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From the 11/19/2021 release of VAERS data:

Found 19,249 cases where Vaccine is COVID19 and Patient Died

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Case Details

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VAERS ID: 1546090 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-18
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood culture, Body temperature, Chest X-ray, Computerised tomogram, Death, Dyspnoea, Increased upper airway secretion, Inflammatory marker test, Lung opacity, Pyrexia, SARS-CoV-2 test, SARS-CoV-2 test negative, Specialist consultation, Urine analysis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve repair (due to valvular bleeding); Atrial fibrillation; Coronary artery disease; Hypertension; Memory impairment; Metabolic syndrome; Pacemaker insertion (cardiac) (inserted due to sick sinus syndrome); Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Blood culture; Result Unstructured Data: Test Result:no growth; Test Name: Body temperature; Result Unstructured Data: Test Result:41.2 Centigrade; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:38.5 Centigrade; Test Name: lung image; Result Unstructured Data: Test Result:Minor inflammatory spectral finding; Comments: Minor inflammatory spectral finding in the low lobe; Test Date: 202102; Test Name: computed tomography; Result Unstructured Data: Test Result:cirrhosis of the liver; Test Name: inflammatory values; Result Unstructured Data: Test Result:moderate; Test Name: Covid test; Test Result: Negative ; Test Name: Covid test; Test Result: Negative ; Test Name: Covid test; Test Result: Negative ; Test Date: 202106; Test Name: gastroenterologist; Result Unstructured Data: Test Result:NASH condition; Comments: it seems that mainly nonalcoholic steatohepatitis (NASH) type of condition in the background.; Test Name: Urine; Result Unstructured Data: Test Result:no obvious infectious
CDC Split Type: FIPFIZER INC202100987847

Write-up: Death; Lung opacity; SARS-CoV-2 test negative; Dyspnoea; Increased upper airway secretion; Pyrexia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FI-FIMEA-20213702. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was not reported), intramuscular on 17Jun2021 (Age of vaccination: Unknown) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) for covid-19 immunization. Medical history included memory impairment, type 2 diabetes mellitus, metabolic syndrome, coronary artery disease, hypertension, atrial fibrillation, cardiac pacemaker insertion as inserted due to sick sinus syndrome , aortic valve repair from 2014 to 2014 due to valvular bleeding , renal failure. The patient''s concomitant medications were not reported. On 18Jun2021 the patient experienced lung opacity, sars-cov-2 test negative, dyspnoea, increased upper airway secretion, pyrexia. 17Jun21 on Thursday the patient received Pfizer second covid vaccine (first received on 24Feb Comirnaty). The next day, a rising fever ad 38.5., During several hours developed severe shortness of breath and mucus. Initiated iv antibiotic. Fever increased despite strong iv antibiotics ad 41.2. Covid test repeatedly (3x) negative. In blood cultures there is no growth, in the urine there is no obvious infectious, in lab tests the inflammatory values are moderate all the time. Minor inflammatory spectral finding in the low lobe in the lung image. On 23Jun2021 the patient died. The patient underwent lab tests and procedures which included blood culture: no growth on an unspecified date, body temperature: 41.2 centigrade on an unspecified date, body temperature: 38.5 centigrade on 18Jun2021 , chest x-ray: minor inflammatory spectral finding on Minor inflammatory spectral finding in the low lobe , computerised tomogram: cirrhosis of the liver on Feb2021 , inflammatory marker test: moderate on an unspecified date, sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date, sars-cov-2 test: negative on an unspecified date, specialist consultation: nash condition on Jun2021 it seems that mainly nonalcoholic steatohepatitis (NASH) type of condition in the background , urine analysis: no obvious infectious on an unspecified date. The patient died on 23Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Lung opacity; SARS-CoV-2 test negative; Dyspnoea; Increased upper airway secretion; Pyrexia; Death


VAERS ID: 1546175 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE7010 / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996498

Write-up: Death unexplained; This is a spontaneous report received from a contactable other health professional downloaded from a regulatory authority. A 38-year-old male patient received bnt162b2 (COMIRNATY), first single dose intramuscular, administered in Arm Right on 26Jul2021 11:20 (Batch/Lot Number: FE7010) for covid-19 immunisation at age of 38-year-old. The patient medical history was not reported. The patient had no history of allergy or hypersensitivity to certain substances or other declared vaccines. The patient''s concomitant medications were not reported. Without any clinical warning signs known by the declarant to date, the patient''s death was observed on the public highway in the afternoon of 26Jul2021, with urgent care by the Emergency Service. The autopsy is scheduled for Friday 30Jul2021.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1546228 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angioedema, Hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal allergic conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   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: Peanut allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Angioedema; Antiallergic therapy; Drug allergy; Mite allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100987871

Write-up: Allergic reaction; angioedema; This is a spontaneous report received from a contactable pharmacist downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-MP20215744. A 22-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 26Jul2021 14:20 (Lot Number: FF4213) at the age of 22-years-old as single dose for covid-19 immunisation. Medical history included respiratory allergy to mites and ongoing food allergy to peanuts, demonstrated by skin tests in 2001 (consultation in allergology following angioedema), since then, peanut and peanut oil avoidance recommendations and emergency kit within reach; drug allergy; antiallergic background treatment (specialty not found) which would had been interrupted. Family history of allergies in mother (allergy to dust mites and cat hair), father (history of angioedema). Patient was not considered to be at risk of developing a severe form of COVID-19 disease. Patient previously received treatment with epinephrine hydrochloride (ANAPEN) syringes within reach. On 26Jul2021 at 2:55 p.m., patient exit from the vaccination center after a 30-minute surveillance during which no symptoms were reported. On 26Jul2021 in the evening: evening meal at the restaurant, ingestion of a sauce with doubt about the presence of peanuts, 10 minutes later, a tingling sensation in the neck, pruritus, respiratory problems and the onset of edema in the neck. The patient identifies an allergic reaction, no Anapen within reach, he went home alone to take his treatment. At home, deterioration of his condition with discomfort. His sister called the fire department. The patient died in the ambulance at 12:20 a.m. Conclusion: Allergic reaction with angioedema in the patient with a history of food allergy, more than 6 hours after a first dose of Comirnaty and immediately following a probable ingestion of a food allergen. Patient died on 27Jul2021 at 12:20 a.m.. Autopsy initially refused but requested subsequently (had not performed). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: angioedema; Allergic reaction


VAERS ID: 1546234 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF4213 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   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: RISPERDAL; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Psychotic disorder NOS; Stroke (at age 20)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996406

Write-up: Death unexplained; patient found in his room with vomiting, painful face; patient found in his room with vomiting, painful face; tired; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20212991. A 38-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 23Jul2021 (Batch/Lot Number: FF4213) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included stroke at age 20 , psychotic disorder. Concomitant medication(s) included risperidone (RISPERDAL) taken for an unspecified indication, start and stop date were not reported; acetylsalicylate lysine (KARDEGIC) taken for an unspecified indication, start and stop date were not reported. The patient experienced death unexplained on 28Jul2021. Day 2 (25Jul2021) : family walk. The patient feels tired. The family finds him "a little less well". Day 5 (28Jul2021): patient found in his room with vomiting, painful face and 7 open sachets of KARDEGIC. The patient died on 28Jul2021. An autopsy was performed and results were not provided. Outcome of death was fatal, of others was unknown. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death of undetermined cause, possibly vascular


VAERS ID: 1546241 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-04-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal cardiac arrest, Maternal exposure before pregnancy
SMQs:, Congenital and neonatal arrhythmias (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 62
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100987903

Write-up: Foetal cardiac arrest; 30Apr2021, 2nd injection of bnt162b2, 11May2021, ovulation period, 21May2021, diagnosis of pregnancy.; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority -WEB, regulatory authority number FR-AFSSAPS-NY20213048. This consumer reported information for both mother and fetal. This is a fetal report. Foetus patient without specified medical history. Concomitant medications were not reported. The patient''s mother received bnt162b2 (COMIRNATY, concentrate for injection. COVID-19 mRNA vaccine (modified nucleoside) (mRNA encoding the peak viral protein (S) of SARS-CoV-2), lot number ET6956) Intramuscularly administered in left arm on 30Apr2021 for Vaccination against covid-19. The fetus of an unspecified gender received the same vaccine transplacentally. On 01Jul2021, 63 Day after the last drug administration, the patient developed fetal cardiac arrest which led to death on 01Jul2021. Fetal cardiac arrest at 9 weeks of amenorrhea, 63 days after the second injection of the bnt162b2 vaccine by the mother. 30Apr2021, 2nd injection of bnt162b2, 11May2021, ovulation period, 21May2021, diagnosis of pregnancy. 01Jul2021, announces that the heart of the embryo has stopped. Miscarriage at 2 months of pregnancy. The event foetal cardiac arrest resulted in death. The patient diead on 01Jul2021. It was unknown if an autopsy was performed. The cause of death was foetal cardiac arrest. The outcome of foetal cardiac arrest was fatal. The outcome of other event was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-202100988084 fetal/maternal case; Reported Cause(s) of Death: Foetal cardiac arrest


VAERS ID: 1546245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-01-23
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Troponin, Troponin abnormal
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-01-24
   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: Hypercholesterolaemia
Allergies:
Diagnostic Lab Data: Test Date: 20210123; Test Name: troponin; Result Unstructured Data: Test Result:16000
CDC Split Type: FRPFIZER INC202100987854

Write-up: Troponin abnormal; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-PB20214903 A 75-year-old male patient received first dose of bnt162b2 (COMIRNATY), Intramuscularly on 19Jan2021 (lot number EJ6795) as single dose for COVID-19 immunisation. Medical history included hypercholesterolemia as antecedents. Concomitant medications were not reported. He presented on 23Jan2021 a troponin at 16,000 the day before his death. It was unknown if Autopsy Done. The outcome of the event was fatal on 24Jan2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Troponin abnormal


VAERS ID: 1546281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-06-20
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dehydration, Epistaxis, Fall, Personality disorder, Renal failure, SARS-CoV-2 test, Selective eating disorder, Sudden death, Vaccination failure
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Lack of efficacy/effect (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TOVIAZ; SOTALOL AF [SOTALOL HYDROCHLORIDE]; SERESTA; APIXABAN; MIRTAZAPINE; CIRCADIN; LASILIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Cardiac ischemia; Cardiac pacemaker insertion; Dementia of the Alzheimer''s type NOS; Hypercholesterolemia; Neuralgia
Allergies:
Diagnostic Lab Data: Test Date: 20210727; Test Name: COVID-19 PCR +; Test Result: Positive ; Comments: variant L452R
CDC Split Type: FRPFIZER INC202101004086

Write-up: dehydration with renal failure; Asthenic patient; food / drink stop; dehydration with renal failure; Sudden death; Vaccination failure; COVID-19; fall; espitaxis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TO20216127, Safety Report Unique Identifier FR-AFSSAPS-2021103108. A 92-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EJ6788, Expiration Date was not reported) via intramuscular on 23Feb2021 as dose 2, single and received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported, Expiration Date was not reported) via intramuscular on 02Feb2021 as dose 1, single for COVID-19 immunization. The patient''s medical history included dementia of the alzheimer''s type NOS, cardiac failure, cardiac pacemaker insertion from 2005, neuralgia, hypercholesterolemia, possible cardiac ischemic sequelae. Concomitant medications included fesoterodine fumarate (TOVIAZ), sotalol hydrochloride (SOTALOL AF [SOTALOL HYDROCHLORIDE]), oxazepam (SERESTA), apixaban, mirtazapine, melatonin (CIRCADIN), furosemide (LASILIX [FUROSEMIDE]), all taken for unknown indications from an unknown date. It was reported that, the patient was hospitalized for fall and epistaxis on 20Jun2021 and on 27Jul2021 PCR +, variant L452R. Asthenic patient, food/drink stop, dehydration with renal failure. Patient was found dead in his bed on 28Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (variant L452R) on 27Jul2021. The patient died on 28Jul2021. It was not reported if an autopsy was performed. Follow up attempts are completed. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1546286 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-19
Onset:2021-04-20
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, 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: 2021-04-01
   Days after onset: 19
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Reduced general condition
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: SARS-CoV-2 test; Test Result: Positive ; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:negative; Comments: the day before vaccination
CDC Split Type: FRPFIZER INC202100996227

Write-up: COVID-19 aggravated; Covid confirmed by antigen test.; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-TS20213242. An 85-years-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EW4815) intramuscularly on 19Apr2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history included ongoing general physical health deterioration. The patient''s concomitant medications were not reported. On 20Apr2021, patient confirmed COVID by antigen test. Possible contamination by his daughter who made her second corona in 1 year, the first time was not infected. The patient was hospitalized for COVID-19 aggravated (COVID-19) from Apr2021 to an unknown date. The patient underwent lab tests and procedures which included SARS-COV-2 test: positive on 20Apr2021 the day before - negative. The patient died in Apr2021 due to COVID-19 aggravated and COVID confirmed by antigen test. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information was expected.; Reported Cause(s) of Death: COVID-19 aggravated; Covid confirmed by antigen test.


VAERS ID: 1546298 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: real-time reverse transcriptase PCR; Test Result: Positive.
CDC Split Type: FRPFIZER INC202101012192

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; sudden death; This is a literature report from the Regulatory Authority, 2021; DOI: 10.1016/j.cmi.2021.06.038 entitled SARS-CoV-2 infection in a long-term care facility after COVID-19 BNT162b2 mRNA vaccination. A 98-year-old female patient received the first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced SARS-CoV-2 infection and sudden on an unspecified date, which were reported as fatal. The patient underwent lab tests and procedures which included real-time reverse transcriptase polymerase chain reaction (PCR): positive on an unspecified date. The patient died on an unspecified date. The cause of death was reported as SARS-CoV-2 infection and sudden death. It was not reported if an autopsy was performed. Coronavirus disease 2019 (COVID-19) is a life-threatening disease, especially for older individuals and people with multiple risk factors. Geriatric environments are therefore at high risk of COVID- 19 outbreaks with increased mortality. We describe an outbreak of nosocomial COVID-19 in a long-term care facility (LTCF) starting 1 month after a double-dose vaccination campaign with the BNT162b2 mRNA vaccine. The 93 residents of the LTCF included 66 females and 27 males with a median age of 88 years (range 63-99 years), none of them immunocompromised. Seventy residents (75.3%) and 38 HCWs (52.1%) were fully vaccinated with two doses of the BNT162b2 mRNA vaccine on 25Jan2021 and 15Feb2021. Among the other 23 residents (24.7%) not vaccinated at the beginning of the outbreak, 11 were not vaccinated due to the residents'' decision, two received one dose of vaccine, and ten received two doses on 9Apr2021 and 30Apr2021 each during the outbreak. Between 15Mar2021 and 06May2021, 40 subjects tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection using either rapid antigen detection (n=18) (Biosynex COVID-19 BSS IgG/IgM) and/or real-time reverse transcriptase PCR (RT-PCR) tests (Biosynex) (n=22) on nasopharyngeal swabs. These COVID-19 cases included 24/93 residents (25.8%) and 16/73 healthcare workers (HCWs) (21.9%). Positive residents were older and more frequently male than their uninfected counterparts: age 91 years (range 72-99 years) and 87 years (range 63-97 years), and of these 10/24 (41.7%) and 17/69 (24.66%) were male, respectively. COVID-19 cases were more frequent among residents who were not fully vaccinated (12/23, 52.2%) than among fully vaccinated residents (12/70, 17.1%). Residents who were vaccinated versus those not fully vaccinated were asymptomatic (four versus two) or displayed mild (four versus three), moderate (four versus four) or severe (none versus three) symptoms. One unvaccinated 83-year-old woman died 1 month after being hospitalized and a 98-year-old fully vaccinated female resident died of sudden death. Variant screening by RT-PCR (COMPANY NAME., COUNTRY NAME) and Sanger sequencing of the spike protein gene identified the SARSCov- 2 alpha variant in all positive samples. Quantitative measurement of anti-spike (S) IgG (Abbott SARS-CoV-2 IgG II Quant assay) was carried out for 79 residents on 6Apr2021, including 62 fully vaccinated residents who all except one displayed positive serology. Three vaccinated residents were infected after that date despite previous high anti-S IgG titres (1452, 4842 and 2861 AU/mL, respectively). To assess the effectiveness of the BNT162b2 mRNA vaccine, we conducted a time-to-event analysis using a multivariate proportional hazard Cox model with vaccination status, age, and gender as covariates. The hazard of developing a SARS-CoV-2 infection was, for fully vaccinated residents, 0.32 times that of subjects who were not fully vaccinated (95%CI 0.14-0.73, p 0.006). Male residents were at significantly higher risk of developing COVID-19 (HR 2.79, 95%CI 1.18-6.59, p 0.02), as were older subjects with an HR of 1.62 for a 5-year increase in age (95%CI 1.16-2.27, p 0.005). The adjusted hazard ratio (HR) for fully versus not fully vaccinated residents was used to estimate the vaccine effectiveness ((1-HR) x100) at 68% (95%CI 27-86%). Sixteen unvaccinated HCWs (16/35, 45.7%; median age 35 years, r 19-59) tested positive for COVID-19 with mild to moderate symptoms, while all the vaccinated HCWs were COVID-19-negative (p < 0.0001). Our results confirm that the BNT162b2 mRNA vaccine was highly effective in preventing COVID-19 infection. Residents who were not fully vaccinated were three times more likely to develop COVID-19. The protective effect of the vaccine is also underscored by the fact that none of the vaccinated residents developed severe COVID-19, whereas this was the case for three residents who were not fully vaccinated. Most of the vaccinated residents had anti-SIgG at the time of the outbreak. Several data on vaccination report the effectiveness of a two-dose regimen with BNT162b2 mRNA vaccine in preventing COVID-19, both in the general population and in older people, including those infected by the alpha variant. Our study confirms the protective effect of the vaccine but underscores that elderly people, despite being vaccinated and displaying positive anti-S IgG up to 4842 AU/mL, are at greater risk of SARS-CoV-2 infection. In our cohort, the vaccine effectiveness (68%) appears lower than the 95% previously reported by Polack et al., possibly related to the age of the LTCF patients reported with natural immunity which, although effective in preventing COVID-19, is lower in older people. This outbreak highlights the critical importance of a high rate of vaccination of residents and HCWs.; Sender''s Comments: 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: sudden death; SARS-CoV-2 infection


VAERS ID: 1546839 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Headache
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: 2021-07-17
   Days after onset: 66
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100987848

Write-up: 12May2021 headache; 17Jul2021: Temporal occipital cortical-subcortical stroke. Upon awakening aphasic, right hemisyndrome. Access to the emergency room at 8.30; 12May2021 headache; 17Jul2021: Temporal occipital cortical-subcortical stroke. Upon awakening aphasic, right hemisyndrome. Access to the emergency room at 8.30; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number IT-MINISAL02-763201. A 68-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: FA5831) via intramuscular route, administered in Left Arm on 12May2021 at 18:09 (68-year-old at vaccination) as Dose 2, 0.3 mL, single for Covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EW2246) via unspecified route of administration on 21 Apr2021 at 13:44 as Dose 1, 0.3 mL, single for Covid-19 immunization. The patient had no adverse event after first dose of vaccination. Physician commented that the second dose of Pfizer vaccine was administered on last 12May, so more than two months before the date of the stroke that led to the death. However, already from the same day of the second dose of Pfizer the patient presented a headache in the left parieto-temporal region of moderate intensity (never had in the past), daily with subsequent improvement but never complete remission. Furthermore, it was reported that the patient had a prior history of completely false before stroke. On 17Jul2021, the patient experienced Temporal occipital cortical-subcortical stroke. Upon awakening aphasic, right hemisyndrome. Access to the emergency room at 8.30. The patient died on 17Jul2021. It was not reported if an autopsy was performed. Health authority comment: Lot and expiry date of physiological solution not available; vaccine reconstitution time not available. No follow-up attempts possible. No further information expected.; Reporter''s Comments: The second dose of Pfizer vaccine was administered on last 12May , so more than two months before the date of the stroke that led to the death. However, already from the same day of the second dose of Pfizer the patient presented a headache in the left parieto-temporal region of moderate intensity (never had in the past), daily with subsequent improvement but never complete remission. Furthermore, it is reported that the patient had a prior history of completely false before stroke; Reported Cause(s) of Death: stroke


VAERS ID: 1547035 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Maternal exposure during pregnancy
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100987608

Write-up: Cerebral venous sinus thrombosis; 25-year-old pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: not reported, Expiration date: not reported), intramuscular on an unspecified date; This is a spontaneous report from a contactable pharmacist received from a Pfizer sales representative. A 25-year-old pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number: not reported, Expiration date: not reported), intramuscular on an unspecified date as dose number unknown, single for COVID-19 immunisation. Body temperature before vaccination, family history, medical history, and concomitant medication were not reported. On an unknown date, the patient experienced cerebral venous sinus thrombosis. On an unknown date, the patient was admitted to the reporting hospital. The course of the event was as follows: The patient was in early pregnancy. On an unknown date, the patient experienced cerebral venous sinus thrombosis after receiving intramuscular BNT162b2. On an unknown date, the patient died after admission to the hospital. The reporting pharmacist reported that the causal relationship was unknown. The reporting pharmacist classified the event as serious (death) and assessed the causality between the event and BNT162b2 was unknown. Therapeutic measures were taken as a result of cerebral venous sinus thrombosis. The patient died on an unspecified date. It was not reported if an autopsy was performed.On an unknown date, the outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events: Cerebral Venous Sinus Thrombosis And Maternal Exposure During Pregnancy and the administration of the 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: Cerebral venous sinus thrombosis


VAERS ID: 1547043 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-08-01
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery disease, Death, Glycosylated haemoglobin
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Reflux oesophagitis; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain
Allergies:
Diagnostic Lab Data: Test Name: HbA1c; Test Result: 8.5 %
CDC Split Type: JPPFIZER INC202101008072

Write-up: Death; coronary artery lesion; This is a spontaneous report from a contactable physician received from the Regulatory authority. Regulatory authority report number is v21122550. A 53-year and 4-month-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, lot number: FD1945, Expiration date: 31Oct2021), via an unspecified route of administration, on 20Jul2021 at 15:30 (the day of vaccination), (at the age of 53-year and 4-month-old) as a single dose for covid-19 immunization. The patient medical history included ongoing type 2 diabetes mellitus (taking medication) from an unknown start date, ongoing reflux oesophagitis (taking medication) from an unknown start date, and chest pain (past history) around 10Jul. Body temperature before vaccination, family history was not reported. The patient concomitant medications included uspecified 2 diabetes mellitus and reflux oesophagitis medications. In Aug2021 (after the vaccination), the patient experienced death. The course of the event was as follows: On 20Jul2021, the patient received the first dose of the vaccine. Afterwards, the patient did not have poor health condition. On the night of 03Aug2021 (around 23:00), the patient''s housemate noticed his abnormality and requested an ambulance. The patient was taken to a hospital while undergoing cardiopulmonary resuscitation. Afterwards, the patient received treatment; however, the death was confirmed (at an unknown time). The cause of death was unknown; thus, an autopsy was scheduled to be performed at Police Station A on 05Aug2021. The patient was a (masked) and a consulate is intervening. Outcome of the event coronary disease was unknown. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was chest pain (past history) around 10Jul. The reporting physician commented as follows: The patient had uncontrolled diabetes mellitus (haemoglobin A1c (HbA1c): 8.5%). The possibility of coronary artery lesion could not be ruled out. The reporting physician requested to contact Police Station A for the autopsy result. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1547058 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Leg ulcer; Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LSJNJFOC20210816486

Write-up: DEATH; This spontaneous report received from a consumer concerned a 68 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: limb ulcer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced death within 12 hours of vaccination. The cause of death was unknown and it was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: This spontaneous report received from consumer and concerned a 68 year-old male who died within 12 hours of receiving the Janssen COVID-19 vaccine. Medical history includes limb ulcer. Concomitant medications were not reported. Laboratory studies, imaging or other diagnostics were not provided. Information is limited in this case, however, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate. This case will be reassessed if new information is received.; Reported Cause(s) of Death: DEATH CAUSE UNKNOWN


VAERS ID: 1547059 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Hypertension
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LSJNJFOC20210816511

Write-up: DEATH; This spontaneous report received from a consumer concerned a 73 year old male. Case reference numbers include The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension. The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number and expiry date not reported) dose and vaccination date not reported, once in total, for prophylactic vaccination. No concomitant medications were reported. The company will perform follow-up to obtain the batch number. On an unspecified date, within 12 hours of vaccination, it was reported that the patient had died. The cause of death was not reported and it was also not reported if an autopsy was performed. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. This report was serious (death). This case, from the same reporter, is linked to cases 20210816481, 20210816515 and 20210816486.; Sender''s Comments: V0: This spontaneous report received from a consumer and concerned a 73 year-old male who died within 12 hours of receiving the Janssen COVID-19 vaccine. Medical history includes hypertension. Concomitant medications were not reported. Laboratory studies, imaging or other diagnostics were not provided. Information is limited in this case, however, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate. This case will be reassessed if new information is received.; Reported Cause(s) of Death: DEATH


VAERS ID: 1547060 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LSJNJFOC20210816515

Write-up: DEATH; This spontaneous report received from a consumer concerned a 74 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced death within 12 hours of vaccination. Cause of death was unknown and it was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: This spontaneous report received from a consumer and concerned a 74 year-old female who died within 12 hours of receiving the Janssen COVID-19 vaccine. Medical history was not reported. Concomitant medications were not reported. Laboratory studies, imaging or other diagnostics were not provided. Information is limited in this case, however, considering the temporal relationship with vaccination, a relationship with Janssen Covid-19 vaccine cannot be ruled out. Therefore, the relationship is considered indeterminate. This case will be reassessed if new information is received.; Reported Cause(s) of Death: DEATH CAUSE UNKNOWN


VAERS ID: 1547170 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood uric acid, Death, Myocardial infarction, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: The patient had history of many diseases (unspecified).
Allergies:
Diagnostic Lab Data: Test Name: Uric acid; Result Unstructured Data: high
CDC Split Type: PHJNJFOC20210811199

Write-up: DEAD ON ARRIVAL; HEART ATTACK; HANDS WERE SWOLLEN; This spontaneous report received from a consumer via a company representative concerned a 7 decade old male of unspecified race and ethnicity. The patient''s height, and weight were not reported. The patient had a history of many diseases (unspecified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, 3 days after getting vaccinated the patient experienced heart attack and was dead on arrival to the hospital. It was reported that the patient had swollen hands. Laboratory data (dates unspecified) included: Uric acid (NR: not provided) high. On an unspecified date, the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on arrival on an unspecified date, and the outcome of heart attack and hands were swollen was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20210816399.; Sender''s Comments: V0: 20210811199-covid-19 vaccine ad26.cov2.s -Dead on arrival, Heart attack. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1547172 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHJNJFOC20210816399

Write-up: DEATH; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age, sex, ethnicity and race. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN and Expiry: UNKNOWN) dose, frequency 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died three days after receiving vaccine and cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome was fetal. This report was serious (Death). This case, from the same reporter is linked to 20210811199.; Sender''s Comments: V0: 20210816399-COVID-19 VACCINE AD26.COV2.S.- Death. This event is considered unassessable. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1547292 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Embolic stroke, Embolism venous, Guillain-Barre syndrome, Pulmonary embolism
SMQs:, Peripheral neuropathy (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTJNJFOC20210809369

Write-up: DEEP VEIN THROMBOSIS; PULMONARY THROMBOEMBOLISM; VENOUS THROMBOEMBOLISM; EMBOLIC STROKE; GUILLAIN-BARRE SYNDROME; This spontaneous report was received from a physician via the Regulatory Authority, case reference number PT-INFARMED-J202107-4266, and concerned a 58 year old female. Initial information was processed with additional information received on 06-AUG-2021. The patient''s weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, intramuscular, batch number: XD955) .5 ml, administered on 15-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced Guillain-Barre Syndrome. On 21-JUL-2021, the patient experienced embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism. On 23-JUL-2021 the patient died due to an unspecified cause. It was unknown if an autopsy was performed. The outcome for the events deep vein thrombosis, pulmonary thromboembolism, venous thromboembolism and embolic stroke were fatal. The outcome of Guillain-Barre syndrome was not reported. This report was serious (Death, and Other Medically Important Condition).; Reporter''s Comments: Sender''s Comments: This spontaneous report, received from a physician via the Regulatory Authority, (case reference number PT-INFARMED-J202107-4266), concerning a 58-year-old female of unknown ethnicity who experienced Guillain-Barre Syndrome on an unspecified date. She was also reported to have experienced time an, embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism 67 days post vaccination. She and died 2 days later. It was unknown if an autopsy was performed. No other pertinent information is reported. Information is limited in this case, and the occurrence of the events could represent background incidence of such events in the general population. Therefore, the relationship of GBS, embolic stroke, deep vein thrombosis, pulmonary thromboembolism, and venous thromboembolism to vaccination is considered unclassifiable due to insufficient information.


VAERS ID: 1548803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-18
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: PCR; Result Unstructured Data: Test Result:Variant B.1.1.7
CDC Split Type: ATPFIZER INC202101016121

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is AT-BASGAGES-2021-39206. A 91-years-old female patient received bnt162b2 (Comirnaty, solution for injection, Lot Number: EJ6797 and expiry date was not reported), dose 2 via an unspecified route of administration on an unspecified date in 2021 as dose 2, single and bnt162b2 (Comirnaty, solution for injection, Lot Number: EL1491 and expiry date was not reported), dose 1 via an unspecified route of administration on 12Jan2021 as Dose 1, single both for COVID-19 immunization. No relevant medical history and no concomitant medications were reported. On 18Apr2021, the patient experienced sars-cov-2 infection and vaccination failure. The patient underwent lab tests and procedures which PCR with results variant b.1.1.7 on an unspecified date in Apr2021. The patient died on an unspecified date due to SARS-CoV-2 infection. The case was assessed as serious. It was not reported if an autopsy was performed. Product quality complaint Conclusion for EL1491: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EL1491. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Product quality complaint Conclusion for EJ6797: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot "EJ6797". A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The outcome was fatal for SARS-CoV-2 infection. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1548809 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-18
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH PS.FC.2336 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: ADAMTS13 activity assay, ADAMTS13 activity decreased, Autoimmune disorder, Coagulation test, Coagulopathy, Pericardial haemorrhage, Platelet count, Sudden death, Thrombocytopenia, Thrombotic thrombocytopenic purpura
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Renovascular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Diflucan; BIKTARVY; EUSAPRIM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: HIV infection (Recent diagnosis of HIV with rapid drop in viral load under HIV inhibitors)
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: ADAMTS13 activity decreased; Result Unstructured Data: Test Result:decreased; Test Date: 20210618; Test Name: Coagulation disorder; Result Unstructured Data: Test Result:Coagulation disorder; Test Date: 20210618; Test Name: Thrombocytopenia; Result Unstructured Data: Test Result:Thrombocytopenia
CDC Split Type: BEPFIZER INC202100987820

Write-up: Sudden death on 18Jun; Blood clotting problem, Coagulation disorder; Autopsy shows much bloody pericardial fluid, Effusion pericardial bloody; thrombotic thrombocytopenic purpura; Thrombocytopenia; Postmortem Diagnostics shows presence of ADAMTS13 inhibitor, ADAMTS13 activity decreased; Autoimmune disorder; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number BE-FAMHP-DHH-N2021-102885. A 52-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 05Jun2021 (Lot Number: PS.FC.2336) as dose 1, single for covid-19 immunisation; fluconazole (DIFLUCAN 100 mg), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 1 DF 1x/day for an unspecified indication; bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate (BIKTARVY), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 1 DF 1x/day for an unspecified indication; sulfamethoxazole, trimethoprim (EUSAPRIM) via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 0.5 DF 1x/day for an unspecified indication. Medical history included hiv infection, recent diagnosis of HIV with rapid drop in viral load under HIV inhibitors. Concomitant medications were not reported. The patient experienced sudden death, blood clotting problem, coagulation disorder, autopsy shows much bloody pericardial fluid, effusion pericardial bloody, thrombotic thrombocytopenic purpura, thrombocytopenia, postmortem diagnostics showed presence of ADAMTS13 inhibitor, ADAMTS13 activity decreased, autoimmune disorder on 18Jun2021. It was unknown if therapeutic measures were taken as a result of event. The patient died on 18Jun2021. An autopsy was performed that revealed autopsy showed abundant bloody pericardial fluid. Postmortem diagnosis shows presence of adamts13 inhibitor which allows the diagnosis of an acquired thrombotic thrombocytopenic purpura, which is often autoimmune and possibly vaccine related. Underlying patient had a recent diagnosis of hiv with rapid drop in viral load under hiv inhibitors. The action taken in response to the event, for fluconazole; bictegravir sodium, emtricitabine, tenofovir alafenamide fumarate; sulfamethoxazole, trimethoprim was unknown. The outcome of events was fatal.; Reported Cause(s) of Death: Sudden death on 18Jun; Blood clotting problem, Coagulation disorder; Autopsy shows much bloody pericardial fluid, Effusion pericardial bloody; thrombotic thrombocytopenic purpura; Thrombocytopenia; Postmortem Diagnostics shows presence of ADAMTS13 in; Autopsy-determined Cause(s) of Death: Autopsy shows abundant bloody pericardial fluid. Postmortem diagnosis shows presence of ADAMTS13 inhibitor which allows the diagnosis of an acquired thrombotic thrombocytopenic purpura, which is often autoimmune and possibly vaccine related. Underlyi


VAERS ID: 1548821 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-29
Onset:2021-06-12
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001530 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Acid reflux (esophageal) (segnalato reflusso, data diagnosi esatta non nota, trattato dal 10.12.2013,); Hip replacement (protesi anca destra)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: Thrombose der Arteria Basilaris; Thrombose der Arteria Basilaris; This regulatory authority case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ISCHAEMIC STROKE (Thrombose der Arteria Basilaris) and ARTERIAL THROMBOSIS (Thrombose der Arteria Basilaris) in a 72-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch nos. 3001941 and 3001530) for COVID-19 vaccination. The patient''s past medical history included Acid reflux (esophageal) (segnalato reflusso, data diagnosi esatta non nota, trattato dal 10.12.2013,) and Hip replacement (protesi anca destra) in March 2021. Concomitant products included PANTOPRAZOLE from 10-Dec-2013 to 14-Jun-2021 for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jun-2021, the patient experienced ISCHAEMIC STROKE (Thrombose der Arteria Basilaris) (seriousness criteria death, hospitalization and medically significant) and ARTERIAL THROMBOSIS (Thrombose der Arteria Basilaris) (seriousness criteria death and hospitalization). The patient died on 14-Jun-2021. The reported cause of death was Arterial thrombosis and Ischaemic stroke. An autopsy was not performed. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication details was reported. Company comments: This is a case of ischaemic stroke and arterial thrombosis which caused the death of a 72-year-old male with history of acid reflux.. Very limited information has been provided at this time. No further information is expected. Reviewed pending translation.; Sender''s Comments: This is a case of ischaemic stroke and arterial thrombosis which caused the death of a 72-year-old male with history of acid reflux.. Very limited information has been provided at this time. No further information is expected. Reviewed pending translation.; Reported Cause(s) of Death: Arterial thrombosis; Ischaemic stroke


VAERS ID: 1548845 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Computerised tomogram head, Interchange of vaccine products, Magnetic resonance imaging head
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT skull; Result Unstructured Data: Test Result:Sinus vein thrombosis with stasis bleeding.; Test Date: 202107; Test Name: MR skull; Result Unstructured Data: Test Result:Sinus vein thrombosis with stasis bleeding.
CDC Split Type: DEPFIZER INC202100996168

Write-up: Sinus vein thrombosis with congestive bleeding; interchange of vaccine products; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority, regulatory authority number DE-PEI-202100152859. A 38-years-old male patient received second dose of bnt162b2 (COMIRNATY; Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 19Jul2021 (at the age of 38-years-old) as a DOSE 2, SINGLE for covid-19 immunisation and covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration on an un-specified date in May2021 (Batch/Lot Number: UNKNOWN), as a DOSE 1, SINGLE for an unspecified indication. The patient medical history and no concomitant medications. The patient experienced interchange of vaccine products on 19Jul2021, and experienced sinus vein thrombosis with congestive bleeding on 22Jul2021. The patient underwent lab tests and procedures which included computerised tomogram head that reflected sinus vein thrombosis with stasis bleeding and magnetic resonance imaging head that reflected sinus vein thrombosis with stasis bleeding on an unspecified date in Jul2021. It was reported as, 3 days after vaccination, on 22Jul2021 the patient experienced Thrombosis of venous sinuses (Sinus vein thrombosis with stasis bleeding). Assessment (source:PEI) was given as unclassifiable. The event required hospitalization and patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the Sinus vein thrombosis with congestive bleeding was fatal whereas, interchange of vaccine products was unknown. No follow-up activities possible. No further information expected. Batch/LOT number could not be obtained. ; Reported Cause(s) of Death: Thrombosis of venous sinuses


VAERS ID: 1548884 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-02
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abscess neck, Asthenia, Cerebrovascular accident, Head discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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), Guillain-Barre 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: Asthma
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210817073

Write-up: STROKE; ABSCESS ON THE NECK; SWOLLEN HEAD; WEAKNESS; FEVER; This spontaneous report received from a consumer via a Regulatory Authority [DE-PEI-CADR2021150254] concerned a 69 year old female. The patient''s weight was 50 kilograms, and height was 160 centimeters. The patient''s concurrent conditions included: asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C1601) dose was not reported, 1 total, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-JUL-2021, the patient experienced abscess on the neck, swollen head, weakness and fever. On 20-JUL-2021, the patient experienced stroke. On an unspecified date, the patient died from accident cerebrovascular. It was unknown if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of stroke on an unspecified date, and had not recovered from weakness, fever, abscess on the neck, and swollen head. This report was serious (Death).; Sender''s Comments: V0: 20210817073-covid-19 vaccine ad26.cov2.s- stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: ACCIDENT CEREBROVASCULAR


VAERS ID: 1548896 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-10
Onset:2021-07-24
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Auscultation, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood glucose, Blood osmolarity, Blood potassium, Blood pressure measurement, Blood sodium, Blood urea, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Gamma-glutamyltransferase, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, PCO2, PO2, Physical examination, Platelet count, Prothrombin level, Prothrombin time, Respiratory rate, SARS-CoV-2 test, Vaccination failure, White blood cell count, pH body fluid
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ACFOL; AMLODIPINE; ELIGARD; ELIQUIS; FLUDROCORTISONE; FUROSEMIDE; MASTICAL D; OMEPRAZOLE; PREDNISONE; HIDROFEROL; PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse drug reaction; Aortic regurgitation; Atrial fibrillation; Blood pressure high; Chronic kidney disease stage 3 ((IgA vasculitis)); Colon cancer; Dysautonomia; Dyslipidemia; Henoch Shonlein purpura (Renal + cutaneous outbreak); Iron deficiency anemia; Lacunar stroke; Microangiopathy; Pulmonary embolism; Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:18 IU/l; Test Name: AST; Result Unstructured Data: Test Result:33 IU/l; Test Name: Cardiac Auscultation; Result Unstructured Data: Test Result:arrhythmic, I do not auscultate murmurs; Comments: arrhythmic, I do not auscultate murmurs...(interfered with by respiratory sounds); Test Name: Lung auscultation; Result Unstructured Data: Test Result:Vesicular murmur decreased, rales in both lung...; Test Name: Pulmonary Auscultation; Result Unstructured Data: Test Result:CVS, bilateral rales (auscultation performed in...; Test Name: arterial bicarbonate; Result Unstructured Data: Test Result:31.6 mmol/L; Test Name: Total Bilirubin; Test Result: 0.2 mg/dl; Test Name: Chloride; Result Unstructured Data: Test Result:119 mmol/L; Test Name: Creatinine; Test Result: 1.88 mg/dl; Test Name: Glucose; Test Result: 141 mg/dl; Test Name: Osmolality calculated; Result Unstructured Data: Test Result:Unknown results mosm/kg; Comments: Not calculable; Test Name: Potassium; Result Unstructured Data: Test Result:3.7 mmol/L; Test Name: Blood Pressure; Result Unstructured Data: Test Result:110/50; Test Name: Blood Pressure; Result Unstructured Data: Test Result:102/52; Test Name: Sodium; Result Unstructured Data: Test Result:158 mmol/L; Test Name: Urea; Test Result: 90 mg/dl; Test Name: Chest X-ray; Result Unstructured Data: Test Result:increased CTI, free costophrenic sinuses; Comments: bilateral interstitial parenchymal infiltrate.; Test Name: Protein c-reactive; Result Unstructured Data: Test Result:221.9 mg/l; Test Name: Gamma-Glutamyltransferase; Result Unstructured Data: Test Result:29 IU/l; Test Name: Hemoglobin; Result Unstructured Data: Test Result:8.9 g/dl; Test Name: Heart rate; Result Unstructured Data: Test Result:62; Comments: Beats for minute; Test Name: INR; Result Unstructured Data: Test Result:1.41; Test Name: Lymphocytes; Result Unstructured Data: Test Result:0.9; Comments: 10*3/ul; Test Name: Neutrophil; Result Unstructured Data: Test Result:6.5; Comments: 10*3/ul; Test Name: NT proBNP; Result Unstructured Data: Test Result:11029 pg/mL; Test Name: arterial O2 saturation; Test Result: 80.9 %; Test Name: saturation; Test Result: 85 %; Test Name: saturation; Test Result: 97 %; Test Name: arterial PCO2; Result Unstructured Data: Test Result:44.300 mmHg; Test Name: arterial pH; Result Unstructured Data: Test Result:7.462; Test Name: Abdomen; Result Unstructured Data: Test Result:air-fluid noises, Soft, depressible; Comments: not painful on palpation. I did not palpate masses or visceromegaly. No data on lung infection.; Test Name: Lower limbs; Result Unstructured Data: Test Result:no edema, no DVT data; Test Name: Platelets; Result Unstructured Data: Test Result:180; Comments: 10*3/ul; Test Name: arterial PO2; Result Unstructured Data: Test Result:46.4 mmHg; Test Date: 20210724; Test Name: arterial PO2; Result Unstructured Data: Test Result:Unknown results mmHg; Test Name: Prothrombin activity; Test Result: 50 %; Test Name: Prothrombin time; Test Result: 16.5 s; Test Name: Breaths per minute; Result Unstructured Data: Test Result:22; Comments: Breaths per minute; Test Date: 20210724; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210725; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Name: Leukocytes; Result Unstructured Data: Test Result:7.76; Comments: 10*3/ul
CDC Split Type: ESPFIZER INC202101003420

Write-up: COVID-19 pneumonia; vaccination failure; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. A 85-year-old male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EX8679), via intramuscularly on 10May2021 as single dose for COVID-19 immunization. The patient received second dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/Lot Number: EW2239), via intramuscularly on 14Apr2021 as single dose for COVID-19 immunization. Medical history included hypertension, adverse drug reaction (ADR to trazodone (akathisia)), dyslipidaemia (No Diabetes mellitus), atrial fibrillation and aortic valve incompetence, henoch-schonlein purpura from 2020 to an unknown date (Renal + cutaneous outbreak), chronic kidney disease (IgA vasculitis), pulmonary embolism, autonomic nervous system imbalance, lacunar stroke, Microangiopathy, Colon cancer, Urinary tract infection and Iron deficiency anemia all from an unknown date and unknown if ongoing. Concomitant medications included folic acid (ACFOL); amlodipine (AMLODIPINE); leuprorelin acetate (ELIGARD); apixaban (ELIQUIS); fludrocortisone (FLUDROCORTISONE); furosemide (FUROSEMIDE); calcium carbonate, colecalciferol (MASTICAL D); omeprazole (OMEPRAZOLE); prednisone (PREDNISONE); calcifediol (HIDROFEROL) and paracetamol (PARACETAMOL) all concomitant medications were taken for an unspecified indication, start and stop date were not reported. It was reported that the patient who woke up with a regular general condition, afebrile with stable hemodynamics, experienced COVID-19 pneumonia with vaccination failure on 24Jul2021. The patient underwent lab tests and procedures which included alanine aminotransferase: 18 IU/l on an unspecified date, aspartate aminotransferase: 33 IU/l on an unspecified date, auscultation: arrhythmic, (I do not auscultate murmurs (interfered with by respiratory sounds)), auscultation: Vesicular murmur decreased, rales in both lung fields (Anamnesis made difficult by the patient''s baseline situation. At our evaluation, a patient with significant respiratory effort, non-productive cough. It did not impress with pain on other levels) on an unspecified date, auscultation: CVS, bilateral rales (auscultation performed in anterior fields) on an unspecified date, blood bicarbonate: 31.6 mmol/l on an unspecified date, blood bilirubin: 0.2 mg/dl on an unspecified date, blood chloride: 119 mmol/l on an unspecified date, blood creatinine: 1.88 mg/dl on an unspecified date, blood glucose: 141 mg/dl on an unspecified date, blood osmolarity: not calculable mosm/kg on an unspecified date, blood potassium: 3.7 mmol/l on an unspecified date, blood pressure measurement: 110/50 on an unspecified date, blood pressure measurement: 102/52 on an unspecified date, blood sodium: 158 mmol/l on an unspecified date, Blood urea: 90 mg/dl on an unspecified date, Chest X-ray: increased CTI, free costophrenic sinuses, bilateral interstitial parenchymal infiltrate on an unspecified date, C-reactive protein: 221.9 mg/l on an unspecified date, Gamma-glutamyltransferase: 29 IU/l on an unspecified date, Haemoglobin: 8.9 g/dl on an unspecified date, Heart rate: 62 Beats for minute on an unspecified date, International normalised ratio: 1.41on an unspecified date, Lymphocyte count: 0.9 10E3 / microL on an unspecified date, Neutrophil count: 6.5 10E3 / microL on an unspecified date, N-terminal prohormone brain natriuretic peptide: 11029 pg/mL on an unspecified date, Oxygen saturation: 80.9% on an unspecified date, Oxygen saturation: 85% and 97%on an unspecified date, PCO2: 44.300mmHg on an unspecified date, pH body fluid:7.462 on an unspecified date, Platelet count: 180 10E3 / microL on an unspecified date, PO2: :46.4mmHg on an unspecified date, Prothrombin level: 50% on an unspecified date, Prothrombin time: 16.5 seconds on an unspecified date, Respiratory rate: 22 Breaths per minute on an unspecified date, White blood cell count: 7.76x10E3 /microL on an unspecified date, SARS-CoV-2 test: Positive (antigen test) on 24Jul2021, SARS-CoV-2 test: Positive CT = 16 (PCR test) on25Jul2021. Physical examination included Abdomen: air-fluid noises and soft, depressible, not painful on palpation. The patient did not palpate masses or visceromegaly. No data on lung infection, on an unspecified date. Physical examination of lower limbs: no edema, no DVT data on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event vaccination failure was reported as Unknown at this time of the report. Clinical judgment: - COVID + bilateral pneumonia. Brescia 2. Seimc-Score 23. Respiratory failure secondary to the above, Acute renal failure on CKD. FG CDK-EPI 31.9. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 pneumonia; vaccination failure


VAERS ID: 1548906 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart failure (Known and effectively treated moderate heart failure); Hypercholesterolemia; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996158

Write-up: Decompensation cardiac; Feeling sick; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-NC20213150.A 86-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 01May2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included heart failure, Known and effectively treated moderate heart failure, hypercholesterolemia, Hypertension arterial.The patient''s concomitant medications were not reported. Malaise and cardiac decompensation that required hospitalization and created loss of independence and a 2nd cardiac decompensation that resulted in death 7 weeks later.Her father felt ill a few hours after the 1st injection of the vaccine and 48 hours after he had the malaise and the decompensation, after his hospitalization, he came to my house and I and I had to hospitalize him again where he died after 2 days.The patient was vaccinated on 01May. At the end of the day, he feels tired. He had a very bad night from May 1st to 2nd and from May 2nd to 3rd. He was breathless on 02May. On 03May21, he felt unwell in the yard of his house. He was then transported and hospitalized near his home. A diagnosis of cardiac decompensation was made. After 10 days of hospitalization, which were difficult for the patient (initially autonomous and active, he became dependent and depressed), the patient was transferred to the Follow-up Care and Rehabilitation for 3 to 4 weeks. His daughter decided to take him home by car, with the doctors agreement.At his daughter''s home, the patient was again short of breath (as soon as he ate, he had dyspnea) with progressive deterioration. He was hospitalized again for a new cardiac decompensation with a fatal evolution 2 days after the beginning of his re-hospitalization.The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of decompensation was fatal, of malaise was recovered. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Decompensation cardiac


VAERS ID: 1548910 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-13
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   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: Dermatosclerosis; Hypertension arterial; Polyarthritis; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100996116

Write-up: Retrosternal chest pain; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-RE20212058 An 85-years-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 10Jul2021 (Batch/Lot Number: FE2707) as dose 1, single for covid-19 immunisation. Medical history included Hypertension arterial, Stroke, Dermatosclerosis, Polyarthritis. The patient''s concomitant medications were not reported. Patient considered to be at risk of developing a severe form of COVID-19 disease, not having contracted COVID-19, not having performed a COVID-19 test. On 10Jul2021, First injection intramuscular with COMIRNATY in right arm. On 12Jul2021, Nothing to report. On 13Jul2021, Appearance of intense retrosternal chest pain leading to the death of the patient. The patient died on 13Jul2021. 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: Intense retrosternal chest pain


VAERS ID: 1549926 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anti-neutrophil cytoplasmic antibody positive vasculitis, Antineutrophil cytoplasmic antibody, Asthenia, Oxygen saturation, Oxygen saturation decreased, Pulmonary alveolar haemorrhage, Renal failure, Slow speech
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Vasculitis (narrow), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Disuse syndrome; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: MPO-ANCA; Result Unstructured Data: Test Result:Most positive; Comments: MPO-ANCA$g=300; Test Date: 20210712; Test Name: SpO2; Result Unstructured Data: Test Result:Decreased
CDC Split Type: JPPFIZER INC202100999793

Write-up: The patient had pulmonary alveolar haemorrhage and renal failure.; The patient had pulmonary alveolar haemorrhage and renal failure.; SpO2 decreased; Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis; the patient spoke slowly; lacked energy; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21122421. A 88-year and 9-month-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 10Jul2021 (the day of vaccination) (Lot number: unknown, Expiration date: unknown) as dose 1, single for covid-19 immunisation. The patient had medical histories of hypertension and disuse syndrome. The family history was not provided. The patient''s concomitant medications were not reported. Body temperature before vaccination was not provided. On 11Jul2021 (one day after vaccination), the patient spoke slowly, and he lacked energy. On 12Jul2021 (2 days after the vaccination), the patient experienced anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis. Since the SpO2 decreased, an ambulance was called at the direction of the visiting physician. The patient had pulmonary alveolar haemorrhage and renal failure. Based on the examination findings of positive P-ANCA (perinuclear ANCA), the patient was diagnosed with ANCA associated vasculitis. On 14Jul2021 (4 days after vaccination), the blood test showed MPO-ANCA$g=300, most positive. On 29Jul2021 (19 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The outcome of the events were unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. It was not reported whether there was other possible cause of the event such as any other diseases.The reporting physician commented as follows: Although it was unknown whether the event was induced by the vaccination or not, the event became severe obviously affected by the vaccination, and thus, this case was reported. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Anti-neutrophil cytoplasmic antibody (ANCA) associated vasculitis


VAERS ID: 1553546 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Myocarditis, Palpitations
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210814534

Write-up: VACCINE INDUCED MYOCARDITIS; MALIGNANT ARRHYTHMIA; HEART RACING; This spontaneous report received from a physician via a Regulatory Authority concerned a 40 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose not reported,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vaccine induced myocarditis, malignant arrhythmia, and heart racing. On 2021, the patient died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of vaccine induced myocarditis and malignant arrhythmia on 2021, and the outcome of heart racing was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender''s Comments: V0-20210814534-Covid-19 vaccine ad26.cov2.S- Vaccine induced myocarditis, Malignant arrhythmia, Heart racing. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1553588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7958 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Pneumonia
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101004009

Write-up: Dyspnoea/breathing slightly difficult; Acute pneumonia; Cough/dry cough; This is a spontaneous report from a non-contactable consumer downloaded from the Agency Regulatory Authority-WEB [DE-PEI-CADR2021142173]. A 100-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 21Jun2021 (Lot Number: FD7958) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 24Jun2021 the patient experienced Cough. On 29Jun2021 the patient experienced Dyspnoea, Acute pneumonia. The outcome of all events was fatal. Clinical course reported that patient got a slight dry cough about three days after the vaccination, which made breathing slightly difficult after a few days. Called a doctor 1 week after the vaccination, who then diagnosed pneumonia. The patient did not want to be admitted to the hospital. It was then treated with antibiotics as well as inhalation and expectorant drugs at home. The cough was relieved, but the shortness of breath was not. On 03Jul2021 called emergency doctor because of increasing difficulty breathing, he still supplied fluid and oxygen. On 04Jul2021, patient was died at breakfast in the morning. The patient died on 04Jul2021. It was not reported if an autopsy was performed. Senders comment: Are you or the person concerned known of any allergies? If yes, which? no. Information on risk factors or previous illnesses: Very old age and the resulting physical old age. Living in one''s own house was only possible with the help of relatives. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cough/dry cough; Dyspnoea/breathing slightly difficult; Acute pneumonia


VAERS ID: 1554595 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Bronchospasm, Cough, Myocardial infarction, Pain
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101004079

Write-up: severe asthma attack; Aches; cough; Bronchospasm; Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 67-year-old female patient received BNT162B2 (COMIRNATY), intramuscularly on 15Jul2021 (lot number FE2707) as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced aches, cough, onset of bronchospasm on 16Jul2021 worsening despite the ventolin taken repeatedly. Hospitalization in severe asthma attack on 19Jul2021. Admission to the emergency room on 19Jul2021. Gradual improvement under treatment of severe asthma attack. The patient died of infarct myocardial in 2021. No autopsy was done. The outcome of event infarct myocardial was fatal, outcome of other events were resolving. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1554604 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-07-01
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Atrial fibrillation; CVA; Ex-alcoholic (weaned alcoholism); Stroke
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: desaturation; Test Result: 65 %; Test Date: 20210727; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210727; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: L452R mutation
CDC Split Type: FRPFIZER INC202101004096

Write-up: COVID-19; Vaccination failure; intestinal obstruction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority FR-AFSSAPS-SE20211964. A 90-years-old female patient received first dose of bnt162b2 (Comirnaty, Solution for injection, lot number: EJ6788), via an unspecified route of administration on 04Feb2021 as dose 1, single and second dose of bnt162b2 (Comirnaty, Solution for injection, lot number: EJ6789), via intramuscular route of administration in left arm on 25Feb2021 as dose 2, single at nursing home; both were for COVID-19 immunisation. The patient medical history included arterial hypertension, atrial fibrillation, stroke, CVA (Cerebrovascular accident), weaned alcoholism. Patient at risk of developing a severe form of COVID-19 disease due to high blood pressure and age. Received anticoagulant as treatment. Concomitant medications were not reported. On 27Jul2021, the patient experienced vaccination failure, COVID-19 with desaturation and intestinal obstruction. She was in a retirement home. Due to vaccination failure, she was die. It was unknown if autopsy was done. On 28Jul2021, she was hospitalized. Portal declaration made on 29Jul2021, medically confirmed. Contracted COVID-19 with L452R mutation with a positive antigen test on 27Jul confirmed by PCR test. Appearance of severity criteria with desaturation at 65% on 28Jul leading to emergency hospitalization and death a few hours later. In emergencies was also diagnosed with intestinal obstruction. Conclusion: declaration of a vaccination failure (Dose2 on 25Feb2021) with the COMIRNATY vaccine in a 90-years-old patient who contracted COVID-19 (positive antigen test on 27Jul) with desaturation and death on 28Jul2021. The patient was died on 28Jul2021.; Reported Cause(s) of Death: Vaccination failure


VAERS ID: 1554645 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:2021-05-02
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101005991

Write-up: 5-month-old male patient; Death; This is a spontaneous report from a contactable consumer received from a regulatory authority. A 5-month-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Apr2021 (Lot number was not reported) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Patient has not had symptoms associated with COVID-19. The patient''s concomitant medications were not reported. T The patient died on 02May2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on unknown date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1554666 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-25
Onset:2021-05-03
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Drug ineffective, Dyspnoea, X-ray
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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:
Current Illness: Arterial hypertension (Arterial hypertension); Bilateral inguinal hernia (Bilateral inguinal hernia); Carotid artery stenosis (bilateraly carotid artery stenosis 50-55%); Diabetes mellitus (Diabetes); Hemiparesis (right) (right-side Hemiparesis); Psychoorganic syndrome (Psychoorganic syndrome)
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular event (Cerebrovascular stroke 2015.); Lichenoid dermatitis (dermatitis lichenoids submammary region)
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: X-ray; Result Unstructured Data: Test Result:radiological development of COVID 19 pneumonia
CDC Split Type: HRPFIZER INC202100990652

Write-up: Drug ineffective; radiological development of COVID 19 pneumonia; Breathing difficult; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB regulatory authority number HR-HALMED-300049880. A 83-year-old female patient received second dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via intramuscular route of administration, administered on 25Jan2021 as dose 2, 0.3 mL, single and patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: unknown), via intramuscular route of administration, administered on Jan2021 as dose 1, 0.3 mL, single for covid-19 immunization. Medical history included Lichenoid dermatitis from an unknown date and unknown if ongoing (dermatitis lichenoids submammary region), ongoing diabetes mellitus (Diabetes), ongoing carotid artery stenosis (bilateraly carotid artery stenosis 50-55%), ongoing Psychoorganic syndrome, cerebrovascular event from an unknown date to 2015 (Cerebrovascular stroke 2015), ongoing Bilateral inguinal hernia, ongoing Arterial hypertension, ongoing hemiparesis right (right-side Hemiparesis). Concomitant medications were not reported. The patient experienced drug ineffective on 03May2021, radiological development of covid 19 pneumonia on 03May2021, breathing difficult on 03May2021. The patient was hospitalized for drug ineffective from 06May2021 to an unknown date. The patient was hospitalized for radiological development of covid 19 pneumonia from 06May2021 to an unknown date. The patient was hospitalized for breathing difficult from 06May2021 to an unknown date. The patient underwent lab tests and procedures which included x-ray: radiological development of covid 19 pneumonia on 06May2021. Therapeutic measures were taken with antiviral treatment, and oxygen replacement therapy as a result of event drug ineffective, radiological development of covid 19 pneumonia, breathing difficult. ADR is adequately labelled was No. The patient died on 09May2021. It was not reported if an autopsy was performed. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1554668 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-06
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest X-ray, Laboratory test, Pulmonary embolism, Ultrasound abdomen, Urinary tract infection, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cachexia; Chemotherapy; Malignant neoplasm of colon; Peritoneal metastases
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no novum abnormalities; Comments: other than urinary tract infection were confirmed; Test Date: 20210706; Test Name: Laboratory test; Result Unstructured Data: Test Result:no novum abnormalities; Comments: other than urinary tract infection were confirmed; Test Date: 20210706; Test Name: Ultrasound abdomen; Result Unstructured Data: Test Result:no novum abnormalities; Comments: other than urinary tract infection were confirmed
CDC Split Type: HUPFIZER INC202101003331

Write-up: Pulmonary embolism; profuse thrombosis of femoral veins both sides; urinary tract infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority HU-OGYI-673321. A 68-year-old female patient received the second dose of BNT162B2 (COMIRNATY, lot number: FD4555, strength: 0.3 ml) (tozinameran), via intramuscular in left arm on 02Jul2021 at 09:21 at 0.3 ml, single dose for COVID-19 immunisation. Medical history included malignant neoplasm of colon since 2018, cachexia, peritoneal metastases and several combined chemotherapeutic treatment since 2019. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: FD1921) on 10Jun2021 at single dose for COVID-19 immunisation. On 06Jul2021, the patient went to the emergency department due to severe abdominal pain. In her home, she experienced frequent urination stimuli, temporary inability to urinate, and then bloody urine. Her stool was a little looser the day before. There was no vomiting. When the patient arrived, she had no difficulty breathing, she was complaining of severe diffuse abdominal pain. Her legs were swollen since a couple of weeks. Abdominal ultrasound, chest X-ray and laboratory examination were performed, no novum abnormalities other than urinary tract infection were confirmed. Hospitalization was recommended due to significant deterioration, severe pain, and dyspnea. Dyspnea did not improve after oxygen support. Her limbs became cool, damp, and she died on 06Jul2021 at 18:30. Autopsy was done, pulmonary embolism due to profuse thrombosis of femoral veins both sides were confirmed as cause of death. Stop date of event pulmonary embolism was reported as 06Jul2021. The outcome of the events pulmonary embolism and profuse thrombosis of femoral veins both sides was fatal. The outcome of the event urinary tract infection was unknown. Sender''s Comment: The patient died 4 days after BNT162B2 vaccination. Cause of death was pulmonary embolism, probably associated with the patient''s underlying disease. The causal relationship between the reported death and Comirnaty is considered unlikely. The case is serious due to hospitalization and fatal outcome. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: profuse thrombosis of femoral veins both sides; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1554744 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-19
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Body temperature, Brain herniation, Cerebral haemorrhage, Computerised tomogram head
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Three-dimensional CT angiography/venography; Result Unstructured Data: Test Result:No apparent cause was found; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: before vaccination; Test Date: 20210719; Test Name: Head CT; Result Unstructured Data: Test Result:Subcortical haemorrhage; Comments: in the left parietal lobe
CDC Split Type: JPPFIZER INC202101001002

Write-up: brain herniation; Cerebral haemorrhage resulted from consciousness disturbed; This is a spontaneous report from a contactable physician received from a regulatory authority. A 49-year and 11-month-old female patient received?the first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) on 15Jul2021 at 10:00 at single dose for COVID-19 immunization. Body temperature before vaccination was 36 degrees centigrade. The patient''s family history and medical history were not reported. There were no points to be considered on the vaccine screening questionnaire. The patient''s concomitant medications were not reported. On 15Jul2021 at 10:00 (the day of vaccination), the patient received?the first dose of BNT162B2. On 19Jul2021 at 10:30 (4 days/hours/minutes after the vaccination), the patient experienced consciousness disturbed. On 24Jul2021 (9 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 19Jul2021, since the patient presented with headache, she made a call to her husband. Thereafter, due to progressing consciousness disturbance, the patient was urgently transferred to the reporting hospital. Head computed tomography (CT) showed subcortical haemorrhage in the left parietal lobe. Three-dimensional CT angiography/venography was performed, but no apparent cause was found. Because of the large haematoma and the sign of brain herniation, craniotomy was performed to remove the haematoma. On 24Jul2021, the patient was discharged dead due to brain herniation. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. There was no other possible cause of the event such as any other diseases. Outcome of the events was fatal. The patient died on 24Jul2021. It was not reported if an autopsy was performed. Reporter''s comment: The patient had cerebral haemorrhage and died. The causal relationship was unknown. However, this case was considered necessary to be reported.; Reporter''s Comments: The patient had cerebral haemorrhage and died. The causal relationship was unknown. However, this case was considered necessary to be reported.; Reported Cause(s) of Death: Cerebral haemorrhage resulted from consciousness disturbed; Brain herniation


VAERS ID: 1554745 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-20
Onset:2021-06-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cholelithiasis, Computerised tomogram, Dysphonia, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Parkinson-like events (broad), Gallbladder related disorders (narrow), Gallstone related disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: contrast-enhanced CT; Result Unstructured Data: Test Result:Unkown results; Comments: for gallstones
CDC Split Type: JPPFIZER INC202101001980

Write-up: Subarachnoid haemorrhage; symptom of difficulty in voicing; gallstones; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. An 86-year-old female patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) on 20Jun2021 at single dose for COVID-19 immunization. Medical history included hypertension. The family history was not provided. The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number unknown, Expiration date unknown) on an unspecified date at single dose for COVID-19 immunization. On 20Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2. On 23Jun2021 (3 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 23Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 20Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2 vaccination. On 21Jun2021 (1 day after vaccination), the patient visited another hospital for contrast-enhanced computerised tomogram (CT) for gallstones. After the CT, the patient had a symptom of difficulty in voicing. On 23Jun2021 (3 days after vaccination), the patient died of subarachnoid haemorrhage. The causality between the event and BNT162b2 was not provided. The patient died on 23Jun2021. It was not reported if an autopsy was performed. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information currently available and known drug safety profile, the reported event subarachnoid haemorrhage more likely represented intercurrent illness, but not related to BNT162B2. The patient''s underlying risk factors/predisposing condition hypertension and the advanced age of the patient have been assessed to provide alternative explanations. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1554747 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Blood pressure systolic, Blood pressure systolic decreased, Body temperature, C-reactive protein, C-reactive protein increased, Heart rate, Heart rate increased, Movement disorder, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:99/60; Comments: with antibiotic and oxygen administration; Test Date: 20210702; Test Name: blood pressure; Result Unstructured Data: Test Result:normal; Test Date: 20210703; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:70; Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Comments: in the afternoon; Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:39.0 Centigrade; Comments: in the evening; Test Name: CRP; Result Unstructured Data: Test Result:high; Test Name: pulse rate; Result Unstructured Data: Test Result:decreased to 50; Test Date: 20210703; Test Name: pulse rate; Result Unstructured Data: Test Result:130-131; Test Name: SpO2; Result Unstructured Data: Test Result:decreased to around 90; Test Name: SpO2; Result Unstructured Data: Test Result:improved to 97; Comments: with antibiotic and oxygen administration; Test Date: 20210702; Test Name: SpO2; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC202101007558

Write-up: the patient had difficulty in moving and it became easy for the patient to fall over; systolic blood pressure was 70; Pulse rate was 130-131; SpO2 decreased to around 90; pyrexia from 37.0 to 39.0; consciousness was slightly unclear; high level of CRP; Respiratory arrest; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 9-decade-old patient of an unspecified gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on 01Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. On 01Jul2021, the patient of unknown gender in late 80s received BNT162b2 (COMIRNATY, Solution for injection, Dose number, Lot number and Expiration date were not reported) via an unspecified route of administration as the first single dose for COVID-19 immunization at a medical facility different from the reporter''s. On 02Jul2021 (1 day after the vaccination), the patient had difficulty in moving and it became easy for the patient to fall over. Therefore, the patient was admitted to the reporter''s hospital. The patient''s consciousness was slightly unclear, so the patient visited the neurosurgery department. There were no problems in particular. Since high level of CRP (C-reactive protein) was noted, the patient was referred to the internal medicine. Shortly after the hospitalization, blood pressure and SpO2 (oxygen saturation percutaneous) were in normal range. One day after the hospitalization (03Jul2021) in the afternoon, the patient developed fever of 37.0 degrees Centigrade. In that evening, it went up to 39.0 degrees Centigrade. Pulse rate was 130-131, and systolic blood pressure was 70. SpO2 decreased to around 90, but SpO2 and blood pressure improved to 97 and 99/60 respectively with antibiotic and oxygen administration. However, several days after, pulse rate decreased to 50 and respiratory arrest developed, and then the patient died. It was unknown whether autopsy was performed. The reporting physician''s opinion was as follows: The causal relationship between the with BNT162b2 was unknown. Since the symptoms occurred after the vaccination resulted in death, this case was reported. The outcome of respiratory arrest was fatal, outcome of systolic blood pressure was 70, spo2 decreased to around 90 was recovering, outcome of other events was unknown. The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events movement disorder, Blood pressure systolic decreased, Altered state of consciousness, heart rate increased, oxygen saturation decreased and respiratory arrest cannot be totally excluded/assessed. The case will be reassessed when the information particularly about patient''s medical history and concomitant medication 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.; Reported Cause(s) of Death: Respiratory arrest


VAERS ID: 1554749 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-01
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   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: Test Date: 20210721; Test Name: body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101007602

Write-up: Death; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 54-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 21Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was a 54-year-old male. Body temperature before vaccination was 36.0 degrees centigrade. The patient had no medical history or history of allergy according to the screening questionnaire. On 21Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) intramuscularly as a single dose for COVID-19 immunization. On 01Aug2021 (eleven days after the vaccination), the patient died. Cause of death was unknown. The course of the event was as follows: On 21Jul2021, the day of vaccination, the wife of the patient was visiting the reporter clinic, and the patient received the first dose of Comirnaty with the wife. On 03Aug2121, the local police found the vaccination coupon and the patient registration card and contacted the reporter to inform that the patient had died at home on 01Aug2021. On 04Aug2021, the son of the patient called the reporter to cancel the second dose because the patient had died. The son told that the patient played golf with the wife on 28Jul2021 (seven days after the vaccination). The clinic had not heard of poor condition or anything. Legal autopsy was performed as suspicious death. There was no more information as of this report. The reporting physician classified the event as serious (death) and commented the causality was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: The information on the circumstances of the patient''s death is too limited to perform a meaningful company causality assessment: this event is handled as related to the suspect product BNT162B2 as a cautionary measure and for reporting purposes. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1554750 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination complication
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101025315

Write-up: Vaccination adverse reaction; This is a spontaneous report from a non-contactable consumer (a patient''s relative) via Pfizer sales representative. A patient of unspecified age and gender received BNT162b2 (COMIRNATY, Batch/Lot number was not reported) on an unspecified date (at an unspecified age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side reactions with vaccine manufactured by Pfizer (Vaccination adverse reaction). On 05Aug2021 at 13:34, the consumer reported via phone that the patient died from side reactions with vaccine manufactured by Pfizer on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Vaccination adverse reaction


VAERS ID: 1554751 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN; BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Chronic kidney disease; Renal failure; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021904535

Write-up: death/ Acute cardiac death was reported as possible causes of the event such as any other diseases; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21119953. A 82-year-old (reported as 82-year and 7-month-old) male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 07Jul2021 (Batch/Lot Number: FC5947; Expiration Date: 30Sep2021) as DOSE 1, SINGLE for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade. Medical history included chronic kidney disease, type 2 diabetes mellitus, renal failure and cardiac failure; all from an unknown date and unknown if ongoing. Concomitant medications included warfarin and acetylsalicylic acid (BAYASPIRIN) both taken for an unspecified indication from an unspecified start date and ongoing. On 15Jul2021 at 14:00 (8 days after the vaccination), the patient died. The course of the events was as follows: On 07Jul2021, the patient received the vaccine. After the vaccination, he was observed for 30 minutes and then he returned home. The police informed the reporter that the patient was found dead at home on 15Jul2021. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was not related to BNT162b2. Acute cardiac death was reported as possible causes of the event such as any other diseases. The reporting physician commented as follows: The patient had renal failure and cardiac failure and he was supposed to receive hemodialysis, and just prior to that, he died. Therefore, it was considered that the event was not related to BNT162b2 directly. It was not reported if an autopsy was performed.; Sender''s Comments: The 82-year-old died just prior to receive hemodialysis for her underlying renal failure and cardiac failure. The reported acute cardiac death was likely due to her pre-existing diseases/conditions and unrelated to vaccine of BNT162b2.; Reported Cause(s) of Death: Cardiac death


VAERS ID: 1554813 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-25
Onset:2021-07-25
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatinine, Blood sodium, Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Chest X-ray, Diarrhoea, Dyspnoea, Eosinophil count, Fibrin D dimer, Glomerular filtration rate, Haematocrit, Haemoglobin, Hypoxia, Investigation, Lymphocyte count, Oxygen saturation, Platelet count, SARS-CoV-2 test, Tachypnoea, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Respiratory failure (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: 2021-07-28
   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: DOXAZOSIN; AMLODIPINE; ELTROXIN; GLICLAZIDE; OMNIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; Diabetes; Hypertension; Hypothyroidism; Non-smoker
Allergies:
Diagnostic Lab Data: Test Date: 20210725; Test Name: Creatinine; Result Unstructured Data: Test Result:130 umol/l; Comments: raised; Test Date: 20210725; Test Name: sodium; Result Unstructured Data: Test Result:134 mmol/L; Test Date: 20210725; Test Name: body temperature; Result Unstructured Data: Test Result:37.1; Test Date: 20210725; Test Name: chest x-ray; Result Unstructured Data: Test Result:Confulent air space shadowing at periphery of the; Comments: Confulent air space shadowing at periphery of the right upper lobe. Patchy consolidation at periphery of left middle to lower lung zones. Findings suggestive of COVID pneumonia; Test Date: 20210725; Test Name: CRP; Result Unstructured Data: Test Result:60.6 mg/l; Comments: raised; Test Date: 20210725; Test Name: eosinophils; Result Unstructured Data: Test Result:0.0 x10 9/l; Test Date: 20210725; Test Name: D-Dimer; Result Unstructured Data: Test Result:880 ng/ml; Comments: raised; Test Date: 20210725; Test Name: EGFR; Result Unstructured Data: Test Result:47; Comments: raised; Test Date: 20210725; Test Name: haematocrit; Test Result: 38 %; Test Date: 20210725; Test Name: haemoglobin; Result Unstructured Data: Test Result:13.3 g/dl; Comments: decreased; Test Date: 20210725; Test Name: red cell count; Result Unstructured Data: Test Result:4.37 x10 12/l; Test Date: 20210725; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.66 x10 9/l; Comments: decreased; Test Date: 20210725; Test Name: SpO2; Test Result: 83 %; Test Date: 20210725; Test Name: SpO2; Test Result: 98 %; Comments: after given 10L NFM; Test Date: 20210725; Test Name: platelets; Result Unstructured Data: Test Result:95 x10 9/l; Comments: decreased; Test Date: 20210725; Test Name: RT-PCR test; Test Result: Positive ; Comments: RT-CPR, new infection, CT15
CDC Split Type: MTPFIZER INC202101005054

Write-up: Acute kidney injury; hypoxemia; dyspnea; Tachypnea; Diarrhea; positive for COvid-19 on RT-PCR test; COVID 19 pneumonia; positive for COvid-19 on RT-PCR test; This is a spontaneous report from a contactable physician. A 95-year-old male patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6136), via intramuscular route of administration on 25Feb2021, as dose 2, single in left arm; and received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6134), via intramuscular route of administration on 04Feb2021, as dose 1, single for COVID-19 immunization. The patient''s medical history included hypertension, diabetes, benign prostatic hyperplasia, hypothyroidism, and patient was a non-tobacco user. Concomitant medication included doxazosin 4 mg, daily; amlodipine 5 mg, daily; levothyroxine sodium (ELTROXIN) 100 mg, daily; gliclazide 40 mg, daily; and tamsulosin hydrochloride (OMNIC) 0.4 mg, daily; all taken for unspecified indications, start and stop date were not reported. On 25Jul2021, 5 months after the second dose of vaccine, the patient was tested positive for COVID-19 on RT-PCR test, indicating vaccination failure. On 28Jul2021, 5 months and 3 days after the second dose, the patient experienced COVID-19 pneumonia. Events COVID-19 and COVID-19 pneumonia were reported as fatal. On an unspecified date, after the second dose of vaccine, the patient experienced acute kidney injury, hypoxemia, dyspnea, tachypnea and diarrhea; which led to hospitalization on 25Jul2021 up to an unspecified date. The patient receives additional therapies for COVID-19 that included: Remdesivir on 25Jul2021 and 6mg dexamethasone daily on 25Jul2021. The patient was not admitted to an Intensive Care Unit. No pre-existing diseases worsened during the SARS-CoV2 infection. The patient has not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The patient underwent lab tests and procedures which included body temperature: 37.1; SpO2: 83% on air which improved to 98% on 10L NFM, desaturation to about 85% with minimal exertion, moving to edge of bed; chest x-ray: confluent air space shadowing at periphery of the right upper lobe, patchy consolidation at periphery of left middle to lower lung zones, findings suggestive of COVID pneumonia; SARS-CoV-2 test: positive (RT-CPR, new infection, CT15); fibrin d dimer (normal range 0 - 500 ng/ml): 880 raised; haemoglobin (normal range: 14.1 - 17.2 g/dl): 13.3 decreased; haematocrit (normal range: 40.4 - 50.4 %): 38; platelet count (normal range: 146 - 302x10^9/L): 95 decreased; lymphocyte count (normal range: 1.30 - 3.60 x 10^9/L): 0.66 decreased; Eosinophils (normal range: 0.10 - 0.70x10^9/L): 0; Red cell count (normal range: 4.60 - 5.90 x 10^12/L): 4.37; blood creatinine (normal range: 59-104 umol/l): 130 raised; glomerular filtration rate: 47 raised; C-reactive protein (normal range: 0-5 mg/L): 60.6 raised; and sodium (normal range: 136-145mmol/l): 134. The patient died on 28Jul2021. An autopsy was not performed. Primary cause of death was reported as COVID-19 pneumonia. The clinical outcome of events COVID-19 pneumonia, COVID-19, and vaccination failure was fatal. The clinical outcome of all other events was unknown. Follow-up activities completed. No further information expected.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the all the reported events and the suspect drug BNT162B2 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: covid-19 pneumonia


VAERS ID: 1554835 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-19
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary fibrosis, Respiratory disorder
SMQs:, Interstitial lung disease (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101007835

Write-up: pulmonary fibrosis; Respiratory disorder; This is a spontaneous report from a contactable physician from a regulatory authority. A 78-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 06Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced respiratory disorder on 19Jul2021, pulmonary fibrosis on unspecified date. The patient died on 19Jul2021. It was not reported if an autopsy was performed. The events were reported as unrelated to vaccine. The outcome of events was fatal. Reporters description of AEFI: CARM report onset date is death date and onset time unknown. The patient had covid vaccine 06Jul2021. Died on 19Jul2021 - of pulmonary fibrosis (Report states death as 18Jul2021 but NHI date used). Death not unexpected but thought should report as just had vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the information currently available, the events respiratory disorder and pulmonary fibrosis most likely represented the intercurrent /underlying medical conditions and were unrelated to Bnt162b2 vaccine. Case will be re-assessed upon the additional information provided.; Reported Cause(s) of Death: pulmonary fibrosis; Respiratory disorder


VAERS ID: 1554836 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101007888

Write-up: Myocardial infarction; Chest discomfort; Dizziness; Dyspnoea; This is a spontaneous report from a contactable consumer received from the regulatory authority. Regulatory authority report number is AEFI-A-008000. A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on 18Jul2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chest discomfort, dizziness, dyspnoea and myocardial infarction on 23Jul2021. The events were considered serious due to death. The events were considered unrelated to the vaccine. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on plausible temporal relationship, a possible causal association between the all the reported events and the suspect drug BNT162B2 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: Chest discomfort; Dizziness; Dyspnoea; Myocardial infarction


VAERS ID: 1554837 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-03
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agitation, Angioedema, Anxiety, Bronchospasm, Chest discomfort, Dizziness, Feeling of body temperature change, Headache, Mouth ulceration, Pyrexia, Rash, Urticaria, Vaccination site pain, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Dementia (broad), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC202101007905

Write-up: Agitation; Angioedema; Anxiety; Bronchospasm; Chest discomfort; Dizziness; Feeling of body temperature change; Headache; Injection site pain; Mouth ulceration; Pyrexia; Rash; Urticaria; Vomiting; This is a spontaneous report from a contactable consumer from the Medsafe. Regulatory authority report number is AEFI-A-008036. A 66-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 28May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Historical Vaccine included Comirnaty (Dose1, single) for COVID-19 immunization and experienced Ulcers. Also ulcers Had a lot of this after 1st jab but worsened after 2nd. Events: Agitation, Angioedema, Anxiety, Bronchospasm, Chest discomfort, Dizziness, Feeling of body temperature change, Headache, Injection site pain, Mouth ulceration, Pyrexia, Rash, Urticaria, Vomiting on 03Jun2021. Seriousness was provided as died. The event outcome was Died-unclassifiable. The patient died in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Agitation; Angioedema; Anxiety; Bronchospasm; Chest discomfort; Dizziness; Feeling of body temperature change; Headache; Injection site pain; Mouth ulceration; Pyrexia; Urticaria; Vomiting; Rash


VAERS ID: 1554876 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-26
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FB5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   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: PHPFIZER INC202101007720

Write-up: Cough; Fever; Difficulty breathing; This is a spontaneous report from a contactable other hcp. This is a report received from the regulatory authority. Regulatory authority report number PH-PHFDA-300094757. A 76-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 02Jul2021 (Batch/Lot Number: FB5996) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced cough and fever, difficulty breathing on 26Jul2021. The patient died on 26Jul2021. The outcome of all events was fatal. No follow-up attempts are possible. No further information is expected. ; Reported Cause(s) of Death: Cough; Fever; Difficulty breathing


VAERS ID: 1555437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-03-15
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: COVID-19 PCR TEST; Test Result: Positive ; Comments: Variant PCR based: B.1.1.7
CDC Split Type: ATPFIZER INC202101016126

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory authority number AT-BASGAGES-2021-39202. An 85-year-old male patient received bnt162b2 (COMIRNATY, Formulation: solution for injection), dose 2 via an unspecified route of administration on 29Jan2021 (Lot Number: EJ6134; Expiration Date: 30Apr2021) as DOSE 2, SINGLE and dose 1 via an unspecified route of administration on 08Jan2021 (Lot Number: EJ6796; Expiration Date: 30Apr2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient had no relevant medical history and concurrent conditions. No concomitant medications were reported. On 15Mar2021, the patient experienced sars-cov-2 infection and vaccination failure. The patient underwent lab tests and procedures on an unspecified date in 2021 included sars-cov-2 test: positive for Variant PCR based: B.1.1.7. The patient died on an unspecified date.It was not reported if an autopsy was performed or not. Conclusion: The investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect was not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. Conclusion: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6134. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555438 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-06-07
   Days after vaccination:117
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210607; Test Name: SARS-CoV-2 test PCR; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016173

Write-up: SARS-CoV-2 infection/ Variant PCR based: B.1.1.7; N501Y positive; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39210. A 98-year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6136), via an unspecified route of administration on 10Feb2021 as dose 2, single dose and first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6796), via an unspecified route of administration on 20Jan2021 as dose 1, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 07Jun2021, patient experienced SARS-CoV-2 infection, variant PCR based: B.1.1.7; N501Y positive. Physician reported as serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Jun2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event vaccination failure was unknown and SARS-CoV-2 infection was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555439 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-12
   Days after vaccination:38
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Sars-cov-2 test; Result Unstructured Data: Test Result:variant sequenced: B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016151

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Authority number AT-BASGAGES-2021-39211. An 81-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), second dose via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EJ6797) as a single dose and first dose via an unspecified route of administration on 12Jan2021 (Batch/Lot Number: EJ6796) as a single dose for COVID-19 immunisation. No medical history and concomitant medications were reported. On 12Mar2021, the patient had sars-cov-2 infection, vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: variant sequenced: b.1.1.7; n501y positive on an unspecified date in 2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555440 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-03-23
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: sars-cov-2 PCR test; Test Result: Positive; Comments: B.1.1.7, N501Y.
CDC Split Type: ATPFIZER INC202101016143

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB with regulatory authority number AT-BASGAGES-2021-39214. An 86-year-old male patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EJ6796) via an unspecified route of administration on 13Jan2021 as dose 1, single and received BNT162b2 (COMIRNATY, Solution for injection, Lot Number: EJ6134) via an unspecified route of administration on 03Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 23Mar2021 the patient experienced vaccination failure, Sars-cov-2 infection (COVID-19). The patient underwent lab tests and procedures which included Sars-cov-2 test (B.1.1.7, N501Y) with result as positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. As of 10Aug2021, QC investigation results for batch EJ6796 and EJ6134 received from PQC team. Investigation summary from PQC conclusion included that the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6134. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555441 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-19
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Sars-cov-2 test; Test Result: Positive; Comments: PCR variant based B.1.1.7; N501Y positive.
CDC Split Type: ATPFIZER INC202101016147

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39215. A 92-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6134, Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location, with unknown dosage on 04Feb2021 as single dose and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6797, Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location, with unknown dosage on 14Jan2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on 19Feb2021, the patient developed sars-cov-2 infection and the patient died on an unspecified date in 2021 due to this. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (PCR variant based B.1.1.7; N501Y positive). The outcome for the event sars-cov-2 infection was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: sars-cov-2 infection


VAERS ID: 1555442 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-03-26
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210326; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result: positive.
CDC Split Type: ATPFIZER INC202101016159

Write-up: SARS-CoV-2 infection/variant sequenced B.1.1.7; N501Y positive; vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39216. A 81-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6797), via an unspecified route of administration on 04Feb2021 as dose 2, single dose and BNT162B2 (COMIRNATY, Solution for injection, Lot number: EJ6796), via an unspecified route of administration on 14Jan2021 as dose 1, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Mar2021, patient experienced SARS-CoV-2 infection, variant sequenced B.1.1.7; N501Y positive and vaccination failure. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Mar2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection.


VAERS ID: 1555443 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-03-23
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016162

Write-up: SARS-CoV-2 infection; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-39217. A 96-year-old female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection), second dose via an unspecified route of administration on 09Feb2021 (Batch/Lot Number: EJ6136), as a single, first dose via an unspecified route of administration on 15Jan2021 (Batch/Lot Number: EJ6797), as a single for COVID-19 immunisation. No medical history and concomitant medications were reported. On 23Mar2021, the patient experienced Sars-Cov-2 infection. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-10
Onset:2021-04-10
   Days after vaccination:59
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: SARS-CoV-2; Result Unstructured Data: Test Result: Positive.
CDC Split Type: ATPFIZER INC202101016154

Write-up: SARS-CoV-2 infection; drug ineffective; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39218. A 83-year-old female patient received bnt162b2 (COMIRNATY; Solution for Injection, Batch/Lot Number: EK9788), via an unspecified route of administration on 10Feb2021, as DOSE 2, SINGLE, dose 1 intramuscular on 19Jan2021 (COMIRNATY; Solution for Injection, Batch/Lot Number: EJ6797) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient experienced Sars-COV-2 infection, Vaccination failure on 10Apr2021.The patient underwent lab tests and procedures which included covid-19: positive on 10Apr2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2.


VAERS ID: 1555445 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-03-28
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, 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: 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: SARS-CoV-2 test; Result Unstructured Data: Test Result:positive
CDC Split Type: ATPFIZER INC202101016166

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority. The regulatory authority report number is AT-BASGAGES-2021-39219. A 86-years-old male patient received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6134 and Expiration date was not reported), via an unspecified route of administration on 09Feb2021 as dose 2, single and first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EL1491 and Expiration date was not reported), via an unspecified route of administration on 19Jan2021 as dose 1, single for covid-19 immunization. The patient''s medical history and concurrent conditions was reported as no. The patient''s concomitant medications were not reported. On 28Mar2021 the patient experienced vaccination failure, sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test positive on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1555446 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-30
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: SARS-CoV-2 test PCR; Test Result: Positive ; Comments: Variant PCR based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016193

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable Physician from Regulatory Authority. An 82-years-old female patient received first dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, lot number: EL1491, expiry date: unknown) via unspecified route of administration on 21Jan2021 as dose 1, single and second dose of BNT162B2 (COMIRNATY, Formulation: solution for injection, lot number: EJ6134, expiry date: unknown) via unspecified route of administration on 11Feb2021 as dose 2, single for Covid-19 immunisation. No relevant medical history and no concomitant medications were reported. On 30Apr2021, patient experienced SARS-CoV-2 infection and vaccination failure. The patient underwent lab test which included SARS-CoV-2 PCR test, with positive results (Verbatim: Variant PCR based B.1.1.7; N501Y positive) on 30Apr2021. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555447 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-04-07
   Days after vaccination:55
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-07
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: SARS-COV-2; Result Unstructured Data: Test Result:N501Y positive
CDC Split Type: ATPFIZER INC202101016198

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-39228. A 85-years-old male patient received bnt162b2 (COMIRNATY, Solution for Injection), dose 2 via an unspecified route of administration on 11Feb2021 (Lot Number: EJ6790) as dose 2, single and dose 1 via an unspecified route of administration on 21Jan2021 (Lot Number: EJ6134) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Apr2021, the patient was diagnosed with SARS-COV-2 infection i.e. SARS-COV-2 test showed N501Y positive and he was died due to same. On an unknown date vaccination failure was noted. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555448 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-11
Onset:2021-05-05
   Days after vaccination:83
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: ATPFIZER INC202101016187

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable Physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-39229. A 95-year-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number: EK9788, Expiration Date was not reported) via an unspecified route of administration on 11Feb2021 as dose 2, single and received first dose (Batch/Lot number: EL1491, Expiration Date was not reported) via an unspecified route of administration on 21Jan2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, On 05May2021, it was reported that vaccination failure and patient experienced SARS-CoV-2 infection. DE: N501Y positive.The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed and reported cause of death was SARS-CoV-2 infection and vaccination failure. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1555449 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-03-10
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, 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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 infection; Result Unstructured Data: Test Result:SARS-CoV-2 infection
CDC Split Type: ATPFIZER INC202101016185

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-39230. A 94-year-old male patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: EJ6134), via an unspecified route of administration on 26Jan2021 as dose 1, single and again received BNT162B2 (COMIRNATY, Formulation: solution for injection, Batch/Lot Number: EJ6790), via an unspecified route of administration on 16Feb2021 as dose 2, single for COVID-19 immunization. No medical history and concomitant medications were reported. On 10Mar2021, the patient experienced vaccination failure following a SARS-CoV-2 infection. The patient underwent lab tests which included SARS-CoV-2 test: Positive (SARS-CoV-2 infection) on an unspecified date in 2021. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1555450 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-04-26
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: COVID-19 PCR; Result Unstructured Data: Test Result:DE: variant PCR based B.1.1.7; N501Y positive; Comments: DE: variant PCR based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016210

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39231. A 69-year-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- EJ6790) via an unspecified route of administration on 17Feb2021 as dose 2 single and received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number- EJ6134) via an unspecified route of administration on 27Jan2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 26Apr2021 the patient experienced SARS-CoV-2 infection, vaccination failure. On an unspecified date, DE: variant PCR based B.1.1.7; N501Y positive. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555451 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-15
   Days after vaccination:56
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016212

Write-up: SARS-CoV-2 infection; Drug ineffective; This is a spontaneous report from a contactable physician from Austria downloaded from the regulatory authority, regulatory authority number AT-BASGAGES-2021-39236. A 74-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EP2163; Batch no: not reported) via an unspecified route of administration on 18Feb2021 as dose 2 and BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Lot Number: EJ6134; Batch no: not reported) via an unspecified route of administration on 28Jan2021 as dose 1 both as single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 15Apr2021 the patient experienced SARS-COV-2 infection (Covid-19) with drug ineffective. The patient died on an unspecified date. The cause of death was SARS-COV-2 infection. It was not reported if an autopsy was performed. No sequencing of the virus variant was available. No follow-up attempts is possible. No further information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555452 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-04-11
   Days after vaccination:51
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: COVID-19 test; Test Result: Positive ; Comments: N501Y positive
CDC Split Type: ATPFIZER INC202101016220

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report received from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39237. An 81-years-old male patient received second dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EP2163), via an unspecified route of administration on 19Feb2021 as dose 2, single and first dose via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: EJ6136) as dose 1, Single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 11Apr2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. The patient underwent lab tests and procedures which included COVID-19 test: positive on N501Y positive. The patient died on an unspecified date. It was not reported if an autopsy was performed. Cause of death was unknown. The outcome for event SARS-CoV-2 infection was fatal. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1555453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-04-03
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210403; Test Name: Sars-cov-2 test; Test Result: Positive ; Comments: No sequencing of the virus variety available
CDC Split Type: ATPFIZER INC202101016223

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-39238. An 86-years-old male patient received second dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: ET1831), via an unspecified route of administration on 15Mar2021 as dose 2, single and first dose of bnt162b2 (COMIRNATY, formulation: Solution for injection, Lot number: EP2163), via an unspecified route of administration on 22Feb2021 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on 03Apr2021, the patient developed Vaccination failure, sars-cov-2 infection and the patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures on 03Apr2021 which included sars-cov-2 test: positive (No sequencing of the virus variety available). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1555454 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-11
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016227

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority AT-BASGAGES-2021-39239. A 71-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot number EJ6790) at single dose for COVID-19 immunisation on 24Feb2021, and the second dose of BNT162B2 (COMIRNATY, Lot number ET1831) at single dose for COVID-19 immunisation on 17Mar2021. No relevant medical history was reported. Relevant concomitant drug was not reported. On 11Apr2021 the patient experienced Vaccination failure, and SARS-CoV-2 infection. The patient died due to the event on unknown date. No sequencing of the virus variant was available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1555455 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-07-10
   Days after vaccination:78
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016230

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB AT-BASGAGES-2021-39262. A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot number ET7205) at single dose for COVID-19 immunisation on 02Apr2021, and the second dose of BNT162B2 (COMIRNATY, Lot number EX0893) at single dose for COVID-19 immunisation on 23Apr2021. No relevant medical history was reported. Relevant concomitant drug was not reported. On 10Jul2021 the patient experienced Vaccination failure, and SARS-CoV-2 infection. The patient died due to the events on unknown date. No sequencing of the virus variant was available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1555489 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9309 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety (of work); Chronic gingivitis; Cigarette smoker (4-5 a day); Fibula fracture; Lymphadenopathy (left cervical x3, Axillary: 1 on each side, less than 1 cm, Inguinal: 1 on each side); Migraine without aura; Pollen allergy; Surgery (Surgical History included tibia and fibula fracture (ski).); Thrombocytosis (Thrombocytosis (936x103 / uL) of unknown origin, for 1 year); Tibia fracture
Allergies:
Diagnostic Lab Data: Test Name: Thrombocytosis; Result Unstructured Data: Test Result:936; Comments: 10*3/ul
CDC Split Type: ESPFIZER INC202101003487

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority WEB ES-AEMPS-962569. A 34-year-old male patient received first dose of BNT162B2 (COMIRNATY), via intramuscular route on 23Jul2021 (Batch/Lot Number: FD9309), as single dose for COVID-19 immunisation. Medical history included chronic gingivitis (2014), Episodes of anxiety (work), Migraine without aura under occasional treatment with naproxen (since February he has not picked up any containers at the pharmacy, which suggests that he has not suffered many episodes in recent months), Pollen allergy. Surgical History included tibia and fibula fracture (ski). Activity information included a lot of mountain and bicycle. Toxic habits included Tobacco 4 to 5 cigarettes a day. The patient was under study for Thrombocytosis (936x103 / uL) of unknown origin, for 1 year. At the last Hematology consultation (17Jun2021), a body CT scan and molecular study of thrombocythemia are requested. Lymphadenopathy: left cervical x3, Axillary: 1 on each side, less than 1 cm, Inguinal: 1 on each side, harder; but mobile and not painful. Concomitant medications were not reported. On 24Jul2021, the patient was found dead in his house. After notification to the emergency room, he is transferred to carry out a judicial autopsy. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death


VAERS ID: 1555601 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fatigue, Pneumonia, Pyrexia, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: body temperature; Result Unstructured Data: Test Result:fever
CDC Split Type: GRPFIZER INC202101004131

Write-up: Thrombosis NOS; Fatigue; Pneumonia; Fever; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20216286. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 30Apr2021 (Batch/Lot Number: Unknown) as DOSE 2, single for covid-19 immunization. The patient medical history was not reported. The patient received the first single dose of Comirnaty on 09Apr2021 intramuscular for covid-19 immunization. The patient''s concomitant medications were not reported. The patient presented fever, fatigue and pneumonia on the first days of May and he was admitted to hospital (9 days hospitalization). The patient experienced thrombosis nos on 28May2021. All the events were fatal, medical significant and causality hospitalization. The patient died on 28May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Thrombosis NOS; fatigue; fever; pneumonia


VAERS ID: 1555628 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101016117

Write-up: Vaccination carried out in the afternoon. In the evening onset of convulsions and loss of consciousness. Called 118 and rushed to hospital.; Vaccination carried out in the afternoon. In the evening onset of convulsions and loss of consciousness. Called 118 and rushed to hospital.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority:IT-MINISAL02-767116. An 86-year-old female patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, lot number: unknown) via intramuscular route of administration on 01Jun2021 (at the age of 86 years old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jun2021, the patient''s vaccination carried out in the afternoon, in the evening onset of convulsions and loss of consciousness, called 118 and rushed to hospital. The patient died on an unspecified date in 2021. The death was due to convulsions and loss of consciousness. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information was expected.; Reporter''s Comments: It should be noted that the patient, despite her age, did not have heart or hypertensive pathologies, nor had she ever suffered from convulsions, was independent and in general good health.; Reported Cause(s) of Death: Vaccination carried out in the afternoon. In the evening onset of convulsions and loss of consciousness. Called 118 and rushed to hospital.; Vaccination carried out in the afternoon. In the evening onset of convulsions and loss of consciousness. Call


VAERS ID: 1555662 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: body temperature; Result Unstructured Data: Test Result:35.4 Centigrade; Comments: Before vaccination; Test Date: 20210603; Test Name: CT; Result Unstructured Data: Test Result:thoracoabdominal aortic dissection
CDC Split Type: JPPFIZER INC202101002522

Write-up: Thoracoabdominal aortic dissection; Cardio-respiratory arrest; shock; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122525. A 79-year-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021), via an unspecified route of administration on 01Jun2021 at 10:30 at single dose for COVID-19 immunization. Body temperature before vaccination was 35.4 degrees centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Medical history and concomitant medications were not reported. On 03Jun2021 (2 day after the vaccination), the patient experienced thoracoabdominal aortic dissection and cardio-respiratory arrest. On 03Jun2021 (2 days after the vaccination), the patient was admitted to the hospital. The course of the event was as follows: On 03Jun2021, 08:30 (one day and 22 hours after vaccination), the patient suddenly had back pain. At 10:05 (one day, 23 hours, and 35 minutes after vaccination), the patient visited the emergency outpatient department of the reporting hospital. CT showed thoracoabdominal aortic dissection. Although the patient was tried to be transferred to another hospital, several minutes later, the patient had shock and cardiopulmonary arrest (CPA). Resuscitation was continued, and the patient was admitted to the reporting hospital. Eventually, on the same day, at 12:59 (2 days, 2 hours, and 29 minutes after vaccination), the patient was confirmed to die. On 03Jun2021 (2 days after the vaccination), the outcome of the events was fatal. The reporting physician classified the events as serious (death) and assessed that the events was unrelated to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Nothing particular.; Sender''s Comments: Based on close temporal association the role of the usage of the vaccine BNT162B2 in contributing/triggering the events thoracoabdominal aortic dissection, cardiopulmonary arrest and shock cannot be excluded. The case will be reassessed once additional information regarding patients medical history and concomitant medications are reported.; Reported Cause(s) of Death: Thoracoabdominal aortic dissection; Cardio-respiratory arrest


VAERS ID: 1555664 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-08-02
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Blood test, Body temperature, Cardio-respiratory arrest, Chest pain, Dyspnoea, Electrocardiogram abnormal, Glycosylated haemoglobin, Loss of consciousness, Respiratory disorder, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: MEDROL [METHYLPREDNISOLONE]; THYRADIN S
Current Illness: Hypothyroidism; Rheumatoid arthritis
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes steroid-induced; Type 2 diabetes mellitus.
Allergies:
Diagnostic Lab Data: Test Date: 20210802; Test Name: blood test; Result Unstructured Data: Test Result: no increased cardiac-related enzyme and; Comments: no increased cardiac-related enzyme and negative troponin T; Test Date: 20210729; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination; Test Date: 20210802; Test Name: ECG; Result Unstructured Data: Test Result: no obvious findings of ACS; Comments: no obvious findings of ACS but monitor showed ventricular fibrillation; Test Date: 2021; Test Name: HbA1c; Result Unstructured Data: Test Result:7.4 to 7.6 %.
CDC Split Type: JPPFIZER INC202101023480

Write-up: Respiratory discomfort; Chest pain; Dyspnoea; Ventricular fibrillation; cardio-respiratory arrest; arrhythmia; Loss of consciousness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21123274. A 60-year and 5-month-old female patient received the second dose of BNT162b2 (COMIRNATY, solution for injection, Lot number FD1945, Expiration date 31Oct2021), via an unspecified route of administration on 29Jul2021 at 13:30 (the day of vaccination), as Dose 2, single for COVID-19 immunization. Body temperature before vaccination was 36.1 degrees centigrade, on 29Jul2021. Patient''s relevant medical history included rheumatoid arthritis, hypothyroidism, type 2 diabetes mellitus, and diabetes steroid- induced, all from an unspecified date to an unspecified date. The patient (historical vaccine) previously received the first dose of BNT162b2 (COMIRNATY, solution for injection, Lot: EW0203, Expiration date 30Sep2021), via an unspecified route of administration, on 08Jul2021, for COVID-19 immunisation. Concomitant medications included ongoing methylprednisolone (MEDROL) 2mg, from an unspecified date, via an unspecified route of administration for rheumatoid arthritis and ongoing levothyroxine sodium (Thyradin S) 75 mcg, from an unspecified date, via an unspecified route of administration, for hypothyroidism. On 02Aug2021 at 14:30 (4 days/1 hour after the vaccination), the patient experienced chest pain. The course of the event was as follows: The patient was prescribed methylprednisolone (MEDROL) 2 mg for rheumatoid arthritis at her nearby hospital, and levothyroxine sodium hydrate (THYRADIN-S) 75 mcg was supplemented for hypothyroidism at the reporting hospital. Thus, the thyroid function was shifted favourably at least. Since the patient had underlying diseases such as type 2 diabetes mellitus or diabetes steroid-induced, the HbA1c level was approximately 7.4 to 7.6 percent, on an unspecified date in 2021. On 29Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On 02Aug2021, at 14:30 (4 days and 1 hour after vaccination), the patient visited the reporting hospital for chest pain, respiratory discomfort, and Dyspnoea. The blood examination showed no increased cardiac-related enzyme and negative troponin T. Although ECG showed no obvious findings of ACS, after the examinations, the patient had loss of consciousness, and a hurry call was made in the hospital. On the same date, the monitor showed ventricular fibrillation (VF), and a countershock and cardiopulmonary resuscitation were tried with administration of adrenaline (BOSMIN) and sodium bicarbonate (MEYLON); however, normal sinus rhythm was not achieved. At 16:00 (4 days, 2 hours, and 30 minutes after vaccination), the patient was emergently transferred to the emergency medical care centre of the university hospital. At the same hospital, on the same date, V-A ECMO (extracorporeal membrane oxygenation) was tried; however, VF did not resolve, and the patient had arrhythmia and cardio-respiratory arrest. On the same day, at 21:59 (4 days, 8 hours, and 29 minutes after vaccination), the patient died. On 02Aug2021 (4 days after the vaccination), the outcome of the events ''ventricular fibrillation, cardio-respiratory arrest, arrhythmia'' was fatal, while the outcome for the rest of the events were unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was arrhythmia. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown. Based on the clinical course and the laboratory data, the cause of death could not be regarded as acute coronary syndrome or myocarditis. As of this date, the cause of death was considered as arrhythmia. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardio-respiratory arrest; arrhythmia; Ventricular fibrillation.


VAERS ID: 1555687 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-05
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood calcium, Blood chloride, Blood creatinine, Blood glucose, Blood osmolarity, Blood phosphorus, Blood potassium, Blood sodium, Blood urea, Body temperature, C-reactive protein, COVID-19, COVID-19 pneumonia, Cardiac failure congestive, Chest X-ray, Dyspnoea, Eosinophil count, Fibrin D dimer, Glomerular filtration rate, Granulocyte count, Haematocrit, Haemoglobin, Hypoxia, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Monocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Oxygen saturation, Platelet count, Red blood cell count, Red blood cell nucleated morphology, Renal failure, SARS-CoV-2 test, Tachypnoea, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
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; AMLODIPINE; ASPIRIN BAYER; BURINEX; DIPYRIDAMOLE; GLICLAZIDE; PREDNISOLONE; SIMVASTATIN; GOSERELIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebrovascular accident; Chronic kidney disease; Congestive heart failure; Diabetes; Gout; Hypertension; Non-smoker (Not a current smoker. Unknown whether previous smoker.); Prostate carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: calcium; Result Unstructured Data: Test Result:2.12 mmol/L; Test Date: 20210712; Test Name: serum chloride; Result Unstructured Data: Test Result:108.3 mmol/L; Test Date: 20210713; Test Name: serum chloride; Result Unstructured Data: Test Result:109.8 mmol/L; Test Date: 20210723; Test Name: serum chloride; Result Unstructured Data: Test Result:114.7 mmol/L; Test Date: 20210712; Test Name: serum creatinine; Result Unstructured Data: Test Result:199 umol/l; Test Date: 20210713; Test Name: serum creatinine; Result Unstructured Data: Test Result:187 umol/l; Test Date: 20210715; Test Name: serum creatinine; Result Unstructured Data: Test Result:211 umol/l; Test Date: 20210716; Test Name: serum creatinine; Result Unstructured Data: Test Result:210 umol/l; Test Date: 20210718; Test Name: serum creatinine; Result Unstructured Data: Test Result:242 umol/l; Test Date: 20210719; Test Name: serum creatinine; Result Unstructured Data: Test Result:258 umol/l; Test Date: 20210721; Test Name: serum creatinine; Result Unstructured Data: Test Result:247 umol/l; Test Date: 20210723; Test Name: serum creatinine; Result Unstructured Data: Test Result:242 umol/l; Test Date: 20210712; Test Name: glucose (random); Result Unstructured Data: Test Result:11.33 mmol/L; Test Date: 20210712; Test Name: osmolality calculated; Result Unstructured Data: Test Result:313 mosm/kg; Test Date: 20210719; Test Name: phsophate; Result Unstructured Data: Test Result:1.69 mmol/L; Test Date: 20210719; Test Name: potassium; Result Unstructured Data: Test Result:3.22 mmol/L; Test Date: 20210721; Test Name: sodium; Result Unstructured Data: Test Result:147 mmol/L; Test Date: 20210723; Test Name: sodium; Result Unstructured Data: Test Result:150 mmol/L; Test Date: 20210712; Test Name: urea; Result Unstructured Data: Test Result:17.2 mmol/L; Test Date: 20210713; Test Name: urea; Result Unstructured Data: Test Result:16.8 mmol/L; Test Date: 20210715; Test Name: urea; Result Unstructured Data: Test Result:16 mmol/L; Test Date: 20210716; Test Name: urea; Result Unstructured Data: Test Result:16.1 mmol/L; Test Date: 20210718; Test Name: urea; Result Unstructured Data: Test Result:20.8 mmol/L; Test Date: 20210719; Test Name: urea; Result Unstructured Data: Test Result:22.2 mmol/L; Test Date: 20210721; Test Name: urea; Result Unstructured Data: Test Result:23.5 mmol/L; Test Date: 20210723; Test Name: urea; Result Unstructured Data: Test Result:26.1 mmol/L; Test Date: 20210712; Test Name: body temperature; Result Unstructured Data: Test Result:38.2; Test Date: 20210712; Test Name: chest X-Ray; Result Unstructured Data: Test Result:clear; Test Date: 20210719; Test Name: chest X-Ray; Result Unstructured Data: Test Result:Bilateral increased interstitial markings and righ; Comments: Bilateral increased interstitial markings and right sided pleural effusion in keeping with an element of pulmonary venous congestion. New confluent air space shadowing in left lower lung zone which in the clinical context is suggestive of a consolidation; Test Date: 20210715; Test Name: C-reactive protein; Result Unstructured Data: Test Result:64.1 mg/l; Test Date: 20210716; Test Name: C-reactive protein; Result Unstructured Data: Test Result:91.4 mg/l; Test Date: 20210718; Test Name: C-reactive protein; Result Unstructured Data: Test Result:91.2 mg/l; Test Date: 20210719; Test Name: C-reactive protein; Result Unstructured Data: Test Result:104.2 mg/l; Test Date: 20210721; Test Name: C-reactive protein; Result Unstructured Data: Test Result:180.3 mg/l; Test Date: 20210723; Test Name: C-reactive protein; Result Unstructured Data: Test Result:127 mg/l; Test Date: 20210712; Test Name: eosinophils; Result Unstructured Data: Test Result:0.03 x10 9/l; Test Date: 20210715; Test Name: eosinophils; Result Unstructured Data: Test Result:0.01 x10 9/l; Test Date: 20210718; Test Name: eosinophils; Result Unstructured Data: Test Result:0.00 x10 9/l; Test Date: 20210719; Test Name: eosinophils; Result Unstructured Data: Test Result:0.00 x10 9/l; Test Date: 20210721; Test Name: eosinophils; Result Unstructured Data: Test Result:0.00 x10 9/l; Test Date: 20210723; Test Name: eosinophils; Result Unstructured Data: Test Result:0.00 x10 9/l; Test Date: 20210713; Test Name: D-Dimer; Result Unstructured Data: Test Result:582 ng/ml; Test Name: eGFR; Result Unstructured Data: Test Result:32; Comments: eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7; Test Name: eGFR; Result Unstructured Data: Test Result:22; Comments: eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7; Test Name: eGFR; Result Unstructured Data: Test Result:24; Comments: eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7; Test Date: 20210723; Test Name: immature granulocytes; Result Unstructured Data: Test Result:0.16 x10 9/l; Test Date: 20210712; Test Name: haematocrit; Test Result: 31.8 %; Test Date: 20210715; Test Name: haematocrit; Test Result: 35.2 %; Test Date: 20210718; Test Name: haematocrit; Test Result: 28.9 %; Test Date: 20210719; Test Name: haematocrit; Test Result: 29.6 %; Test Date: 20210721; Test Name: haematocrit; Test Result: 33.9 %; Test Date: 20210723; Test Name: haematocrit; Test Result: 32.4 %; Test Date: 20210712; Test Name: haemoglobin; Result Unstructured Data: Test Result:11 g/dl; Test Date: 20210715; Test Name: haemoglobin; Result Unstructured Data: Test Result:12.1 g/dl; Test Date: 20210718; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.4 g/dl; Test Date: 20210719; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.5 g/dl; Test Date: 20210721; Test Name: haemoglobin; Result Unstructured Data: Test Result:11.1 g/dl; Test Date: 20210723; Test Name: haemoglobin; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210712; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.75 x10 9/l; Test Date: 20210715; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:1.04 x10 9/l; Test Date: 20210718; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.36 x10 9/l; Test Date: 20210719; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.39 x10 9/l; Test Date: 20210721; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.46 x10 9/l; Test Date: 20210723; Test Name: lymphocytes Abs; Result Unstructured Data: Test Result:0.27 x10 9/l; Test Date: 20210715; Test Name: mean cell Hb; Test Result: 32.2 pg; Test Date: 20210718; Test Name: mean cell Hb; Test Result: 32.5 pg; Test Date: 20210719; Test Name: mean cell Hb; Test Result: 32.3 pg; Test Date: 20210721; Test Name: mean cell Hb conc; Result Unstructured Data: Test Result:32.7 g/dl; Test Date: 20210715; Test Name: mean cell volume; Result Unstructured Data: Test Result:93.6; Test Date: 20210721; Test Name: mean cell volume; Result Unstructured Data: Test Result:94.7; Test Date: 20210723; Test Name: mean cell volume; Result Unstructured Data: Test Result:93.1; Test Date: 20210715; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.36 x10 9/l; Test Date: 20210718; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.17 x10 9/l; Test Date: 20210719; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.21 x10 9/l; Test Date: 20210721; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.18 x10 9/l; Test Date: 20210723; Test Name: monocytes Abs; Result Unstructured Data: Test Result:0.35 x10 9/l; Test Date: 20210723; Test Name: neutrophils Abs; Result Unstructured Data: Test Result:10.02 x10 9/l; Test Date: 20210712; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1127 pg/mL; Test Date: 20210721; Test Name: NT-proBNP; Result Unstructured Data: Test Result:1649 pg/mL; Test Date: 20210712; Test Name: SpO2; Test Result: 97 %; Test Date: 20210723; Test Name: platelets; Result Unstructured Data: Test Result:348 x10 9/l; Test Date: 20210712; Test Name: red cell count; Result Unstructured Data: Test Result:3.48 x10 12/l; Test Date: 20210715; Test Name: red cell count; Result Unstructured Data: Test Result:3.76 x10 12/l; Test Date: 20210718; Test Name: red cell count; Result Unstructured Data: Test Result:3.20 x10 12/l; Test Date: 20210719; Test Name: red cell count; Result Unstructured Data: Test Result:3.25 x10 12/l; Test Date: 20210721; Test Name: red cell count; Result Unstructured Data: Test Result:3.58 x10 12/l; Test Date: 20210723; Test Name: red cell count; Result Unstructured Data: Test Result:3.48 x10 12/l; Test Date: 20210721; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.02 x10 9/l; Test Date: 20210723; Test Name: nucleated red blood cells; Result Unstructured Data: Test Result:0.05 x10 9/l; Test Name: Sars-cov-2 RT-PCR test; Result Unstructured Data: Test Result:positive; Test Date: 20210712; Test Name: Sars-cov-2 RT-PCR test; Result Unstructured Data: Test Result:positive; Comments: CT 15; Test Date: 20210726; Test Name: Sars-cov-2 RT-PCR test; Result Unstructured Data: Test Result:positive; Comments: CT 27
CDC Split Type: MTPFIZER INC202101005064

Write-up: positive for Covid-19 on RT-PCR test; positive for Covid-19 on RT-PCR test; covid-19 pneumonia; Congestive heart failure worsened; dyspnea; tachypnea; hypoxemia; Renal failure; This is a spontaneous report from a contactable physician. An 86-years-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Lot Number: EJ6788; Expiration date was not reported), second dose via intramuscular route, administered in Arm Left on 05Feb2021 as DOSE 2, single, first dose via intramuscular route on 15Jan2021 (Batch/Lot Number: EJ6796) as DOSE 1, single for covid-19 immunisation. Medical history included hypertension from an unknown date, diabetes mellitus, congestive heart failure, chronic kidney disease (eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7), prostate carcinoma, gout, cerebrovascular accident, non-smoker (Not a current smoker. Unknown whether previous smoker) from an unknown date and unknown if ongoing. Concomitant medications included allopurinol (ALLOPURINOL); amlodipine (AMLODIPINE); acetylsalicylic acid (ASPIRIN BAYER); bumetanide (BURINEX); dipyridamole (DIPYRIDAMOLE); gliclazide (GLICLAZIDE); prednisolone (PREDNISOLONE); simvastatin (SIMVASTATIN); goserelin (GOSERELIN) implant taken for an unspecified indication, start and stop date were not reported. The patient experienced positive for covid-19 on RT-PCR test, covid-19 pneumonia, congestive heart failure worsened, dyspnea, tachypnea, hypoxenmia, renal failure on an unspecified date. The patient was hospitalized from 12Jul2021 to an unknown date due to the events. Therapeutic measures were taken as a result of the events. On admission, fever 38.2 and SpO2 97% on RA. However, oxygen supplementation requirements increased throughout inpatient stay with SpO2 90% on RA on a background of congestive heart failure. The patient received additional therapies for COVID-19 that included 6mg dexamethasone daily on 21Jul2021 and Co-amoxiclav on 24Jul2021. Progression of tachypnoea and desaturation led to initiation of dexamethasone. On admission patient was maintaining SpO2 97% RA. The patient underwent lab tests and procedures which included: Sars-cov-2 test: positive on unspecified date. EGFR was 32, 22, 24 on unspecified dates (eGFR fell from 32 on the 13/7 to 22 on 19/7 and 24 on 23/7). On 12Jul2021 body temperature: 38.2, chest x-ray: clear, oxygen saturation: 97 %, sars-cov-2 test: positive CT 15, lymphocytes Abs: 0.75 x10^9/L, eosinophils abs 0.03 x10^9/L, red cell count: 3.48 x10^12/L, haemoglobin 11 g/dl, haematocrit 31.8%, urea (serum) 17.2 mmol/l, creatinine (serum) 199 umol/l, chloride (serum) 108.3 mmol/l, glucose (random) 11.33 mmol/l, NT-proBNP 1127 pg/ml, osmolality calculated 313 mosm/kg. On 13Jul2021, D-Dimer 582 ng/ml, urea (serum) 16.8 mmol/l, creatinine (serum) 187 umol/l, chloride (serum) 109.8 mmol/l. On 15Jul2021 lymphocytes Abs: 1.04 x10^9/L, eosinophils abs 0.01 x10^9/L, monocytes abs 0.36 x10^9/L, red cell count: 3.76 x10^12/L, haemoglobin 12.1 g/dl, haematocrit 35.2%, mean cell volume 93.6 fL, mean cell Hb 32.2 pg, urea (serum) 16 mmol/l, creatinine (serum) 211 umol/l, C-reactive protein 64.1 mg/L. On 16Jul2021 urea (serum) 16.1 mmol/l, creatinine (serum) 210 umol/l, C-reactive protein 91.4 mg/L. On 18Jul2021 lymphocytes Abs: 0.36 x10^9/L, Eosinophils Abs 0.00 x10^9/L, Monocytes Abs 0.17 x10^9/L, red cell count: 3.20 x10^12/L, haemoglobin 10.4 g/dl, haematocrit 28.9%, Mean cell Hb 32.5 pg, urea (serum) 20.8 mmol/l, creatinine (serum) 242 umol/l, C-reactive protein 91.2 mg/L. On 19Jul2021, chest x-ray: bilateral increased interstitial markings and right sided pleural effusion in keeping with an element of pulmonary venous congestion. New confluent air space shadowing in left lower lung zone which in the clinical context is suggestive of a consolidation; lymphocytes abs: 0.39 x10^9/L, eosinophils abs 0.00 x10^9/L, monocytes abs 0.21 x10^9/L, red cell count: 3.25 x10^12/L, haemoglobin 10.5 g/dl, haematocrit 29.6 %, mean cell Hb 32.3 pg, urea (serum) 22.2 mmol/l, creatinine (serum) 258 umol/l, C-reactive protein 104.2 mg/L, potassium 3.22 mmol/l, calcium 2.12 mmol/l, phosphate 1.69 mmol/l. On 21Jul2021 lymphocytes abs: 0.46 x10^9/L, eosinophils abs 0.00 x10^9/L, monocytes abs 0.18 x10^9/L, red cell count: 3.58 x10^12/L, haemoglobin 11.1 g/dl, haematocrit 33.9 %, mean cell volume 94.7 fL, mean cell Hb conc 32.7 g/dl, nucleated red blood cells 0.02 x10^9/L, urea (serum) 23.5 mmol/l, creatinine (serum) 247 umol/l, sodium 147 mmol/l, C-reactive protein 180.3 mg/L, NT-proBNP 1649 pg/ml. On 23Jul2021 lymphocytes abs: 0.27 x10^9/L, eosinophils abs 0.00 x10^9/L, monocytes abs 0.35 x10^9/L, red cell count: 3.48 x10^12/L, haemoglobin 10.9 g/dl, haematocrit 32.4 %, mean cell volume 93.1 fL, nucleated red blood cells 0.05 x10^9/L, platelets 348 x10^9/L, immature granulocytes 0.16 x10^9/L, neutrophils abs 10.02 x10^9/L, urea (serum) 26.1 mmol/l, creatinine (serum) 242 umol/l, sodium 150 mmol/l, chloride 114.7 mmol/l, C-reactive protein 127 mg/L. Sars-cov-2 test: positive, CT 27 on 26Jul2021. The patient died on 27Jul2021. Clinical outcome of the events positive for covid-19 on RT-PCR test, covid-19 pneumonia, congestive heart failure was fatal, and the outcome of other events was unknown. An autopsy was not performed. Follow-up activities completed. No further information expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events vaccination failure, Covid 19, Covid 19 pneumonia, dyspnoea, hypoxia, tachypnoea and the suspect drug BNT162B2.Also the temporal association between event cardiac failure and renal failure and drug BNT162B2 cannot be excluded though also to consider contributory factor patients medical history of congestive cardiac failure and chronic kidney disease. 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: covid-19 pneumonia; Congestive Heart Failure; positive for Covid-19 on RT-PCR test


VAERS ID: 1555696 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-19
Onset:2021-05-25
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA3082 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CRESTOR; LISINOPRIL; ACETYLSALICYLIC ACID; HYDROCHLOROTHIAZIDE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101004135

Write-up: According to the municipal coroner patient died approximately on 25May2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number NL-LRB-00646841. A 77-year-old female patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19May2021 (Lot Number: FA3082) as single dose for COVID-19 immunization. Medical history was not reported. Previous COVID-19 infection was none. Concomitant medication included rosuvastatin calcium (CRESTOR), lisinopril, acetylsalicylic acid hydrochlorothiazide. The patient received the first dose of BNT162B2 via an unspecified route of administration on 14Apr2021 as single dose for COVID-19 immunization and no side effect reported. Patient''s body was found on 31May2021, 12 days after vaccination. According to the municipal coroner patient died approximately on 25May2021, 6 days after vaccination. Unfortunately, no autopsy performed. Other diagnostic procedure was none. No obduction was done, so cause of death remains unknown. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reporter''s Comments: -BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 4/14/2021 - May 31, body find Additional information ADR: wrsch death around May 25 according to municipal coroner, unfortunately no autopsy performed - COVID-19 Previous COVID-19 infection: No - Other diagnostic procedures: no; Reported Cause(s) of Death: unknown


VAERS ID: 1555697 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-05
Onset:2021-03-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia (Family history: false); Heart failure (Family history: false).
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101016233

Write-up: Epileptic insults; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other hcp downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00654539. An 81-year-old female patient received BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on 05Mar2021 as dose 2, 0.3ml single for COVID-19 immunization. Medical history included heart failure, arrhythmia. Patient had no previous COVID-19 infection. Concomitant medications were not reported. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- unknown) via an unspecified route of administration on 18Feb2021 as dose 1, 0.3ml single for COVID-19 immunization and no adverse reaction with first dose. On 19Mar2021, patient experienced epileptic insults, then slightly recovered. It was reported that Monday 22Mar2021 a serious 45 minute seizure, which became fatal to her 23Mar2021. It was unknown autopsy was done. Reporter comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Adverse Drug reactions: No Date: 18Feb2021 Epileptic insults Additional information Adverse Drug Reaction: First 19Mar 3, then slightly recovered, Monday 22Mar a serious 45 minute seizure, which became fatal to her 23 Mar. She had heart failure and arrhythmia, but was not known to have epilepsy. Previous COVID-19 infection: No No follow-up attempts possible. No further information expected. Batch/LOT number cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Adverse Drug reactions: No Date: 18Feb2021 Epileptic insults Additional information Adverse Drug Reaction: First 19Mar 3, then slightly recovered, Monday 22Mar a serious 45 minute seizure, which became fatal to her 23 Mar. She had heart failure and arrhythmia, but was not known to have epilepsy. Previous COVID-19 infection: No; Reported Cause(s) of Death: Epileptic insults


VAERS ID: 1555698 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: NLPFIZER INC202101011663

Write-up: Brain hemorrhage leading to death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB NL-LRB-00646770. This consumer reported similar events for two patients. This is the second of two reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced brain hemorrhage leading to death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101004145 same reporter/drug/event, different patient; Reported Cause(s) of Death: Brain hemorrhage leading to death


VAERS ID: 1555724 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   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: Chest pain (admitted at a hospital last 12Jul2021); Dyspnea (admitted at a hospital last 12Jul2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101007719

Write-up: difficulty of breathing; chest pain; fever; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300094461. A 77-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 16Jul2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included the patient was admitted at a hospital last 12Jul2021 due to on and off dyspnea and chest pain. The patient''s concomitant medications were not reported. On 17Jul2021 the patient had fever; On 26Jul2021, she experienced again dyspnea and chest pain and brought to a hospital. The patient died on 26Jul2021. 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: difficulty of breathing; chest pain


VAERS ID: 1555725 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD5996 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Haematemesis, Malaise, Pyrexia
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal haemorrhage (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101007721

Write-up: Cough; Hematemesis; Fever; body malaise; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300095356. A 66-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 20Jul2021 (Batch/Lot Number: FD5996) as dose number unknown, single for covid-19 immunisation at the age of 66-year-old. The patient medical history and concomitant medications were not reported. The patient experienced fever on 20Jul2021, body malaise on 20Jul2021, cough on 24Jul2021, hematemesis on 24Jul2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of all events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; body malaise; Hematemesis; Cough


VAERS ID: 1555737 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Drug ineffective, Pneumonia bacterial, Polymerase chain reaction, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Guillain-Barre syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PANTOPRAZOLE; BACLOFENE; QUETIAPINE; LORAZEPAM; AMLODIPINE; METFORMINE HCL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Debility marked
Allergies:
Diagnostic Lab Data: Test Name: PCR test; Test Result: Positive ; Test Name: SARS-CoV-2; Test Result: Negative ; Test Name: SARS-CoV-2; Test Result: Negative
CDC Split Type: PTPFIZER INC202101016217

Write-up: Reported apparently bacterial pneumonia; Marked weakness; Vaccination failure; SARS-CoV-2 infection; This is a Spontaneous report from a contactable Physician downloaded from the Regulatory authority report number PT-INFARMED-R202107-5351 with Safety Report Unique Identifier PT-INFARMED-R202107-5351. A 77-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via intramuscular route of administration on 27May2021 as DOSE 2, 30 mcg/0.3 ML SINGLE and received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot number was not reported), via intramuscular route of administration on an unspecified date as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history was reported as marked debility background. Concomitant medications included pantoprazole; baclofene; quetiapine; lorazepam; amlodipine; metformin hydrochloride. The patient was admitted to hospital for pneumonia, apparently bacterial, marked weakness on an unspecified date. On 29Jul2021, the patient experienced vaccination failure and sars-cov-2 infection. The adverse reaction (ADR) occurred 2 months after the administration of the dose 2 of the suspected drug. The patient underwent lab tests and procedures which included sars-cov-2 test: negative, sars-cov-2 test: negative (two subsequent negative tests, carried out on an unspecified date after contact with a person infected with SARS-CoV-2), PCR test: positive on an unspecified date (on hospital admission). The patient died on an unspecified date. Reported apparently bacterial pneumonia as the cause of death. It was not reported if an autopsy was performed. The reporters assessment of the causal relationship of the event with the suspect product was: relatedness of drug to reaction(s)/event(s): Source of assessment: reporter, Method of assessment: unknown, Result of Assessment: possible. Health authority comment: Concomitant Drug: Pantoprazole, quetiapine, lorazepam, amlodipine, baclofene, metformine. Has a medication error occurred: No. Further information: Admitted to hospital due to pneumonia, apparently bacterial. Marked weakness. Full COVID vaccination scheme. Two subsequent negative tests, performed after contact with a person infected with SARS-CoV-2. Positive PCR test on hospital admission. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: bacterial pneumonia


VAERS ID: 1557886 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-02
Onset:2021-03-02
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6797 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: variant sequenced B.1.1.7, N501Y positive; Test Result: Positive.
CDC Split Type: ATPFIZER INC202101016135

Write-up: death; Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-39208]. A 93-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6796; Expiration Date: 30Apr2021) via an unspecified route of administration on 12Jan2021 as dose 1, single and BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot Number: EJ6797; Expiration Date: 30Apr2021) via an unspecified route of administration on 02Feb2021 as dose 2, single both for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure, sars-cov-2 infection on 02Mar2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Investigation report received from product complaint team for Lot: EJ6796, Batch-Expiry Date: 30Apr2021 included conclusion as, the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6796. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed on the evaluation of reference samples. No root cause or CAPA were identified as the complaint was not confirmed. and for Lot: EJ6797, Batch-Expiry Date: 30Apr2021 included conclusion as, the investigation included reviewing the involved batch records, deviation investigation, evaluation of reference samples, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6797. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that a regulatory notification was required. The reported defect could not be confirmed on the reference samples. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death


VAERS ID: 1557887 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-19
Onset:2021-03-24
   Days after vaccination:64
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1491 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: SARS-CoV-2 test PCR; Result Unstructured Data: Test Result:N501Y positive
CDC Split Type: ATPFIZER INC202101016167

Write-up: SARS-CoV-2 infection; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number AT-BASGAGES-2021-39221.Case narrative including clinical course, therapeutic measures, outcome and additional relevant information: An 84-years-old female patient received first dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EL1491) via intramuscular route of administration on 19Jan2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient received second dose of BNT162B2 (COMIRNATY, formulation: solution for injection, batch/lot number: EJ6134) via an unspecified route of administration on 09Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 24Mar2021, the patient experienced vaccination failure and SARS-CoV-2 infection. The patient underwent lab tests and procedures which included SARS-CoV-2 test with results N501Y positive on an unspecified date in 2021. The patient died on an unspecified date in 2021 due to vaccination failure and SARS-CoV-2 infection. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information was expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1557888 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-04-13
   Days after vaccination:54
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016216

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [AT-BASGAGES-2021-39232]. A 82-year-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EP2163), via an unspecified route of administration on 18Feb2021 as a dose 2, single and the patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EJ6134), via an unspecified route of administration on 28Jan2021 as a dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Apr2021, the patient experienced vaccination failure, other, fatal SARS-CoV-2 infection and resulted in death. No sequencing of the virus variant available. The cause of death was reported as SARS-CoV-2 infection. It was unknown that, autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1557903 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC 8736 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LITALIR; LOSARTANUM; TORASEMIDUM
Current Illness: Age-related macular degeneration; Auricular fibrillation (diagnosis date unknown, slow auricular fibrillation); Essential thrombocytosis (treated with Litalir); Hypertension (diagnosis date unknown, treated with Losartan and Torasemide); Renal failure (diagnosis date unknown; renal failure with usual Clearance of 30 ml/min); Rotator cuff injury (right shoulder rotator cuff tear right shoulder rotator cuff tear)
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia microcytic (exact diagnosis date unknown); COVID-19; Fall (Exact diagnosis date unknown. Left omalgia after accidental fall.); Macrocytic anemia; Omalgia (Exact diagnosis date unknown. Left omalgia after accidental fall.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC202101004672

Write-up: found deceased at 4:15 p.m. in front of her TV; not feeling well; very fatigued; This is a spontaneous report received from a contactable pharmacist via Regulatory Authority. Regulatory authority report number CH-SM-2021-17518. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 31May2021 (Lot Number: FC 8736) (at age of 96-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Feb2021, not ongoing; essential thrombocythaemia from Jan2017 and ongoing, treated with Litalir; microcytic anaemia from Feb2021, macrocytic deficiency anemia; ongoing hypertension diagnosis date unknown, treated with Losartan and Torasemide; left omalgia after accidental fall in Dec2020, not ongoing; ongoing slow auricular fibrillation diagnosis date unknown; ongoing renal failure with usual Clearance of 30 ml/min diagnosis date unknown; ongoing age-related macular degeneration; right shoulder rotator cuff tear right shoulder rotator cuff tear from 30Sep2013 and ongoing. Concomitant medications included hydroxycarbamide (LITALIR) taken for an unspecified indication from 2017 to an unspecified stop date; losartan (LOSARTANUM) taken for an unspecified indication from 2017 to an unspecified stop date; torasemide (TORASEMIDUM) taken for an unspecified indication from 2017 to an unspecified stop date. On 01Jun2021, patient was not feeling well and very fatigued, the constants were correct and at tea time at 15.30 she did not have any particular problems. At 16.15 she was found dead in front of the television. Autopsy not performed at the behest of her family. We have considered the therapy the one indicated by attending physician doctor (not the one at the discharge from the hospital). The patient died on 01Jun2021. An autopsy was not performed. The outcome of event "At 16.15 she was found dead in front of the television" was fatal, events "not feeling well" and "fatigued" was unknown. A causal relationship between Comirnaty and Death was assessed as unlikely. Medic assessed this case as serious with seriousness criterion Results in death. Reporter comment: Death of 94-year-old patient, the day after vaccination with Comirnaty. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Death of 94-year-old patient, the day after vaccination with Comirnaty.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Found dead in front of the TV


VAERS ID: 1557909 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-04-07
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac failure, Cardiac failure chronic, Circulatory collapse, Dyspnoea
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (narrow), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-13
   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: L-THYROXIN [LEVOTHYROXINE SODIUM]; RAMIPRIL; TORASEMID; VISMED; ASS; NOVAMINSULFON; AMLODIPINE; AMLODIPINE; METOPROLOL; GABAPENTIN
Current Illness: Lymphoedema (Chronic lymphoedema with ulcer); ulcus cruris (Chronic lymphoedema with ulcer)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Hashimoto''s thyroiditis; Knee prosthesis user; Obesity; Recurrent infection (Known recurrent infections); Sleep apnea syndrome; Type II diabetes mellitus.
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101003427

Write-up: Decompensation cardiac; Heart failure NYHA class IV; Dyspnoea; Circulatory collapse; Atrial fibrillation; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB. The number is DE-DCGMA-21191310. Safety report unique identifier DE-PEI-202100133892. An 89 years old female patient received 2nd dose of BNT162B2 (COMIRNATY) intramuscular on 17Mar2021 single dose for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: Arterial hypertension, Obesity, Knee prosthesis user, ongoing Lymphoedema, ongoing Ulcus cruris, Hashimoto''s thyroiditis, Type II diabetes mellitus, Sleep apnea syndrome, Recurrent infection. Concomitant medications included acetylsalicylic acid (ASS), torasemide (TORASEMID), metoprolol, amlodipine, amlodipine, ramipril, levothyroxine sodium (L-THYROXIN), novaminsulfon, gabapentin, hyaluronate sodium (VISMED). On 07Apr2021, the patient experienced Atrial fibrillation, Decompensation cardiac, Heart failure NYHA class IV, Circulatory collapse, Dyspnoea. The event outcome was fatal. The patient died on 13Apr2021. No autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Atrial fibrillation; Decompensation cardiac; Heart failure NYHA class IV; Circulatory collapse; Dyspnoea.


VAERS ID: 1557936 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-16
Onset:2021-04-17
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal neoplasm, Activated partial thromboplastin time, Activated partial thromboplastin time ratio, Alanine aminotransferase, Anion gap, Aspartate aminotransferase, Atrial thrombosis, Base excess, Basophil count, Bicytopenia, Bilirubin conjugated, Blood bicarbonate, Blood bilirubin, Blood chloride, Blood creatinine, Blood culture, Blood fibrinogen, Blood glucose, Blood lactate dehydrogenase, Blood lactic acid, Blood potassium, Blood pressure diastolic, Blood pressure systolic, Blood sodium, Blood urea, Body temperature, C-reactive protein, Chest X-ray, Computerised tomogram abdomen, Computerised tomogram head, Confusional state, Echocardiogram, Eosinophil count, Erythroblast count, Glomerular filtration rate, Glucose urine, Haematocrit, Haemoglobin, Heart rate, Immature granulocyte count, International normalised ratio, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean cell volume, Mean platelet volume, Monocyte count, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Neutrophil/lymphocyte ratio, Nitrite urine, Oxygen saturation, PCO2, PO2, Platelet count, Platelet distribution width, Polyuria, Positron emission tomogram, Procalcitonin, Protein total, Prothrombin level, Red blood cell count, Red cell distribution width, Respiratory failure, SARS-CoV-2 test, Subclavian vein thrombosis, Urine analysis, Urine ketone body, Urobilinogen urine, White blood cell count, pH body fluid, pH urine
SMQs:, Anaphylactic reaction (broad), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (narrow), Hypoglycaemia (broad), Non-haematological tumours of unspecified malignancy (narrow), Hypokalaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 4
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: DABIGATRAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Benign prostatic hyperplasia; Cataracts; Gonarthrosis; Ischemic heart disease; Knee prosthesis insertion; Metastatic neoplasm; Pacemaker insertion (cardiac); Spondyloarthrosis; Thyroid nodule
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Thromboplastin Time; Test Result: 38 s; Test Date: 20210415; Test Name: Thromboplastin Time Ratio; Result Unstructured Data: Test Result:1.46; Test Date: 20210415; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:30 IU/l; Test Date: 20210415; Test Name: Anion gap; Result Unstructured Data: Test Result:9.4 mEq/l; Test Date: 20210415; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result:29 IU/l; Test Date: 20210415; Test Name: Base excess; Result Unstructured Data: Test Result:-2.5 mmol/L; Comments: (-3 - 3); Test Date: 20210415; Test Name: Basophils; Result Unstructured Data: Test Result:0.01; Comments: 10*3/ul; Test Date: 20210415; Test Name: Basophils; Test Result: 0.1 %; Test Name: Bicytopenia; Result Unstructured Data: Test Result:observed (normocytic-normochromic anemia...; Comments: ...thrombopenia); Test Date: 20210415; Test Name: Direct bilirubin; Test Result: 1.24 mg/dl; Test Date: 20210415; Test Name: CO3H; Result Unstructured Data: Test Result:22.6 mmol/L; Test Date: 20210415; Test Name: Bilirubin; Test Result: Negative ; Comments: (<1); Test Date: 20210415; Test Name: Bilirubin; Test Result: 2.12 mg/dl; Test Date: 20210415; Test Name: Chlorine; Result Unstructured Data: Test Result:108 mEq/l; Test Date: 20210415; Test Name: Creatinine; Test Result: 1.26 mg/dl; Test Name: blood cultures; Test Result: Negative ; Test Date: 20210415; Test Name: Derived fibrinogen; Test Result: 291 mg/dl; Test Date: 20210415; Test Name: Glucose; Test Result: 106 mg/dl; Test Date: 20210415; Test Name: Lactate dehydrogenase; Result Unstructured Data: Test Result:318 IU/l; Test Date: 20210415; Test Name: Lactate; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210415; Test Name: Potassium; Result Unstructured Data: Test Result:4.73 mEq/l; Test Date: 20210417; Test Name: Diastolic pressure; Result Unstructured Data: Test Result:72; Test Date: 20210417; Test Name: Systolic pressure; Result Unstructured Data: Test Result:117 mmHg; Test Date: 20210415; Test Name: sodium; Result Unstructured Data: Test Result:140 mEq/l; Test Date: 20210415; Test Name: Urea; Test Result: 134 mg/dl; Test Date: 20210417; Test Name: Temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Test Date: 20210409; Test Name: chest X-ray; Result Unstructured Data: Test Result:with a well-positioned probe and without...; Comments: ...complications; Test Date: 20210415; Test Name: chest X-ray; Result Unstructured Data: Test Result:Study in the supine position did not ...; Comments: ...identify new-onset infiltrates or pleural effusion. 15 mm right hilar pulmonary nodule Unicameral pacemaker with end VI Calcific aortic atheromatosis.; Test Date: 20210415; Test Name: Abdominal CT; Result Unstructured Data: Test Result:Space-occupying hepatic lesion in caudate lobe...; Comments: ...-Floating thrombus in the right atrium -Lung nodule in LID. Findings: Liver of normal size and morphology, a space occupying lesion located in the caudate lobe with centronecrotic and peripheral vascularization is identified. Lymphadenopathy in the hepatic hilum, periduinal. and perihepatic and tail nodular images of the pancreas probably related to implants. 10x14mm LID pulmonary nodule. Floating thrombus of 47x38mm pericateter in the right atrium. Cysts bilateral cortical kidney stones. Diverticulosis in the descending colon and sigmoid without signs of acute diverticulitis Hiatal hernia No free fluid, collections, or pneumoperitoneum are identified. Bilateral pleural effusion and passive atelectasis in both lower lobes.; Test Date: 20210415; Test Name: CT brain; Result Unstructured Data: Test Result:- Signs of small vessel arteriopathy...; Comments: ...Findings: No evidence of acute intra- or extra-axial bleeding. No space-occupying lesions that condition displacement of intracranial structures are observed. Centered midline. Signs of small vessel artery disease. Dilated ventricular system related to degree of cortical atrophy. Posterior fossa and cisternae of the base without alterations.; Test Date: 20210415; Test Name: C Reactive Protein; Result Unstructured Data: Test Result:22.3 mg/l; Test Name: Bedside echocardiogram.; Result Unstructured Data: Test Result:LV not dilated, slightly hypertrophic...; Comments: ...normofunctioning. Lead in right cavities with image at the proximal level (RA) of 4x5cm spheroidal morphology compatible with thrombus. Thrombus-free IVC as well as distal RV lead regions; Test Name: echocardiogram; Result Unstructured Data: Test Result:moderate dilatation of the left atrium...; Comments: ...and undilated left ventricle with good global and segmental systolic function, Aortic sclerosis, Insufficiencies light mitral and tricuspid; Test Date: 20210415; Test Name: Eosinophils; Result Unstructured Data: Test Result:0; Comments: 10*3/ul; Test Date: 20210415; Test Name: Eosinophils; Test Result: 0 %; Test Date: 20210415; Test Name: Erythroblasts; Result Unstructured Data: Test Result:0.05; Comments: 10*3/ul; Test Date: 20210415; Test Name: Erythroblasts; Test Result: 0.5 %; Test Date: 20210415; Test Name: Glomerular filtration estimate; Result Unstructured Data: Test Result:50.60 ml/min; Comments: Multiply by 1,159 if black race.; Test Date: 20210415; Test Name: Glucose; Test Result: Negative ; Comments: (15); Test Date: 20210415; Test Name: Hematocrit; Test Result: 33.9 %; Test Date: 20210415; Test Name: Hemoglobin; Result Unstructured Data: Test Result:10.9 g/dl; Test Date: 20210417; Test Name: Heart rate; Result Unstructured Data: Test Result:103; Comments: beats/min; Test Date: 20210415; Test Name: Immature granulocytes; Result Unstructured Data: Test Result:0.11; Comments: 10*3/ul; Test Date: 20210415; Test Name: Immature granulocytes; Test Result: 1.1 %; Test Date: 20210415; Test Name: INR; Result Unstructured Data: Test Result:2.11; Test Date: 20210415; Test Name: Lymphocytes; Result Unstructured Data: Test Result:1.85; Comments: 10*3/ul; Test Date: 20210415; Test Name: Lymphocytes; Test Result: 19 %; Test Date: 20210415; Test Name: MCH; Test Result: 29.5 pg; Test Date: 20210415; Test Name: MCHC; Result Unstructured Data: Test Result:32.2 g/dl; Test Date: 20210415; Test Name: MCV; Result Unstructured Data: Test Result:91.9; Comments: fL; Test Date: 20210415; Test Name: Mean platelet volume; Result Unstructured Data: Test Result:13.3; Comments: fl; Test Date: 20210415; Test Name: Monocytes; Result Unstructured Data: Test Result:0.95; Comments: 10*3/ul; Test Date: 20210415; Test Name: Monocytes; Test Result: 9.8 %; Test Date: 20210415; Test Name: Neutrophils; Result Unstructured Data: Test Result:6.82; Comments: 10*3 /ul; Test Date: 20210415; Test Name: Neutrophils; Test Result: 70 %; Test Date: 20210415; Test Name: Neutrophil / Lymphocyte Ratio; Result Unstructured Data: Test Result:3.7; Test Date: 20210415; Test Name: Nitrites; Test Result: Negative ; Test Date: 20210415; Test Name: NTpro Natriuretic Peptide B; Result Unstructured Data: Test Result:4825 pg/mL; Test Date: 20210417; Test Name: Oxygen saturation; Test Result: 94 %; Comments: basal; Test Date: 20210415; Test Name: SatO2; Test Result: 54.6 %; Test Date: 20210415; Test Name: pCO2; Result Unstructured Data: Test Result:38.2 mmHg; Test Date: 20210415; Test Name: pH; Result Unstructured Data: Test Result:7.38; Test Date: 20210415; Test Name: urine pH; Result Unstructured Data: Test Result:5.5; Test Date: 20210415; Test Name: Platelet; Result Unstructured Data: Test Result:65; Comments: 10*3/ul; Test Date: 20210415; Test Name: Platelet cell distribution width; Test Result: 18.4 %; Test Date: 20210415; Test Name: po2; Result Unstructured Data: Test Result:33.8 mmHg; Test Date: 20210417; Test Name: Diuresis; Result Unstructured Data: Test Result:900; Test Date: 2000; Test Name: Positron emission tomography; Result Unstructured Data: Test Result:unknown; Test Date: 20210415; Test Name: Procalcitonin; Result Unstructured Data: Test Result:0.26 ng/ml; Test Date: 20210415; Test Name: Protein; Test Result: 15 mg/dl; Comments: (25); Test Date: 20210415; Test Name: Prothrombin Activity; Test Result: 29.9 %; Test Date: 20210415; Test Name: Erythrocytes; Result Unstructured Data: Test Result:12; Comments: /field; Test Date: 20210415; Test Name: Erythrocytes; Result Unstructured Data: Test Result:67; Comments: /ul; Test Date: 20210415; Test Name: Red blood cells; Result Unstructured Data: Test Result:2+; Comments: /ul; Test Date: 20210415; Test Name: Red blood cells; Result Unstructured Data: Test Result:3.69 10*6/uL; Test Date: 20210415; Test Name: RDW-CV; Test Result: 18.7 %; Test Date: 20210415; Test Name: RDW-SD; Result Unstructured Data: Test Result:56.6; Test Date: 20210415; Test Name: PCR SARS-CoV-2; Test Result: Negative ; Test Date: 20210415; Test Name: density; Result Unstructured Data: Test Result:1027; Test Date: 20210415; Test Name: Methyl ketone; Test Result: Negative ; Comments: (5); Test Date: 20210415; Test Name: Urobilinogen; Test Result: 2 mg/dl; Comments: (1); Test Date: 20210415; Test Name: Leukocytes; Test Result: Negative ; Comments: /ul; Test Date: 20210415; Test Name: Leukocytes; Result Unstructured Data: Test Result:2; Comments: /field; Test Date: 20210415; Test Name: Leukocytes; Result Unstructured Data: Test Result:11; Comments: /ul; Test Date: 20210415; Test Name: Leukocytes; Result Unstructured Data: Test Result:9.74; Comments: 10*3/ul
CDC Split Type: ESPFIZER INC202100996569

Write-up: intracardiac floating thrombosis; Subclavian vein thrombosis; acute confusional syndrome; Probable intra abdominal neoplasm with liver and lung spread; respiratory failure requiring oxygen therapy; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority ES-AEMPS-960203. An 88-yrs-old male patient (pt) received 2nd dose of bnt162b2 (COMIRNATY; Solution injection; Batch/Lot:ET1831), IM on 16Mar2021 as single dose for covid-19 immunization. Medical hist. included metastatic neoplasm, cardiac pacemaker insertion, AF, myocardial ischaemia, cataract, osteoarthritis, spinal osteoarthritis, benign prostatic hyperplasia, thyroid mass & knee arthroplasty. Conc medication: dabigatran for AF. Pt previously took clopidogrel, digoxin, atenolol & pantoprazole. On 17Apr2021, pt had intracardiac floating thrombosis & subclavian vein thrombosis. Pt was admitted to the hospital due to the presence of a recent onset intracardiac thrombus in the R atrium of 47mmm in a pt with recent pacemaker placement. ECG done during his previous admi. a mnth ago did nt reveal the existence of thrombosis. Pt also had thrombopenia. Cardiology ruled out a surgical approach. Also had impaired edema with filling of the left U limb, possibly related to subclavian vein thrombosis. Pt evolved unfavorably. Thoraco-Abd CT scan performed with lesions suggestive of intra-Abd neoplasia with implants close to the bile duct & metastatic liver & lung lesions. On admission, presented due to general discomfort with a mnth of asthenia, dizziness & chest discomfort. Went to a hospital finding AF of uncertain chronology, cardioverting after IV digoxin &ended up coming to center after an episode of loss of consciousness of the syncope profile (seconds complete & spontaneous recovery, short duration). Exits from AF with bradycardia at 30-45bpm with hypotensive bumps were described, so it implanted. A pacemaker on 08Apr2021. Cranial CT scan done without findings. As an incidence during admission, self-limited febrile picture without focus & -ve HCx2, however empirical ATB administered (Amox/Clav from 5Apr-12Apr). Brought to the hospital for an episode of loss of consciousness. HD with BP over 100/50mmhg. HR:50bpm in own rhythm. SatO2 96% baseline. Image compatible with thrombus at the level of the RA surrounding the pacemaker lead. Lesion occupying the hepatic space & pulmonary nodule in the L R lobe. It points to an imp prothrombotic situation since all this occurs in the context of an anticoagulated pt for about 10-15 days with a DOAC. The pt''s symptoms not very suggestive of massive PE, the low level of consciousness intermittent without being accompanied by other data such as marked respiratory failure or hypotension significant enough to lead to unconsciousness. However, to consider looking for embolic phenomena in the pulmonary arterial territory. From a thrombus point of view, it was recommended switching from DOAC to UFH. Evolution & comments: Admission due to the presence of generalized deterioration associated with the presence of a 47 mmm R atrial thrombus of recent appearance, in a pt with recent pacemaker placement. Hematology was consulted who recommended management with low mole. Wt. heparin at therapeutic doses & cardiology ruled out a surgical approach. In admi., he had deterioration of renal function & edema with filling of the L U limb, possibly related to subclavian vein thrombosis. The pt evolved unfavorably developing respiratory failure requiring O2 therapy & acute confusional syndrome with brain CT without relevant findings & without initially justifying laboratory abnormalities. In an emergency, thoracic Abd CT scan performed with lesions suggestive of intra-Abd neoplasia with implants close to the bile duct & metastatic liver & lung lesions with pathological adenopathy. Given the existence of acute thrombosis & thrombopenia, it was not possible at the time of admission to take biopsies for diagnosis. Given the serious situation of the pt & the possible disseminated neoplasm origin, the presence of intracardiac thrombosis was chosen once agreed with the family & given the impossibility of offering curative alternatives for a conservative management maintaining the anticoagulant treatment. Lab tests included on 15Apr2021 Sys urine showed pH: 5.5 Density:1027 Leukocytes: -ve num/ul, RBC: 2+ num/uL Nitrites:-ve uarb Protein:15mg dL;Glucose: -vemg/dL; Methyl ketone: -ve mg/dL;Urobilinogen: 2.0mg/dL; Bilirubin:-vemg/dL. Urinary sediment Erythrocytes /ul: 67 Erythrocytes /field: 12 Leukocytes /ul: 11 Leukocytes /field: 2 Glucose:106 mg/dL;Cr:1.26 mg/dL;CKD-EPI: 50.60 mL/min. Multiply by 1159 if black race.Urea:134 mg/dL;Na: 140 mEq/L;K: 4.73 mEq/L; Anion gap: 9.4 mEq/L:Cl:108mEq/L; GOT/AST: 29 U / L, Ritis R AST/ALT:0.97;Lactate dehydrogenase:318U/L;Bilirubin:2.12mg/dL;D. bilirubin:1.24mg/dL;CReactive Protein:22.3mg/L;rocalcitonin:0.26ng/mL;NTpro Natriuretic Peptide B:4825pg/mL.Venous blood gasespH:7.38;pCO2:38.2mmHg;pO2:33.8mmHg;CO3H:22.6mmol/L;Base excess:-2.5mmol/L;SO2:54.6%, Lactate:4.30mmol/L;Leukocytes:9.74 10 E 3/uL;RBC:3.69 10 E 6/uL ;Hb:10.9g/dL;Hematocrit:33.9%; MCV:91.9fL;MCH:29.5pg;MCHC:32.2 g/dL;RDW-CV:18.7%;RDW-SD:56.6;Plat:65 10 E 3/uL;VPM:13.3 fL; PDW:18.4%;Erythroblasts:0.05 10 E 3/uL;Erythroblasts:0.50;Neutrophils:6.82 10 E 3/uL; Lymphocytes:1.85 10 E 3/uL;Monocytes:0.95 10 E 3/Ul;Eosinophils:0.00 10 E 3/uL;Basophils:0.01 10 E 3/uL;Granulocytesimmature:0.11 10 E 3/uL; Neutrophils:70.0%; Lymphocytes:19.0%;Monocytes:9.8%;Eosinophils:0.0%;Basophils:0.1%;Immaturegranulocytes:1.1%; Neutrophil/Lymphocyte Ratio:3.7,Prothrombin Activity:29.90%;INR:2.11,Thromboplastin Time: 38.00 s; Thromboplastin Time Ratio:1.46; Derived fibrinogen:291 mg/dL. Chest x-ray in the supine position did not identify new-onset infiltrates or pleural effusion, 15 mm R hilar pulmonary nodule & unicameral pacemaker with end VI calcific aortic atheromatosis. Abd CT: Space-occupying hepatic lesion in caudate lobe, floating thrombus in the R atrium & pulmonary nodule in R L lobe. Liver of normal size &morphology, a space occupying lesion located in the caudate lobe with centronecrotic &peripheral vascularization identified. Lymphadenopathy in the hepatic hilum, periduinal, perihepatic &tail nodular images of the pancreas probably related to implants. 10x14mm LID pulmonary nodule. Floating thrombus of 47x38mm pericateter in the R atrium. Cysts bilateral cortical kidney stones. Diverticulosis in the descending colon &sigmoid without signs of acute diverticulitis Hiatal hernia, collections, or pneumoperitoneum are identified. B/L pleural effusion &passive atelectasis in both L lobes. CT brain: signs of small vessel arteriopathy. Centered midline. Signs of small vessel artery disease. Dilated ventricular system related to degree of cortical atrophy. Posterior fossa &cisternae of the base without alterations. Activated partial thromboplastin time: 38s. Activated PT time ratio:1.46, ALT:30iu/l, AST:29 iu/l, anion gap:9.4meq/l, bicytopenia: observed (normocytic-normochromic anemia thrombopenia), bilirubin conjugated:1.24 mg/dl, blood bicarbonate:22.6 mmol/l, blood bilirubin:-Ve and 2.12 mg/dl, blood Cl:108meq/l &blood Cr:1.26mg/dl. On 17Apr2021, Physical exploration: Input 1300 diuresis 900 Systolic pressure (mmHg):117, Diastolic pressure (mm Hg):72, Temp:37.1,HR:103bpm, O2Sat: 94 Basal, base excess: -2.5mmol/l, basophil count:0.01 10 3/ul, basophil count:0.1%. Patient died on 21Apr2021. It was not reported if an autopsy was performed. No FU-up attempts possible. No further information expected.; Reported Cause(s) of Death: intracardiac floating thrombosis; Subclavian vein thrombosis


VAERS ID: 1558007 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-26
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5089 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: CARDIOASPIRIN; QUETIAPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ischemic stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101003966

Write-up: Covid Pfizer vaccine was performed in the morning, access to the emergency room in the evening for pulmonary embolism susp; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority IT-MINISAL02-765349. A 93-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 23Jun2021 (Lot Number: FC5089) as SINGLE for covid-19 immunisation; quetiapine, via an unspecified route of administration from an unspecified date to an unspecified date for an unspecified indication. Medical history included ischaemic stroke from an unknown date and unknown if ongoing. Concomitant medication included acetylsalicylic acid (CARDIOASPIRIN) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 (COMIRNATY, lot: EY7065) on 19May2021 for covid-19 immunisation. The patient experienced covid pfizer vaccine was performed in the morning, access to the emergency room in the evening for pulmonary embolism susp on 26Jun2021. The action taken in response to the event for quetiapine was not applicable. The patient died on 12Jul2021. 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: Embolism lung


VAERS ID: 1558709 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Inappropriate schedule of product administration
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), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-30
   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: NLPFIZER INC202101004264

Write-up: first dose of bnt162b2 (COMIRNATY) on 20May2021 / second dose of bnt162b2 (COMIRNATY) on 30Jul2021; Death: Cardiac Arrest; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB and received via Regulatory Authority NL-LRB-00647001. A 61-years-old male patient received second dose of bnt162b2 (COMIRNATY), at the age of 61-years-old via an unspecified route of administration on 30Jul2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no previous COVID-19 infection. The patient previous took first dose of bnt162b2 (COMIRNATY) on 20May2021 as 0.3 ml single dose for covid-19 immunisation. The patient experienced cardiac arrest (death) on 30Jul2021. The patient died on 30Jul2021. The outcome of cardiac arrest was fatal. It was not reported if an autopsy was performed. Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 20May2021 COVID19 : Previous COVID-19 infection: No No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. ; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty): Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): yes Date: 20May2021 COVID19 : Previous COVID-19 infection: No; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1558710 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-30
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebellar infarction
SMQs:, Ischaemic central nervous system vascular conditions (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? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202101004166

Write-up: Cerebellar infarction; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB NL-LRB-00648160. A 43-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Jul2021 (Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Patient previously took the first dose of vaccine on an unknown date at dose 1 single for covid-19 immunization with no adverse reaction. Patient previously didn''t experience COVID-19 infection. The patient medical history and concomitant medications were not reported. The patient experienced cerebellar infarction (death, hospitalization, life threatening) on 30Jul2021. Cerebellar infarction was treated with posterior cranial fossa decompression left. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. Reporter comment: Past drug therapy Pfizer/BioNTech: yes. ADR: no. Date unknown. Cerebellar infarction. Additional information ADR: Cerebellum Infarction. Previous COVID-19 infection: No. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: Past drug therapy Pfizer/BioNTech: yes. ADR: no. Date unknown. Cerebellar infarction Additional information ADR: Cerebellum Infarction COVID-19 Previous COVID-19 infection: No; Reported Cause(s) of Death: Cerebellar infarction


VAERS ID: 1558719 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-15
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: PEPFIZER INC202101007494

Write-up: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and first dose via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient death was reported. It was not reported if an autopsy was performed. Outcome of the event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the limited information, a causal association between the reported event death and suspect drug bnt162b2 cannot be excluded. The case will be re-assessed once further information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1565992 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-07-19
   Days after vaccination:150
Submitted: 0000-00-00
Entered: 2021-08-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Maternal exposure during pregnancy, SARS-CoV-2 test
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-07-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.); Pregnancy
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202101005881

Write-up: Maternal exposure during pregnancy; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory authority. Regulatory authority report number (GB-MHRA-WEBCOVID-202108042255110690-DRTHG). Safety Report Unique Identifier (GB-MHRA-ADR 25756910). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included pregnancy, Lactation decreased, Pregnancy (Patient no longer pregnant at the time of reporting.) Patient has not had symptoms associated with COVID-19 Patient is not currently breastfeeding. Concomitant medication(s) included folic acid taken for Folic acid supplementation, start and stop date were not reported. The patient experienced maternal exposure during pregnancy (death, hospitalization, medically significant, life threatening, congenital anomaly) on an unspecified date, miscarriage of pregnancy (death, hospitalization, medically significant, life threatening, congenital anomaly) on 19Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: yes - positive covid-19 test on an unknown date. The outcome of events were fatal. It was not reported if an autopsy was performed. Patient died on 24-JUL-2021. Patient has not tested positive for COVID-19 since having the vaccine, Patient is not enrolled in clinical trial. Did the medicine have an adverse effect on any aspect of the pregnancy: Yes Pregnancy adverse effects details: 18 week miscarriage. Details of previous pregnancies: All 4 live birth no problems. Patient was exposed to the medicine Before pregnancy. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: miscarriage of pregnancy; Maternal exposure during pregnancy


VAERS ID: 1571139 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
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: 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: DEMODERNATX, INC.MOD20212

Write-up: died after first dose Moderna; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (died after first dose Moderna) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. Very limited information regarding this event has been provided at this time. Further information is not expected as there is no contact information. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up does not contain any new information.; Sender''s Comments: Very limited information regarding this event has been provided at this time. Further information is not expected as there is no contact information.; Reported Cause(s) of Death: Unknown cause of Death


VAERS ID: 1571239 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-12
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 49
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210819528

Write-up: DEATH, UNKNOWN; SHORTNESS OF BREATH; This spontaneous report received from a consumer via a Regulatory Authority [DE-PEI-CADR2021155652] concerned a 69 year old male, race and ethnicity unknown. The patient''s weight was 90 kilograms, and height was 172 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: XD975 expiry: Unknown) frequency one total, dose was not reported, administered on 09-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-JUN-2021, the patient experienced dyspnoea, and was hospitalized (date unspecified). On 31-JUL-2021, the patient died due to unknown cause of death. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death, unknown and shortness of breath on 31-JUL-2021. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0: 20210819528 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Death, unknown and Shortness of breath. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1571286 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214004 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   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: Hypertension arterial; Osteoporosis
Preexisting Conditions: Medical History/Concurrent Conditions: Inflammation; Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20212

Write-up: Sudden death, cause unknown; This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death, cause unknown) in a 62-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 214004) for COVID-19 vaccination. The patient''s past medical history included Obesity and Inflammation. Concurrent medical conditions included Osteoporosis and Hypertension arterial. On 09-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. The patient died on 19-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications are reported. No treatment medications are reported. Sender''s (Case) Safety Report Unique Identifier: FR-AFSSAPS-TO20216066. Company Comment: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Sender''s Comments: Very Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1571450 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-15
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPTAKEDA2021TJP067947

Write-up: Subarachnoid hemorrhage; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 02-Jul-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 15-Jul-2021, the patient experienced HEADACHE (Headache) (seriousness criterion death). On 24-Jul-2021, the patient experienced SUBARACHNOID HAEMORRHAGE (Subarachnoid hemorrhage) (seriousness criteria death and medically significant). The patient died on 24-Jul-2021. The reported cause of death was Headache and Subarachnoid haemorrhage. It is unknown if an autopsy was performed. Patient was experienced mild headache on 15-Jul-2021, headache was exacerbated On 20-Jul-2021, headache subsided On 23-Jul-2021. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company comment: Very limited information regarding these events has been provided at this time. However, more information is required for further assessment.; Sender''s Comments: This case concerns a female of unknown age who experienced a serious unexpected event of death 22 days after receiving her 1st dose of mRNA-1273. Very limited information regarding these events has been provided at this time. However, more information is required for further assessment.; Reported Cause(s) of Death: Headache; Subarachnoid haemorrhage


VAERS ID: 1573433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-20
Onset:2021-04-23
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: PCR; Test Result: Positive ; Comments: variant PCR based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016251

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39240. A 93-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP2166), via an unspecified route of administration on 27Feb2021 as dose 1, single and BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: ET1831), via an unspecified route of administration on 20Mar2021 as dose 2, single, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced sars-cov-2 infection on 23Apr2021. The patient underwent lab tests and procedures which included polymerase chain reaction: variant PCR based b.1.1.7; n501y positive on an 23Apr2021 variant PCR based B.1.1.7; N501Y positive. The patient died on an unspecified date in 2021, due to COVID-19 and vaccination failure. It was not reported if an autopsy was performed. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: COVID-19; Vaccination Failure


VAERS ID: 1573434 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-23
Onset:2021-05-12
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Investigation; Result Unstructured Data: Test Result:Variant sequenced B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016236

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39241. A 94-year-old female patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ET1831) as single dose, dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot Number: EP2166) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced SARS-COV-2 infection on 12May2021. The patient underwent lab test which included investigation: variant sequenced b.1.1.7; n501y positive on unknown date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of SARS-COV-2 infection was fatal. No follow-up attempts are possible, no information is expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; SARS-CoV-2 infection


VAERS ID: 1573435 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-04-11
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2163 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: COVID-19 PCR TEST; Test Result: Positive ; Comments: PCR variant based B.1.1.7; N501Y positive
CDC Split Type: ATPFIZER INC202101016232

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number AT-BASGAGES-2021-39246. An 82 years old male patient received 1st dose of BNT162B2 (COMIRNATY; lot EP2163) on 03Mar2021 and 2nd dose (lot EP2163) on 24Mar2021 for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant drugs were not provided. On 11Apr2021 the patient experienced Vaccination failure, other, SARS-CoV-2 infection. PCR variant based B.1.1.7; N501Y positive. Event outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1573436 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-06-23
   Days after vaccination:85
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET3620 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 7
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101016239

Write-up: Drug ineffective; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Report number: AT-BASGAGES-2021-39250. An 86-year-old male patient received the BNT162B2 (COMIRNATY), dose 1 via unspecified route on 09Mar2021 as single dose (Batch/Lot Number: ET 1831), dose 2 via unspecified route on 30Mar2021 as single dose (Batch/Lot Number: ET3620), for COVID-19 immunisation. No relevant medical history reported. No concomitant medication reported. On 23Jun2021, the patient experienced vaccination failure, other. On 30Jun2021, the patient experienced SARS-CoV-2 infection death. The patient''s outcome was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: vaccination failure; SARS-CoV-2 infection


VAERS ID: 1573437 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-21
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: PCR test; Test Result: Positive ; Comments: PCR
CDC Split Type: ATPFIZER INC202101016106

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) WEB, regulatory authority number AT-BASGAGES-2021-39251. A 95-year-old male patient received second dose of BNT162B2(COMIRNATY), via an unspecified route of administration on 01Apr2021, as single dose (Lot Number: ET7205; Expiration Date: 31Jul2021) and received first dose of BNT162B2(COMIRNATY), via an unspecified route of administration on 12Mar2021, as single dose (Lot Number: ET1831; Expiration Date: 30Jun2021) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced vaccination failure and sars-cov-2 infection on 21Apr2021. The patient underwent lab tests and procedures which included polymerase chain reaction(PCR): positive on an unspecified date. The outcome was fatal. It was not reported if an autopsy was performed. This case was reported as serious due to medically significant and fatal outcome. New information provided from Product Complaint Team, included: Investigation conclusion for lot ET1831: The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ''ET1831''. A complaint sample was not returned. No related quality issues were identified during the investigation.There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. Investigation conclusion for lot ET7205:The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ET7205.A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 infection


VAERS ID: 1573464 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Activated partial thromboplastin time, Asthenia, Atrial fibrillation, Bacterial test, Base excess, Bladder catheter permanent, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood glucose, Blood pH, Blood pressure systolic, Blood urea, C-reactive protein, COVID-19 pneumonia, Chest X-ray, Chest pain, Cholelithiasis, Differential white blood cell count, Echocardiogram, Haemophilus test, Headache, Hypotension, Oxygen saturation, PCO2, PO2, Platelet count, Procalcitonin, Prothrombin time, Red blood cell count, Respiratory failure, SARS-CoV-2 test, Septic shock, Staphylococcus test, Stress cardiomyopathy, Ultrasound scan, White blood cell count
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (narrow), Gallbladder related disorders (narrow), Gallstone related disorders (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-28
   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: LOKREN; STACYL; EUTHYROX
Current Illness: Decreased appetite; Dizziness; Epigastric pain; Ex-smoker (3 daily formerly); Hypertension arterial (on betablocators); Thyroid disorder (substitution)
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation; Hysterectomy; Varicose vein operation
Allergies:
Diagnostic Lab Data: Test Date: 20210228; Test Name: APTT; Test Result: 66.4 s; Test Date: 20210226; Test Name: Bacteria stool test; Result Unstructured Data: Test Result:Staphylococcus aureus; Comments: Staphylococcus aureus; Test Date: 20210226; Test Name: Bacteria urine; Result Unstructured Data: Test Result:legionella and pneumococcus negative; Comments: legionella and pneumococcus negative; Test Date: 20210228; Test Name: Base excess; Result Unstructured Data: Test Result:-8.1 mmol/L; Comments: -8.1 mmol/l; Test Date: 20210226; Test Name: Bladder catheter permanent; Result Unstructured Data: Test Result:Escherichia coli; Comments: Escherichia coli 10*5/ml extended spectrum beta-lactamases; Test Date: 20210228; Test Name: Bicarbonate; Result Unstructured Data: Test Result:21.1 mmol/L; Comments: actual; Test Date: 20210228; Test Name: Bicarbonate; Result Unstructured Data: Test Result:17.7 mmol/L; Comments: standard; Test Date: 20210228; Test Name: Bilirubin; Result Unstructured Data: Test Result:43.3 mmol/L; Test Date: 20210228; Test Name: Creatinine; Result Unstructured Data: Test Result:355 umol/l; Test Date: 20210228; Test Name: Serum glucose; Result Unstructured Data: Test Result:11.8 mmol/L; Test Date: 20210228; Test Name: Blood pH; Result Unstructured Data: Test Result:7.177; Test Date: 20210220; Test Name: Systolic blood pressure; Result Unstructured Data: Test Result:90 mmHg; Test Date: 20210228; Test Name: Urea; Result Unstructured Data: Test Result:19.2 umol/l; Test Date: 20210224; Test Name: CXR; Result Unstructured Data: Test Result:infiltrates; Comments: infiltrates corresponding to bilateral viral pneumonia; Test Date: 20210225; Test Name: CXR; Result Unstructured Data: Test Result:developed interstitial syndrome; Comments: developed interstitial syndrome without effusion, progression obvious; Test Date: 20210228; Test Name: C-reactive protein; Result Unstructured Data: Test Result:274.9 mg/l; Test Date: 20210228; Test Name: Differential WBC count; Result Unstructured Data: Test Result:92.4 ; 2.9 %; Comments: neutrofils 92.4 %, lymphocytes 2.9 %; Test Date: 20210221; Test Name: Echocardiography; Result Unstructured Data: Test Result:significant left atrium dilatation; Comments: significant left atrium dilatation, left ventricle ejction fraction 35 %; Test Date: 20210226; Test Name: Transthoracic echocardiography; Result Unstructured Data: Test Result:stress cardiomyopathy; Comments: stress cardiomyopathy very suspected, severe systolic dysfunction, left ventricle ejection fraction 35-30 %, apical akinesia, midventricular hypokinesa anteroseptal. Without signs of low cardiac output, now 5-5.4 l/min cardiac output, without severe valve defects or right-sided dilatation; Test Date: 20210226; Test Name: Haemophilus test; Result Unstructured Data: Test Result:upper respiratory ways; Comments: upper respiratory ways; Test Date: 20210221; Test Name: Oxygen saturation; Test Result: 94 %; Test Date: 20210228; Test Name: Partial pressure CO2; Result Unstructured Data: Test Result:7.58; Comments: 7.58 kPa; Test Date: 20210228; Test Name: Platelet count; Result Unstructured Data: Test Result:112; Comments: 112/nL; Test Date: 20210228; Test Name: Partial pressure O2; Result Unstructured Data: Test Result:7.8; Comments: 7.8:kPa; Test Date: 20210228; Test Name: Procalcitonin; Result Unstructured Data: Test Result:107.93 umol/l; Test Date: 20210228; Test Name: Quick''s test; Result Unstructured Data: Test Result:2.17; Comments: INR 2.17; Test Date: 20210228; Test Name: RBC count; Result Unstructured Data: Test Result:3.51; Comments: 3.51/pL; Test Date: 20210221; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210226; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210226; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 20210226; Test Name: Staphylococcus aureus; Result Unstructured Data: Test Result:Staphylococcus aureus; Test Date: 20210219; Test Name: Echography; Result Unstructured Data: Test Result:cholecystolithiasis; Comments: cholecystolithiasis; Test Date: 20210228; Test Name: WBC count; Result Unstructured Data: Test Result:17.65; Comments: 17.65/nL
CDC Split Type: CZPFIZER INC202101003447

Write-up: septic shock; stress cardiomyopathy; respiratory failure; SARS-CoV-2 pneumonia/breathlessness progresssion, due to pulmonary infiltrates high-flow nasal oxygen 30l oxygen fraction 83 %; hypotension/lowered blood pressure; atrial fibrillation; progressive weakness; abdominal pains; chest pain - sternum and nape region; strong pain of the back of the head; cholecystolithiasis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority number CZ-CZSUKL-21008826. A 76-year-old female patient received BNT162B2 (COMIRNATY), dose 1 intramuscular on 19Feb2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Patient age at vaccination was 76-year-old. Medical history included arterial hypertension on betablocators from 1990 and ongoing, varices surgery in 1995, hysterectomy in 2004, thyreopathy on substitution from 2010 and ongoing, cataract surgery in 2016 and 2018, abuses: ex-smoker for 20 years, 3 daily formerly. Patient was preceded by epigastrium pain, lack of appetite, dizziness since 12Feb2021. Concomitant medications included betaxolol hydrochloride (LOKREN), acetylsalicylic acid (STACYL) and levothyroxine sodium (EUTHYROX), all taken for an unspecified indication, start and stop date were not reported. Patient was preceded by epigastrium pain, lack of appetite, dizziness since 12Feb2021 and followed by strong pain of rear side of head on 19Feb2021 after the vaccination. Since 20Feb2021 progressive weakness, abdominal pain, chest pain of sternum and nape, lowered blood pressure, beta-blocators were withdrawn. On 21Feb2021 she was admissed to internal department, antigen SARS-CoV-2 positive. Atrial fibrillation appeared, anticoagulated by low-molecular weight heparin, beta-blocator administered, ejection fraction of left ventricle decreased to 35 %, persistent fast response of ventricles. On 24Feb2021 amiodaron, breathlessness progresssion, due to pulmonary infiltrates high-flow nasal oxygen 30l oxygen fraction 83 %, at first saturation satisfactory, then with hyposaturation, oxygen saturation max 85 %, Remdesivir (since 25Feb), corticoids (since 21Feb), C-reactive protein increased to 250 mg/l, procalcitonine 32 umol/l, lactate (6.6 mmol/l) metabolic acidosis, anuria. On 25Feb2021 non improving status on high-flow nasal oxygen, ad noninvasive ventilation with minimal or transient improvement intermitently sinus only, otherwise atrial tachyfibrillation on antiarythmic therapy of amiodarone continually by perfusor. On 26Feb admissed to intensive care unit due to pulmonary finding progression, sinus rhythm after electro-cardioversion, bolus opiates, oxygen saturation does not go over 85 %, oliguria lasts in spite of bolus and continual administration of Furosemid and dobutamin - combined vasopresoric support, severe interstitial pulmonary process (acute respiratory distress syndrome), stress/posttachycardic cardiomyopathy diagnosed at the same time. After drug administration adequate cardiac output and organ perfusion restored, patient with a good response to ventilation in pronation position. In spite of adequate antibiotic treatment (27Feb - Tazo, Ciphin and 28Feb2021- Mero, Zyvox, Amikacin) there is a ventricular tachycardia 170/min, cardioverted by 1st discharge, then atrial fibrillations repeatedly 140-160/min without reaction to electro-cardioversion or amiodaron, Levosimendan indicated, volumotherapy, septic shock development, procalcitonine 67 umol/l, lactate increase, metabolic acidosis development with continual alcalisation needed. 3 transfusion units of fresh-frozen plasma administered due to coagulopathy, oligo/anuria development, severe vasoparalysis. On 28Feb2021 persisting severe shock status, exitus at 14 o''clock. Patient underwent lab tests which included: 19Feb2021 ultrasonography: cholecystolithiasis, 20Feb2021 blood pressure: 90 mmHg systolic, 21Feb2021 SARS-CoV-2 antigen test positive, saturation 94 %, echocardiography - significant left atrium dilatation, left ventricle ejction fraction 35 %, 24Feb2021 chest x-ray: infiltrates corresponding to bilateral viral pneumonia, 25Feb2021 chest x-ray: developed interstitial syndrome without effusion, progression obvious, 26Feb2021 transthoracal echocardiography: stress cardiomyopathy very suspected, severe systolic dysfunction, left ventricle ejection fraction 35-30 %, apical akinesia, midventricular hypokinesa anteroseptal. Without signs of low cardiac output, now 5-5.4 l/min cardiac output, without severe valve defects or right-sided dilatation, 26Feb2021 urine: legionella and pneumococcus negative, stool: Staphylococcus aureus, upper respiratory ways: Haemophillus influenzae, neck: Staphylococcus aureus, permanent urinary catheter: Escherichia coli 10*5/ml extended spectrum beta-lactamases, polymerase chain reaction SARS-CoV-2 positive, antigen negative, 28Feb2021 urea 19.2 mmol/l, creatinine 355 umol/l, bilirubin 43.3 mmol/l, C-reactive protein 274.9 mg/l, procalcitonin 107.93 umol/l, blood pH 7.177, pCO2 7.58 kPa, actual bicarbonates 21.1 mmol/l, standard bicarbonates 17.7 mmol/l, base excess actual: 8.1 mmol/l, pO2 7.8 kPa, glucose 11.8 mmol/l, leukocytes 17.65/nl, erythrocytes 3.51/pl, thrombocytes 112/nl, differential neutrofils 92.4 %, lymphocytes 2.9 %, Quick test INR 2.17, activated partial thromboplastin time 66.4 s. The patient died on 28Feb2021. An autopsy was not performed. Cause of death was reported as viral pneumonia (COVID-19 pneumonia), respiratory failure, septic shock, stress cardiomyopathy and hypotension/lowered blood pressure. Outcome of viral pneumonia (COVID-19 pneumonia), respiratory failure, septic shock, stress cardiomyopathy and hypotension/lowered blood pressure was fatal. Outcome of progressive weakness and atrial fibrillation was not resolved. Outcome of other events was unknown. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reported Cause(s) of Death: respiratory failure; septic shock; stress cardiomyopathy; viral pneumonia, respiratory failure, septic shock, stress cardiomyopathy; hypotension/lowered blood pressure


VAERS ID: 1573471 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD9234 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute left ventricular failure, Acute myocardial infarction, Autopsy, Brain injury, Cardiac arrest, Pulmonary oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   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: Mitral valve stenosis; Old myocardial infarction
Allergies:
Diagnostic Lab Data: Test Name: autopsy; Result Unstructured Data: Test Result:a fresh anterior wall infarction; Comments: In addition to the known findings, the autopsy showed macroscopically a fresh anterior wall infarction, several older myocardial infarction scars as well as the morphological, possibly a mitral valve stenosis without any further assessment of the hemodynamic relevance.
CDC Split Type: DEPFIZER INC202100987691

Write-up: Acute left ventricular failure; Arrest cardiac; Acute myocardial infarction; Pulmonary oedema; Hypoxic brain damage; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority number DE-PEI-202100134122. A 39-years-old female patient received bnt162b2 (COMIRNATY), Solution for injection, Lot number: FD9234 and Expiry date: Unknown), via an unspecified route of administration on 22Jun2021 as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunization. Medical history included myocardial infarction, mitral valve stenosis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On 22Jun2021 the patient experienced acute left ventricular failure, arrest cardiac, acute myocardial infarction, pulmonary oedema, hypoxic brain damage. The patient underwent lab tests and procedures which included autopsy: a fresh anterior wall infarction on. In addition to the known findings, the autopsy showed macroscopically a fresh anterior wall infarction, several older myocardial infarction scars as well as the morphological, possibly a mitral valve stenosis without any further assessment of the hemodynamic relevance.The patient died on 24Jun2021.An autopsy was performed that revealed acute myocardial infarction. Reporter''s comments: In addition to the known findings, the autopsy showed macroscopically a fresh anterior wall infarction, several older myocardial infarction scars as well as the morphological, possibly a mitral valve stenosis without any further assessment of the hemodynamic relevance. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: In addition to the known findings, the autopsy showed macroscopically a fresh anterior wall infarction, several older myocardial infarction scars as well as the morphological, possibly a mitral valve stenosis without any further assessment of the hemodynamic relevance.; Autopsy-determined Cause(s) of Death: Acute myocardial infarction


VAERS ID: 1573473 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987576

Write-up: Fibrillation ventricular; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority, authority number DE-PEI-202100142230. A 75-year-old male patient received unspecified dose of BNT162B2 (COMIRNATY, solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on 03Jun2021 as dose number unknown, 0.3 mL, single dose for covid-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On an unspecified date on 2021, the patient experienced fibrillation ventricular. The patient died on an unspecified date. It was not reported if an autopsy was performed. The casual relationship of Comirnaty and Fibrillation ventricular assessed as Unclassifiable by the Regulatory Authority. No follow-up attempts possible. No further information expected. Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: fibrillation ventricular


VAERS ID: 1573485 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-23
Onset:2021-07-24
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101010418

Write-up: Exitus letalis, medical post-mortem examination; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority report number is DE-PEI-202100155990. An 83-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 23Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. There was no medical history or concomitant medications. 1 day after vaccination, on 24Jul2021 the patient experienced. The lethal outcome, medical post-mortem examination (unknown cause of death). The outcome of the event was fatal. It was not reported if an autopsy was performed. This report was assessed by the reporting physician as serious (death). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: The lethal outcome, medical post-mortem examination


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