufacturer unknown) 1 DF, 1x/day, citalopram (manufacturer unknown). On an unknown date the 1st dose of bnt162b2, the patient experienced problem with the breathing, oxygen saturation decreased/saturation remained okay, very short of breath, fever, her condition deteriorated after vaccination and the symptoms were over after 48 hours. Her health status was certainly good at the time of the second vaccine administration. On 05Feb2021 the 2nd dose of bnt162b2, the patient experienced violent reaction to vaccine with the same events occurred with the 2st dose: problem with the breathing, saturation 58, very short of breath, fever 38 centigrade, her condition deteriorated sharply during the day after vaccination, but mor intense. She was treated: perdolan suppo against fever, oxygen therapy, temesta 1 mg, dafalgan, morphine 2 x 5 mg at 6:00 pm, morphine subcutaneous 20 mg at 7:15 pm, and 2 ampoules of buscopan. Morphine was administered because her condition deteriorated sharply during the day after vaccination to support breathing. The patient died on 05Feb2021, 26 hours after administration. The outcome of events was fatal. It was not reported if an autopsy was performed. Reporter''s comments: Treatment - Yes perdolan suppo against fever oxygen therapy temesta 1 mg dafalgan morphine 2 x 5 mg at 6:00 pm morphine subcutaneous 20 mg at 7:15 pm and 2 ampoules of buscopan Evolution of the ADR - Died. Situations - Other: Violent reaction to vaccine. ADR description - lady of 84 years, living in Inpatient care center, had Covid in November 2020 day. after second dose vaccination, saturation 58, very short of breath, 38 centigrade died 26 hours after administration also had the same symptoms after first dose vaccination but milder, was over after 48 hours. Frailty 7: Completely dependent for personal care regardless of the cause (physical or cognitive). Despite their care needs, they appear stable and there does not appear to be an increased risk of death (within 6 months). after the first vaccination, saturation remained okay, even though the lady had some fever. Her health status was certainly good at the time of the second vaccine administration. Morphine was administered because her condition deteriorated sharply during the day after vaccination to support breathing. Very low saturation. Died 26 hours after administration of the second dose. Batch/lot number: EM0477. Comirnaty, Reaction(s) / Event(s) Assessed: Fever. Relatedness of drug to reaction(s)/event(s). Source of assessment: FAMHP. Method of assessment: WHO. Result of Assessment: POSSIBLE. Comirnaty, Reaction(s) / Event(s) Assessed: Respiratory disorder, Oxygen saturation low, Shortness of breath, General physical health deterioration. Relatedness of drug to reaction(s)/event(s). Source of assessment: FAMHP. Method of assessment: WHO. Result of Assessment: unclassifiable. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Treatm perdolan vs fever O2 ther temesta 1mg dafalgan morph2x5mg morph sbc20mg+2ampoul buscopan.Violent react to vacc.Lady84yo,inpatient care cent,Covid Nov2020 aft 2vacc,sat58,short breath,38C,same milder sympt aft 1vacc,over aft 48hr.Frailty7:Compl dep for personal care regard of cause.Appear stable,not an increas death risk(within6mo).Aft 1vacc,satur ok, though had some fever.Health status good at 2vacc.Morphine as her cond deter sharp day aft vacc to supp breath.Low sat.Died26hrs aft 2dose; Reported Cause(s) of Death: Problem with the breathing; saturation 58; very short of breath; Fever 38 centigrade; her condition deteriorated sharply during the day after vaccination


VAERS ID: 1064473 (history)  
Form: Version 2.0  
Age: 99.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Auscultation, Body temperature normal, Depressed level of consciousness, Heart rate normal, Hypotension, Sedation, Unresponsive to stimuli
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   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: METHYLPREDNISOLONE; ASA EG; BISOPROLOL EG; RISPERIDON SANDOZ; L-THYROXINE [LEVOTHYROXINE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety aggravated (increased anxiety and agitation treated with Risperdal); Arterial hypertension; Choking (Short admission due to choking, probably without aspiration); Cognitive deterioration (cognitive decline (MMSE 12/30)); COVID-19 virus test negative; CVA (CVA with paresis left arm); Diaphragmatic hernia; Fall (Admission due to recurrent fall); Fall (Admission due to fall); Fever (Fever +deterioration general condition due to pyelitis,no hospitalisation, recovery under antibiotic); Frailty (frailty: dependent on care, wheelchair bound, score 8.); Gait disorder; Gastrooesophageal reflux; General physical health deterioration (Fever +deterioration general condition due to pyelitis,no hospitalisation, recovery under antibiotic); Hip prosthesis user (bilateral hip prosthesis); Home care (frailty: dependent on care, wheelchair bound, score 8.); Hypercholesterolaemia; Hypothyroidism; Increased agitation (increased anxiety and agitation treated with Risperdal); Knee prosthesis user (knee prosthesis right); Left arm paresis (CVA with paresis left arm, good recovery); Osteoarthritis knee (Osteoarthritis symptomatic mainly at the cervical spine, cervical vertebrae and left knee); Osteoarthritis of cervical spine (Osteoarthritis symptomatic mainly at the cervical spine, cervical vertebrae and left knee); Osteoarthritis of neck (Osteoarthritis symptomatic mainly at the cervical spine, cervical vertebrae and left knee); Pyelitis (Fever +deterioration general condition due to pyelitis,no hospitalisation, recovery under antibiotic); Urinary incontinence (Chronic); Wheelchair user (frailty: dependent on care, wheelchair bound, score 8.)
Allergies:
Diagnostic Lab Data: Test Date: 20210210; Test Name: Lungs; Result Unstructured Data: Test Result:some expir ronchi; Comments: Lugs auscultation; Test Date: 20210210; Test Name: body temperature; Result Unstructured Data: Test Result:no fever; Test Date: 20210210; Test Name: pulse; Result Unstructured Data: Test Result:90/min; Test Date: 20210210; Test Name: blood pressure; Result Unstructured Data: Test Result:60/40
CDC Split Type: BEPFIZER INC2021192195

Write-up: Blood pressure difficult to measure 60/40 Pulse: regular 90 / min; well drowsy; she showed a sudden drop in consciousness during the meal, slowly recovering without any symptoms of failure after she had been put to bed.; a bit restless; difficult to respond to questions; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB regulatory authority BE-FAMHP-DHH-N2021-77633. A 99-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY) at single dose on 09Feb2021 14:00 for covid-19 immunisation. Medical history included Sars-cov-2 test negative on 10Feb2021, arterial hypertension, hypercholesterolaemia, hypothyroidism, chronic urinary incontinence, gastro-oesophageal reflux / diaphragmatic hernia, venous insufficiency, osteoarthritis symptomatic mainly at the cervical spine, cervical vertebrae and left knee (bilateral hip prosthesis, knee prosthesis right). 2012: admission due to recurrent fall. Neurological and cardiac examination more reassuring. 2015: Admission due to fall / gait disorder and cognitive decline (MMSE 12/30). 2016: CVA with paresis left arm, good recovery. 2017: Short admission due to choking, probably without aspiration. 2018: Fever with very strong deterioration general condition due to pyelitis, no hospital admission, recovery under antibiotic. Patient has not had a covid infection in the past and has always tested negative, frailty: dependent on care, wheelchair bound, score 8 frailty: dependent on care, wheelchair bound, score 8, increased anxiety and agitation treated with Risperdal. . Concomitant medication included methylprednisolone (manufacturer unknown) 1 mg, daily, acetylsalicylic acid (ASA EG) 1 DF, daily, bisoprolol fumarate (BISOPROLOL EG 2.5mg) 1 DF, daily, risperidone (RISPERIDON SANDOZ 1mg) 0.25 DF, alternate day, l-thyroxine (L-THYROXINE 25ug) 1 DF, daily. The patient received the 1st dose of bnt162b2 (COMIRNATY) at single dose on an unknown date for covid-19 immunisation and she had no side effects. On 10Feb2021 the patient experienced blood pressure difficult to measure 60/40 pulse: regular 90/min, well drowsy, she showed a sudden drop in consciousness during the meal, slowly recovering without any symptoms of failure after she had been put to bed, a bit restless, difficult to respond to questions. The patient died on 12Feb2021. All events were considered fatal. An autopsy was not performed. Course of events: In recent months, her physical condition has been reasonably good and stable considering her age. There was, however, a noticeable deterioration on the cognitive level and due to increased anxiety and agitation, a low dose of Risperdal was started. Even after her second vaccination, she showed no immediate side effects. On 10Feb2021 there was a sudden drop in consciousness during the meal, slowly recuperating without loss of symptoms after she had been put to bed. In clinical examination after midday: conscious, drowsy, somewhat restless, inadequate and difficult to respond to questions. Blood pressure difficult to measure 60/40, Pulse: regular 90/min, Cor: nl, Lungs: some expir ronchi, No fever, No dropout or lateralization. Suspected of an episodic or permanent circulatory insufficiency of unclear cause. There was a negative advance directive and thus no hospital admission. She fell ill shortly afterwards. Reporter comments: frailty: dependent on care, wheelchair bound, score 8. Patient has not had a covid infection in the past and has always tested negative. In recent months, her physical condition has been reasonably good and stable considering her age. There was, however, a noticeable deterioration on the cognitive level and due to increased anxiety and agitation, a low dose of Risperdal was started. After the first vaccination she had no side effects. A possible association with the second vaccination due to the strong immune response is not excluded. Relatedness of drug to reaction(s)/event(s): Comirnaty to all events: reported as unclassifiable by FAMHP. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: frailty:on care,wheelch,score 8.No past covid inf.Rec,phys cond good,stable.A cogn lev deter due incr anx+agitat,Risperdal start.After 1vacc no AE.After her 2vacc no immed AE.10Feb2021:sudd consc drop,slow recup w/o symptoms loss after to bed.Clin ex:consc,drowsy,restless,inad+difficult to resp to quest.BP60/40 Pulse:regular90/min Cor:nl Lungs:some expir ronchi.No fever No dropout/lateraliz.Suspec epis/perm circul ins uncl cause.No hosp.Fell ill.Poss assoc w 2vacc due to strong imm resp no excl; Reported Cause(s) of Death: Blood pressure difficult to measure 60/40 Pulse: regular 90 / min; well drowsy; On 17/02 she showed a sudden drop in consciousness during the meal, slowly recovering without any symptoms of failure after she had been put to bed.; a bit restless; diff


VAERS ID: 1064474 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477/PAA15657 / UNK - / 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: 2021-01-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO; METOJECT; TOREM [TORASEMIDE]; SIFROL; CALCIMAGON D3; NITRODERM; NOVALGIN [METAMIZOLE SODIUM]; TARGIN; PANTOZOL [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; AMIODAR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholangiocarcinoma; Erosive osteoarthritis (erosive finger poly-arthrosis in the MPO-ANCA fingers of unclear significance); Fracture femur; Hypertensive heart disease; Peripheral obliterative arteriopathy; Plate osteosynthesis; Restless leg syndrome (Date of diagnosis not known); Venous insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021198792

Write-up: died due to cardiac arrest; This is a spontaneous report received from a contactable physician via regulatory authority with Regulatory authority report number CH-SM-2021-10701. A 94-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, lot number: EM0477/PAA156571), intramuscularly on 21Jan2021 at single dose for covid-19 immunisation. Medical history included distal femur fracture from 23Dec2020 and plate osteosynthesis from 02Jan2021; Peripheral obliterative arteriopathy stage I right from an unknown date, hypertensive heart disease from an unknown date, venous insufficiency from an unknown date; Cholangiocarcinoma from Jul2019, restless legs syndrome from an unknown date, erosive finger poly-arthrosis in the MPO-ANCA fingers of unclear significance due to age, comorbidities and poly-morbidity from an unknown date. Concomitant medication included rivaroxaban (XARELTO), methotrexate sodium (METOJECT), torasemide (TOREM), pramipexole dihydrochloride (SIFROL), calcium carbonate, colecalciferol (CALCIMAGON D3), glyceryl trinitrate (NITRODERM), metamizole sodium (NOVALGIN), naloxone hydrochloride, oxycodone hydrochloride (TARGIN), pantoprazole sodium sesquihydrate (PANTOZOL), amiodarone hydrochloride (AMIODAR). This concerns a 94 year old polymorbid female elderly home resident known for plate osteosynthesis on 02Jan2021 following distal femoral fracture on 23Dec2020, known for stage I peripheral obliterative arteriopathy on the right, venous insufficiency, hypertensive heart disease, cholangiocarcinoma (first diagnosed Jul2019), restless leg syndrome, and erosive finger poly-arthrosis in the MPO-ANCA fingers of unclear significance due to age, comorbidities and poly-morbidity. On 21Jan2021 the patient was administered Comirnaty vaccine and the following day, on 22Jan2021, the patient died. Further course unknown. The patient died due to cardiac arrest on 22Jan2021. An autopsy was not performed. The outcome of event cardiac arrest was fatal. Reporter''s comment: Death in a temporal correlation with the administration of Comirnaty. Sender''s comment: Death occurred 1 day after administration of COVID-19 vaccine Comirnaty, of a 94-year-old frail, polymorbid, poly-medicated elderly woman, compromised at the cardiac level by hypertensive heart disease and diagnosed with cholangiocarcinoma. In the immediate aftermath of vaccination, the patient did not manifest any adverse reactions. Specifically, she did not show any symptomatology referable to possible allergic reactions or anaphylaxis. In view of her already compromised state of health, the treating physician''s assessment of death due to cardiac arrest is likely, given her comorbidities and advanced age. We do not have imaging, laboratory or autopsy diagnostics to support the causal hypothesis because they have not been performed. At the current state of knowledge, despite the temporal link, in view of the compromised clinical picture and the advanced age of the patient, we consider it unlikely that there is a direct causal correlation between Comirnaty vaccination and the death of the patient. A causal relationship between Comirnaty and Death was assessed as being unlikely. Swissmedic assessed this case as serious, results in death.; Reporter''s Comments: Death in a temporal correlation with the administration of Comirnaty.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1064480 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-18
Onset:2021-01-26
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Pneumonia, SARS-CoV-2 test
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Below knee amputation
Allergies:
Diagnostic Lab Data: Test Date: 20210126; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: CZPFIZER INC2021190786

Write-up: Bilateral pneumonia; COVID-19; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. This is a report received from the regulatory authority report number is CZ-CZSUKL-21001001. An 88-year-old male patient received the first dose of the bnt162b2 (COMIRNATY), via an unspecified route of administration on 18Jan2021 at a single dose for COVID-19 immunization. The patient''s medical history included below knee amputation on 07Feb2020. Concomitant medications were not reported. On 26Jan2021, the patient experienced COVID-19 (death, hospitalization, medically significant, life threatening). On an unspecified date, the patient experienced bilateral pneumonia (death, hospitalization, medically significant). The patient underwent lab tests and procedures which included SARS-CoV-2 test: positive on 26Jan2021. The clinical outcome of the events: bilateral pneumonia and COVID-19, was fatal. The patient died on 04Feb2021 due to bilateral pneumonia and COVID-19. An autopsy was not performed. No follow-up attempts are possible; information about batch/lot number cannot be obtained. ; Reported Cause(s) of Death: Bilateral pneumonia; COVID-19


VAERS ID: 1064487 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Haemoglobin, Ileus paralytic, Microcytic anaemia, Pneumonia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Haematopoietic erythropenia (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), Gastrointestinal obstruction (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-08
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.9 g/dl
CDC Split Type: DEPFIZER INC2021191545

Write-up: Paralytischer Ileus; Acute kidney failure; Microcytic anemia; Pneumonia; This is a spontaneous report downloaded from the Medicines Agency (MA) regulatory authority-WEB DCGMA number DE-DCGMA-21187968. This report was forwarded via RA (PEI) however no RA number was provided. A non-contactable physician reported that a 97-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (lot: EJ6796) on 31Dec2020 at a single dose for COVID-19 immunisation. Medical history included hypertension arterial. Concomitant medications were not reported. On 06Jan2021 after vaccination the patient developed ileus paralytic (paralytischer ileus), microcytic anemia, pneumonia and acute renal failure, lasting for unknown. Lab test included haemoglobin (result: 6.9, unit: g/dl). The patient was hospitalized on an unspecified date and died on 08Jan2021. Death cause was reported as Ileus paralytic. It was unknown if an autopsy was performed. The outcome of events microcytic anemia, pneumonia and acute renal failure was unknown. All events/ PEI / Inconsistent causal association. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Ileus paralytic


VAERS ID: 1064501 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-31
Onset:2021-01-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6796 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021191487

Write-up: The lethal outcome; This is a spontaneous report from a non- contactable physician downloaded from the Regulatory Authority- DE-PEI-PEI2021002730. A 78-years-old male patient received first dose of bnt162b2 (COMIRNATY, lot no.: EJ6796), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced the lethal outcome on 04Jan2021. The patient died on 04Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: The lethal outcome


VAERS ID: 1064502 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-23
Onset:2021-01-28
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 2 - / -

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

Life Threatening? No
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021191481

Write-up: The lethal outcome; This is a spontaneous report from a non- contactable physician downloaded from the Medicines Agency (MA) regulatory authority- DE-PEI-PEI2021002731. A female 79-year-old patient received NT162B2 (COMIRNATY, batch/lot number.: EL1491) second dose on 23Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY) first dose on 31Dec2020 (age at vaccination was 79-year-old) at single dose for COVID-19 immunization and had been tolerated. 5 days after vaccination (28Jan2021) the patient developed Death, lasting for unknown. The patient is dead. It was unknown if autopsy was performed. Source of assessment: Attending Physician. Result of Assessment : Inconsistent causal association. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: The lethal outcome


VAERS ID: 1064503 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-02-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acidosis, Chronic obstructive pulmonary disease, Cor pulmonale, Dyspnoea, Hyperkalaemia, Respiratory failure, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (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), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: Bronchopulmonary disease
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR test; Result Unstructured Data: Test Result:negative/negative NA
CDC Split Type: DEPFIZER INC2021191486

Write-up: Respiratory failure; Cor pulmonale; Dyspnoea; Acidosis; Hyperkalaemia; COPD Exacerbation; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority (DE-PEI-PEI2021002735). A 72-year-old female patient received the second dose of BNT162B2 (COMIRNATY), via an unspecified route of administration, on 02Feb2021 (at the age of 72-years-old) at a single dose for COVID-19 immunisation. It was reported that this was probably the patient''s second dose. Medical history included bronchopulmonary disease. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced cor pulmonale, dyspnoea, acidosis, hyperkalaemia, COPD exacerbation, and respiratory failure on 03Feb2021, which were all reported as fatal. The patient underwent lab tests and procedures which included COVID-19 PCR test: negative/negative NA on an unspecified date. Therapeutic measures were taken as a result of the events, which included oxygen therapy. The patient died on 04Feb2021. The cause of death was reported as respiratory failure. An autopsy was performed, and results were not provided. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Respiratory failure


VAERS ID: 1064505 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Myocardial infarction
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021199868

Write-up: Cardiac arrest; Heart attack; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB DE-PEI-PEI2021002771. A 56-year-old female patient was vaccinated with the second dose of bnt162b2 (COMIRNATY, batch/lot no.: EL8723), via an unspecified route of administration on 17Feb2021 at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient took first dose of bnt162b2 (COMIRNATY) on 27Jan2021 for COVID-19 immunization and had been tolerated. On the same day after vaccination, the patient developed heart attack and cardiac arrest. The patient was dead on 17Feb2021. Death cause was reported as cardiac arrest and heart attack. It was not reported if an autopsy had been performed. Outcome of events were fatal. Relatedness of drug to reactions/events assessed as D. Unclassifiable by PEI. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Heart attack; Cardiac arrest


VAERS ID: 1064506 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-17
Onset:2021-01-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / -

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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021199869

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB [DE-PEI-PEI2021002772]. A 86-years-old female patient received bnt162b2 (COMIRNATY, lot number EM0477), via an unspecified route of administration on 17Jan2021 at single dose for covid-19 immunisation . The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced exitus letalis on 30Jan2021. The patient died on 30Jan2021. 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: 1064507 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-10
Onset:2021-01-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021199870

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority report number DE-PEI-PEI2021002773. A 76-year-old male patient received bnt162b2 (COMIRNATY, lot/batch number: EM0477), intramuscularly on 10Jan2021 at single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. After vaccination, the patient died on 13Jan2021, lasting for unknown. An autopsy was not performed. Event Assessment: Attending Physician / C. Inconsistent causal association. No follow up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1064508 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021199875

Write-up: Letal death; This is a spontaneous report a non-contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB [regulatory authority DE-PEI-PEI2021002780]. A 74-year-old female patient received the first dose of bnt162b2 (COMIRNATY) (batch/lot: EJ6797) on 06Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. 9 days after vaccination the patient developed letal death. The patient was dead on 14Jan2021. It was unknown if an autopsy was performed. Source of assessment: Attending Physician. Result of Assessment: Inconsistent causal association. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Letal death


VAERS ID: 1064509 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-14
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021199878

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002783. A 90-year-old male patient started to receive bnt162b2 (COMIRNATY) (batch no.: EJ6797), via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 9 day(s) after vaccination the patient developed Death. The patient died on 14Jan2021. It was not reported if an autopsy was performed. Comirnaty/ Attending Physician / Inconsistent causal association No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1064510 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2020-12-27
Onset:2021-01-09
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021199880

Write-up: Letal death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority DE-PEI-PEI2021002784. A 77-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6797), via unspecified route of administration on 27Dec2020 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were not reported. The patient experienced letal death on 09Jan2021. Narrative reported as: 13 day(s) after vaccination the patient developed Death. The patient was dead. Relatedness of drug to reaction/event was Comirnaty/ Attending Physician /Inconsistent causal association. The patient died on 09Jan2021. The autopsy was not performed. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Letal death


VAERS ID: 1064511 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-26
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6797 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021199882

Write-up: Death; This is a spontaneous report a non-contactable physician downloaded from the Regulatory Authority-WEB [regulatory authority DE-PEI-PEI2021002787]. A 96-year-old male patient received the first dose of BNT162B2 (COMIRNATY) on 06Jan2021 at single dose (Lot # EJ 6797) for covid-19 immunisation. Concomitant medication was not reported. 20 days after vaccination on 26Jan2021, the patient developed death. It is unknown if autopsy was done. Source of assessment by attending physician. Result of assessment was inconsistent causal association. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1064512 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-01-27
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

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

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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021199886

Write-up: Exitus letalis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB DE-PEI-PEI2021002790. A female 97-years old patient received first dose of BNT162B2 (COMIRNATY) Lot number EJ6797, on 06Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. 21 day(s) after vaccination (27Jan2021) the patient was dead (Exitus letalis). Autopsy was done and autopsy results was not available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1064513 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-06
Onset:2021-02-04
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021196429

Write-up: Exitus letalis; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-PEI2021002792. An 84-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number EJ6797) , via an unspecified route of administration on 06Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced exitus letalis (death) on 04Feb2021. It was reported that 29 day(s) after vaccination the patient developed death. The patient died on 04Feb2021. It was not reported if an autopsy was performed. Attending Physician / Inconsistent causal association. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Exitus letalis


VAERS ID: 1064515 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-30
Onset:2021-01-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 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? 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? No
Previous Vaccinations:
Other Medications: MOTILIUM [DOMPERIDONE]; MADOPAR QUICK; MADOPAR 62.5; HJERDYL; ACTILAX [SODIUM PICOSULFATE]; PARACETAMOL ORIFARM; ESOMEPRAZOL MYLAN; BETOLVEX [CYANOCOBALAMIN]; BENDROZA; AMLODIPIN TEVA; MAGNESIUM; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SO
Current Illness: Abdominal pain (In the week prior to her death, the patient complains about abdominal pain (maybe gastric acid)); Angina pectoris; Constipation; Cramps calf; Dystonia; Esophageal acid reflux; Hypertension; Living in nursing home (Living in nursing home); Nausea; Neuropathic pain; Osteoporosis; Pain; Parkinson''s disease; Stiffness; Swallowing disorder (Problems with her swallowing muscles)
Preexisting Conditions: Medical History/Concurrent Conditions: Facial nerve disorder, unspecified (treated with ostridium botulinum, type A toxin (BOTOX))
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC2021189934

Write-up: Sudden death in the evening; This is a spontaneous report from a contactable physician downloaded from the Regulatory Agency. Regulatory Authority Report Number: DK-DKMA-WBS-0031912, Safety Report Unique Identifier DK-DKMA-ADR 24689105. This is a spontaneous case, received on 03Feb2021 from a physician with follow-up received by telephone from the reporting physician before transmitting version 001 to EV, which describes the occurrence of Sudden death (Sudden death in the evening) in a 69 year old female patient trested with COMIRNATY (tozinameran). A 69-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY, Lot # EK9788) at single dose on 30Jan2021 for covid-19 immunisation. Medical history included ongoing living in nursing home, ongoing constipation, ongoing dystonia, ongoing osteoporosis, ongoing hypertension, ongoing pain, esophageal acid reflux, Parkinson''s disease, stiffness, cramps calf, nausea, angina pectoris, neuropathic pain, patient complained about abdominal pain (maybe gastric acid) in jan2021 and ongoing in the week prior to her death ongoing, swallowing disorder (problems with her swallowing muscles), facial nerve disorder unspecified treated with Clostridium botulinum, type A toxin (BOTOX). Past medication included Clostridium botulinum, type A toxin (BOTOX). Concomitant medication included domperidone (MOTILIUM) oral 10 mg, as needed (when needed, max one time a day) from 09Sep2016 for nausea, benserazide hydrochloride, levodopa (MADOPAR QUICK 62,5) oral 1 DF, as needed (max twice a day) from 21Aug2019 for stiffness, benserazide hydrochloride, levodopa (MADOPAR 62.5, strength 50mg + 12.5mg) 8 DF, daily from 09Sep2016 for Parkinson''s disease, acetylsalicylic acid (HJERDYL) oral 75 mg, daily form 12Sep2012 for Anticoagulant therapy, sodium picosulfate (ACTILAX) oral 7.5 mg/ml, as agreed with the physician from 01Oct2018 for Constipation, paracetamol (PARACETAMOL ORIFARM) oral 3000 mg, as needed (1000 mg morning, midday and evening and when needed) from 05Jun2018 for pan, esomeprazole magnesium (ESOMEPRAZOL MYLAN 20 mg) oral 20 mg, daily for Esophageal acid reflux, cyanocobalamin (BETOLVEX, 1 mg) oral 1 mg, daily from 11Sep2020 for Vitamin B12 deficiency, bendroflumethiazide, potassium chloride (BENDROZA 2.5+573 mg) oral 2 DF, daily from 26Aug2019 for Diuretic therapy, amlodipine besilate (AMLODIPIN TEVA, 10 mg) oral 10 mg, daily form 19Sep2018 for Hypertension, magnesium (MAGNESIUM, 360 mg) oral 360 mg, daily for Cramps calf, macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) oral 1 DF, as needed from 26Nov2012 for Constipation, colecalciferol (VITAMIN NOS, 35ug) oral 70 ug, daily from 18Sep2018 for Vitamin D deficiency, biperiden lactate (AKINETON, 2 mg) oral 1 mg, daily from 21Aug2019 for Dystonia, alendronate sodium (ALENDRONAT SANDOZ, 70 mg) oral 70 mg, weekly form 20May20109 for Osteoporosis, nicotine polacrilex (NICORETTE COOLDROPS 2 mg) oral as agreed with the physician. for Smoking cessation therapy, pregabalin (PREGABALIN ACCORD, 75 mg) oral 225 mg, daily from 25Apr2019 for Neuropathic pain, glyceryl trinitrate (NITROLINGUAL) sublingual 0.4 mg, as needed from 27Jan2021 for Angina pectoris, potassium chloride (KALEORID, 750 mg) oral 3000 mg, daily from 16Sep2018 for Potassium supplementation, morphine sulfate (CONTALGIN, 10 mg) oral 40 mg, daily (10 mg morning, 20 mg midday and 10 mg evening) form 27Oct2020 for pain, ascorbic acid, calcium carbonate, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol palmitate, riboflavin, thiamine hydrochloride, tocopherol (APOVIT MULTI VOKSEN multi-vitamin preparation) 1 DF, daily as a dietary supplement. The patient was treated with Diuretic therapy, Anticoagulant therapy, Potassium supplementation, and Smoking cessation therapy and for Vitamin D deficiency. The patient previously took botox for facial nerve disorder, comirnaty for covid-19 immunisation. The patiente was vaccinated with the 1st dose of COMIRNATY (batch number: EJ6797) at single dose on 03Jan2021 for covid-19 immunisation. On 30Jan2021 the patient suddenly died in the evening. Sudden death was reported by the physician as life threatening and fatal. No treatment was reported and no medical procedure was performed. Cause of death was reported as unknown cause of death. The police has been informed by the physician for the purpose of inquest. The physician believes that an autopsy has been performed. and results were not provided Causality (reporting physician): The reporting physician does not offhand believe that the patient''s death is caused by Comirnaty, but he can not exclude it. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death; Unknown cause of death


VAERS ID: 1064516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-07
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death, Pyrexia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-14
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Weakness (severely age-related)
Allergies:
Diagnostic Lab Data: Test Date: 20210107; Test Name: body temperature; Result Unstructured Data: Test Result:fever
CDC Split Type: DKPFIZER INC2021196311

Write-up: died; Fever; Swelling face; This is a spontaneous report downloaded from the Regulatory Authority-WEB DK-DKMA-WBS-0032387. The case was received from a contactable consumer or other non-healthcare professional. A 97-year-old female patient received the first dose of bnt162b2 (COMIRNATY, lot number: EM0477, Expiration date: 30Apr2021), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunisation. Medical history included weakness (severely age-related). The patient had not experienced any illness for the last many months despite "severe age-related weakness". The patient''s concomitant medications were not reported. On 07Jan2021, the patient developed fever and swelling. The patient was treated with antihistamin and antibiotics. The adverse events were reported as serious and seriousness criteria were resulting in hospitalization. On 14Jan2021, the patient died. The outcome of event ''fever'' was not recovered while of ''swelling face'' was recovering. The cause of death was reported as unknown. An autopsy was not performed. There is no information regarding test results. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: died


VAERS ID: 1064567 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-12
Onset:2021-02-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Electrocardiogram, Fatigue, X-ray
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FUROSEMID HAMELN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Aortic stenosis; Cardiac insufficiency; Osteoarthritis; Paroxysmal atrial fibrillation (Marevan treatment)
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: ECG; Result Unstructured Data: Test Result:No ischemic or new changes in the ECG; Test Date: 202102; Test Name: lung X-ray; Result Unstructured Data: Test Result:an image of cardiac insufficiency
CDC Split Type: FIPFIZER INC2021196430

Write-up: Fatigue; Death; This is a spontaneous report from a non-contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB FI-FIMEA-20210713. A 94-year-old male patient received 2nd dose of bnt162b2 (COMIRNATY), intramuscular on 12Feb2021 at single dose for COVID-19 immunisation. Medical history included Alzheimer''s disease, severe aortic stenosis, cardiac insufficiency, flimmer paroxysms (marevan treatment), osteoarthritis. Concomitant medication included furosemide sodium (FUROSEMID HAMELN) from 05Feb2021 to 14Feb2021 for cardiac insufficiency. The patient previously received 1st dose of bnt162b2 on 21Jan2021 for COVID-19 immunization and experienced shortness of breath. The patient experienced death on 14Feb2021, fatigue on an unspecified date. The patient underwent lab tests and procedures which included electrocardiogram (ECG): no ischemic or new changes in the ECG, and lung X-ray: an image of cardiac insufficiency, both on unknown date of Feb2021. Additional information included: ''4/2019 Cardiologist outlined the medical treatment line related to the heart situation. Hospitalized wards in 2019, treatment cycles for cardiac insufficiency. He arrived on 04Feb2021 to the ward of the rehabilitation center 3 due to shortness of breath. No chest pain. No ischemic or new changes in the ECG. In lung X-ray, an image of cardiac insufficiency and started its treatment with intravenous furosemide. Also treated obstruction with Ventolinella and cortisone. The weight decreased as planned. On 12Feb2021 given the second dose of Covid19 vaccine (Comirnaty). After that, no sign of adverse events, fever, etc. He was tired throughout the treatment period. Died in the ward calmly on 14Feb2021. The patient had severe aortic stenosis and cardiac insufficiency and the cause of death is associated with these. Death certificate made with these diagnoses. Adverse reaction report to FIMEA was also made due to the new vaccine.'' The outcome of fatigue was also reported as fatal. The patient died on 14Feb2021. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: Cardiac insufficiency; Aortic stenosis; Fatigue


VAERS ID: 1064574 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-02-04
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-04
   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: AERIUS [EBASTINE]; APIXABAN; ATENOLOL; DIFFU-K; DOLIPRANE; ESOMEPRAZOLE; FUROSEMIDE; LACRIFLUID; ZESTORETIC; LERCAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm enlargement; Atrial flutter; Cognitive disturbance; Coxarthrosis; Dyslipidaemia; Fibrillation atrial; Heart failure; Hip prosthesis user; Hypertension arterial; Hypoacusis; Seafood allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021180562

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable Other Health Professional (HCP) downloaded from the regulatory authority-WEB FR-AFSSAPS-AN20210344. This is a report received from the Regulatory Authority. A 91-year-old female patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6795), via intramuscular on left arm on 28Jan2021 at single dose for COVID-19 vaccination. Medical history included cognitive disturbance, hypertension arterial, heart failure, atrial flutter, hip prosthesis user, hypoacusis, seafood allergy, dyslipidaemia, abdominal aortic aneurysm enlargement, coxarthrosis, fibrillation atrial, all from unspecified dates and unknown if ongoing. Concomitant medication included ebastine (AERIUS), apixaban, atenolol, potassium chloride (DIFFU-K), paracetamol (DOLIPRANE), esomeprazole, furosemide, carbomer (LACRIFLUID), hydrochlorothiazide, lisinopril (ZESTORETIC), lercanidipine hydrochloride (LERCAN). The patient experienced cardio-respiratory arrest on 04Feb2021. The event was reported as serious due to death and life-threatening. Case narrative: The first injection of Comirnaty carried out on 28Jan2021. On 04Feb2021, the patient presented with cardio-respiratory arrest leading to her death. Death from cardiopulmonary arrest 7 days after the first injection of Comirnaty. The patient died on 04Feb2021. It was not reported if an autopsy was performed. The outcome of the event was fatal. No medical observation available for this patient according to the declarant. No follow-up attempts possible. No further information expected. Follow-up (23Feb2021): New information received from the same contactable Other Health Professional (HCP) downloaded from the regulatory authority FR-AFSSAPS-AN20210344 includes: No medical observation available for this patient according to the declarant. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1064584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-26
Onset:2021-02-06
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety aggravated (before the vaccination, recently lost his wife); Asthma; COPD; COVID-19 (Had Covid-19. Test on 21Oct2020.); Dementia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20201021; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Had Covid-19
CDC Split Type: FRPFIZER INC2021197527

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority, regulatory authority report number FR-AFSSAPS-BX20210769. A 94-year-old male patient received first dose of bnt162b2 (COMIRNATY, lot number: EJ6788), intramuscularly on left arm on 26Jan2021 at single dose for COVID-19 immunization, oxazepam (SERESTA) orally from 04Feb2021 to 06Feb2021 at 10 mg, twice daily for anxiety attack. Medical history included asthma , had Covid-19 (Test on 21Oct2020), dementia, hypertension arterial, chronic obstructive pulmonary disease, patient in an institution who recently lost his wife, increased ambulation and anxiety before the vaccination, significant anxiety crisis on 04Feb2021. In this context, treatment with oxazepam 10 mg twice a day for two days. No psychotropic treatment. The patient''s concomitant medications were not reported. The patient was found dead in bed on 06Feb2021 04:15 am. The action taken in response to the event for oxazepam was not applicable. The patient died on 06Feb2021. 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 NOS


VAERS ID: 1064619 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Lung disorder, Oxygen saturation decreased, Pneumonia aspiration, Respiratory distress, Respiratory tract congestion, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease (with total gabatization.); Bedridden; COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: COVID-19 test; Test Result: Negative ; Comments: at 7 a.m.
CDC Split Type: FRPFIZER INC2021197529

Write-up: respiratory congestion with desaturation (no quantified value).; respiratory congestion with desaturation (no quantified value).; inhalation lung disease; Distress respiratory; Pneumonia aspiration; This is a spontaneous report from physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-MA20210469. A 95-years-old female patient received first dose of bnt162b2 (COMIRNATY, lot EJ6788), intramuscular in left arm on 09Feb2021 at single dose for covid-19 immunisation. Medical history included ATCD COVID-19 yes in October 2020, without respiratory failure, severe Alzheimer''s disease with total gabatization, bedridden. The patient''s concomitant medications were not reported. The patient experienced distress respiratory on 10Feb2021, pneumonia aspiration on 10Feb2021, appearance of respiratory congestion with desaturation (no quantified value) on 10Feb2021 09:00 p.m. Diagnosis of inhalation lung disease. The patient underwent lab tests and procedures which included Covid test: negative on 11Feb2021 at 7 a.m. The patient died on 12Feb2021. It was not reported if an autopsy was performed. The seriousness criteria was death, hospitalization, life threatening. No follow-up attempts are possible, information on batch number already obtained.; Reported Cause(s) of Death: Distress respiratory; Pneumonia aspiration; respiratory congestion; desaturation; inhalation lung disease


VAERS ID: 1064641 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral disorder, Death, Epilepsy, Off label use, Product use issue, SARS-CoV-2 test negative
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (narrow), Medication errors (broad), COVID-19 (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: Bronchial carcinoma; Ischemic stroke; Metastasis; Permanent atrial fibrillation
Allergies:
Diagnostic Lab Data: Test Date: 20210114; Test Name: Covid 19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021197533

Write-up: epilepsy; intracranial process; concomitant medications included Anticoagulant, immunotherapy; concomitant medications included Anticoagulant, immunotherapy; Death unexplained; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority, number FR-AFSSAPS-NT20210317. A 90-years-old male patient received second dose of BNT162b2 (COMIRNATY, lot#: EJ6789), intramuscular in right arm on 11Feb2021 09:45 at single dose for Covid-19 immunisation. Medical history included Right sylvian ischemic stroke, permanent anticoagulated AF, multimetastatic small cell bronchial carcinoma under immunotherapy. The patient''s concomitant medications included Anticoagulant, immunotherapy. Patient was death in unknown circumstances occurred 13 hours after the injection. Hypothesis put forward by the reporter: epilepsy complicating an intracranial process. It was unknown whether autopsy done. Patient had Covid 19 test on 14Jan2021 with negative result. No follow-up attempts possible. No further information expected.; Sender''s Comments: The limited information provided precludes a full clinical assessment of the case. As a cautionary measure and for reporting purposes, and assuming a drug-events temporal association, the company cannot completely exclude a causal association between the reported 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: Death unexplained


VAERS ID: 1064690 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Heart rate, International normalised ratio, Malaise, 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: 2021-02-11
   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: ABASAGLAR; DAFALGAN; FORLAX; FUROSEMIDE ARROW; MOPRAL [OMEPRAZOLE MAGNESIUM]; PAROXETINE EVOLUGEN; PREVISCAN [FLUINDIONE]; RISPERIDONE EG; NUTRIVISC; FIBRELINE MELANGE DE FIBRES
Current Illness: Living in nursing home
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve incompetence; Benign colonic polyp; Diabetes mellitus insulin-dependent; Heart failure; Hernia inguinal; Hypertension arterial; Infarct myocardial; Major neurocognitive disorder; Osteoarthritis; Permanent cardiac pacemaker insertion; Subdural hematoma; Tachycardia atrial; Traumatic brain injury; Ulcer gastric; Ventricular hypokinesia (heart failure due to hypokinetic heart disease)
Allergies:
Diagnostic Lab Data: Test Date: 20210211; Test Name: blood pressure; Result Unstructured Data: Test Result:100/600 mmHg; Test Date: 20210211; Test Name: temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210211; Test Name: regular pulse; Result Unstructured Data: Test Result:92 bpm; Test Date: 20210210; Test Name: INR; Result Unstructured Data: Test Result:1.2
CDC Split Type: FRPFIZER INC2021191106

Write-up: sudden Death unexplained; Feeling sick; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NY20210288 This is a report received from the Regulatory Authority. A 91-year-old male patient received bnt162b2 (COMIRNATY, lot EJ6795) intramuscular at single dose on 11Feb2021 08:45 for covid-19 immunisation. Medical history included living in home care, a long history including cardiovascular disease: arterial hypertension, heart failure due to hypokinetic heart disease, insulin-dependent diabetes, hiatus hernia, major vascular neurocognitive disorder, aortic valve incompetence, Permanent cardiac pacemaker insertion, gastric ulcer, large intestine polyp, atrial tachycardia, myocardial infarction, subdural hematoma in 2000, head trauma in 2004, osteoarthritis. Concomitant medication included insulin glargine (ABASAGLAR), subcutaneously 6 iU, daily for Dementia paracetamol (DAFALGAN) oral 4 DF, daily for Arthrosis, macrogol 4000 (FORLAX) oral 1 DF, 1x/day on demand for Constipation, furosemide (FUROSEMIDE ARROW) orla 1 DF, daily for Cardiac failure, omeprazole magnesium (MOPRAL) oral 1 DF, 1x/day (1 or 0.5 /day) for Ulcer gastric, paroxetine hydrochloride (PAROXETINE EVOLUGEN) oral 1 DF, 1x/day for Depression, fluindione (PREVISCAN) oral for Arrhythmia, risperidone (RISPERIDONE EG) oral 0.5 mg, 1x/day for Dementia, NUTRIVISC Eye drops, FIBRELINE as Food supplement. The patient received the 1st dose of bnt162b2 (COMIRNATY, lot # EJ6788) at single dose on 21Jan2021 for covid-19 immunisation, well tolerated with no side effects. The patient experienced feeling sick (fatal) sudden unexplained death on 11Feb2021 1.5 hours after receiving the 2nd dose of COMIRNATY, with heavy cardiovascular medical history and vascular dementia. Course of events: On 11Feb2021: measuring of constants: blood pressure 100/60 mm Hg, regular pulse at 92 bpm, temperature 36.6 Centigrade, no signs of infection, good reactivity and good conscience, INR (international normalized ratio) measured the day before (10Feb2021 at 1.2). At 8.45 am, he received the 2nd injection of COMIRNATY. Good tolerance during the 15 minutes of observation. He was transferred to the service around 9:30 am. At 9.50 am, he called for discomfort. The patient was placed in a lying position in his bed. Around 10 a.m., the nurse arrived and noticed the absence of vital parameters. Medical report of death performed at 10h20. He died approximately 1.5 hours after receiving the 2nd dose of COMIRNATY, with mention of illness before the death certificate. An autopsy was not performed. Imputability Method: C2S1=I1 (dubious).; Reported Cause(s) of Death: sudden Death unexplained


VAERS ID: 1064697 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-27
Onset:2021-01-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Electrocardiogram, Heart rate, International normalised ratio, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Dehydration (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: AMLOR; PREVISCAN [FLUINDIONE]; LOXAPAC [LOXAPINE]; LASILIX [FUROSEMIDE]; BISOCE; LANSOPRAZOLE; PAROXETINE; DOLIPRANE; GLUCOSE; VITABACT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac arrhythmia; Cardiac failure; Conjunctivitis; Fracture of neck of femur; Hypertension arterial; Peripheral arterial occlusive disease; Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20201109; Test Name: Atrial ECG; Result Unstructured Data: Test Result:a bundle branch block with the presence of; Comments: frequency at 40/min, without suggestive clinical sign (malaise, chest pain); Test Date: 20210130; Test Name: Electrocardiogram; Result Unstructured Data: Test Result:the sounds of the heart are always irregular; Comments: and rapid without a crackling rattle; Test Date: 20210130; Test Name: heart rate; Result Unstructured Data: Test Result:180; Comments: bpm; Test Name: INR; Result Unstructured Data: Test Result:stable
CDC Split Type: FRPFIZER INC2021203718

Write-up: Tachycardia (180 bpm); Atrial fibrillation; This is a spontaneous report downloaded from the Regulatory Authority-WEB [Regulatory Authority number FR-AFSSAPS-PC20210117] from a contactable physician. A 97-year-old female patient received the 2nd dose of bnt162b2 (COMIRNATY, lot# EJ6788), intramuscular in arm left, on 27Jan2021, at single dose, for COVID-19 immunisation. Medical history included cerebrovascular accident, hypertension, peripheral arterial occlusive disease, femoral neck fracture, arrhythmia, cardiac failure, conjunctivitis. Concomitant medication included amlodipine besilate (AMLOR), fluindione (PREVISCAN) from 05Jan2020 for cardiac arrhythmia with stable INR, loxapine (LOXAPAC), furosemide (LASILIX), bisoprolol fumarate (BISOCE), lansoprazole (unknown manufacturer), paroxetine (unknown manufacturer), paracetamol (DOLIPRANE), glucose (unknown manufacturer), picloxydine dihydrochloride (VITABACT) from 20Jan2021 for conjunctivitis. The patient previously took Rifamycin for conjunctivitis and 1st dose of Comirnaty for COVID-19 immunisation. The patient experienced tachycardia (180 bpm) and atrial fibrillation both on 30Jan2021 with fatal outcome on 31Jan2021. The patient underwent lab tests and procedures which included atrial electrocardiogram: a bundle branch block with the presence of frequency at 40/min, without suggestive clinical sign (malaise, chest pain) on 09Nov2020, electrocardiogram: the sounds of the heart are always irregular and rapid without a crackling rattle on 30Jan2021, heart rate: 180 bpm on 30Jan2021, international normalised ratio: stable on unknown date. Therapeutic measures were taken as a result of the events and included treatment with Bisoce 2.25 mg (dosage increased), morphine and midazolam SB. It was not reported if an autopsy was performed. Description of the adverse reaction: 30Jan2021: occurrence of tachycardia at 180bpm with bundle branch block still present. Absence of the usual oral treatments. Evidence of an atrial electrogram, the sounds of the heart are always irregular and rapid without a crackling rattle. Increase in dosage by Bisoce 2.25mg prescribed that day. Context of prescription of Morphine and midazolam SB (without notion of administration during the night). Patient followed for the long term in a residential establishment for dependent elderly people. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Atrial fibrillation; Tachycardia


VAERS ID: 1064709 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-08
Onset:2021-02-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Alzheimer''s disease; Arrhythmia
Allergies:
Diagnostic Lab Data: Test Date: 20201217; Test Name: COVID 19; Result Unstructured Data: Test Result:unknown results
CDC Split Type: FRPFIZER INC2021197583

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RN20210481. An 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, batch/lot #: EJ6789), intramuscular on 08Feb2021 at single dose at left arm for covid-19 immunisation. Medical history included dementia Alzheimer''s disease, complete arrhythmia due to AFib from an unknown date and unknown if ongoing, and patient had no history of covid-19. The patient''s concomitant medications were not reported. No biological assessment or clinical examination done recently because patient was doing well. The patient experienced sudden death on 13Feb2021, his death was declared at 9:30 am. The patient underwent lab tests and procedures which included COVID 19 test on 17Dec2020. No autopsy was performed. No follow-up attempts are possible, batch number already obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1064715 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-02-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-12
   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: Arterial hypertension; COVID-19; Diabetes mellitus insulin-dependent; Ischemic stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210209; Test Name: COVID-19 test; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: FRPFIZER INC2021196428

Write-up: Death NOS; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (Regulatory Authority number FR-AFSSAPS-TO20210652). An 81 years old male patient received the second single dose of BNT162B2 (COMIRNATY; lot EJ6788) intramuscular, in left arm, on 11Feb2021, for COVID-19 immunization. The first vaccine dose was given on an unknown date. Medical history included diabetes mellitus insulin-dependent, ischemic stroke, arterial hypertension and COVID, all from an unknown date and unknown if ongoing. Concomitant medications were not reported. On 09Feb2021 the patient had a COVID-19 test with unknown results. The patient died on 12Feb2021. The event was described as sudden death of the patient the night following the injection without prodrome during the day (no flu syndrome, no allergic sign). It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1064741 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-01-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0739 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, COVID-19 pneumonia, Diarrhoea, Drug ineffective, SARS-CoV-2 test, Viral test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), 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), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-08
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALLOPURINOL; ATORVASTATIN CALCIUM; BISOPROLOL FUMARATE; FUROSEMIDE SODIUM; LISINOPRIL ANHYDROUS; WARFARIN; LISINOPRIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210121; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210124; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210126; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210128; Test Name: COVID-19 virus test; Test Result: Negative ; Test Date: 20210130; Test Name: COVID-19 virus test; Test Result: Positive ; Test Date: 20210126; Test Name: Virus stool test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021199155

Write-up: acute kidney injury; Covid pneumonitis/Covid postive; Covid pneumonitis/Covid postive; Acute diarrhea; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Agency (MHRA). Regulatory authority report number GB-MHRA-EYC 00241369, Safety Report Unique Identifier GB-MHRA-ADR 24791249. An 84-year-old male patient receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL0739), intramuscular on 14Jan2021 at 0.3 mL, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included allopurinol, atorvastatin calcium, bisoprolol fumarate, furosemide sodium, lisinopril anhydrous, warfarin, lisinopril. The patient experienced acute diarrhea (death) on 15Jan2021, covid pneumonitis/covid postive (death, medically significant) on 30Jan2021, acute kidney injury (death, hospitalization, medically significant) on 20Jan2021. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 21Jan2021, COVID-19 virus test: negative on 24Jan2021, COVID-19 virus test: negative on 26Jan2021, COVID-19 virus test: negative on 28Jan2021, COVID-19 virus test: positive on 30Jan2021, Virus stool test: negative on 26Jan2021. The patient died on 08Feb2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. The clinical course was reported as follows: Developed Diarrhoea. Diagnosis with acute kidney injury on 20Jan2021 and admitted to hospital. Died on 08Feb2021. Covid pneumonitis. Reporter was aware patient died of covid -but impact of vaccine on possible cause of admission reporter wish to report. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Covid pneumonitis/Covid postive; Acute kidney injury; Covid pneumonitis/Covid postive; Acute diarrhea


VAERS ID: 1065047 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Culture, Malaise, Muscle spasms, Urinary tract infection
SMQs:, Dystonia (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: CIPROFLOXACIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Malaise (before vaccination)
Allergies:
Diagnostic Lab Data: Test Date: 20210122; Test Name: culture; Result Unstructured Data: Test Result:urinary tract infection
CDC Split Type: NLPFIZER INC2021191184

Write-up: general malaise since 22-1 2x antibiotic for urinary tract infection (based on culture), kink 1-2; general malaise since 22-1 2x antibiotic for urinary tract infection (based on culture), kink 1-2; general malaise since 22-1 2x antibiotic for urinary tract infection (based on culture), kink 1-2; This is a spontaneous report from a contactable physician downloaded from the regulatory authority NL-LRB-00443431. A 91-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY, Lot # EJ6134) on 29Jan2021 at single dose for covid-19 immunisation. The patient medical history malaise. No previous COVID-19 infection. Concomitant medication included ciprofloxacin (CIPROFLOXACIN tablet 500mg) for urinary tract infection. On 01Feb2021, 3 days after vaccination, the patient experienced general malaise since 22-1 2x antibiotic for urinary tract infection (UTI) (based on culture), kink 1-2 (as reported). Patient already had malaise before vaccination. The outcome of malaise was fatal. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Reporters comments: BioNTech / Pfizer vaccine (Comirnaty). Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no. General malaise from 22-1 2x AB for UTI (based on culture), kink 1-2. Additional information ADR: patient eventually died. COVID19 - Previous COVID-19 infection: No. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no malaise from 22-1 2x AB for UTI (based on culture), kink 1-2 Additional information ADR: patient eventually died COVID19 - Previous COVID-19 infection: No; Reported Cause(s) of Death: general malaise; urinary tract infection (UTI)


VAERS ID: 1065048 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM0477 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cachexia, Depressed level of consciousness, Fatigue, Malaise
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-13
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL; ESOMEPRAZOLE; FENTANYL
Current Illness: Reduced general condition (before vaccination)
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Cognitive disorder; Diabetes mellitus; Fractured sacrum; Gonarthrosis; Hypertension; Incontinence of urine (due to cognitive problem); Infection (antibiotic); Osteoporosis; Phacoemulsification (OD2007); Pneumonia; Prosthesis fracture (Status after left neck prosthesis due to fracture); Scabies; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021199233

Write-up: cachexia; partly conscious; Not feeling well; Fatigue; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) regulatory authority-WEB NL-LRB-00444118, Safety Report Unique Identifier NL-LRB-00445742. An 89 years old female patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, lot number: EM0477), via an unspecified route of administration on 29Jan2021 at single dose (1 dose form) for COVID-19 immunisation. Medical history included Hypertension, Osteoporosis, Diabetes mellitus from 2015, Gonarthrosis from 2012, Alzheimer''s disease, Pneumonia from 2014, Infection toe wv antibiotic from 2011, Scabies from 2010, phacoemulsification from 2007 (reported as "OD2007"), sacrum fracture in osteoprorosis from 2003, Status after left neck prosthesis due to fracture from 1992, Type 2 diabetes mellitus (DM2) from 1990, Incontinence of urine due to cognitive problem, health was already declining before vaccination and ongoing. Concomitant medications included paracetamol, esomeprazole, fentanyl patch. On 31Jan2021, the patient experienced not feeling well (death), fatigue (death) following administration bnt162b2 for covid 19 immunisation. Physician described that the patient''s health was already declining before vaccination and that there was doubt if the patient should be vaccinated. Her health declining was predominantly caused by her stopping to eat and drink. Drugs and latency for bnt162b2 and malaise/ fatigue was 2 days after start. It was reported that follow-up on 16Feb2021, the patient died on 13Feb2021 due to cachexia when stopping drinking, partly conscious. The patient was already vulnerable, admitted to a nursing institution for psychogeriatric patients, there were still doubted as to whether she should be vaccinated, eventually she died after consultation. The decline was mainly indicated in the context of the decline in stopping eating and drinking. Events not feeling well, fatigue and cachexia Resulted in death. No corona test was taken. No autopsy was performed. The outcome of the event partly conscious was unknown, of the events was fatal. Case Summary and Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no confounding factors confounding factors: Alzheimer''s dementia COVID19 Previous COVID-19 infection: No; Other diagnostic procedures: no comments to report form: Already worsening with doubts about whether she should be vaccinated. Would say she died in deterioration with the corona vaccination rather than that she died as a result of the vaccination. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech / Pfizer vaccine (Comirnaty) Past drug therapy BioNTech / Pfizer vaccine (Comirnaty): no confounding factors confounding factors: Alzheimer''s dementia COVID19 Previous COVID-19 infection: No; Other diagnostic procedures: no comments to report form: Already worsening with doubts about whether she should be vaccinated. Would say she died in deterioration with the corona vaccination rather than that she died as a result of the vaccination. ; Reported Cause(s) of Death: cachexia; malaise; fatigue


VAERS ID: 1065049 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-02-06
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / UNK - / -

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: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MIDAZOLAM; MORFINE
Current Illness: COPD; Emphysema pulmonary
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210206; Test Name: COVID-19; Result Unstructured Data: Test Result:positive
CDC Split Type: NLPFIZER INC2021191175

Write-up: COVID-19; This is a spontaneous report received from a contactable physician, downloaded from the Regulatory Authority NL-LRB-00444454. A 90-year-old female patient received bnt162b2 (COMIRNATY) (Lot # EJ6134), via an unspecified route of administration at single dose on 29Jan2021 for covid-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease, ongoing emphysema. Concomitant medication included midazolam, morfine. The patient experienced Covid-19 on 06Feb2021 with fatal outcome. The patient died on 12Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 06Feb2021. It was not reported if an autopsy was performed. The patient died at home using palliative sedation as a result of complications from Covid-19. Unknown if there was a relationship with vaccination with Comirnaty. Clinical course as follows: 5 days after vaccination, the patient experienced symptoms of a Covid-19 infection, 8 days after vaccinations the patient had a positive SARS COV 2 test and 14 days after vaccination the patient deceased with palliative sedation. The patient died of complications of a Covid-19 infection. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: complications of COVID19


VAERS ID: 1065050 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-01-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-03-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM 0477 / 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: 2021-01-29
   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: AMLODIPINE; PERINDOPRIL ARGININE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021202398

Write-up: The person concerned has suffered a CVA and died on 29/01; This is a spontaneous report a contactable physician downloaded from the Regulatory Authority-WEB [regulatory authority NL-LRB-00446641] A 99-years-old female patient received first dose of bnt162b2 (COMIRNATY, Lot number: EM 0477), via an unspecified route of administration on 29Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included amlodipine, perindopril arginine. The patient experienced the person concerned has suffered a cva and died on 29/01 on 29Jan2021. The patient deceased within 1 day after vaccination. The patient died on 29Jan2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reporter''s Comments: BioNTech/Pfizer vaccin (Comirnaty) -Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): no ---------- COVID19 -Previous COVID-19 infection: No Other -diagnostic procedures: no; Reported Cause(s) of Death: CVA


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