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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: 1531350 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100999547

Write-up: Myocardial infarction; This is a spontaneous report from a contactable other health professional via the Goods Administration (GA). Regulatory authority report number is 593870. A male patient of an unspecified age received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced myocardial infarction on an unspecified date. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocardial infarction


VAERS ID: 1531428 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-03-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA G 26761 A; LOT / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood cholesterol, Blood creatine phosphokinase, Blood glucose, Glycosylated haemoglobin, Granulocytes abnormal, Haemoglobin, Lymphocyte count, Myocardial infarction, Platelet count, Troponin T
SMQs:, Haematopoietic leukopenia (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METFIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lumbar spine compression fracture Type II diabetes mellitus; Comments:
Allergies:
Diagnostic Lab Data: Test Date: 20201028; Test Name: Cholesterin; Result Unstructured Data: 4.94 mmol/l,; Test Date: 20201028; Test Name: CK; Result Unstructured Data: 1643 U/L; Test Date: 20210310; Test Name: Glucose; Result Unstructured Data: 18,2; Test Date: 20201028; Test Name: HbA1c; Result Unstructured Data: 4.8%; Test Date: 20210310; Test Name: Granulocytes; Test Result: Inconclusive ; Result Unstructured Data: 84; Test Date: 20201028; Test Name: HB; Result Unstructured Data: 15.1; Test Date: 20210310; Test Name: HB; Result Unstructured Data: 16,4; Test Date: 20201028; Test Name: LC; Result Unstructured Data: 8.5; Test Date: 20210310; Test Name: LC; Result Unstructured Data: 23,5; Test Date: 20201028; Test Name: Platelets; Result Unstructured Data: 313 G/L; Test Date: 20210310; Test Name: Troponin T; Result Unstructured Data: 886
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of MYOCARDIAL INFARCTION in a 77-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. G 26761 A; LOT 300042723) for COVID-19 vaccination. The patient''s past medical history included Type II diabetes mellitus, Adipositas and Lumbar spine compression fracture on 21-Dec-2020. Concomitant products included METFORMIN HYDROCHLORIDE (METFIN) from 01-Jan-2021 to 10-Mar-2021 for Type 2 diabetes mellitus. On 03-Mar-2021, the patient received dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 200 microgram. On 10-Mar-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced MYOCARDIAL INFARCTION (seriousness criteria death and medically significant). The patient died on 10-Mar-2021. The cause of death was not reported. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Oct-2020, Blood cholesterol: 4.94 (normal) 4.94 mmol/l. On 28-Oct-2020, Blood creatine phosphokinase: 1643 (High) 1643 U/L. On 28-Oct-2020, Blood glucose:. On 28-Oct-2020, Glycosylated hemoglobin: 4.8% (normal) 4.8%. On 28-Oct-2020, Granulocytes abnormal:. On 28-Oct-2020, Hemoglobin: 15.1 (normal) 15.1. On 28-Oct-2020, Lymphocyte count: 8.5 (Low) 8.5. On 28-Oct-2020, Platelet disorder: 313 (normal) 313. On 28-Oct-2020, Troponin T:. On 10-Mar-2021, Blood glucose: 18,2 (High) 18,2. On 10-Mar-2021, Granulocytes abnormal: 84 (Inconclusive) 84. On 10-Mar-2021, Hemoglobin: 16,4 (normal) 16,4. On 10-Mar-2021, Lymphocyte count: 23,5 (normal) 23,5. On 10-Mar-2021, Troponin T: 886 (High) 886. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Blood test was conducted on 28-NOV-2020 & 10-MAR-2021. Lab test was conducted on 28.10.2020 Kreatinin 68,Lc 8.5, Tc 313. Treatment information not provided.; Sender''s Comments: COVID-19 Vaccine Moderna das SARS-CoV-2-Virus verursachten Coronavirus-2019-Erkrankung (COVID-19). COVID-19 Vaccine Moderna. 2021 Case Safety Reports, ?Anterior myocardial infarction (LLT)?. COVID-19 Vaccine Moderna. CO-VID-19 Vaccine Moderna, Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 1531430 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute pulmonary oedema, Blood creatinine, C-reactive protein, Chills, Cold sweat, Dyspnoea, Emotional distress, Feeling cold, Feeling hot, Feeling of body temperature change, Glycosylated haemoglobin, Micturition urgency, N-terminal prohormone brain natriuretic peptide, Neutrophil count, Pyrexia, Respiratory arrest, Sepsis, Troponin T, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (uncontrolled)
Allergies:
Diagnostic Lab Data: Test Name: creatinine; Result Unstructured Data: Test Result:174 umol/l; Test Name: CRP; Result Unstructured Data: Test Result:285; Test Name: HbA1c; Result Unstructured Data: Test Result:146; Test Name: Neutrophils; Result Unstructured Data: Test Result:19.4 x10 9/l; Test Name: proBNP; Result Unstructured Data: Test Result:22527; Test Name: TROPONIN T; Result Unstructured Data: Test Result:28; Test Name: WBC; Result Unstructured Data: Test Result:28.1 x10 9/l
CDC Split Type: CKPFIZER INC202100971002

Write-up: Acute pulmonary oedema; sepsis; insisted on using the bathroom; Pyrexia; chills; hot body; distress; Dyspnoea; stopped breathing at that time; clammy skin; cold; Feeling of body temperature change; This is a spontaneous report from a contactable other health professional. Regulatory authority report number is AEFI-A-004936. A 41-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 29May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus uncontrolled. The patient''s concomitant medications were not reported. The patient experienced dyspnoea (death) on 30May2021, stopped breathing at that time (death, medically significant) on 30May2021, acute pulmonary oedema (death, medically significant) on an unspecified date, sepsis (death, medically significant) on an unspecified date, insisted on using the bathroom on 30May2021 with outcome of unknown, pyrexia on 30May2021 with outcome of unknown, feeling of body temperature change on 29May2021 with outcome of unknown, chills on 30May2021 with outcome of unknown, hot body on 29May2021 with outcome of unknown, distress on 30May2021 with outcome of unknown, cold on 30May2021 with outcome of unknown, clammy skin on 30May2021 with outcome of unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed. The clinical course was reported as follows: A few hours after vaccination (29May21), she developed a "hot body" and chills. She took paracetamol and seemed to be well. She didn''t report nor notify health provider at that time. Next day (30May21), she had with chills and fever again but again seemed to improve, then husband was not worried. He left the house to do something. Upon his return he discovered she was in distress, he called for the ambulance she was cold and with clammy skin and insisted on using the bathroom, when she came back to the room she was unable to get onto the bed and stopped breathing at that time. When ambulance arrived, CPR attempted. Death on arrival at ED. Blood tests showed CREATININE 174 ?mol/L, HbA1c 146, CRP 285, TROPONIN T 28, proBNP 22,527, WBC 28.1 x109/L , Neutrophils 19.4 x109/L. Cause of death- Not decided yet. Vaccine related vs. sepsis and diabetes related complications. Probable cause: Sepsis (source of infection??) & Acute pulmonary oedema (secondary to uncrontrolled diabetic, acute sepsis) No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Sepsis; Dyspnoea; stopped breathing at that time; Acute pulmonary oedema


VAERS ID: 1531795 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Artificial cardiac pacemaker wearer; Cardiac failure; Coronary artery disease; Diabetes; Infarct myocardial
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987589

Write-up: Death; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority-WEB DE-DCGMA-21191315, Safety Report Unique Identifier DE-PEI-202100133929 . A 74-year old male patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on 04Jun2021 (Lot Number: Unknown) at the age of 74-year old as 0.3 ml dose for COVID-19 immunization. Medical history included coronary artery disease, diabetes, artificial cardiac pacemaker wearer, cardiac failure, arterial hypertension, all unknown ongoing and not ongoing infarct myocardial. No concomitant medication reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 14May2021 at the age of 74-year old as single dose for COVID-19 immunization. On an unspecified date, the patient experienced death. Autopsy was unknown whether had done. The outcome of event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1532292 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Influenza like illness, Myocarditis, Somnolence
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
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: Lipoedema
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987703

Write-up: Myocarditis; Groggy; Flu-like symptoms; This is a spontaneous report from a non-contactable Physician downloaded from the regulatory authority-WEB. The regulatory authority report number is DE-PEI-202100133875. A 26-years-old female patient received unspecified dose of bnt162b2 (COMIRNATY. Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Jun2021 as dose number unknown, single for COVID-19 immunisation. Medical history included lipoedema from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. On an unspecified date the patient experienced also Flu-like symptoms, grogg and myocarditis. The patient died on 06Jul2021. An autopsy was performed and results were not provided. Outcome of the events was fatal. Patient notes: pathologically and anatomically unclear, macroscopically conspicuous cardiac findings, suspected myocarditis (histology still pending). No follow-up attempts possible. No further information expected. Batch/Lot numbers cannot be obtained.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1532294 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-07
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210808959

Write-up: ACUTE MYOCARDIAL INFARCTION; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP] concerned a 51 year old male of unknown race and ethnic origin. 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: XD974 expiry: unknown) dose was not reported, one total frequency, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUL-2021, the patient experienced acute myocardial infarction. On 07-JUL-2021, the patient died from acute myocardial infarction. It was unknown if the autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0:20210808959-covid-19 vaccine ad26.cov2.s-acute myocardial infarction. 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: ACUTE MYOCARDIAL INFARCTION


VAERS ID: 1532305 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-04-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Dyspnoea exertional, Limb discomfort, Nightmare, Oedema
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac insufficiency; Complex regional pain syndrome; Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987596

Write-up: Confused dreams, body aches, exertional dyspnea, lower leg edema; Confused dreams, body aches, exertional dyspnea, lower leg edema; Confused dreams, body aches, exertional dyspnea, lower leg edema; Confused dreams, body aches, exertional dyspnea, lower leg edema; Confused dreams, body aches, exertional dyspnea, lower leg edema; This is a spontaneous report from a non-contactable consumer and downloaded from the regulatory authority-WEB, regulatory authority number DE-PEI-CADR2021141475. Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100140049. A 88-year-old female patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 13Apr2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included hypertension, complex regional pain syndrome and cardiac insufficiency, all ongoing. No known allergy. No concomitant medication reported. On 14Apr2021 the patient experienced nightmares, limb discomfort, dyspnoea exertional, edema. On 17Apr2021 the patient experienced unknown cause of death. Autopsy was none. The outcome of unknown cause of death was fatal, the outcome of other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1532424 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-07-16
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   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: Medical History/Concurrent Conditions: Alzheimer''s disease; Aortic valve stenosis; Gout; Hypertension arterial; Slipping rib syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC202100987917

Write-up: Vaccination failure; COVID-19; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-CN20212454. A 95-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscular on 04Feb2021 (Batch/Lot Number: EJ6788) as dose 2, single, and dose 1 intramuscular on 14Jan2021 (Batch/Lot Number: EM0477) as dose 1, single for covid-19 immunisation. Medical history included Alzheimer disease, aortic valve stenosis, hypertension arterial, gout, recent slipping syndrome. The patient''s concomitant medications were not reported. Identical screening profile E484K - / E484Q - / L452R +. This profile was strongly suggestive of an Indian variant. Sequencing was underway in the laboratory, but results will not be available for several days. The patient contracted covid-19 infection (positive test on 16Jul2021) lead to his death on 23Jul2021. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 16Jul2021. Vaccination failure reported stop date 23Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Death NOS


VAERS ID: 1532584 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-21
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Cardiac murmur, Coma scale, Computerised tomogram, Intestinal infarction, Large intestine perforation, Oxygen saturation, Physical examination, Radial pulse
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal perforation (narrow), Pulmonary hypertension (broad), Ischaemic colitis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALDACTONE A; PAROXETINE; AMANTADINE; STALEVO [CARBIDOPA MONOHYDRATE;ENTACAPONE;LEVODOPA]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Digestion impaired; Disease Parkinson''s; Obsessive-compulsive disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210521; Test Name: blood pressure; Result Unstructured Data: Test Result:100/80 mmHg; Comments: blood pressure is initially impregnable/The blood pressure is unbearable.; Test Date: 20210521; Test Name: heart murmur; Result Unstructured Data: Test Result:no perceived; Comments: The vesicular murmur is symmetrical without added noise.; Test Date: 20210521; Test Name: Glasgow score; Result Unstructured Data: Test Result:8; Test Date: 20210521; Test Name: CT scan; Result Unstructured Data: Test Result:Gastrointestinal perforation; Comments: digestive perforation with parietal pain in the right colon and a right inguinal hernia. There is a significant pneumatosis, an airborne, a major diffuse gas and fluid effusion; there is also a hepatic tumor syndrome of the right liver and the left liver/with evidence of hepatic tumor syndrome on CT scan; Test Date: 20210521; Test Name: saturation; Test Result: 50 %; Comments: under 9 liters / min of oxygen; Test Date: 20210521; Test Name: Abdominally; Result Unstructured Data: Test Result:extremely distended; Comments: exhibits generalized defense. A scrotal hernia is suspected.; Test Date: 20210521; Test Name: radial pulse; Result Unstructured Data: Test Result:not perceived
CDC Split Type: FRPFIZER INC202100973541

Write-up: Colonic perforation; mesenteric infarction; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) EudraVigilance-WEB FR-AFSSAPS-RS20212455. A 69-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular, administered in Arm Left on 11May2021 (Lot Number: EX6537) as single dose for COVID-19 immunisation. Medical history included obsessive-compulsive disorder, parkinson''s disease, digestive discomfort. Concomitant medications included spironolactone (ALDACTONE A); paroxetine; amantadine; carbidopa monohydrate, entacapone, levodopa (STALEVO). The patient experienced colonic perforation (death) on 21May2021, mesenteric infarction (death) on 21May2021. The clinical course was reported as follows: Undesirable effect: The case is reported by a doctor at the vaccination center. 11May2021: patient received Dose1 COMIRNATY, lot EX6537, left arm; his wife is vaccinated the same day. In Jun2021: the declaring doctor sees the patient''s wife for her 2nd dose in the vaccination center. She reports that her husband died of a mesenteric infarction after the first dose. The reporting physician has no additional information on this subject. Additional information obtained by the CRPV from the attending physician and the hospital where the patient was treated: - call to the attending physician: for her, death has nothing to do with vaccination. - Report from hospital: 10 days after vaccination, that is 21May2021, Urgent Medical is contacted for acute abdominal pain in this patient; this pain follows a digestive discomfort that appeared 3 weeks ago. When help arrives, the patient is in respiratory distress. blood pressure is 100/80 mmHg, saturation is about 50% under 9 liters / min of oxygen. The Glasgow score is 8. The patient is therefore intubated and sedated. Hemodynamically, the patient is mottled up to the thorax with a greatly increased recoloration time. Radial pulses are not perceived. The blood pressure is initially impregnable. There is no perceived heart murmur. The vesicular murmur is symmetrical without added noise. Hemodynamic support by NORADRENALINE 1 mg / H. During hospitalization: On entering the ward, shocked with marbling and a recoloration time of more than 5 seconds. The blood pressure is unbearable. Respiratory, patient intubated in assisted ventilation. The oxygen saturation is impregnable. Neurologically, patient sedated by MIDAZOLAM and SUFENTANIL. Abdominally, the abdomen is extremely distended and exhibits generalized defense. A scrotal hernia is suspected. Patient immediately transferred to the scan which shows a Gastrointestinal perforation with parietal pain in the right colon and a right inguinal hernia. There is a significant pneumatosis, an airborne, a major diffuse gas and fluid effusion; there is also a hepatic tumor syndrome of the right liver and the left liver which cannot be labeled as content of incomplete iodine dynamics. The surgical treatment seems unreasonable in the context of refractory shock with extensive digestive distress. The patient is then transferred to intensive care where he dies a few minutes later. No platelet value available. In total, fatal digestive perforation in a 69-year-old patient, 10 days after Dose1 COMIRNATY, in a context of digestive discomfort prior to vaccination, with evidence of hepatic tumor syndrome on CT scan. Emergency Room Visit and Physician Office Visit for events. Therapeutic measures were taken as a result of events. The patient died on 21May2021. An autopsy was not performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Colonic perforation; mesenteric infarction


VAERS ID: 1532612 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bronchospasm, Candida test, Corynebacterium test, Cytomegalovirus test, Escherichia bacteraemia, Herpes simplex test, Multiple organ dysfunction syndrome, Staphylococcal abscess, Staphylococcus test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (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), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (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: candida albicans; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Candida glabrata; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Candida tropicalis; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Corynebacterium striatum; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Cytomegalovirus; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Escherichia coli; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Herpes simplex virus type 1; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Staphylococcus epidermidis; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission; Test Name: Staphylococcus capitis; Result Unstructured Data: Test Result:UNKNOWN; Comments: Pathogens detected during extracorporeal membrane oxygenation admission
CDC Split Type: GBPFIZER INC202100969128

Write-up: multi-organ failure; Bronchospasm; This is a spontaneous report from a contactable other hcp received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-ADR 25720260. Safety Report Unique Identifier GB-MHRA-ADR 25720260. A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 17Dec2020 (Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced bronchospasm, multi-organ failure on an unspecified date. 56-year-old male patient receiving extracorporeal membrane oxygenation. 61 days from vaccination to extracorporeal membrane oxygenation treatment. 58 days after vaccination admitted hospital and then to severe respiratory failure Centre 3 days later. Patient experienced bronchospasm. Discharged from severe respiratory failure Centre alive 15 days later. Subsequently died, cause of death believed to be multi-organ failure. Pathogens detected during extracorporeal membrane oxygenation admission include candida albicans, Candida glabrata, Candida tropicalis, Corynebacterium striatum, Cytomegalovirus, Escherichia coli, Herpes simplex virus type 1, Staphylococcus capitis and Staphylococcus epidermidis. Case was reported as serious, other medically important condition. Outcome of bronchospasm was unknown and multi-organ failure was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: multi-organ failure


VAERS ID: 1532622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-14
Onset:2021-03-30
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0141 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: B-cell lymphoma, Lymphadenopathy, Medication error
SMQs:, Malignant lymphomas (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 114
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100943262

Write-up: medication error; Enlarged B-Cell Lymphoma /Enlarged Lymph nodes; Enlarged B-Cell Lymphoma /Enlarged Lymph nodes; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00256933, Safety Report Unique Identifier GB-MHRA-ADR 25699099. An 87-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via parenteral on 14Jan2021 (Batch/Lot Number: el0141) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced enlarged b-cell lymphoma /enlarged lymph nodes on 30Mar2021, medication error on an unspecified date. Medication Error Details: the patient was firsted diagnosed with Enlarged B Lymph Nodes - Before he was confirmed with Blood Cancer The patient was taking BNT162b2 for: Government suggested to take as was told was vulnerable to covid. The patient died on 22Jul2021. It was not reported if an autopsy was performed. The outcome of the event enlarged b-cell lymphoma /enlarged lymph nodes was fatal, while the other event was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Enlarged B-Cell Lymphoma /Enlarged Lymph nodes; Enlarged B-Cell Lymphoma /Enlarged Lymph nodes


VAERS ID: 1533246 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1471 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Bleeding time, Bleeding time prolonged, Chest pain, Confusional state, Pneumonia
SMQs:, Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chest pain; Enlarged prostate; Pneumonia
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: Bleeding time; Result Unstructured Data: Test Result:prolonged
CDC Split Type: GBPFIZER INC202100976645

Write-up: Pneumonia NOS; Bleeding time prolonged; Confusion; Loss of balance; Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. Regulatory authority report number (GB-MHRA-WEBCOVID-202107301258141360-VSNYS), Safety Report Unique Identifier (GB-MHRA-ADR 25732878). An 88-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Er1471), via an unspecified route of administration on 01Jul2021 as second dose, single for COVID-19 immunization. Medical history included chest pain, pneumonia, enlarged prostate. The patient''s concomitant medications were not reported. Patient has not had symptoms associated with covid-19 and not had a covid-19 test. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. On unspecified date in Jul2021, the patient experienced pneumonia nos, bleeding time prolonged, confusion, loss of balance and chest pain. Outcome of all the events was fatal (also reported as not recovered for the events confusion, loss of balance, chest pain while unknown for the event bleeding time prolonged). The patient died on 28Jul2021. 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: Pneumonia NOS; Bleeding time prolonged; Confusion; Loss of balance; Chest pain


VAERS ID: 1533309 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Congenital anomaly
SMQs:, Congenital, familial and genetic disorders (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-04-02
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100951112

Write-up: Congenital anomaly/birth defect; Early miscarriage; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory Authority report number is GB-MHRA-WEBCOVID-202107241955066220-YERYI, Safety Report Unique Identifier GB-MHRA-ADR 25703364. This physician reported information for both mother and fetus. This is a fetal report. A fetus of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported) via transplacental route on 30Mar2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. It was reported that the patient''s mother became pregnant on an unspecified date in 2021 (between Mar2021 to Apr2021) while taking BNT162B2. Patient experienced congenital anomaly further reported as birth defect and early miscarriage on 02Apr2021. The events were reported as serious (death, medically significant, life threatening, congenital anomaly). The patient died on 02Apr2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : GB-PFIZER INC-202100943362 maternal case; Reported Cause(s) of Death: Congenital anomaly/birth defect; Early miscarriage


VAERS ID: 1533335 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-19
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Encephalitis viral
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100975640

Write-up: Viral encephalitis; This is a spontaneous report from a contactable consumer via medical information team. An 87-year-old male patient (reporter''s father) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at single dose on 19Mar2021 for COVID-19 immunisation. The first dose was on 08Jan2021 (Lot number: BN ej1688). Medical history and concomitant medications were not reported. The reporter''s father died after the second dose of the COVID-19 vaccine due to viral encephalitis. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of event was fatal. The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Viral encephalitis


VAERS ID: 1533357 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-11
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Atrial fibrillation, Blood pressure measurement, Cardiac arrest, Death, Hypotension, Myocardial infarction, Pulmonary oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart valve replacement; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210411; Test Name: Blood pressure; Result Unstructured Data: Test Result:8/3.5
CDC Split Type: GRPFIZER INC202100973441

Write-up: Cardiac arrest/heart attack; Cardiac arrest/heart attack; Acute renal insufficiency; Atrial fibrillation; fluid in lungs; Hypotension, blood pressure 8/3.5; Death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number GR-GREOF-20216067. A senior male patient of an unspecified age received the first dose of BNT162B2 (COMIRNATY, lot number: unknown) on 03Apr2021 at single dose for COVID-19 immunisation. Medical history included heart valve replacement from 2009 and hypertension. Concomitant medication included rivaroxaban (XARELTO). On 11Apr2021, the patient experienced hypotension. The patient went to the hospital where he was diagnosed with atrial fibrillation and fluid in lungs. On 12Apr2021 at 08:00 in the morning, the doctors told us that the patient had had two heart attacks, that they brought him back to life and intubated him. Two hours later the patient died, because after the second cardiac arrest, the patient had acute renal failure, and the artificial kidney couldn''t endure the low pressure. The patient underwent lab tests and procedures which included blood pressure: 8/3.5 on 11Apr2021. The outcome of the events cardiac arrest, acute kidney insufficiency and death was fatal. The outcome of other events was unknown. The patient died on 12Apr2021. An autopsy was not 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: Cardiac arrest/heart attack; Acute renal insufficiency; Death


VAERS ID: 1533359 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-05-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Neoplasm malignant, Neoplasm progression, Skin disorder
SMQs:, Malignancy related conditions (narrow), Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 42
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: GRPFIZER INC202100985177

Write-up: Skin and subcutaneous tissue disorder; initial and metastatic cancer(aggravation/cause); initial and metastatic cancer(aggravation/cause); This is a spontaneous report from a contactable consumer. This is second of two reports. The first report was downloaded from the Regulatory Authority-WEB GR-GREOF-20216150. A 73-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 16Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient experienced skin and subcutaneous tissue disorder and initial and metastatic cancer(aggravation/cause) on 01May2021. The events were reported serious with criteria of death and medically significant. The patient died on 12Jun2021. 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: initial and metastatic cancer(aggravation/cause); skin and subcutaneous tissue disorder; initial and metastatic cancer (aggravation/cause)


VAERS ID: 1533365 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort
SMQs:, Anaphylactic reaction (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 125
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: Esophageal carcinoma; Operation NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRPFIZER INC202100982628

Write-up: tightness around the heart; This is a spontaneous report from a contactable consumer. This is second of two reports. The first report wad downloaded from the Regulatory Authority-WEB regulatory authority number HR-HALMED-300049723. A 78-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), intramuscular on 23Feb2021 (at unknown age) as 0.3 ML SINGLE for COVID-19 immunisation. The person was healthy before vaccination, had a history of oncological disease (Esophageal carcinoma, operated on in the initial stage in 2014, without metastases) which was considered cured in 2014, regularly monitored at the Hospital, all findings regarding this tumor are in order. Good psychophysical condition, active, no cardiac symptoms before, never taking any chronic therapy. The patient''s concomitant medications were not reported. After the first dose he noticed tightness around the heart (death, hospitalization, life threatening) on Feb2021 that he had never felt before, but it did not intensify. The patient died on 07Jun2021. It was unknown if an autopsy was performed. Due to good health before the vaccine and the sudden onset of symptoms and rapid deterioration, there is a suspicion of an association. A casual relationship between COMIRNATY and event Chest pressure was assessing: Unassessable/Unclassifiable. Source of assessment: Regulatory Authority. Method of assessment: WHO- Causality. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender''s Comments: Linked Report(s) : HR-PFIZER INC-202100974257 same reporter/patient/drug, different dose/events; Reported Cause(s) of Death: tightness around the heart


VAERS ID: 1533398 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac disorder, Death, Medication error
SMQs:, Medication errors (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: ITJNJFOC20210801314

Write-up: DEATH; HEART PROBLEMS; POTENTIAL MEDICATION ERROR; This spontaneous report received from a patient via a company representative from social media concerned a male of unspecified age, 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 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. Per procedure, no follow-up will be requested for this case. Non-company suspect vaccine included: MRNA 1273 ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination; and BNT 162 ( form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient dies for heart problems after the third dose. The patient experienced potential medication error as he received first had first J&J vaccine then MRNA and then BNT 162. It was unknown if an autopsy was performed. As heart problems was not the cause of death. On an unspecified date, the subject died from unknown cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of heart problems and potential medication error was not reported. This report was serious (Death).; Sender''s Comments: V0:20210801314- Covid-19 vaccine ad26.cov2.s - Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: 1533571 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-21
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3558 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Loss of personal independence in daily activities, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Dementia (broad), 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: LANSOPRAZOLE; ALLOPURINOL; TAMSULOSIN; BISOPROLOL FUMARATE; ATORVASTATIN; LASIX [FUROSEMIDE]; CLOPIDOGREL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aphasia; Chronic renal failure (moderate); Dysphagia; Hypertensive heart disease NOS (severe heart disease); Stroke (2020 resulting in aphasia and dysphagia); Unilateral leg swelling
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100973358

Write-up: total loss of autonomy until death within 1 month and a half; already had a swollen leg, both swollen in the days; already had a swollen leg, both swollen in the days; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB IT-MINISAL02-761751. A 78-year-old male patient (reporter''s father) received the first dose of BNT162B2 (COMIRNATY, lot number: FC3558), via intramuscular in left arm (also reported as left shoulder) on 25May2021 at single dose for COVID-19 immunisation. Medical history included stroke (resulting in aphasia and dysphagia in 2020), aphasia from 2020, dysphagia from 2020, chronic renal failure (moderate), hypertensive heart disease NOS (severe heart disease) and swollen leg. Concomitant medications included lansoprazole (strength: 30 mg) at 30 mg; allopurinol; tamsulosin; bisoprolol fumarate; atorvastatin (strength: 40 mg) at 40 mg; furosemide (LASIX, strength: 25 mg) at 25 mg; clopidogrel (strength: 75 mg) at 75 mg. The patient had a severe heart disease, and he already had a swollen leg. The patient experienced both swollen in the days following the vaccination, total loss of autonomy until death within 1 month and a half on 21Jun2021. The reporter decided not to give the patient the second dose but it was useless, he didn''t make it. The reporter cannot say that it was the vaccine but the aggravation was clear. The outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. Sender''s comments: 26Jul2021 added concomitant drugs. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: already had a swollen leg, both swollen in the days; total loss of autonomy until death within 1 month and a half; already had a swollen leg, both swollen in the days


VAERS ID: 1533591 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAKEPRON; BI SIFROL; MENESIT; MUCODYNE-DS; LULLAN; CRAVIT; CALONAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrostomy; Parkinson''s disease; Pneumonia aspiration; Pyrexia
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210621; Test Name: body temperature; Result Unstructured Data: Test Result:37 Centigrade
CDC Split Type: JPPFIZER INC202100942657

Write-up: Cardio-respiratory arrest; Suspicion of upper airway obstruction due to sputum; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. Regulatory authority report number is V21121594. An 88-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection), intramuscular, administered in left arm on 21Jun2021 at 16:30 (Batch/Lot Number: FC3661; Expiration Date: 30Sep2021) (at the age of 88-years-old) as dose 1, single for COVID-19 immunisation. Medical history included Parkinson''s disease (classification of severity: Hoehn and Yahr 5), state of gastrostomy. As for diseases within one month before the report, from 04Jun2021 to 11Jun2021, the patient had pneumonia aspiration, for which intravenous drip infusion of sulbactam/ampicillin (SBT/ABPC) was administered. On 18Jun2021, pyrexia of 38.1 degrees Centigrade developed, and administration of levofloxacin (LVFX) 500 mg was started by a tube. On 19Jun2021, the patient had a slight fever. On 20Jun2021, fever was reduced. On 21Jun2021, body temperature was 37 degrees Centigrade. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the following medications within 2 weeks of vaccination: lansoprazole (TAKEPRON OD Tablets 15), pramipexole dihydrochloride (BI SIFROL Tablets 0.5mg), carbidopa, levodopa (MENESIT Combination Tablets 100), carbocisteine (MUCODYNE-DS 50%), perospirone hydrochloride (LULLAN Tablets 8mg), levofloxacin (CRAVIT Tablets 500 mg), and paracetamol (CALONAL Fine granules 50%). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Since the vaccination, the patient has not been tested for COVID-19. On 22Jun2021 at 08:30 (1 day after the vaccination), the next morning after the vaccination, the patient was found in cardio-respiratory arrest. The patient died. The cause of death was unknown but upper airway obstruction due to sputum and association with the vaccination were suspected. The patient received no treatments for the event. The reporting physician assessed the event as serious (death). Autopsy was not performed. The reporting physician assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was a possibility of upper airway obstruction due to sputum. The reporting physician provided the following comment: Although sputum was not noted at the pharynx or larynx on consultation, this observation was done after aspiration operation. The reporting physician thus considered that upper airway obstruction due to sputum was highly suspected as the cause of death. However, there was no fact of increased amount of sputum after the vaccination specifically, and the event occurred within 24 hours of the vaccination. Therefore, it was reported that the adverse reaction due to the vaccine also could not be denied as the cause of death.; Reporter''s Comments: Upper airway obstruction due to sputum was highly suspected as the cause of death. However, there was no fact of increased amount of sputum after the vaccination specifically, and the event occurred within 24 hours of the vaccination. Therefore, it was reported that the adverse reaction due to the vaccine also could not be denied as the cause of death.; Reported Cause(s) of Death: possibility of upper airway obstruction due to sputum; cardio-respiratory arrest


VAERS ID: 1533593 (history)  
Form: Version 2.0  
Age: 96.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature, Cardio-respiratory arrest, Foaming at mouth, Multiple organ dysfunction syndrome, Pallor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   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: PREDONINE [PREDNISOLONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anti-neutrophil cytoplasmic antibody positive vasculitis
Allergies:
Diagnostic Lab Data: Test Date: 20210721; Test Name: Body temperature; Result Unstructured Data: Test Result: 36.9 Centigrade; Comments: before vaccination.
CDC Split Type: JPPFIZER INC202100943885

Write-up: Multi-organ failure resulting from asphyxia due to vomiting; Multi-organ failure resulting from asphyxia due to vomiting; Multi-organ failure resulting from asphyxia due to vomiting; cardio-respiratory arrest; Complexion ill; Foaming at mouth; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21120990. A 96-year and 3-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 21Jul2021 at 14:17 (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) (at the age of 96-years-old) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.9 degrees centigrade. Family history was unknown. Medical history included antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. Concomitant medications included prednisolone (PREDONINE) orally ongoing at 6 mg/day taken for an unspecified indication, start and stop date were not reported. On 21Jul2021, the patient experienced complexion ill and foaming at mouth at 14:22 (5 minutes after the vaccination). On 21Jul2021, the patient died with multi-organ failure resulting from asphyxia due to vomiting. The course of the events was as follows: On 21Jul2021 at 14:17 (the day of vaccination), the patient received the coronavirus vaccination. At 14:22 (5 minutes after the vaccination), complexion ill was noted. The patient was found foaming at the mouth. At 14:25 (8 minutes after the vaccination), medical review was done in a sitting position. The carotid artery was not palpable at that time. At 14:28 (11 minutes after the vaccination), the reporting physician was called, went to hospital. The physician assessed the patient was in cardio-respiratory arrest. At 14:30 (13 minutes after the vaccination), cardiac massage was started by another person. At 14:33 (16 minutes after the vaccination), an ambulance was called. At 14:35 (18 minutes after the vaccination), an automated external defibrillator (AED) was used, but no improvement was obtained. The reporting physician classified the events as serious (hospitalization) and assessed the causality between the events and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases included asphyxia due to vomiting. The patient died on 21Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: The information was from Primary care. There was a contact from the hospital where the patient was urgently taken, and it notified that the death cause was multi-organ failure resulting from asphyxia due to vomiting.; Reporter''s Comments: The information was from Hospital. There was a contact from the hospital where the patient was urgently taken, and it notified that the death cause was multi-organ failure resulting from asphyxia due to vomiting.; Reported Cause(s) of Death: Multi-organ failure resulting from asphyxia due to vomiting; Multi-organ failure resulting from asphyxia due to vomiting; Multi-organ failure resulting from asphyxia due to vomiting


VAERS ID: 1533626 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-20
Onset:2021-07-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve insufficiency; Atrial fibrillation paroxysmal; Renal impairment; Thoracic aortic aneurysm.
Allergies:
Diagnostic Lab Data: Test Date: 20210720; Test Name: Body Temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: Before vaccination; Test Date: 20210721; Test Name: imaging results; Result Unstructured Data: Test Result: Aortic dissection.
CDC Split Type: JPPFIZER INC202100951721

Write-up: Cardio-respiratory arrest; Aortic dissection; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121082. A 93-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 20Jul2021 09:40 (Batch/Lot Number: EY0573; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Medical history included Atrial fibrillation paroxysmal, Thoracic aortic aneurysm, Aortic valve insufficiency, and Renal impairment. The patient had no family history. The patient''s concomitant medications were not reported. The patient took the first dose of BNT162B2 (COMIRNATY) on an unspecified date for COVID-19 immunization. Body temperature before vaccination was 36.6 degrees centigrade on 20Jul2021. On 21Jul2021 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. On 21Jul2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 21Jul2021, the patient experienced cardio-respiratory arrest and was transferred to medical center. The patient''s heartbeat did not return and he was confirmed dead. Aortic dissection was suspected based on the imaging results. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unassessable. Other possible causes of the event such as any other diseases were aortic valve insufficiency and aortic dissection.; Reported Cause(s) of Death: Cardio-respiratory arrest; Aortic dissection


VAERS ID: 1533631 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Anuria, Aspartate aminotransferase, Base excess, Blood albumin, Blood alkaline phosphatase, Blood bicarbonate, Blood bilirubin, Blood creatinine, Blood gases, Blood lactate dehydrogenase, Blood potassium, Blood pressure decreased, Blood pressure measurement, Blood urea, Body temperature, C-reactive protein, Cardiac failure, Cerebral infarction, Chest X-ray, Computerised tomogram head, Creatinine renal clearance, Cyanosis, Dyspnoea, Electrocardiogram, Gamma-glutamyltransferase, Generalised oedema, Glomerular filtration rate, Haemoglobin, Hemiplegia, Hypokalaemia, Liver disorder, Malnutrition, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Platelet count, Pleural effusion, Protein total, Prothrombin time, Pyrexia, Renal failure, Respiratory alkalosis, Tachycardia, Urine output, Weight increased, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Angioedema (broad), Asthma/bronchospasm (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), Ischaemic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WYSTAL; HEPARIN; TAKECAB; BAYASPIRIN; CLOPIDOGREL; ACETAMINOPHEN; ANHIBA; HANP; FUROSEMIDE; SOLDACTONE; EDARAVONE; PASIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bile duct cancer; Biliary stent placement; Catheterisation venous (500 mL of infusion per day was continued since 04Jun2021); Cholangitis; Dementia; Device related infection; Inappetence; Pyrexia.
Allergies:
Diagnostic Lab Data: Test Date: 20210715; Test Name: ALT; Result Unstructured Data: Test Result:328; Test Date: 20210715; Test Name: AST; Result Unstructured Data: Test Result:849; Test Date: 20210715; Test Name: BE; Result Unstructured Data: Test Result:0.0; Test Date: 20210715; Test Name: Alb; Result Unstructured Data: Test Result:2.4; Test Date: 20210715; Test Name: ALP; Result Unstructured Data: Test Result:475; Test Date: 20210715; Test Name: HCO3; Result Unstructured Data: Test Result:21.2; Test Date: 20210715; Test Name: TB; Result Unstructured Data: Test Result:1.2; Test Date: 20210715; Test Name: Cr; Result Unstructured Data: Test Result:2.75; Test Date: 20210715; Test Name: Blood gas; Result Unstructured Data: Test Result: respiratory alkalosis; Test Date: 20210715; Test Name: LD; Result Unstructured Data: Test Result:891; Test Date: 20210715; Test Name: K; Result Unstructured Data: Test Result:2.45; Test Date: 20210717; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: decreased; Test Date: 20210715; Test Name: UN; Result Unstructured Data: Test Result:43.4; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:37.0-36.8 Centigrade; Comments: before vaccination; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:37.5 Centigrade; Comments: at 14:00; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:37.9 Centigrade; Comments: at 16:00; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: at 20:00; Test Date: 20210702; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Comments: at 14:55; Test Date: 20210703; Test Name: Body temperature; Result Unstructured Data: Test Result:38.8 Centigrade; Comments: at 14:00; Test Date: 20210708; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210709; Test Name: Body temperature; Result Unstructured Data: Test Result:38.1 Centigrade; Test Date: 20210712; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210713; Test Name: Body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:38.9 Centigrade; Test Date: 20210715; Test Name: Body temperature; Result Unstructured Data: Test Result:39.0 Centigrade; Test Date: 20210716; Test Name: Body temperature; Result Unstructured Data: Test Result:38.2 Centigrade; Test Date: 20210713; Test Name: Chest roentgenogram; Result Unstructured Data: Test Result: right pleural effusion; Test Date: 20210702; Test Name: Head CT test; Result Unstructured Data: Test Result: left-predominant old Lacunar infarction; Comments: left-predominant old Lacunar infarction and chronic ischemic change; disorder involving Broca''s area was suspected; Test Date: 20210705; Test Name: Head CT test; Result Unstructured Data: Test Result: no new lesion; Comments: the same as before and no new lesion could be pointed out; Test Date: 20210715; Test Name: CRP; Result Unstructured Data: Test Result:5.0; Test Date: 20210702; Test Name: CCR; Result Unstructured Data: Test Result:27.2; Test Date: 20210702; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: no atrial fibrillation; Comments: pacemaker rhythms and there was no possibility of cardiogenic cerebral infarction as the same as before; Test Date: 20210715; Test Name: gamma GT; Result Unstructured Data: Test Result:336; Test Date: 20210702; Test Name: eGFR; Result Unstructured Data: Test Result:38.6; Test Date: 20210715; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.0; Test Date: 20210715; Test Name: O2S; Test Result: 96.7 %; Test Date: 20210715; Test Name: PCO2; Result Unstructured Data: Test Result:26.2; Test Date: 20210715; Test Name: pH; Result Unstructured Data: Test Result:7.526; Test Date: 20210715; Test Name: Platelets; Result Unstructured Data: Test Result:13.8; Test Date: 20210715; Test Name: PO2; Result Unstructured Data: Test Result:76.0; Test Date: 20210715; Test Name: TP; Result Unstructured Data: Test Result:5.9; Test Date: 20210715; Test Name: PT (INR); Result Unstructured Data: Test Result:2.2; Test Date: 20210712; Test Name: Urine output; Result Unstructured Data: Test Result:1600 mL mL; Comments: a day; Test Date: 20210713; Test Name: Urine output; Test Result: 2000 mL; Comments: a day; Test Date: 20210714; Test Name: Urine output; Test Result: 660 mL; Comments: a day; Test Date: 20210715; Test Name: Urine output; Test Result: 55 mL; Comments: a day; Test Date: 20210716; Test Name: Urine output; Test Result: 135 mL; Comments: a day; increased a little; Test Date: 20210715; Test Name: WBC; Result Unstructured Data: Test Result:10500.
CDC Split Type: JPPFIZER INC202100951740

Write-up: dyspnoea; decrease in oxygenation; tachycardia; blood pressure decreased; cyanosis of extremities; anuria; renal failure; hypokalaemia; respiratory alkalosis; undernutrition; high grade liver disorder; right pleural effusion; gained 6.7 kg in a week; generalised oedema (complicated by cardiac failure); generalised oedema (complicated by cardiac failure); hemiplegia (flaccid); Cerebral infarction; Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority (Regulatory authority report number is v21121095) with information received from the same contactable physician received via a Pfizer sales representative. An 83-year and 9-month-old (at vaccination) female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 01Jul2021 10:45 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) as dose 2, 0.3 mL single for covid-19 immunisation; Edaravone, via an unspecified route of administration from 02Jul2021 (Batch/Lot number was not reported) to an unspecified date, at 30 mg, twice a day for cerebral infarction; pazufloxacin mesilate (PASIL), via an unspecified route of administration from 09Jul2021 (Batch/Lot number was not reported) to an unspecified date, at 0.5 g, twice a day for an unspecified indication. Medical history included complication of pyrexia possibly due to catheter-related bloodstream infection or retrograde cholangitis from 25Jun2021 to 30Jun2021, biliary metallic stent placement for middle bile duct cancer, oral intake was inadequate due to dementia (inappetence due to dementia), for which total parenteral nutrition (TPN) catheter was inserted via the right groin for water and nutrition control. 500 mL of infusion per day was continued since 04Jun2021. Concomitant medication included cefoperazone sodium, sulbactam sodium (WYSTAL) 1 g twice daily taken for pyrexia started on 29Jun2021 and from 02Jul2021 to 08Jul2021, heparin 10.000 unit/day from 02Jul2021 to 09Jul2021, vonoprazan fumarate (TAKECAB) 20 mg started on 02Jul2021, which was changed to 10 mg on 08Jul2021, acetylsalicylic acid (BAYASPIRIN) 200 mg started on 02Jul2021, which was changed to 100 mg on 08Jul2021, clopidogrel 75 mg started on 02Jul2021, acetaminophen 400 mg as needed taken for pyrexia on 01Jul2021, paracetamol (ANHIBA) suppository (200) 2 DFs taken for pyrexia on 02Jul2021 and 03Jul2021, carperitide (HANP) started on 12Jul2021, furosemide 20 mg started on 12Jul2021, and potassium canrenoate (SOLDACTONE) 100 mg started on 12Jul2021. On 10Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number and expiration date were not reported) 0.3 mL intramuscular. On 25Jun2021, the patient had complication of pyrexia possibly due to catheter-related bloodstream infection or retrograde cholangitis. On 29Jun2021, WYSTAL 1 g twice daily was added for pyrexia. On 30Jun2021 (2 days before 2nd vaccination), pyrexia resolved and general condition was good. Body temperature before vaccination was 37.0 to 36.8 degrees centigrade. On 02Jul2021 at around 17:00 (around 1 day 6 hours 15 minutes after the vaccination), the patient experienced cerebral infarction. The course of the event cerebral infarction was as follows: On 01Jul2021 at 10:45, the patient received the second dose of COMIRNATY intramuscular injection 0.3 mL in arm left. Body temperature before vaccination was 37.0-36.8 degrees centigrade. On the same day at 14:00, the patient developed pyrexia of 37.5 degrees centigrade. At 16:00, body temperature was 37.9 degrees centigrade, which was treated with acetaminophen 400 mg as needed. At 20:00, pyrexia resolved to 36.8 degrees centigrade. On 02Jul2021 at 14:55, body temperature rose again to 38.2 degrees centigrade, for which ANHIBA suppository (200) two dosage forms were inserted into the rectum. At 17:00, paralysis of right upper limb and aphasia appeared. The patient had no consciousness disturbed. Head CT test was emergently conducted, which showed left-predominant old Lacunar infarction and chronic ischemic change, for which disorder involving Broca''s area was suspected. Electrocardiogram showed no atrial fibrillation. It showed pacemaker rhythms and there was no possibility of cardiogenic cerebral infarction as the same as before. The patient was diagnosed with cerebral infarction and treatment was initiated which included 1) infusion at a total volume of 1400 mL/day, 2) heparin 10.000 unit/day, 3) EDARAVONE 30 mg twice daily, and 4) WYSTAL 1 g twice daily. Renal function was creatinine clearance (CCR) 27.2 and estimated glomerular filtration rate (eGFR) 38.6. TAKECAB 20 mg and BAYASPIRIN 200 mg/clopidogrel 75 mg (dual anti-platelet therapy [DAPT]) were concurrently initiated. On 03Jul2021, aphasia and paralysis of right upper limb were unchanged. At 14:00, the patient developed high fever of 38.8 degrees centigrade, which resolved with ANHIBA suppository (200) two dosage forms. On 05Jul2021, the condition progressed to right hemiplegia (flaccid), for which head CT test was conducted again. CT finding was the same as before and no new lesion could be pointed out. On 07Jul2021, the patient spoke and paralysis of right lower limb improved to some extent. There was a chance of improvement. On 08Jul2021, body temperature was 38.4 degrees centigrade. The patient was barely able to move right lower limb. Oral medications were changed to BAYASPIRIN 100 mg/clopidogrel 75 mg (DAPT) and TAKECAB 10 mg. On 09Jul2021, since the patient had pyrexia of 38.1 degrees centigrade, antibiotic was changed from WYSTAL to PASIL 0.5 g twice daily. Heparin was discontinued and treatment with DAPT was continued. Infusion volume per day was 1900 mL. On 12Jul2021, body temperature was 38.2 degrees centigrade. The patient gained 6.7 kg in a week and had generalised oedema (complicated by cardiac failure), for which 24-hour HANP therapy and injection of diuretic (furosemide 20 mg and SOLDACTONE 100 mg) via the side tube were initiated. Infusion volume per day was decreased to 1200 mL. Ureteral catheter was inserted. Urine output a day was 1600 mL. On 13Jul2021, body temperature was 38.3 degrees centigrade. Chest roentgenogram showed right pleural effusion. Urine output a day was 2000 mL. On 14Jul2021, body temperature was 38.9 degrees centigrade. Urine output a day was 660 mL. On 15Jul2021, body temperature was 39.0 degrees centigrade and urine output a day was 55 mL. TPN catheter in the right groin was removed and a catheter was newly inserted via the left groin. Blood gas showed respiratory alkalosis. (Oxygen 3 L, ph: 7.526, oxygen partial pressure [PO2]: 76.0, carbon dioxide partial pressure [PCO2]: 26.2, bicarbonate [HCO3]: 21.2, base excess [BE]: 0.0, and oxygen saturation [O2S]: 96.7%). White blood cell (WBC): 10500, haemoglobin: 11.0, platelets: 13.8, C-reactive protein (CRP): 5.0, prothrombin time (PT) (international normalized ratio [INR]): 2.2, potassium: 2.45, total protein (TP): 5.9, albumin (Alb) : 2.4, aspartate aminotransferase (AST): 849, alanine aminotransferase (ALT): 328, LD: 891, ALP: 475, gamma-glutamyl transpeptidase (gamma GT): 336, total bilirubin (TB): 1.2, urea nitrogen (UN): 43.4, and creatinine (Cr): 2.75. Thus, undernutrition, hypokalemia, renal failure, and high grade liver disorder. NEOPHAGEN 80 mL injection via the side tube was added for liver disorder. On 16Jul2021, body temperature was 38.2 degrees centigrade, the patient was in a state of anuria. Dopamine 3 ug/kg/minute was also initiated. Urine output a day increased a little to 135 mL, possibly due to the effect of the treatment. On 17Jul2021 in the early hours, dyspnoea, decrease in oxygenation, tachycardia, etc., appeared. At 02:00, blood pressure decreased, laboured respiration, and cyanosis of extremities appeared. At 03:30, death was confirmed. The patient died on 17Jul2021 due to cerebral infarction. The outcome of other events was unknown. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. Other possible causes of the event such as any other diseases includes middle bile duct cancer and catheter-related bloodstream infection. The reporting physician comment: It was considered that the patient had complication of cerebral infarction which was triggered by pyrexia due to the second vaccination and liver disorder and renal disorder in the clinical course were caused by adverse effect due to therapeutic drug (EDARAVONE or PASIL). Causal relationship between the vaccine and the onset of cerebral infarction could not be denied.; Reported Cause(s) of Death: cerebral infarction


VAERS ID: 1533659 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bacterial sepsis, Bacterial test, Disseminated intravascular coagulation, Malaise, Pneumonia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease
Allergies:
Diagnostic Lab Data: Test Date: 20210707; Test Name: blood: gram-negative rod; Test Result: Positive.
CDC Split Type: JPPFIZER INC202100971377

Write-up: severe pneumonia; sepsis (blood: gram-negative rod positive); DIC; malaise; This is a spontaneous report from a contactable physician received via the Regulatory Authority. A 72-year and three-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, lot number FC3661, expiration date 30Sep2021) at the age of 72-years, intramuscularly in the left arm on 03Jul2021 at unspecified time (the day of vaccination) at single dose for COVID-19 immunization. The patient previously received the first single dose of BNT162b2 (COMIRNATY, lot number FC3661, expiration date 30Sep2021) at the age of 72-years, intramuscularly in the left arm on 12Jun2021 for COVID-19 immunization. Body temperature before vaccination was not reported. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history included chronic obstructive pulmonary disease. Concomitant medications were not reported. On 04Jul2021 at unspecified time (one day after the vaccination), the patient started to experience malaise, outcome of unknown. On 06Jul2021 at unspecified time (three days after the vaccination), the patient experienced pyrexia and respiratory condition worsening and was referred to the reporter hospital by the inoculation/consultation hospital. The events resulted in hospitalization. On 06Jul2021 at unspecified time (three days after the vaccination), the patient experienced severe pneumonia. On 06Jul2021 (three days after the vaccination), the patient was admitted to the hospital. On 07Jul2021 (four days after the vaccination), the patient died from severe pneumonia, sepsis (blood: gram-negative rod positive) and disseminated intravascular coagulation (DIC). On 07Jul2021 (four days after the vaccination), the patient died and was discharged from the hospital. The patient received treatment for pneumonia, sepsis and DIC, but did not recover. The course of the event was as follows: on 03Jul2021, the patient received the second dose of COMIRNATY. No past medical history. On 04Jul2021, the patient started to experience malaise. On 06Jul2021, the patient experienced pyrexia and respiratory condition worsening and was transported from the inoculation/initial consultation hospital to the reporter hospital. On 07Jul2021, the patient died after he experienced severe pneumonia, sepsis and DIC. The reporting physician classified the event as serious (fatal, hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: the causal relationship was unknown. No past medical history meant there was no history of visit/treatment. Since the vaccination, the patient has not been tested for COVID-19. It was unknown if an autopsy was done or not.; Sender''s Comments: Based on information provided. the events are more likely represent intercurrent medical conditions or related to underlying disease but unrelated to BNT162b2. 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: severe pneumonia; sepsis (blood: gram-negative rod positive); DIC


VAERS ID: 1533660 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   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: BAYASPIRIN; NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastrointestinal stromal tumor; Lung cancer recurrent (postoperative recurrent).
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100971452

Write-up: died at home; This is a spontaneous report from a contactable physician received via the Regulatory Authority. A 78-year-old male patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021) intramuscular in the left arm on 05Jul2021 at 11:15 at age of 78 years old as single dose for COVID-19 immunization. Medical history included postoperative recurrent lung cancer and gastrointestinal stromal tumor (GIST) of stomach. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received acetylsalicylic acid (BAYASPIRIN), esomeprazole magnesium hydrate (NEXIUM) and other unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in July2021 at unspecified time (unknown days after the vaccination), the patient died at home, and local police telephoned the reporter. The event resulted in death. It was unknown if the patient received any treatment for the event. The reporting physician assessed the event as serious (death). The cause of death was reported as unknown (the causal relationship could not be denied) lung cancer, the patient had GIST of stomach. It was unknown if autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on current convention, the reported death is assessed as related to BNT162b2 until sufficient information is available to confirm an unrelated cause of death. The patient''s underlying risk factors/predisposing condition postoperative recurrent lung cancer and gastrointestinal stromal tumor (GIST) of stomach have been assessed to provide an alternative explanation. 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: Unknown cause of death


VAERS ID: 1533661 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Dementia; Gastric fistula; Hepatic cirrhosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100971454

Write-up: Assumed acute myocardial infarction; cardiopulmonary arrest; This is a spontaneous report from a contactable physician received via the Regulatory Authority. The patient was a non-pregnant 90-year-old female. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history included cerebral infarction, dementia, hepatic cirrhosis, gastric fistula, and bedridden. On 11Jun2021 at an unknown time, the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) intramuscular for COVID-19 immunization. On 09Jul2021 at an unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) at the age of 90-year-old intramuscular at dose 2, single for COVID-19 immunization. On 12Jul2021 at an unknown time (3 days after the vaccination), the patient experienced assumed acute myocardial infarction and cardiopulmonary arrest. The events resulted in emergency room and death. The outcome of the events was fatal with treatment including cardiopulmonary resuscitation (CPR). The course of the events was as follows: The patient had a medical history of dementia, cerebral infarction, and cirrhosis. The patient had nutritional dependence of gastric fistula, and she was bedridden. On 11Jun2021, the patient received the first single dose of BNT162b2 in another hospital. On 09Jul2021, the patient received the second single dose of BNT162b2. On 12Jul2021, the patient was urgently transferred to the reporting hospital due to cardiopulmonary arrest. The patient did not respond to CPR and died. The cause of lesion could not be identified by autopsy imaging (AI). No autopsy was performed. The cause was considered as acute myocardial infarction and cardiopulmonary arrest. The reporting physician assessed the events as serious (death). Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of events of Acute myocardial infarction and cardiopulmonary arrest cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: cardiopulmonary arrest; Assumed acute myocardial infarction


VAERS ID: 1533662 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100971860

Write-up: Sudden death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21121947. A 88-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 1 via an unspecified route of administration on 24Jul2021 (the day of vaccination) (Batch/Lot Number: EY0583; Expiration Date: 31Oct2021) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Body temperature before vaccination was not provided. The family history was not provided. 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). On 25Jul2021 (one day after the vaccination), the patient experienced sudden death. On 25Jul2021 (one day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 24Jul2021 (the day of vaccination), in the morning, the patient received the first dose of BNT162b2 vaccination, at a dose of 0.3 mL at the reporting hospital, and he went home. After the patient went home, the course was observed without abnormalities. On 25Jul2021 (one day after vaccination), no particular abnormalities were observed. The patient told his family member that he would take a bath, and he took a bath. After a while, when the family member went to see how the patient dosing, he had death on arrival (DOA). The patient was transferred to the general hospital, and he was confirmed to die. An arrangement for an autopsy was made, and as of this date, the cause of death was unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were underling disease and advanced age. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1533663 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood lactate dehydrogenase, Body temperature, C-reactive protein, Computerised tomogram, Interstitial lung disease, Oxygen saturation, Pneumonia bacterial, White blood cell count
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: LDH; Result Unstructured Data: Test Result:311; Test Date: 20210612; Test Name: Body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:38s Centigrade; Test Date: 202106; Test Name: CT; Result Unstructured Data: Test Result: ground glass opacity in the entire lung field; Test Date: 202106; Test Name: CRP; Result Unstructured Data: Test Result:7.11; Test Date: 20210614; Test Name: SpO2; Result Unstructured Data: Test Result:60s %; Comments: room air; Test Date: 202106; Test Name: WBC; Result Unstructured Data: Test Result: 8900.
CDC Split Type: JPPFIZER INC202100971886

Write-up: interstitial pneumonia aggravated accompanying infection; interstitial pneumonia aggravated accompanying infection; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121965. A 77-year-old female (age at vaccination was 77 years old) received the first dose of COVID-19 vaccine (Product name, Lot number and expiration date were not unknown) via an unspecified route of administration as a single dose on 31May2021 at unknown time (the day of vaccination) for COVID-19 immunization. Body temperature before vaccination was unknown. Family history and medical history were unknown. On 12Jun2021 (12 days after the vaccination), the patient experienced interstitial pneumonia aggravated. On 18Jun2021 (18 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows:On 31May2021, the patient received COVID-19 vaccine (trade name was unknown) at another medical institution. On 12Jun2021, the patient developed pyrexia of 37.7 degrees centigrade. On 13Jun2021, the patient developed pyrexia of 38s degrees centigrade and dyspnoea. On 14Jun2021, the patient visited a nearby hospital. SpO2 was 60s % (room air [RA]), for which the patient was transported to the reporting hospital. CT revealed ground glass opacity in the entire lung field. White blood cell (WBC) was 8900, C-reactive protein (CRP) was 7.11, and lactate dehydrogenase (LDH) was 311. It was assessed as interstitial pneumonia aggravated accompanying infection (as reported).The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 vaccine as unassessable. Other possible cause of the event such as any other diseases was pneumonia bacterial. The reporting physician commented as follows:The symptoms occurred more than 1 week after the vaccination; thus, causality was considered unlikely related. The case was reported at the strong request of family member. Information on the lot/batch number has been requested.; Sender''s Comments: Based on known disease pathophysiology, the events of Interstitial pneumonia aggravated and pneumonia bacterial is assessed as not related to COVID-19 vaccine, and more likely due to underlying medical condition of pneumonia bacterial.The case will be reassessed if additional information becomes available.The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Interstitial pneumonia aggravated


VAERS ID: 1533664 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Pneumonia bacterial
SMQs:, Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Hypopharyngeal cancer; Pneumonia aspiration.
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result: 37.0 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100971967

Write-up: Pneumonia bacterial; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121931. The patient was an 86-year and 1-month-old female. Body temperature before vaccination was 37.0 degrees centigrade. The family history was not provided. The patient had medical history of hypopharyngeal cancer, cerebral infarction, for which she was orally taking acetylsalicylic acid (BAYASPIRIN), and bilateral pneumonia aspiration (from03Jul2021 to 06Jul2021). On 08Jul2021 at 15:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5829, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization at the age of 86-year and 1-month-old . On 12Jul2021 (4 days after the vaccination), the patient experienced pneumonia bacterial. On 26Jul2021 at 14:25 (18 days after the vaccination), the outcome of the event was fatal. It was unknown if autopsy was performed. The course of the event was as follows: On 12Jul2021 (4 days after vaccination), the patient experienced pneumonia bacterial (it was diagnosed on the chest X-ray and the blood examination). On 26Jul2021 at 14:25 (18 days after vaccination), the patient died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Pneumonia bacterial


VAERS ID: 1533665 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-18
Onset:2021-07-21
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210718; Test Name: body temperature; Result Unstructured Data: Test Result: 36.5 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100972077

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121966. The patient was a 74-year and 0-month-old male. Body temperature before vaccination was 36.5 degrees centigrade. The family history was not described. 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). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 18Jul2021 at 09:30 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 21Jul2021 (3 days after the vaccination), the patient experienced unknown cause of death. On 21Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The course was unknown. An autopsy was performed at another hospital. Only the vaccination was performed at the reporting hospital. The reporting physician classified the event as serious (death). The causality between the event and BNT162b2 vaccination was not provided. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1533666 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-06-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cardiac failure acute, Cardio-respiratory arrest, Chest pain, Cyanosis, Oxygen saturation, Oxygen saturation decreased
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CLOPIDOGREL; FUROSEMIDE; LIXIANA; BISOPROLOL FUMARATE; DIGOXIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Aortic stenosis; Aortic valve repair; Atrial fibrillation paroxysmal; Cardiac failure chronic.
Allergies:
Diagnostic Lab Data: Test Name: SpO2; Result Unstructured Data: Test Result: latter half of 80%; Comments: it was usually latter half of 80; Test Date: 20210625; Test Name: SpO2; Result Unstructured Data: Test Result: latter half of 70%.
CDC Split Type: JPPFIZER INC202100972115

Write-up: cardiac failure acute; Cardio-respiratory arrest; consciousness disturbed; cyanosis; chest pain; the SpO2 was latter half of 70%; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121932. An 86-year and 7-month-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) via an unspecified route of administration on 25Jun2021 at 15:00 at 86 years old as a single dose for COVID-19 immunization. Body temperature before vaccination was not provided. The patient had medical histories of aortic stenosis, cardiac failure chronic, angina pectoris, aortic valve surgery and atrial fibrillation paroxysmal. The family history was not provided. The concomitant medications included clopidogrel (tablet 75 mg) orally at 75 mg, furosemide (tablet 40mg) orally at 40 mg, edoxaban tosilate hydrate (LIXIANA, Orodispersible tablet 30 mg) orally at 30 mg, bisoprolol fumarate (tablet 2.5 mg) orally at 2.5 mg , and digoxin (tablet 0.125 mg) orally at 0.0625 mg (0.5 tablet). On 26May2021, the patient previously received the first dose of BNT162b2 (Lot number EX3617, Expiration date 31Aug2021) for COVID-19 immunization at 86 years old. On 25Jun2021 (the day of the vaccination), the patient experienced chest pain. On 26Jun2021 (one day after the vaccination), the patient experienced consciousness disturbed, cyanosis, and cardio-respiratory arrest. The course of the event was as follows: On 25Jun2021 (the day of vaccination), at 15:00, the patient received the second dose of BNT162b2 vaccination. After the patient went home, he experienced chest pain, and the SpO2 was latter half of 70% (it was usually latter half of 80%). On 26Jun2021 (one day after vaccination), in the morning, the patient was found to have consciousness disturbed, and he had cyanosis. While the patient was being transferred, he had cardio-respiratory arrest. At 07:15 (one day after vaccination), the patient was confirmed to die. The cause of death was considered as cardiac failure acute (as reported). The patient originally had medical histories of aortic valve surgery and angina pectoris. These symptoms were considered to be aggravated. On 26Jun2021 at 7:15 (one day after the vaccination), the outcome of the events was fatal. It was unknown if autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the events were unrelated to BNT162b2. Other possible causes of the events such as any other diseases were cardiac valvulopathy and angina pectoris. The reporting physician commented as follows: The patient originally had cardiac diseases and he was an elderly. Thus, it was considered that the events was unrelated to BNT162b2 vaccination.; Sender''s Comments: There is no reasonable possibility of causal association between the event of Cardiac failure acute, Chest pain, Oxygen saturation decreased , Cardio-respiratory arrest, Altered state of consciousness , Cyanosis and the drug BNT162b2 . The reported events are confounded by patient''s history of aortic stenosis, cardiac failure chronic, angina pectoris, aortic valve surgery and atrial fibrillation paroxysmal.; Reported Cause(s) of Death: chest pain; the SpO2 was latter half of 70%; Cardio-respiratory arrest; consciousness disturbed; cyanosis; cardiac failure acute


VAERS ID: 1533667 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Blood potassium, Body temperature, Cardiac arrest, Dehydration, Hyperkalaemia, Ileus, Loss of consciousness, Renal failure, Small intestinal obstruction, Subileus, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal obstruction (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parkinson''s disease; Renal failure
Allergies:
Diagnostic Lab Data: Test Name: K; Result Unstructured Data: Test Result: 7.4; Test Date: 20210727; Test Name: body temperature; Result Unstructured Data: Test Result: 36.8 Centigrade; Comments: Before vaccination.
CDC Split Type: JPPFIZER INC202100972170

Write-up: Small intestinal obstruction; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; vomiting due to ileus, and she aspired the vomit; Since the patient was an elderly and had Parkinson''s disease, she inhaled the vomit and had asphyxia; vomiting; loss of consciousness; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21121993. The patient was an 84-year-old female. Body temperature before vaccination was 36.8 degrees centigrade. The family history was unknown. The patient had medical histories of renal failure and Parkinson''s disease. On 06Jul2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW0201, Expiration date 30Sep2021), and no side reactions were observed after the vaccination. On 27Jul2021 at unknown time (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) at 84-year-old, via intramuscular as a single dose for COVID-19 immunization. On 28Jul2021 (one day after the vaccination), the patient had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest. The patient had vomiting due to ileus, and she aspired the vomit. Since the patient was an elderly, and she had Parkinson''s disease, she inhaled the vomit, and she had asphyxia. On 28Jul2021 (one day after the vaccination), the outcome of the events were fatal. The course of the event was as follows: On 21Jul2021, the patient had no appetite, and she did not move, and thus, the family recommended her to take fluid. On 27Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination via intramuscular route. On 28Jul2021 (one day after vaccination), in the morning, the patient experienced vomiting, and thereafter, she was unable to move, and she was sleeping all the time. On the same day at 18:45, the patient was found to be exhausted by her family. The patient had a large amount of vomiting (it was black, but no fresh blood was observed). Thereafter, the patient experienced loss of consciousness, and cardiac massage was initiated. An ambulance was called. At 18:58 , an ambulance service arrived. Electrocardiogram showed cardiac arrest, and cardiopulmonary resuscitation (CPR) was initiated, and adrenaline was administered; however, no electrocardiographic waveform appeared. At 19:25, the patient arrived at the reporting hospital. CPR was continued. Approximately 20 minutes had passed; however, no return of spontaneous circulation was obtained. CPR was continued until the patient''s husband arrived at the hospital at the family''s wish. At 20:10, the family arrived at the reporting hospital. The patient had cardio-respiratory arrest and pupils dilated, and light reflex disappeared. Thus, the patient was confirmed to die. After the death was confirmed, an autopsy imaging (AI) was performed, which showed small intestinal obstruction, and accumulation of vomit in the bronchus was confirmed. Based on the results of the AI and the blood examination, the direct causes of death were explained to the family as follows: 1) the patient had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K 7.4), and thus, the patient had cardiac arrest. 2) the patient had vomiting due to ileus, and she aspired the vomit. Since the patient was an elderly and had Parkinson''s disease, she inhaled the vomit and had asphyxia. 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 small intestinal obstruction. The reporting physician commented as follows: According to the attending physician, although the patient died the following day after the BNT162b2 vaccination, the patient had physical deconditioning before the vaccination. Thus, it was considered that ileus occurred independently of the vaccination, and ileus could not be said as the direct cause of death. However, it could not be said that the death was not affected by the ileus, which was not mentioned at the time of explanation to the family. Causality was unknown. Patient die on 28Jul2021.; Sender''s Comments: Based on information provided, the event ileus more likely represents an intercurrent medical condition which is unrelated to BNT162b2. The case will be reassessed once more information become available.; Reported Cause(s) of Death: had subileus, and existing renal failure was aggravated due to dehydration, and the patient had hyperkalaemia (K of 7.4), and thus, the patient had cardiac arrest.; subileus; asphyxia; Hyperkalaemia; loss of consciousness; Small intestinal obstructio; Autopsy-determined Cause(s) of Death: small intestinal obstruction.


VAERS ID: 1533669 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-26
Onset:2021-07-28
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0572 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Breast cancer; Bronchial asthma; Cholecystolithiasis; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100973859

Write-up: found the patient dead in the toilet; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. The patient was a non-pregnant 87-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medication within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Other medical history included hypertension, bronchial asthma, breast cancer, angina pectoris and cholecystolithiasis. On 26Jul2021 at 11:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0572, Expiration date 31Oct2021) intramuscularly in the left upper arm for COVID-19 immunization. After 15 minutes of resting, there was no problem and the patient went home. On 28Jul2021 (two days after the vaccination), a caretaker visited the patient and found the patient dead in the toilet. The event resulted in death. The cause of death was unknown. Autopsy was not performed. The outcome of the event was fatal without treatment. The reporting physician did not provide any assessment of the event seriousness or the causal relationship to the vaccine. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: Death of unknown cause is assessed related as a cautionary measure and for reporting purposes. The underlying disease may provide an alternative cause. 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 the patient dead in the toilet


VAERS ID: 1533670 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-06-22
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
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: TACROLIMUS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency secondary to chemotherapy (Treated with Tacrolimus)
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100976373

Write-up: Death; This is a spontaneous report from a contactable physician (coroner) received via Regulatory Authority. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 22Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; tacrolimus (TACROLIMUS), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication . The patient medical history included immunocompromised patient. Concomitant medications were not reported. On 01Jun2021 the patient received the first dose of BNT162B2 vaccine. The patient experienced death on an unspecified date. The action taken in response to the event(s) , for tacrolimus was not applicable. The patient died on an unspecified date. An autopsy was performed and results were not provided. Course of the event. On 01Jun2021, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) as single dose for COVID-19 immunization. On 22Jun2021 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were unknown) via an unspecified route of administration as single dose for COVID-19 immunization. On an unspecified date (1 month and 10 days after the second dose of the vaccination), the patient died. An autopsy was performed by the reporter. The cause of death was not reported. The reporter inquired if it was appropriate that the vaccination was given to the patient who was using immunosuppressants (tacrolimus) and if the vaccination should be given to such patients hereafter. The reporter also inquired if there was a causal relationship between the BNT162b2 and the patient''s death, if there was a possibility that the vaccination influenced the death, and if adverse reaction could occur 1 month and 10 days after the vaccination. Information on the lot/batch number has been requested.; Sender''s Comments: The causal relationship between bnt162b2 and the event death cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 1533671 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death
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: AMLODIPINE BESILATE; RABEPRAZOLE SODIUM; DROXIDOPA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Large intestine carcinoma; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100976483

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received via COVID-19 Regulatory Authority. The patient was a non-pregnant 84-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received amlodipine besilate (AMLODIPINE), rabeprazole sodium (RABEPRAZOLE), and droxidopa (DROXIDOPA) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included ascending thoracic aortic aneurysm and large intestine carcinoma. On 16Jun2021 at 17:15 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via intramuscular route of administration in the arm left at single dose for COVID-19 immunization (84-year-old at vaccination). On unknown date in Jun2021 (unknown days/hours/minutes after the vaccination), the patient experienced unknown cause of death. The event resulted in death. The outcome of the event was fatal with without treatment. The reporting physician assessed the event as (death). It was contacted that the patient died at his home (the details were unknown). On 29Jul2021 (one month, 12 day, 6 hours, and 45 minutes after vaccination), the death was revealed by the contact from the police. However, the following day after the vaccination, the patient had no physical deconditioning, and he visited the reporting hospital (at that time, no abnormalities were observed at all). Since the patient did not visit the reporting hospital on 01Jul2021 (14 days, 6 hours, and 45 minutes after vaccination) which was the day of the second dose of BNT162b2 vaccination. Although the physician called the patient and visited his home, no response was obtained. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1533672 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data: Test Date: 20210626; Test Name: Body temperature; Result Unstructured Data: Test Result:35.7 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100977603

Write-up: cardiopulmonary arrest (CPA); This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21122006. A 78-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EY5422, Expiration date 31Aug2021) on 26Jun2021 at single dose for COVID-19 immunization. Body temperature before vaccination was 35.7 degrees centigrade. Family history was not reported. Medical history included cardiac pacemaker insertion. Concomitant medication included rivaroxaban (XARELTO, strength: 10 mg) at 10 mg taken orally and ongoing. On an unspecified date, the patient previously received the first dose of BNT162B2 (lot number: unknown, expiration date: unknown) at single dose for COVID-19 immunization. On 26Jun2021 (the day of vaccination), the patient received the second dose of BNT162B2. On 27Jun2021 in early morning (1 day after the vaccination), the patient experienced cardiopulmonary arrest (CPA). On 27Jun2021 (1 day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 27Jun2021 in early morning, family member found that the patient had CPA in the bedroom at home. The patient died on 27Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was unknown. Reporter''s comment: Causality between the second vaccination and the cause of death could not be estimated.; Reporter''s Comments: Causality between the second vaccination and the cause of death could not be estimated.; Reported Cause(s) of Death: cardiopulmonary arrest (CPA)


VAERS ID: 1533675 (history)  
Form: Version 2.0  
Age: 93.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-24
Onset:2021-07-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arteriosclerosis coronary artery, Cardiac failure acute, Computerised tomogram, Left ventricular dysfunction
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: CT; Result Unstructured Data: Test Result:advanced coronary artery calcification
CDC Split Type: JPPFIZER INC202100977613

Write-up: advanced coronary artery calcification; cardiac failure acute due to marked low left ventricular function; cardiac failure acute due to marked low left ventricular function; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21122465. A 93-year and 0-month-old female patient received the second dose of COVID-19 vaccine (Lot number and expiration date were not reported) via an unspecified route of administration on 24Jul2021, at patient age of 93-year-old, as a single dose for COVID-19 immunization. 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). Family history was not reported. Concomitant medications were not reported. On an unspecified date, the patient previously received COVID-19 vaccine (Lot# and expiration date were not reported). On 24Jul2021 (the day of vaccination), the patient received the second dose of COVID-19 vaccine. Body temperature before vaccination was not reported. On 26Jul2021 at 00:45 (2 days after the vaccination), the patient experienced cardiac failure acute due to marked low left ventricular function. The event resulted in hospitalization. Probably 36 hours after receiving the vaccine at facility, the patient developed pyrexia, blood pressure decreased, and respiratory failure. The patient was transported to emergency center of the reporting hospital. The patient was diagnosed with cardiac failure acute due to marked low left ventricular function. Due to advanced age, invasive therapy was not requested; thus, only drug therapy was initiated. Despite the therapy, on 29Jul2021 (5 days after the vaccination), the patient died. The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 vaccine as un-assessable. Other possible cause of the event such as any other diseases was follows: Computer tomography (CT) revealed advanced coronary artery calcification. There was a possibility of low left ventricular function due to chronic coronary artery disease. The reporting physician commented as follows: Although the event was considered probably unrelated to COVID vaccine, the case was reported since the patient experienced the event about 36 hours after the vaccination and eventually died.; Reported Cause(s) of Death: cardiac failure acute due to marked low left ventricular function; cardiac failure acute due to marked low left ventricular function; advanced coronary artery calcification


VAERS ID: 1533677 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100977642

Write-up: death; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 7-decade-old (reported as 60s) female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), via an unspecified route of administration on 2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unknown date in 2021 (2 days after the vaccination), the patient experienced death. The course of the event was as follows: On unknown date in 2021, the patient died 2 days after the vaccination. Since the physician was not her attending physician, and the physician examined the patient for the first time, the details were unknown. An autopsy was performed by the police. The causality between the event and BNT162b2 was not provided. The outcome of the event was fatal. The patient died on 2021. An autopsy was performed and results were not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review 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: Death


VAERS ID: 1533678 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0573 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Body temperature, Computerised tomogram, Condition aggravated, Ruptured cerebral aneurysm, 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: 2021-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DEPAKENE-R; IMIDAPRIL HYDROCHLORIDE; REBAMIPIDE; MARZULENE S; CELECOX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Hypertension; Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: Autopsy; Result Unstructured Data: Test Result:Subarachnoid haemorrhage; Comments: Subarachnoid haemorrhage due to ruptured cerebral aneurysm (right internal carotid artery to posterior communicating artery bifurcation), performed in the morning; Test Date: 20210728; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Name: CT; Result Unstructured Data: Test Result:intraventricular haemorrhage; Comments: Left and right intraventricular haemorrhage and haemorrhage around the right thalamus were pointed out.; Test Date: 20210729; Test Name: CT; Result Unstructured Data: Test Result:Haemorrhage intracranial
CDC Split Type: JPPFIZER INC202100977649

Write-up: Subarachnoid haemorrhage due to ruptured cerebral aneurysm; Subarachnoid haemorrhage due to ruptured cerebral aneurysm; Subarachnoid haemorrhage due to ruptured cerebral aneurysm; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122468. A 73-year-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0573, Expiration date 30Sep2021), via an unspecified route of administration on 28Jul2021 at 15:03 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.2 degrees centigrade. It was unknown whether the patient had a family history. Medical history included hypertension, epilepsy, and subarachnoid haemorrhage. Allergy, vaccination and disease within one month, past history of adverse reaction was none. Concomitant medications included oral valproate sodium (DEPAKENE-R), oral imidapril hydrochloride, oral rebamipide, oral levoglutamide/sodium gualenate (MARZULENE S) and oral celecoxib (CELECOX). On an unspecified date, the patient previously received the first dose of BNT162b2 for COVID-19 immunisation. On 29Jul2021 at an unknown time (1 day after the vaccination), the patient experienced subarachnoid haemorrhage due to ruptured cerebral aneurysm. The course of the event was as follows: On 28Jul2021 at 15:03, the patient was vaccinated (COVID-19 vaccine manufactured by Pfizer, COMIRNATY). The patient went home with no acute adverse reaction. On the same day at 16:02, the patient reported the family that she had no symptoms. On 29Jul2021 around 09:50, the patient was found dead in her bedroom. On the same day, a computed tomography (CT) performed at the time of necropsy and examination showed haemorrhage intracranial. On the morning of 30Jul2021, subarachnoid haemorrhage due to ruptured cerebral aneurysm (right internal carotid artery to posterior communicating artery bifurcation) was found in an autopsy performed to determine the cause of haemorrhage intracranial. A CT (on unknown date) showed left and right intraventricular haemorrhage and haemorrhage around the right thalamus; however, a detailed examination was scheduled to be performed for details at a later date. 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 possibility of pathologic subarachnoid haemorrhage due to ruptured cerebral aneurysm (not related to the vaccination). The reporting physician commented as follows: At the autopsy of this case, the cause of death with naked eyes was diagnosed as subarachnoid haemorrhage due to ruptured cerebral aneurysm. The causal relationship between the vaccination and the ruptured cerebral aneurysm could not be completely ruled out because of the temporal proximity of death within 24 hours after the second dose of the COVID-19 vaccination. However, at the time of this report, there was no literature or report that clearly had a causal relationship between the COVID-19 vaccine and haemorrhage intracranial. In addition, since it still took time to examine the histological findings of this case (presence or absence of vasculitis, etc.), the causal relationship should be considered as unassessable at the time of this report. On 29Jul2021 (1 day after the vaccination), the outcome of the events was fatal.; Reported Cause(s) of Death: Subarachnoid haemorrhage due to ruptured cerebral aneurysm; Subarachnoid haemorrhage due to ruptured cerebral aneurysm; Subarachnoid haemorrhage due to ruptured cerebral aneurysm


VAERS ID: 1533679 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-03
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4834 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcohol use; Hepatic function disorder; Hepatopathy alcoholic
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: blood examination; Result Unstructured Data: Test Result: mild hepatic function disorder; Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result: 36.4 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202100977652

Write-up: haematemesis; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119409. A 28-year-old (reported as 28-year and 11-month-old) female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY4834, Expiration date 31Aug2021) at 28-year-old, via an unspecified route of administration on 11Jun2021 at 14:00 at single dose for COVID-19 immunization. Body temperature before vaccination was 36.4 degrees centigrade. The family history was not provided. The patient had medical history of mild hepatic function disorder, hepatopathy alcoholic, and drinking alcohol. Concomitant medications were not reported. On an unspecified date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# EW4811, Expiration date 31Jul2021) for COVID-19 immunisation. On 03Jul2021 (21 days and 10 hours after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: On 03Jul2021 (21 days and 10 hours after vaccination), when the patient''s relative (her elder brother) visited the patient''s home, she was found to have cardio-respiratory arrest. It was considered that the patient had cardio-respiratory arrest while she was drinking alcohol and eating snacks, and she also had haematemesis. An autopsy was being performed by the police (the details 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 hepatopathy alcoholic. The reporting physician commented as follows: In Feb2021, the blood examination was performed at the reporting hospital, which showed mild hepatic function disorder. However, considering the underlying disease and her age, the involvement of BNT162b2 vaccination was suspected to be one of the causes of sudden death. On 03Jul2021 (22 days after the vaccination), the outcome of the event cardio-respiratory arrest was fatal, and of event haematemesis was unknown.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1533680 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-30
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection
SMQs:

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: JPPFIZER INC202100977658

Write-up: acute aortic dissection; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is V21119433. Local reference # V21119433_20210731. The patient was an 86-year and 10-month-old female. Body temperature before vaccination was unknown. Reported unknown to 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). On 04Jun2021, the patient previously received the first dose of COVID-19 Vaccine (Lot # and Expiration date were not reported). On 28Jun2021 at unspecified time (the day of vaccination), the patient received the second dose of COVID-19 Vaccine (Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 30Jul2021 at 10:57 (two days after the vaccination), the patient experienced acute aortic dissection. On 30Jul2021 at 13:04 (two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jul2021 at 13:04, the patient died from acute aortic dissection. The reporting physician classified the event as serious (death) and assessed that the causality between the event and COVID-19 Vaccine as unassessable. Other possible cause(s) of the event such as any other diseases was stenosis aortic valve. The reporting physician did not provide any further comment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: acute aortic dissection


VAERS ID: 1533701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Lung disorder, Pulmonary alveolar haemorrhage, Pulmonary hypertension, Right ventricular hypertrophy, Thrombosis
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Interstitial lung disease (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (narrow), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LTPFIZER INC202100973171

Write-up: After II dose - heavy dyspnea; pulmonary hypertension; right ventricular hypertrophy; focal blood vessel thrombosis; intra-alveolic hemorrhages; hypertrophy of smooth muscle of lungs; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number LT-SMCA-4213. A 63-year-old male patient received bnt162b2 (COMIRNATY), second single dose via an unspecified route of administration on 05May2021 (Batch/Lot Number: EX6537) for covid-19 immunisation. The patient previously received first single dose of bnt162b2 (batch# EW9127) on 14Apr2021 and experienced dyspnea on15Apr2021, which was worsening. The patient''s medical history and concomitant medications were not reported. After the second dose, the patient experienced heavy dyspnea and lack of air, and died on 06May2021 in less than 24 hours after vaccination. Autopsy performed included morphological test in May2021 and found pulmonary hypertension, right ventricular hypertrophy, hypertrophy of smooth muscle of lungs, focal blood vessel thrombosis with intra-alveolic hemorrhages. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: After II dose - heavy dyspnea; Autopsy-determined Cause(s) of Death: pulmonary hypertension; right ventricular hypertrophy; focal blood vessel thrombosis; intra-alveolic hemorrhages; hypertrophy of smooth muscle of lungs


VAERS ID: 1533778 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:2021-04-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Cardiac arrest, Dyspnoea, Fatigue, Malaise
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), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Arthritis (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: OMEPRAZOLE; DICLOFENAC SODIUM; BRICANYL TURBUHALER; FLUOXETINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100948850

Write-up: death/becoming unwell and asystole; Fatigue; generalized joint pain/pain in the joints; malaise/not feeling well; shortness of breath/dyspnoea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00632862. A 68-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 26Apr2021 (Batch/Lot Number: EX0893) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history was not reported. No previous COVID-19 infection. Concomitant medications included omeprazole; diclofenac sodium; terbutaline sulfate (BRICANYL TURBUHALER); fluoxetine; all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in 2021 (latency unknown), patient experienced shortness of breath/dyspnoea. On 29Apr2021 (3 days after start), patient experienced fatigue, generalized joint pain/pain in the joints and malaise/not feeling well. On 30Apr2021 (4 days after start), patient experienced death/becoming unwell or suddenly unwell and asystole on arrival ambulance. Treatment for asystole is treated with BLS (basic life support) and pace and adrenaline but no benefit. The outcome of the events was fatal. The patient died on 30Apr2021. It was unknown if autopsy was done. This case was reproted as serious. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no death Additional information ADR: suddenly unwell on 30Apr on arrival ambulance asystole. no benefit from pacing adrenaline and BLS. already complaints of shortness of breath, fatigue and joint pain COVID-19 Previous COVID-19 infection: No No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no death Additional information ADR: suddenly unwell on 30Apr on arrival ambulance asystole. no benefit from pacing adrenaline and BLS. already complaints of shortness of breath, fatigue and joint pain COVID-19 Previous COVID-19 infection: No; Reported Cause(s) of Death: death/becoming unwell and asystole; shortness of breath/dyspnoea; generalized joint pain/pain in the joints; fatigue; malaise/not feeling well


VAERS ID: 1533873 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-01
Onset:2021-03-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: SKPFIZER INC202100981008

Write-up: sudden cerebrovascular hemorrhagic accident; This is a spontaneous report from a contactable physician received via COVAES. A 66-year-old male patient received a dose of BNT162b2 (COMIRNATY), via an unspecified route of administration in Mar2021 (Batch/Lot Number was not reported) (at the age of 66-year-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that: two days after vaccination (in Mar2021) with Pfizer vaccine the patient experienced sudden cerebrovascular hemorrhagic accident and as a consequence of which he died. The patient died on an unspecified date. 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: As an individual case report there is not enough evidence to establish a causal relationship with the suspect vaccine. Currently there is no clear biological plausibility between the vaccine use and the even onset. More information such as complete medical history and concomitant medications are needed for fully medical assessment. 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 cerebrovascular hemorrhagic accident


VAERS ID: 1534544 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0297 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Pyrexia, Respiration abnormal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956269

Write-up: Fever; Abnormal breathing; Weakness; This is a spontaneous report from a non-contactable consumer. An 82-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration on 21Jun2021 (Lot Number: FD0297) for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced fever, abnormal breathing and weakness on 21Jun2021. The outcome of events was fatal. The patient died on 21Jun2021. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: fever; abnormal breathing; weakness


VAERS ID: 1534545 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-06-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0297 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dyspnoea, Nausea, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956428

Write-up: Shortness of breath; Nausea; Diarrhea; Vomiting; This is a spontaneous report from a non-contactable consumer. A 61-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Jun2021 at age of 61-year-old (Batch/Lot Number: FD0297) at single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced shortness of breath, nausea, diarrhea and vomiting on 28Jun2021. The patient died on 28Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information on batch number and expiry date cannot be obtained. ; Reported Cause(s) of Death: Shortness of breath; nausea; diarrhea; vomiting


VAERS ID: 1534546 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-16
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VVC7UC39XCVL / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dry mouth, Fatigue, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956429

Write-up: Extreme fatigue; Dry mouth; Fever; This is a spontaneous report from a non-contactable consumer. An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28May2021 (Batch/Lot Number: VVC7UC39XCVL) as single dose for covid-19 immunization at age of 81 years old. The patient''s medical history and concomitant medications were not reported. The patient experienced fever on 16Jun2021, extreme fatigue and dry mouth on 28Jun2021. The outcome of the events was fatal. The patient died on 28Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Dry mouth; Extreme fatigue; Fever


VAERS ID: 1534547 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-07-02
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (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), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956430

Write-up: Kidney failure; This is a spontaneous report from a non-contactable consumer. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administration on 28May2021 (Batch/Lot number was not reported) at age of 71-year-old at single dose for covid-19 immunization. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient experienced kidney failure on 02Jul2021. The patient died of kidney failure 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: Kidney failure


VAERS ID: 1534548 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-06-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH VX9FVK9JKLEV / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956431

Write-up: Fever; This is a spontaneous report from a non-contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route administration on 24May2021 (Batch/Lot Number: VX9FVK9JKLEV, expiration date not provide) at age of 78 years old as a single dose for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced fever on 01Jun2021 with outcome of fatal. The patient died on an unspecified date. An autopsy was not 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: Fever


VAERS ID: 1534549 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0927 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Local reaction
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: ZAPFIZER INC202100956433

Write-up: Local reaction; This is a spontaneous report from a non-contactable consumer. A 79-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration administration on 09Jul2021 (Batch/Lot Number: FD0927) (at the age of 79-year-old) as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced local reaction on 09Jul2021. The patient died on an unspecified date due to local reaction. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Local reaction


VAERS ID: 1534550 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100956434

Write-up: Heart attack; Local reaction; This is a spontaneous report from a non-contactable consumer or other non hcp. A 68-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecifed route of administration on 14Jul2021 (Batch/Lot Number: FC1436) at the age of 68 years for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced local reaction and heart attack on 15Jul2021. Outcome of the events was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Reported Cause(s) of Death: heart attack; local reaction


VAERS ID: 1534603 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-16
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE3064 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fall, Influenza like illness, Nausea
SMQs:, Acute pancreatitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Epilepsy; Lactic acidosis syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100968744

Write-up: Died; Falling/collapsing; Nausea; Flu-like symptoms; This is a spontaneous report from a contactable physician. A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 14Jul2021 (Batch/Lot Number: FE3064) as dose 1, single for covid-19 immunization. Medical history included epilepsy and clovis lactic syndrome. The patient''s concomitant medications were not reported. The patient previously took lamotrigine, seroquel, omeprazole, rivotril, tramadol. The patient experienced flu-like symptoms (influenza like illness) on 16Jul2021, nausea (nausea) on 19Jul2021. On 27Jul2021, patient reported to be falling/collapsing. Patient died on 28Jul2021. An autopsy was not performed. Outcome for other events was unknown.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event death and the suspect drug. 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: 1534627 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2090 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Fatigue, Foaming at mouth, SARS-CoV-2 antibody test positive, SARS-CoV-2 test
SMQs:, Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Generalised convulsive seizures following immunisation (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus (On treatment); Hypertension (On tdreatment)
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: SARS-COV-2 PCR; Result Unstructured Data: Test Result:POSITIVE
CDC Split Type: ZAPFIZER INC202100971580

Write-up: Demised; COVID-19 antibody test positive; Tiredness; General body weakness; Foaming from mouth; This is a spontaneous report from a non-contactable consumer. A 64-year-old female patient (unknown pregnant) received the second dose of BNT162b2 via an unspecified route of administration on 21Jul2021 at 09:00 (Batch/Lot Number: FE2090; Expiration Date: Oct2021) as single for COVID-19 immunization. Medical history included hypertension and diabetes mellitus, both on treatment. The patient''s concomitant medications were not reported. On 21Jul2021 at 15:00, the patient experienced tiredness and general body weakness. On 21Jul2021, the patient was also foaming from mouth. On an unspecified date, the patient was found demised in the sitting poisition at home. The patient had a COVID-19 antibody positive test on 22Jul2021 (test done in the mortuary). Tests Sars-cov-2 test: positive on 22Jul2021. It was not reported if an autopsy was performed. The outcome of death was fatal, the outcome of other events was unknown.; Reported Cause(s) of Death: death


VAERS ID: 1534630 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-17
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agonal respiration, Asthenia, COVID-19 pneumonia, Chest X-ray, Confusional state, Cough, Death, Drug ineffective, Dyspnoea, Headache, Hypoxia, Pain, Respiratory distress, SARS-CoV-2 antibody test
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-24
   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: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210724; Test Name: Chest X-RAY; Result Unstructured Data: Test Result: BILATERAL DIFFUSED INFILTRATES; Test Date: 20210724; Test Name: COVID PCR swab; Result Unstructured Data: Test Result: negative
CDC Split Type: ZAPFIZER INC202100983912

Write-up: Agonal gasps; Hypoxic; Altered mental state; demise; bilateral diffused infiltrates suggestive of Covid-19 pneumonia; bilateral diffused infiltrates suggestive of Covid-19 pneumonia; Distress; Shortness of breath; Cough; Body pain; Body weakness; Headache; This is a spontaneous report from a contactable physician. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 on 07Jul2021 (Batch/Lot number was not reported) at single dose (at 50 years old) for COVID-19 immunization. Medical history included hypertension. Concomitant medications were not reported. On 17Jul2021, the patient experienced cough, shortness of breath, headache, body pain, body weakness, distressed. On 24Jul2021, 06h30, the patient presented with agonal gasps, altered mental state, hypoxic. On 24Jul2021, 09h45, the patient demised. Relevant tests on 24Jul2021 - chest x-ray: bilateral diffused infiltrates suggestive of Covid-19 pneumonia, Sars-cov-2 antibody test: negative. 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 current available limited information in the case provided, the causal association between the events Death, Covid 19 Pneumonia, drug ineffective, respiratory distress, agonal breathing, hypoxia, confusional state, dysponea, cough and the use of suspect product BNT162B2 cannot be fully assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: Demised


VAERS ID: 1535706 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-28
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Malaise
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210808702

Write-up: DEATH; MALAISE; WEAKNESS; This spontaneous report received from a physician via a Regulatory Authority [EMEA EVHUMAN NLP, DE-DCGMA-21190734] concerned a 69 year old male of unspecified race and ethnic origin. The patient''s weight was 80 kilograms, and height was 175 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, 1 total administered on 28-MAY-2021 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 28-MAY-2021, the patient experienced malaise and weakness. On 02-JUN-2021, the patient died 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 patient died of unknown cause of death on 02-JUN-2021. This report was serious (Death).; Sender''s Comments: V0: 20210808702-Covid-19 vaccine ad26.cov2.s- Death, malaise and weakness. 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: 1535796 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-22
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205C81A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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: PHJNJFOC20210803628

Write-up: LOSS OF CONSCIOUSNESS; SHORTNESS OF BREATH; This spontaneous report received from a health care professional via a Regulatory Authority (PHIFDA,PH-PHFDA-300093728) concerned a 71 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 205C81A expiry: unknown) dose was not reported, frequency 1 total administered on 22-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-JUL-2021, at 16:00 the patient experienced loss of consciousness, shortness of breath. On an unknown date the patient was died due to shortness of breath, and loss of consciousness. 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: 20210803628-COVID-19 VACCINE AD26.COV2.S- loss of consciousness, 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: SHORTNESS OF BREATH; LOSS OF CONSCIOUSNESS


VAERS ID: 1535802 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-26
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 2317218 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Test Date: 20210726; Test Name: Blood pressure; Result Unstructured Data: 140/80 (unit not reported); Test Date: 20210727; Test Name: Respiratory rate; Result Unstructured Data: 18 (Beats per minute); Test Date: 20210727; Test Name: Heart rate; Result Unstructured Data: 92 (Count per minute); Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: 35.5 C; Test Date: 20210727; Test Name: Blood pressure; Result Unstructured Data: 140/80 (unit not reported); Test Date: 20210727; Test Name: Respiratory rate; Result Unstructured Data: 17 (Breath per minute); Test Date: 20210727; Test Name: Heart rate; Result Unstructured Data: 90 (Count per minute); Test Date: 20210727; Test Name: Blood pressure; Result Unstructured Data: 130/80 (unit not reported); Test Date: 20210727; Test Name: Body temperature; Result Unstructured Data: 35.8 C
CDC Split Type: PHJNJFOC20210809945

Write-up: FAINTING; DIZZINESS; This spontaneous report received from a health care professional via a Regulatory Authority [PHIFDA, PH-PHFDA-300095068] concerned a 60 year old female, unspecified race and ethnicity. The patient''s height, and weight were not reported. No past medical history were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 2317218, and expiry: UNKNOWN) dose was not reported, 01 total, administered on 26-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-JUL-2021, at 16:00 the patient experienced dizziness, fainting, and Laboratory data included: Blood pressure (NR: not provided) 140/80 unit not reported. On 27-JUL-2021, at 9:00 Laboratory data included: Blood pressure(BP) (NR: not provided) 130/80 unit not reported, Body temperature (NR: not provided) 35.8 Degree Celsius , Cardiac rate (NR: not provided) 92 Count per minute(CPM), and respiratory rate(RR) (NR: not provided) 18 breath per minute(BPM), and at 9:30 Blood pressure (NR: not provided): 140/80 unit not reported, Body temperature (NR: not provided): 35.5 Degree Celsius, Cardiac rate (NR: not provided) 90 Count per minute, Respiratory rate (NR: not provided) 17 Breath per minute. It was unspecified if an autopsy was performed On an unspecified date, the patient died from dizziness, and fainting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20210809945-covid-19 vaccine ad26.cov2.s-fainting and dizziness. 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: DIZZINESS; FAINTING


VAERS ID: 1536924 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-29
Submitted: 0000-00-00
Entered: 2021-08-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 212C21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Hypotension, Nausea, Seizure, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: Blood pressure; Result Unstructured Data: HYPOTENSION
CDC Split Type: PHJNJFOC20210810013

Write-up: NAUSEA; HYPOTENSION; VOMITING; SEIZURE; This spontaneous report received from a health care professional via a Regulatory Authority [PH-PHFDA-300095376] concerned a 20 year old female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212C21A, and expiry: unknown) dose was not reported, with frequency 1 total administered on 29-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-JUL-2021, the patient experienced seizure at 05:40, hypotension at 05:45, vomiting at 06:25. Laboratory data included: Blood pressure (NR: not provided) hypotension. On an unspecified date, the patient experienced nausea. On an unspecified date, the patient died from nausea, seizure, hypotension, and vomiting. 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, and Other Medically Important Condition).; Sender''s Comments: V0: 20210810013-COVID-19 VACCINE AD26.COV2.S - Seizure, hypotension, and vomiting. 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). 20210810013-COVID-19 VACCINE AD26.COV2.S -Nausea. This event is considered unassessable. The event has an 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: NAUSEA; SEIZURE; HYPOTENSION; VOMITING


VAERS ID: 1537707 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-29
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100999550

Write-up: This is a spontaneous report from a contactable other health professional via the Regulatory Authority. Regulatory authority report number is 594970. An 86-year-old male patient received BNT162B2 (COMIRNATY, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced fall on 29May2021. Onset Time in Days: 18days. The outcome of the event was fatal. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Fall


VAERS ID: 1537939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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: 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 INC202100984328

Write-up: Pulmonary embolism; This is a spontaneous report from a contactable consumer (patient''s brother) based on information received by Pfizer from Biontech manufacturer control number: 77376, license party for Comirnaty. A male patient of an unspecified age received bnt162b2 (COMIRNATY, Batch/Lot Number: UNKNOWN), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died of a pulmonary embolism that developed 3 weeks after the second dose of Comirnaty. The patient died on an unspecified date. 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; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1538032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-30
Onset:2021-07-10
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood lactic acid, Blood pH, Blood potassium, Blood sodium, Body temperature, Calcium ionised, Cardiac arrest, Haematocrit, Haemoglobin, Investigation, Oxygen saturation, PO2, Physical examination, Venous oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abstains from alcohol; Fistula; Hypercholesterolemia; Lumbago (L5-S1 dyscarthrosis, L5-S1 protrusion); Smoker (1/2 pack daily); Vasectomy; Von Willebrand factor deficiency (He has never needed treatment).
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: Venous Glucose; Result Unstructured Data: Test Result:579; Test Date: 20210710; Test Name: Venous Lactate; Result Unstructured Data: Test Result:17; Test Date: 20210710; Test Name: Venous pH; Result Unstructured Data: Test Result:7.13; Test Date: 20210710; Test Name: Venous Potassium; Result Unstructured Data: Test Result:3.2; Test Date: 20210710; Test Name: Venous Sodium; Result Unstructured Data: Test Result:228; Test Date: 20210710; Test Name: Temperature of sample; Result Unstructured Data: Test Result:37; Test Date: 20210710; Test Name: Venous Calcium Ionic; Result Unstructured Data: Test Result:0.79; Test Date: 20210710; Test Name: Venous Hematocrit; Result Unstructured Data: Test Result:35; Test Date: 20210710; Test Name: Venous Total Hemoglobin; Result Unstructured Data: Test Result:1.3; Test Date: 20210710; Test Name: Venous Deoxyhemoglobin; Result Unstructured Data: Test Result:(reduced Hb) 78.6; Comments: Venous Deoxyhemoglobin; Test Date: 20210710; Test Name: Venous Oxyhemoglobin; Result Unstructured Data: Test Result:20.6; Test Date: 20210710; Test Name: Physical examination; Result Unstructured Data: Test Result: In a situation of Cardiorespiratory Arrest; Comments: Cardiac massage with cardio compressor. Generalized lightness. Orotracheal intubation with Fastrach; Test Date: 20210710; Test Name: Venous pO2; Result Unstructured Data: Test Result:23; Test Date: 20210710; Test Name: Venous Inspired Oxygen Fraction; Result Unstructured Data: Test Result:100; Test Date: 20210710; Test Name: Venous O2 Saturation; Result Unstructured Data: Test Result:21.
CDC Split Type: ESPFIZER INC202100987888

Write-up: Sudden death/ cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number ES-AEMPS-956637. A 47-years-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported) intramuscular on 30Jun2021 as dose 2, 0.3 ml single for COVID-19 immunization. Medical history included tobacco user (1/2 pack daily), Von Willebrand disease (he has never needed treatment), hypercholesterolaemia, abstains from alcohol, back pain L5-S1 dyscarthrosis, L5-S1 protrusion, fistula, vasectomy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. No cardiovascular risk factors. Frequent epistaxis in childhood. In follow-up in Hematology due to deficiency of the FVIII / Von Willebrand molecule. He has never needed treatment. Lumbago Mechanical. L5-S1 dyscarthrosis, L5-S1 protrusion .h/ Surgical intervention: fistula and vasectomy. Treatment: Tramadol. No known drug allergies. On 10Jul2021 09:26 patient experienced sudden death/ cardiac arrest. The patient underwent lab tests which included blood glucose: 579 on 10Jul2021, blood lactic acid: 17 on 10Jul2021, blood PH: 7.13 on 10Jul2021, blood potassium: 3.2 on 10Jul2021, blood sodium: 228 on 10Jul2021, body temperature: 37 on 10Jul2021, calcium ionised: 0.79 on 10Jul2021, haematocrit: 35 on 10Jul2021, haemoglobin: 1.3 on 10Jul2021, investigation: (reduced HB) 78.6 on 10Jul2021 Venous Deoxyhemoglobin, oxygen saturation: 20.6 on 10Jul2021, physical examination: in a situation of cardiorespiratory arrest on 10Jul2021 Cardiac massage with cardio compressor. Generalized lightness. Orotracheal intubation with Fastrach, po2: 23 on 10Jul2021, venous oxygen saturation: 100 on 10Jul2021, venous oxygen saturation: 21 on 10Jul2021. Therapeutic measures were taken as a result of sudden death/ cardiac arrest (cardiac arrest). The patient died on 10Jul2021. It was not reported if an autopsy was performed. The patient admitted in a situation of resuscitated cardiac arrest. According to reports, the patient suffered cardiac arrest witnessed at 09:26. At the arrival of the health services (9:40am), an asystole rhythm was noted. Advanced cardiopulmonary resuscitation maneuvers are performed resulting in unsuccessful, so he is transferred to the hospital as a possible non-heart beating donation. Upon arrival at our Unit (10.40 am), cardiac inactivity is observed for 5 minutes, for which death is accredited at 10.46 am on 10Jul2021 according to the criteria of Decree 1723/2012. Physical Examination: In a situation of Cardiorespiratory Arrest. Cardiac massage with cardio compressor. Generalized lightness. Orotracheal intubation with Fastrach. Laboratory Tests: 10Jul2021 Venous Gasometry: Venous pH 7.13, Venous pO2 23, Venous O2 Saturation 21, Venous Total Hemoglobin 1.3, Venous Hematocrit 35, Venous Oxyhemoglobin 20.6, Venous Deoxyhemoglobin (reduced HB) 78.6, Venous Sodium 228, Venous Potassium 3.2, Venous Calcium Ionic 0.79, Venous Glucose 579, Venous Lactate 17, Venous Inspired Oxygen Fraction (FiO2) 100, Temperature of sample 37. Evolution and comments: Upon arrival at the Unit, CPR (cardiopulmonary resuscitation) was stopped and 5 minutes of asystole and therefore death were confirmed. Diagnosis: Cardiorespiratory arrest not recovered. Exitus lethalis. The outcome for event Cardiorespiratory arrest was death. No follow-up attempts are possible. Information about batch number cannot be obtained.; Reported Cause(s) of Death: cardiac arrest.


VAERS ID: 1538226 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bronchospasm, Culture, Inappropriate schedule of product administration, Multiple organ dysfunction syndrome
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (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), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 45
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: Culture; Result Unstructured Data: Test Result:Candida albicans, Candida glabrata, Candida tropic; Comments: Candida albicans, Candida glabrata, Candida tropicalis, Corynebacterium striatum, Cytomegalovirus, Escherichia coli, Herpes simplex virus type 1, Staphylococcus capitis and Staphylococcus capitis
CDC Split Type: GBPFIZER INC202100975309

Write-up: Multi-organ failure; Bronchospasm; Dose 1 on 17Dec2020; dose 2 on 17Mar2021; This is a spontaneous report from a contactable other health professional. This is a report received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-ADR 25726178, Safety Report Unique Identifier is GB-MHRA-ADR 25726178. A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) at the age of 45-year-old as single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization on 17Dec2020. The patient experienced multi-organ failure and bronchospasm in 2021. The events were reported as serious (hospitalization). The patient underwent lab tests and procedures which included culture: candida albicans, candida glabrata, candida tropicalis, corynebacterium striatum, cytomegalovirus, escherichia coli, herpes simplex virus type 1, staphylococcus capitis and staphylococcus capitis on an unspecified date. The patient died on 01May2021 due to multi-organ failure. An autopsy was not performed. Outcome of multi-organ failure was fatal, of bronchospasm was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Reported Cause(s) of Death: Multi-organ failure


VAERS ID: 1538239 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Blood test, Cardiac arrest, Computerised tomogram thorax, Deep vein thrombosis, Dyspnoea, Electrocardiogram, Fatigue, Gait disturbance, Inappropriate schedule of product administration, Limb discomfort, Pain in extremity, Pulmonary embolism, Syncope, Ultrasound scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-17
   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: ASPIRIN [ACETYLSALICYLIC ACID]; OMEPRAZOLE; PREDNISOLONE; TAMSULOSIN; ZOLEDRONIC ACID
Current Illness: Asthma (Reported again on 12Apr2021and 20Jan2021); Ex-smoker; Giant cell arteritis (Reported several times in Jan2020, Feb2021, and Apr2021); Temporal arteritis; Temporomandibular joint disorder; Vitamin D deficiency.
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiectasis; Callosity (On foot. Also reported on 24Aug2020.); Cigarette smoker (1-9 cigarettes/day); Dyspnoea; Food poisoning (suspected); Oesophageal disorder; Steroid therapy.
Allergies:
Diagnostic Lab Data: Test Date: 20201217; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210120; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210415; Test Name: Blood pressure measurement; Result Unstructured Data: Test Result: Unknown results; Test Date: 20201215; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210118; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210215; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210308; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210416; Test Name: Blood test; Result Unstructured Data: Test Result: Unknown results; Test Date: 20210304; Test Name: CT pulmonary angiogram; Result Unstructured Data: Test Result: showed possible bronchiolitis obliterans; Test Date: 20210416; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: Unknown results; Test Date: 20201220; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: Abnormal.
CDC Split Type: GBPFIZER INC202100992316

Write-up: Deep venous thrombosis; Pulmonary embolism; Cardiac arrest; Pain in extremity; difficulty walking; Dyspnoea/shortness of breath; Fatigue; Heavy legs; suddenly collapsed; Dose 1 on 31Jan2021; dose 2 on 31Mar2021; This is a spontaneous report from a contactable physician received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-EMIS-1316-dde7a8f4-9c0d-477f-bfa3-86cbf067b923, Safety Report Unique Identifier GB-MHRA-ADR 25732735. A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 31Mar2021 (batch/Lot number was not reported) at the age of 75-year-old as 0.3 ml single for COVID-19 vaccination; zoledronic acid (manufacturer unknown), via intravenous from 07Apr2021 (Batch/Lot number was not reported) to an unspecified date, at 5mg/100ml for osteoporosis prophylaxis. Medical history included vitamin d deficiency from 22Feb2021 and ongoing, giant cell arteritis and ongoing (reported several times in Jan2020, Feb2021, and Apr2021), temporal arteritis from 18Dec2020 and ongoing, steroid therapy from 17Dec2020 to 18Feb2021, temporomandibular joint disorder from 14Dec2020 and ongoing, cigarette smoker from 21Aug2020 to an unknown date (1-9 cigarettes/day), asthma from 19Aug2020 and ongoing (reported again on 12Apr2021and 20Jan2021), ex-tobacco user from 19Aug2020 and ongoing, callosity from 19Aug2020 to 17Sep2020 (on foot, also reported on 24Aug2020), suspected food poisoning from 21Aug2020 to 19Sep2020, oesophageal disorder and not ongoing, bronchiectasis and not ongoing, dyspnoea from 04Mar2021. Concomitant medications included aspirin taken for an unspecified indication from 01Jan2021 to an unspecified stop date; omeprazole taken for an unspecified indication from 19Jul2018 to an unspecified stop date; prednisolone taken for an unspecified indication from 20Dec2020 at 80mg once a day then reducing to 30mg around time of death; tamsulosin taken for an unspecified indication from 08Jul2019 to an unspecified stop date. The patient previously took influenza virus for flu vaccination on 24Oct2020, 1st dose of bnt162b2 on 31Jan2021 for covid-19 immunization. The patient experienced pulmonary embolism, deep venous thrombosis and cardiac arrest on 17Apr2021; dyspnoea, fatigue, heavy legs, difficulty walking on 08Apr2021, pain in extremity on 12Apr2021, suddenly collapsed in Apr021. Clinical course: This man was having treatment for giant cell arteritis (GCA) diagnosed Dec2020 and was under joint care of general practitioner (GP) and rheumatology. He was initially on high dose steroids which had gradually been reduced and was on aspirin. Intravenous zoledronic acid was given by the hospital because the patient had a history of oesophageal problems (which would have increased risk of oesophagitis with an oral bisphosphonate). He had a background of respiratory problems (asthma/bronchiectasis) and had tests for persistent dyspnoea on 04Mar2021 - a computerised tomogram pulmonary angiogram (CTPA) scan showed possible bronchiolitis obliterans (which may have been longstanding), but NO evidence of a pulmonary embolism (PE).The initial side effects from zoledronic acid were very marked and he sadly then died of a deep vein thrombosis (DVT)/PE. We wonder if the combination of several risk factors for venous thromboembolism (VTE) (age + vasculitis + steroids - though current expert Rheumatology guidelines (Regulatory Authority for Rheumatology, giant cell arteritis 2000) do not recommend prophylactic anticoagulation in this group) + possible prothrombotic effect of Pfizer COVID vaccine + possible prothrombotic effect of intravenous zoledronic acid may + a week of markedly reduced activity due to severe fatigue/shortness of breath may have resulted in the PE. Initially uneventful 2nd dose Pfizer Covid vaccine on 31Mar21 (1st dose was 31Jan2021). Then, on 08Apr2021, 1 day after first dose of intravenous zoledronic acid infusion to prevent osteoporosis, developed severe fatigue, shortness of breath, heavy legs, difficulty walking more than very short distance (normally very active). This improved slightly after about 6 days but 2 days later (8 days after the intravenous zoledronic acid, and 17 days after 2nd Pfizer COVID vaccine) suddenly collapsed at home in cardiac arrest, sadly resuscitation was unsuccessful. Post mortem showed massive pulmonary embolus, originating from DVTs. The patient underwent lab tests and procedures which included blood pressure measurement with unknown results on 17Dec2020, 20Jan2021, 15Apr2021, blood test with unknown results on 15Dec2020, 18Jan2021, 15Feb2021, 08Mar2021 and 16Apr2021, CT pulmonary angiogram: showed possible bronchiolitis obliterans on 04Mar2021, electrocardiogram: unknown results on 16Apr2021, ultrasound scan: abnormal on 20Dec2020. The patient died on 17Apr2021. An autopsy was performed. The action taken in response to the events for zoledronic acid was not applicable. Outcome of pulmonary embolism, deep venous thrombosis was fatal; of cardiac arrest was not recovered; of dyspnoea, fatigue, heavy legs was recovering; of other events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Deep venous thrombosis; Autopsy-determined Cause(s) of Death: Pulmonary embolism


VAERS ID: 1538755 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-29
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bladder cancer, Cardiac failure, Chest pain, Gait disturbance, Microcytic anaemia, Pericardial effusion, Peripheral swelling, Renal failure, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Angioedema (broad), Haematopoietic erythropenia (narrow), Peripheral neuropathy (broad), Systemic lupus erythematosus (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), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 70
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: Esophageal carcinoma (esophageal cancer, operated on in the initial stage in 2014, regularly monitored at the hospital, all findings regarding this tumor are in order, last from Sep2020); Surgical procedure (operated)
Allergies:
Diagnostic Lab Data: Test Date: 202103; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: HRPFIZER INC202100974257

Write-up: diagnostic bladder cancer; legs began to swell; Heart failure; marked w; Microcytic anemia; Pericardial effusion; Kidney failure; Chest pain; inability to stand on feet; This is a spontaneous report from a contactable consumer received from regulatory authority downloaded from the Regulatory Authority. The regulatory authority report number is HR-HALMED-300049723. A 78-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: unknown), via intramuscular on 17Mar2021 (unknown age at time of vaccination) at 0.3 ml single for COVID-19 immunisation. Medical history included esophageal carcinoma from an unknown date to 2014 (not ongoing; esophageal cancer, operated on in the initial stage in 2014, regularly monitored at the Hospital, all findings regarding this tumor are in order, last from Sep2020), Surgical procedure from an unknown date to 2014 (not ongoing; operated). The patient''s concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (COMIRNATY, Batch/Lot Number: unknown) via intramuscular on 23Feb2021 at 0.3 ml single for COVID-19 immunisation and experienced tightness around the heart. The patient experienced legs began to swell on 29Mar2021, heart failure on 29Mar2021, "marked w" on 29Mar2021, microcytic anemia on 29Mar2021, pericardial effusion on 29Mar2021, kidney failure on 29Mar2021, chest pain on 29Mar2021, inability to stand on feet on 29Mar2021. The events were assessed as serious with criteria of death, hospitalization, and life threatening. Narrative: The person was healthy before vaccination, had a history of oncological disease (esophagus cancer, operated on 6 years ago, without metastases) which was considered cured, was monitored by regular check-ups. Good psychophysical condition, active, no cardiac symptoms before, never taking any chronic therapy. After the first dose he noticed tightness around the heart that he had never felt before, but it did not intensify, after the second dose the pain around the heart reappeared, which he did not communicate immediately, his legs started to swell (he had no similar problems before), day 12th after other doses marked weakness, inability to stand on his feet, hospitalized, COVID negative (SARS-CoV-2 test in Mar2021), pericardial effusion punctured, microcytic anemia, but in the next period the condition does not improve, several subsequent hospitalizations (heart failure, kidney failure, diagnostic bladder cancer in the treatment without proven enlargement and without previous symptoms) and 07Jun2021. death ensues. Reaction / event as reported by initial reporter was pericardial effusion. Additional information on drug: ADR Weakness is adequately labelled; ADR Chest pressure, Chest pain, Swelling of legs, Instability gait, Pericardial effusion, Microcytic anemia, Heart failure, Kidney failure are not adequately labelled. The outcome of diagnostic bladder cancer was unknown; outcome of other events was fatal. The patient died on 07Jun2021. It was unknown if an autopsy was performed. Causality: Due to good health before the vaccine and the sudden onset of symptoms and rapid deterioration, there is a suspicion of an association. A causal relationship between Comirnaty and events Chest pain, Swelling of legs, Instability gait, Pericardial effusion, Microcytic anemia, Heart failure, Kidney failure and Weakness was Unassessable/Unclassifiable per Regulatory Authority (Source of assessment) based on WHO Causality (Method of assessment). Sender Comment: 26Jul2021.Reporter was requested for additional information on the cause of death, autopsy report, hospitalization data, lab. results and batch number. So far no follow-up information have been received. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: Linked Report(s) : HR-PFIZER INC-202100982628 same reporter/patient/drug, different dose/events; Reported Cause(s) of Death: legs began to swell; Heart failure; marked w; Microcytic anemia; Pericardial effusion; Kidney failure; Chest pain; inability to stand on feet


VAERS ID: 1538885 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100987857

Write-up: unexpected death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority, regulatory authority number is IT-MINISAL02-762282. A 53-year-old male patient received BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number: FE2707) via intramuscular on 16Jul2021 at 09:56 (age at vaccination 53-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY, Formulation: solution for injection, Lot number: FC1526) via intramuscular on 08Jun2021 at 16:55 as dose 1, single for covid-19 immunisation. On 16Jul2021, the patient died (unexpected death). No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1539015 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Chronic atrial fibrillation; COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100976521

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was an 81-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unspecified medication(s) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included chronic obstructive pulmonary disease (COPD), cardiac failure chronic, and chronic atrial fibrillation. The patient had no relevant past drug history. On 22Jun2021 at 15:00, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# and expiration date were not available/not provided to reporter at the time of report completion) intramuscular in the arm left for COVID-19 immunization. On 13Jul2021 at 14:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not available/not provided to reporter at the time of report completion) intramuscular in the arm left for COVID-19 immunization. On 18Jul2021 at 18:30 (5 days 4 hours after the vaccination), the patient experienced death. The outcome of the event was fatal with treatment including standard resuscitation therapy. No autopsy was done. The cause of death was unknown. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death). Information on the lot/batch number has been requested.; Sender''s Comments: Based on the available information, this 81-year-old male with underlying medical histories of chronic obstructive pulmonary disease (COPD), cardiac failure chronic, and chronic atrial fibrillation received the first dose of BNT162B2 vaccine with no reported adverse event. Coincidentally, the patient died five days after the second dose. There was no evidence that the reported death with unknown cause was related to BNT162B2. The underlying medical histories and the advancing age may have played an important contributory role. This case will be re-assessed should additional information becomes available. The impact of this report on the benefit/risk profile of the product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concerns identified as part of this review, as well as any appropriate actions in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1539020 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Duodenal ulcer haemorrhage, Oesophagogastroduodenoscopy, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow), Gastrointestinal ulceration (narrow), Gastrointestinal haemorrhage (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210713; Test Name: Oesophagogastroduodenoscopy; Result Unstructured Data: Test Result:Duodenal ulcer haemorrhage
CDC Split Type: JPPFIZER INC202100979166

Write-up: gastroduodenal ulcer hemorrhage; the state of shock; This is a spontaneous report from a contactable pharmacist received from the Regulatory Authority. Regulatory authority report number is v21122696. The patient was an 80-year and 1-month-old male. Age at vaccination was 80-year and 1-month-old. Body temperature before vaccination was 36.2 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). On 06Jul2021 at unspecified time (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 13Jul2021 at 18:20 (seven days after the vaccination), the patient experienced haemorrhage of digestive tract. On 14Jul2021 (eight days after the vaccination), the patient died and was discharged from hospital. The course of the event was as follows: On 08Jun2021 (as reported), the patient was admitted to the reporter hospital. On 06Jul2021, the patient received the first dose of vaccination. On 13Jul2021, Haematemesis and melena occurred, and gastroscope was performed urgently. The result was astroduodenal ulcer hemorrhage. Bleeding stopped with the emergency response, but later blood pressure gradually dropped, and the patient became the state of shock. On 14Jul2021, the patient discharged due to die. The reporting pharmacist classified the event as serious (fatal, hospitalization) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting pharmacist did not provide any further comment.; Reported Cause(s) of Death: the state of shock; gastroduodenal ulcer hemorrhage


VAERS ID: 1539021 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-07-28
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100979176

Write-up: Out-of-hospital cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21119434. A 75-year and 8-month-old female patient received BNT162B2 (COMIRNATY, solution for injection) at single dose on 12Jun2021 at 16:05 at the age of 75-year and 8-month-old for COVID-19 immunisation. Body temperature before vaccination was unknown. The patient had no family history. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Concomitant medication was not reported. On 28Jul2021 around 15:00 (46 days after the vaccination), the patient experienced out-of-hospital cardiac arrest. On 28Jul2021, patient died. It was unknown if an autopsy was performed. The outcome of event was fatal. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162B2 as unassessable. There was no other possible cause of the event such as any other diseases. The lot number for the vaccine BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Out-of-hospital cardiac arrest


VAERS ID: 1539022 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-27
Onset:2021-07-30
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

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: Medical History/Concurrent Conditions: Cardiac failure; Pneumonia aspiration; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100979190

Write-up: pneumonia aspiration; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. An 84-year-old female patient received BNT162B2 (COMIRNATY), 1st dose intramuscularly on 27Jul2021 (Batch/Lot number and Expiration date were unknown) at age of 84 years old as 0.3ml, a single dose for covid-19 immunisation. Medical history included rheumatoid arthritis, cardiac failure and pneumonia aspiration. The patient''s concomitant medications were not reported. The patient experienced pneumonia aspiration on 30Jul2021 with outcome of fatal. The patient died on 30Jul2021. It was not reported if an autopsy was performed. Clinical course: On 27Jul2021, the patient received the first dose of Comirnaty on visiting care. On 30Jul2021, the patient was transported by ambulance to hospital, and diagnosed with pneumonia aspiration at the hospital. The patient died. The reporting physician classified the event as serious (fatal) and assessed that the event was possibly related to BNT162b2. The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender''s Comments: There is not a reasonable possibility that event pneumonia aspiration is related to BNT162B2 per current limited information. This elderly patient had underlying cardiac failure and pneumonia aspiration. The event is more likely intercurrent medical condition. 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: pneumonia aspiration


VAERS ID: 1539024 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-22
Onset:2021-07-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0348 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastric cancer
SMQs:, Non-haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastric cancer stage IV
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100979762

Write-up: Death due to gastric cancer; This is a spontaneous report from a contactable physician received from a Pfizer sales representative. The patient was a 79-year-old male. Body temperature before vaccination, family history, and concomitant medication were not reported. Medical history included end stage of gastric cancer. On an unknown date, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Lot# not reported, Expiration date not reported) for COVID-19 immunization. On 22Jul2021 (the day of vaccination), the patient received the second single dose (30ug) of BNT162b2 (COMIRNATY, Solution for injection, Lot number: FD0348, Expiration date: 31Oct2021) via an intramuscular route for COVID-19 immunization. On 22Jul2021 (the same day of the vaccination), the patient experienced death due to gastric cancer. The patient was in the end stage of gastric cancer and was followed up at home. The patient received the second dose of the vaccination. On the same day, the death was confirmed at home. The patient died on 22Jul2021. It was not reported if an autopsy was performed. The outcome of the event death due to gastric cancer was fatal. The reporting physician classified the event as serious (death) and assessed as possibly related to BNT162b2. The reporting physician considered that the causal relationship between the event and BNT162b2 was low.; Sender''s Comments: Based on the information currently available, the reported event fatal gastric cancer is more likely due to the underlying disease progression, but not related to BNT162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Death due to gastric cancer


VAERS ID: 1539025 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood pressure measurement, Blood test, Body temperature, Chest X-ray
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-01
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: WARFARIN POTASSIUM; AMLODIPINE BESILATE; CANDESARTAN CILEXETIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Dementia; Hypertension; Subarachnoid haemorrhage (at the age of 59)
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: blood pressure; Result Unstructured Data: Test Result:gradually decreasing; Test Date: 20210721; Test Name: blood examination; Result Unstructured Data: Test Result:no abnormalities; Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210721; Test Name: chest X-ray; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC202100980128

Write-up: Consciousness disturbed; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122705. An 85-year and 8-month-old male patient received bnt162b2 (COMIRNATY Solution for injection), dose 2 via an unspecified route of administration on 08Jul2021 10:00 (the day of vaccination) (Batch/Lot Number: FD0889; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation at the age of 85-year and 8-month-old. The family history was not provided. The patient had medical histories of hypertension, dementia, atrial fibrillation, and subarachnoid haemorrhage at the age of 59. The concomitant medications included warfarin potassium (WARFARIN), amlodipine besilate (AMLODIPINE), and candesartan cilexetil (CANDESARTAN). On 10Jul2021 (2 days after the vaccination), the patient experienced consciousness disturbed. The course of the event was as follows: Although the patient had dementia, independent gait was possible. The patient walked around and passed urine everywhere, and thus, his movement was active. On 17 of unknown month in 2021, the patient received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for covid-19 immunisation, and thereafter, no change was observed. Body temperature before vaccination was 36.5 degrees centigrade. On 08Jul2021 (the day of vaccination), around 10:00, the patient received the second dose of BNT162b2 vaccination. On 10Jul2021 (2 days after vaccination), in the evening, the patient suddenly tended to have somnolence. Although the patient responded when his name was called, he became motionless from the bed. No paralysis was noted, and the patient made resistance to caregiving. The patient became unable to take meals, and his response gradually became poor. On 21Jul2021 (13 days after vaccination), fluid intake became impossible, and fluid replacement was performed every day. The blood examination and chest X-ray showed no abnormalities. On 28Jul2021 (20 days after vaccination), the patient had open-mouth breathing, and the blood pressure was gradually decreasing. On 01Aug2021, at 23:00 (24 days after vaccination), the patient died. On 01Aug2021 (24 days after the vaccination), the outcome of the event was fatal. The patient died on 01Aug2021. It was not reported if an autopsy was performed. The reporting physician classified the event, consciousness disturbed as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The patient had medical histories of hypertension and dementia. He also had medical history of subarachnoid haemorrhage at the age of 59. However, independent gait was possible, and the patient had appetite, and no signs of geromarasmus were observed at all. After the second dose of BNT162b2 vaccination, the patient suddenly tended to have somnolence, and no paralysis was noted, and cerebral infarction was deniable. Since the causes of sudden onset of the symptoms other than the vaccination were not considerable, the causality between the event and the vaccination was strongly suspected.; Reported Cause(s) of Death: Consciousness disturbed


VAERS ID: 1539026 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cholecystitis; Dementia; Parkinson''s disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100980162

Write-up: Geromarasmus; inappetence; aggravation of consciousness disturbed (consciousness loss); hypotension; aggravation of consciousness disturbed (consciousness loss); This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21119555. The patient was an 87-year and 1-month-old female. Body temperature before vaccination was not reported. Medical history included gallstone cholecystitis, Parkinson''s disease and dementia. Concomitant medications and family history were not provided was provided. The course of the events was as follows: On 01Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 22Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization (at the age of 87-year and 1-month-old). On 01Jul2021 (9 days after the vaccination), hypotension, inappetence, and aggravation of consciousness disturbed (consciousness loss) were noted. On 15Jul2021 (23 days after the vaccination), the outcome of the events for inappetence was not recovered and for other events was fatal. It was not reported if an autopsy was performed. The patient developed hypotension, inappetence, and aggravation of consciousness disturbed (consciousness loss) on 01Jul2021, Geromarasmus on 15Jul2021. The reporting physician classified the events as serious (life-threatening conditions) and assessed that the events were related to BNT162b2. Geromarasmus was reported as another possible cause. The outcome of events for inappetence was not resolved, for other events was death on 15Jul2021. The reporting physician commented as follows: The patient had been in a poor condition since before. It was considered that BNT162b2 triggered further aggravation. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reporter''s Comments: The patient had been in a poor condition since before. It was considered that BNT162b2 triggered further aggravation.; Reported Cause(s) of Death: Geromarasmus; aggravation of consciousness disturbed (consciousness loss); hypotension; aggravation of consciousness disturbed (consciousness loss)


VAERS ID: 1539027 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bone marrow, Blood lactate dehydrogenase increased, Haemophagocytic lymphohistiocytosis, Liver disorder, Multiple organ dysfunction syndrome, Platelet count decreased, Pyrexia
SMQs:, Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Sepsis (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-27
   Days after onset: 36
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: 20210623; Test Name: bone marrow examination; Result Unstructured Data: Test Result:hemophagocytosis; Test Date: 20210623; Test Name: LDH; Result Unstructured Data: Test Result:2500 IU/l; Comments: Peak; Test Date: 20210623; Test Name: platelets decreased; Result Unstructured Data: Test Result:10,1000 mL
CDC Split Type: JPPFIZER INC202100980191

Write-up: multiorgan failure progressed; liver disorder progressed; LDH was high; platelet count decreased (to 10,1000/mL); Haemophagocytic syndrome; pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122069. The patient was a 76-year and 5-month-old female. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient''s concomitant drug was not reported. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunization. On 21Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration at the age of 76-year-old as a single dose for COVID-19 immunization. On 23Jun2021 (2 days after the vaccination), the patient experienced haemophagocytic syndrome. On 27Jul2021 (36 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 23Jun2021, 2 days after the second dose of BNT162b2 vaccination (on 21Jun2021), the patient had pyrexia. Thereafter, liver disorder progressed, and the LDH was high (peak, 2500 IU/L), and the platelet count decreased (to 10,1000/mL). The bone-marrow examination showed hemophagocytosis. The patient was refractory to a steroid and steroid pulse therapy, and multiorgan failure progressed. On 27Jul2021 (36 days after vaccination), the patient died. The outcome of events for haemophagocytic syndrome and multiorgan failure was fatal, for other events was unknown. The patient died on 27Jul2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Other possible cause of the event such as any other diseases was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Haemophagocytic syndrome; multiorgan failure progressed


VAERS ID: 1539033 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC9909 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: Body temperature; Result Unstructured Data: Test Result:35.2 Centigrade; Comments: before vaccination; Test Date: 20210729; Test Name: Body temperature; Result Unstructured Data: Test Result:38 to 39 Centigrade; Comments: 22:18
CDC Split Type: JPPFIZER INC202100986318

Write-up: Cardiac failure aggravated; Pyrexia of 38 to 39 degrees Celsius; This is a spontaneous report from a contactable physician received from the Regulatory Authority and COVID-19 Adverse Event Self-Reporting Solution. Regulatory authority report number is v21122093. The patient was an 89-year and 7-month-old male. Age at vaccination was 89-year and 7-month-old. Body temperature before vaccination was 35.2 degrees centigrade. Other medical history included cardiac failure. The patient concomitant medications were not reported. On 28Jul2021 at 14:00 (the day of vaccination), the patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FC9909, Expiration date 30Sep2021) via intramuscular for COVID-19 immunization. On 29Jul2021 at 22:18 (one day after the vaccination), the patient experienced pyrexia of 38 to 39 degrees Celsius. On 29Jul2021 (one day after the vaccination), the patient was admitted to the hospital. On the same day (29Jul2021), the patient experienced cardiac failure aggravated and died at 22:18. On 29Jul2021 (one day after the vaccination), the outcome of the event was fatal. It is unknown if autopsy done. Events were reported as serious with hospitalization. The course of the event was as follows: On 28Jul2021, the patient received the vaccination of Comirnaty. The next day, on 29Jul2021, the patient had a fever at 38-39 degrees and was admitted to hospital. On the same day, the symptom of cardiac failure aggravated, and the patient died at 22:18. The patient originally had a serious cardiac failure, and there was a possibility that fever made cardiac failure aggravate and resulted in his death. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was cardiac failure. The reporting physician commented as follows: There was a possibility that fever due to Comirnaty leaded to exacerbation of severe cardiac failure.; Reported Cause(s) of Death: fever made cardiac failure aggravate and resulted in his death; fever made cardiac failure aggravate and resulted in his death


VAERS ID: 1539034 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Body temperature, Heart rate, Lack of spontaneous speech, Oxygen saturation, Oxygen saturation decreased, Respiratory failure, Tachycardia, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-02
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arteriosclerosis obliterans; Cardiac failure chronic; Diabetes mellitus; Diabetic nephropathy; Hypertension; Lower extremities ulcers of; Mitral valve stenosis
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:251/118; Test Date: 20210730; Test Name: BP; Result Unstructured Data: Test Result:174/84; Comments: At 6:30; Test Date: 20210731; Test Name: BP; Result Unstructured Data: Test Result:127/81; Test Date: 20210729; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: At 6:30; Test Date: 20210731; Test Name: body temperature; Result Unstructured Data: Test Result:37.0 Centigrade; Test Date: 20210730; Test Name: HR; Result Unstructured Data: Test Result:between 120s and 170s; Test Date: 20210730; Test Name: HR; Result Unstructured Data: Test Result:between 100 and 110; Comments: At 6:30; Test Date: 20210731; Test Name: HR; Result Unstructured Data: Test Result:between 120s and 130s; Test Date: 20210801; Test Name: HR; Result Unstructured Data: Test Result:between 140 and 160; Comments: At 23:45; Test Date: 20210730; Test Name: SpO2; Test Result: 60 %; Test Date: 20210730; Test Name: SpO2; Result Unstructured Data: Test Result:approximately 90 %; Comments: At 6:30; Test Date: 20210731; Test Name: SpO2; Test Result: 89 %
CDC Split Type: JPPFIZER INC202100986325

Write-up: lost his spontaneous speech; Respiratory failure; wheezing; Blood pressure (BP) was 251/118; oxygen saturation (SpO2) was 60%; heart rate (HR) was between 120s and 170s/tachycardia with HR of 140 to 160; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122079. A 77-year-old male patient received the first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration (at the age of 77-year-old) on 29Jul2021 10:03 (Lot Number: FC5947; Expiration Date: 30Sep2021) as single dose for covid-19 immunisation. Medical history included Diabetes mellitus, Diabetic nephropathy stage 4, Hypertension, Mitral valve stenosis, Arteriosclerosis obliterans, Lower extremities ulcers of, chronic cardiac failure. The patient''s concomitant medications were not reported. The patient experienced respiratory failure (death) on 30Jul2021 01:45. The patient experienced wheezing on 30Jul2021 01:45, blood pressure (bp) was 251/118 on 30Jul2021, oxygen saturation (spo2) was 60% on 30Jul2021, heart rate (hr) was between 120s and 170s/tachycardia with hr of 140 to 160 on 30Jul2021, lost his spontaneous speech on 31Jul2021 16:00; all medically significant. The clinical course was reported as follows: The patient was a 77-year and 8-month-old male. Body temperature before vaccination was 36.8 degrees Centigrade (29Jul2021). On 30Jul2021 at 01:45 (15 hours and 42 minutes after the vaccination), the patient experienced respiratory failure. On 30Jul2021 at 01:45 (15 hours and 42 minutes after the vaccination), wheezing was found. Blood pressure (BP) was 251/118, and oxygen saturation (SpO2) was 60%. Administration of oxygen at 5 liters (L) was started. The monitor was placed. Then, heart rate (HR) was between 120s and 170s. One ampule (A) of furosemide (LASIX) (20) was intravenously administered. At 6:30, body temperature (BT) was 37.1, BP 174/84, HR between 100 and 110, SpO2 approximately 90% with 10 L of oxygen. On 31Jul2021 (2 days after the vaccination), BT was 37.0 Centigrade, BP 127/81, HR of 120s to 130s, and SpO2 89% (with 10 L of oxygen). During the treatment, drip infusion was given: 500 mL of KN NO.1, a half ampule of aspara potassium (10) (continued for 24 hours). As other treatments, 1 A of furosemide (20) (intravenously, one-shot), 1 g of ceftriaxone and 100 mL of normal saline solution were given, twice (at 10:00 and 16:00), over 30 minutes through drip infusion. The medications above were performed from 30Jul2021 to 01Aug2021. On 31Jul2021 at 16:00, the patient lost his spontaneous speech. On 01Aug2021 at 23:45 (3 days after the vaccination), the patient had tachycardia with HR of 140 to 160, so additional treatment was performed; 100 mL of normal saline solution, and 250 mL of normal saline solution, 100 mL of intravenous hydrocortisone (SOLU-CORTEF) and 1A of famotidine were administered through drip infusion. On 02Aug2021 (4 days after the vaccination), at around 4:00, respiratory status deteriorated rapidly. At 5:57 (02Aug2021), the patient was confirmed dead. The reporting physician classified the event Respiratory failure 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 acute on chronic heart failure. The reporting physician commented as follows: The cause of death was acute on chronic heart failure. The possibility of indirect involvement with the vaccine to the death could not be ruled out. Therapeutic measures were taken as a result of events (except Lack of spontaneous speech). The outcome of the event Respiratory failure was fatal, events Oxygen saturation low, Blood pressure increased was recovering, others was unknown. The patient died on 02Aug2021 05:57 due to Respiratory failure and acute on chronic heart failure. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: respiratory failure; acute on chronic heart failure


VAERS ID: 1539035 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-30
Onset:2021-07-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1945 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Foaming at mouth, Loss of consciousness, Physical deconditioning
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure; Oxygen therapy (home oxygen)
Allergies:
Diagnostic Lab Data: Test Date: 20210730; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100986362

Write-up: cardiopulmonary arrest; lost consciousness; forming at the mouth; physical deconditioning; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122080. A 79-year-old (reported as 79-year and 5-month-old) male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FD1945, Expiration date 31Oct2021), dose 2 via an unspecified route of administration on 30Jul2021 as single dose for covid-19 immunisation. Medical history included cardiac failure, oxygen therapy (home oxygen). The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunisation. On 30Jul2021 in the morning (the day of vaccination), the patient received the second dose of bnt162b2. Body temperature before vaccination was 36.2 degrees centigrade. On 31Jul2021 at 18:43 (one day after the vaccination), the patient died. The outcome of the event was fatal. The course of the patient''s death was as follows: On 30Jul2021, the patient received the second dose of COVID-19 Vaccine. Since the morning on 31Jul2021, physical deconditioning had occurred. At 17:00, the patient lost consciousness with forming at the mouth, and emergency squad was called. When the arrival of the emergency squad, the patient had cardiopulmonary arrest (CPA). At 18:43, the patient was confirmed dead at hospital. The outcome of event cardiopulmonary arrest was fatal, the rest of events outcome was unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as un-assessable. Other possible causes of the event such as any other diseases were cardiac failure chronic, COPD and diabetes mellitus (DM). The reporting physician commented as follows: The relationship to the vaccination was not clear, but the reporter reported the case because it was the day after the vaccination.; Reported Cause(s) of Death: cardiopulmonary arrest


VAERS ID: 1539036 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-23
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LIXIANA; CRESTOR; SAMSCA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure; Dyslipidaemia; Hypertension; Myocardial infarction; Renal failure chronic
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100986418

Write-up: Cardiac failure; This is a spontaneous case from a contactable physician received via a Pfizer sales representative. A 76-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 04Jul2021 (Lot number unknown, Expiration date unknown) at the age of 76-year-old as single dose for COVID-19 immunization. Medical history included hypertension, atrial fibrillation, dyslipidaemia, cardiac failure, myocardial infarction and renal failure chronic. The family history was not provided. Concomitant medication included edoxaban tosilate (LIXIANA) taken for atrial fibrillation, rosuvastatin calcium (CRESTOR) taken for dyslipidaemia and tolvaptan (SAMSCA) taken for cardiac failure. On 23Jul2021, the patient experienced cardiac failure. The clinical course was as follows: On 04Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 23Jul2021 (19 days after vaccination), the patient was confirmed to die due to cardiac failure (probably). Since the patient''s condition was originally poor, the cause of death could not be identified. However, since cardiac failure probably progressed, it was judged that the cause of death was cardiac failure. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. The cause of death was cardiac failure. Autopsy was not reported. The outcome of event was fatal. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the information currently available, the reported event cardiac failure is more likely due to the progression of underlying disease cardiac failure , but not related to BNT162B2.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1539039 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-07
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Cardiac tamponade, Myocardial infarction
SMQs:, Cardiac failure (narrow), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100990149

Write-up: Myocardial infarction suspected; suspected to have tamponade or cardiac failure; suspected to have tamponade or cardiac failure; This is a spontaneous report from a contactable physician received via a sales representative. The patient was a 79-year-old female. Body temperature before vaccination was not reported. The patient''s family history was not reported. Medical history included hypertension. Historical Vaccine included the first dose of BNT162b2 (COMIRNATY, Lot number unknown, Expiration date unknown) on unknown date for covid-19 immunisation. The patient''s concomitant drug was not reported. On 04Jul2021 (the day of vaccination), the patient received?the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 07Jul2021 (3 days after the vaccination), the patient experienced myocardial infarction suspected. The patient was suspected to have tamponade or cardiac failure. On 07Jul2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 04Jul2021, the patient received the second dose of Comirnaty. The patient had been suffering from hypertension but had no cardiac diseases. On 07Jul2021, the patient ate a smaller breakfast than usual. In the evening, when the patient''s family member came back home, the patient was lying in the room and was already in the state of postmortem rigidity. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 was unknown. Outcome of the events was fatal on 07Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: The presumed time of death was around 12:00. The patient was suspected to have tamponade or cardiac failure. The causality was unknown. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Reporter''s Comments: The presumed time of death was around 12:00. The patient was suspected to have tamponade or cardiac failure. The causality was unknown.; Sender''s Comments: Based on the information given in narrative, the causal relationship between the events myocardial infarction, cardiac tamponade, cardiac failure with fatal outcome and the suspect vaccine BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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: suspected to have tamponade or cardiac failure; suspected to have tamponade or cardiac failure; Myocardial infarction suspected


VAERS ID: 1539040 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antinuclear antibody, Auscultation, Blood creatine phosphokinase, Blood creatine phosphokinase increased, Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, Blood pressure measurement, Blood test, Body temperature, C-reactive protein, Fall, Fibrin D dimer, Glomerular filtration rate, Glycosylated haemoglobin, Hyperhidrosis, Investigation, KL-6, N-terminal prohormone brain natriuretic peptide, Non-high-density lipoprotein cholesterol, Ovarian cancer, Oxygen saturation, Pain, Polymyositis, Pyrexia, White blood cell count
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Ovarian malignant tumours (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Non-haematological malignant tumours (narrow), Infective pneumonia (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Deep vein thrombosis leg
Preexisting Conditions: Medical History/Concurrent Conditions: Cataract operation; Dermatitis asteatotic (2 years before); Diabetes mellitus; Dyslipidaemia; Erythema facial; Gonarthrosis; Hypertension; Knee arthroplasty (in her 50s); Osteoporosis; Swelling
Allergies:
Diagnostic Lab Data: Test Date: 20210712; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210629; Test Name: CRP; Result Unstructured Data: Test Result:10.08; Test Date: 20210706; Test Name: CRP; Result Unstructured Data: Test Result:6.63; Test Date: 201912; Test Name: D-dimer; Result Unstructured Data: Test Result:more than 16; Test Name: eGFR; Result Unstructured Data: Test Result:between 40 to upper half of 30 mL; Comments: estimated glomerular filtration rate (eGFR) decreased at between 40 to upper half of 30 mL.; Test Name: HbA1c; Result Unstructured Data: Test Result:6.2 to 6.7 %; Test Name: HbA1c; Result Unstructured Data: Test Result:7s %; Comments: in recent days; Test Name: Examinations; Result Unstructured Data: Test Result:revealed presence of ovarian cancer; Test Date: 20210706; Test Name: KL-6; Result Unstructured Data: Test Result:3406; Test Name: Non-HDL cholesterol; Result Unstructured Data: Test Result:150s; Test Date: 20210629; Test Name: NT-proBNP; Result Unstructured Data: Test Result:51.4; Test Date: 20210712; Test Name: SpO2; Test Result: 94 %; Test Date: 20210706; Test Name: WBC; Result Unstructured Data: Test Result:11000; Test Date: 20210706; Test Name: ANA; Result Unstructured Data: Test Result:1280; Test Date: 20210629; Test Name: Auscultation; Result Unstructured Data: Test Result:fine crackles; Test Date: 20210629; Test Name: CK; Result Unstructured Data: Test Result:increase; Test Date: 20210629; Test Name: LDH; Result Unstructured Data: Test Result:increase; Test Date: 20210706; Test Name: LDH; Result Unstructured Data: Test Result:60; Test Name: blood pressure; Result Unstructured Data: Test Result:120s to 130s/60s to 70s; Test Date: 20210629; Test Name: blood drawing; Result Unstructured Data: Test Result:revealed the results of C-reactive protein (CRP); Comments: revealed the results of C-reactive protein (CRP) 10.08, increased lactate dehydrogenase (LDH)- creatinine kinase (CK), and N-terminal pro b-type natriuretic peptide (NT-proBNP) 51.4; Test Date: 20210622; Test Name: body temperature; Result Unstructured Data: Test Result:37s Centigrade; Test Date: 20210706; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade
CDC Split Type: JPPFIZER INC202100990322

Write-up: Polymyositis; Ovarian cancer; increased creatinine kinase; increased lactate dehydrogenase; sweaty; pantalgia; fever; feel down; This is a spontaneous report from a contactable physician via a Pfizer sales representative. An 86-years-old female patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration at the age of 86-years-old on 12Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical historyhypertension, diabetes mellitus, dyslipidaemia, osteoporosis, gonarthrosis of the hip joint and left knee, dermatitis asteatotic 2 years before, facial skin discolouration in Dec2020, and right lower thigh swelling in Dec2019, ongoing deep venous thrombophlebitis. Past history was as follows: the patient underwent total knee arthroplasty (TKA) in her 50s and cataract operation for both eyes in 2015. The course of medical history before vaccination was reported as follows: In 2010, the patient was referred from a physician in Hospital A to the reporting physician''s hospital, and had been received treatment for hypertension, diabetes mellitus, and dyslipidaemia. From 2012, the patient had received treatment for osteoporosis, and also been observed for gonarthrosis of the hip joint and left knee at the reporting physician''s hospital that occasionally obtained information from Hospital A. Blood pressure was 120s to 130s/60s to 70s. Hemoglobin A1c (HbA1c) ranged from 6.2 to 6.7% but moved to 7s% in recent days, so follow-up was continued. (Oral drugs were not changed). (illegible characters) Non-HDL cholesterol was 150s. At another department (nephrology), estimated glomerular filtration rate (eGFR) decreased at between 40 to upper half of 30 mL. No test for albumin had been conducted recently. Skin trouble (itching of the back and lumbar) had persisted around 2 years before, and had been treated as dermatitis asteatotic. It became mostly cured. However, from last December (Dec2020), due to covered by a facial mask, her face, particularly forehead and eyelid turned a red color. That made the patient concern. The patient''s concomitant medications was reported as: Direct oral anticoagulant (DOAC) was continued, because right lower thigh swelling developed in Dec2019, and D-dimer level became more than 16, which was treated as deep venous thrombophlebitis (DVT) but it recurred. The patient had no noteworthy family history. The patient previously received first dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on unknown date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. On 12Jun2021 (the day of vaccination), the patient experienced polymyositis. On unknown date (unknown days after the vaccination), the patient was admitted to Hospital B due to polymyositis. Starting on 22Jun2021 (10 days after the vaccination), slight fever of 37s degrees Centigrade persisted, and sweaty and pantalgia were also present. On 29Jun2021 (17 days after the vaccination), the patient visited the reporter''s hospital. Neither weight increased nor oedema was noted, but the reporting physician noticed the patient feel down. Blood drawing was performed that revealed the results of C-reactive protein (CRP) 10.08, increased lactate dehydrogenase (LDH)- creatinine kinase (CK), and N-terminal pro b-type natriuretic peptide (NT-proBNP) 51.4. At that moment, fine crackles(Auscultation) were heard. As the patient returned home after receiving blood drawing only, X-ray (XP) images could not be obtained. The patient, prescribed additional diuretic drug, was to be seen by the reporting physician one week later. On 06Jul2021 (24 days after the vaccination), body temperature (BT) was 36.3 degrees Centigrade, CRP 6.63, white blood cells (WBC) 11,000, LDH 60, KL-6 3406, and antinuclear antibody (ANA) increase to 1280. On 12Jul2021 (30 days after the vaccination), BT became 38 degrees Centigrade, and oxygen saturation (SpO2) 94%. Polymyositis (PM)/dermatomyositis (DM) were suspected. The patient was referred to Hospital B. There, polymyositis was confirmed the cause, and the patient was hospitalized. Examinations performed at Hospital B also revealed presence of ovarian cancer. Afterward, the patient died of ovarian cancer. The patient died on an unspecified date. The outcome of the event ovarian cancer was fatal, of the other events was unknown. It was not reported if an autopsy was performed. The reporting physician assessed that polymyositis was possibly related to BNT162b2. Causality and seriousness assessment from an attending physician of Hospital B was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender''s Comments: based on the available information the causality between suspect vaccine comirnaty and the fatal events ovarian cancer polymyositis fever sweaty and pantalgia increased lactate dehydrogenase (LDH)- creatinine kinase (CK cannot be completely ruled out; Reported Cause(s) of Death: Ovarian cancer


VAERS ID: 1539043 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Appendicitis, COVID-19, Clostridium difficile infection, Drug ineffective, Pain, Pyrexia
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: LBPFIZER INC202100988681

Write-up: He contracted Covid; Covid; Which then led him to catch Chlostrydium Dificile; appendicitis; Fever and febrile state; Sensation of pressure in lower stomach; Severe pain; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The following information was provided: A man had an acute and complicated appendicitis following his second shot of Pfizer vaccine. Day 1: fever and febrile state, Day 2: fever, febrile state and sensation of pressure in lower stomach, Day 3: severe pain (appendicitis). He was treated with antibiotics which then led him to catch Clostridium Difficile. In his visits to the ER, he contracted Covid and died of it. Outcome of the events clostridium difficile infection, appendicitis, fever and febrile state, sensation of pressure in lower stomach, severe pain was unknown. The patient died on an unspecified date. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Covid


VAERS ID: 1539061 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-26
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Cardiac failure, Dystonia, Oculogyric crisis, Seizure
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Dyskinesia (narrow), Dystonia (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-26
   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: MAJNJFOC20210762095

Write-up: HEART FAILURE; OCULOGYRIC CRISIS; CONVULSION (3 EPISODE); REACTION OF ACUTE GENERALIZED DYSTONIA; LARYNX LOCATION WHICH LED TO ASPHYXIA; This spontaneous report was received from a health care professional and from social media article and concerned a 33 year old female of unknown race and ethnicity. Initial information was processed with additional information received on 28-JUL-2021, 29-JUL-2021, 02-AUG-2021, and 06-AUG-2021. The patient''s height and weight were not reported. Relatives of the patient reported that she had no past medical history. No concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiration date were unknown) dose and vaccination site not reported, 1 total, administered on 26-JUL-2021 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 26-JUL-2021, 15 min after receiving vaccine, the patient experienced upper chest discomfort, oculogyric crisis, stiffness and rigidity, which was similar to post neuroleptic effect. Patient was transferred to a care unit where she got cyanosis on her face, followed by 3 episode of convulsion. Patient did not respond to benzodiazepine and died from a heart failure/ sudden cardiac arrest on 26-JUL-2021. Reporter''s assessment: "reaction of acute generalized dystonia'' where the death case was maybe having a larynx location which led to asphyxia" It was reported that this woman, one man and 2 additional women, all of the same age group, and all employees, received the vaccine on the same day at the same vaccination center and had adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart failure was fatal. The outcome of oculogyric crisis, larynx location which led to asphyxia, convulsion (3 episode), and reaction of acute generalized dystonia was not recovered. This case is a duplicate of 20210803557 and 20210763598. This case, from the same reporter is linked to 20210762146, 20210762101, 20210762147 and 20210808596.; Sender''s Comments: V0: This spontaneous case, received from a social media article and a health care professional, concerns a 33-year-old woman who died due to heart failure/cardiac arrest the same day she received the Janssen COVID-19 vaccine. The patient had no reported medical history. Fifteen minutes after receiving vaccine, she experienced chest discomfort, oculogyric crisis, and rigidity. She was brought to a care unit, where she became cyanotic and had 3 seizures. She did not respond to benzodiazepine and died due to heart failure. No additional information about her presentation or treatment were provided. Information is limited in this case, including the root cause of her symptoms and a unifying diagnosis. However, given the temporal relationship, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.; Reported Cause(s) of Death: SUDDEN CARDIAC ARREST


VAERS ID: 1539189 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: 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: PHJNJFOC20210809950

Write-up: FEVER; DIFFICULTY OF BREATHING (DOB); This spontaneous report received from a pharmacist via a Regulatory Authority [PH-PHFDA-300095404] concerned a 66 year old female 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, intramuscular, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 20-JUL-2021 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 21-JUL-2021 10:00 (one day after being vaccinated), the patient experienced fever and after 2 hours at 12:00 had difficulty of breathing (DOB). On an unspecified date, the patient died from fever, and difficulty of breathing (DOB). 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: 20210809950-COVID-19 VACCINE AD26.COV2.S-fever, difficulty of breathing (DOB). 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: FEVER; DIFFICULTY OF BREATHING (DOB)


VAERS ID: 1539191 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC202101000525

Write-up: Dead on arrival; This is a spontaneous report from a contactable other health care professional. This is a report received from the Regulatory Authority. Regulatory authority report number PH-PHFDA-300094004. A 33-year-old female patient received BNT162B2(COMIRNATY), via intramuscular of administration on 16Jul2021, at 33-year-old, as unknown dose number as single dose (Batch/Lot number was not reported) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced dead on arrival on 17Jul2021 19:52. The outcome of event was fatal. The event was reported as serious due to fatal outcome. 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: Dead on arrival


VAERS ID: 1540215 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-05
Onset:2021-06-06
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Monoplegia, Pain in extremity, Vaccination site haematoma, Vaccination site nodule, Vaccination site scar
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHPFIZER INC2021899325

Write-up: Paralyzed arm, and Death.; scar from vaccine no. 1; hematoma from the neck to the shoulder; small painful nodule; The pain in the arm progressed; Paralyzed arm, and Death.; This is a spontaneous report from a contactable consumer or other non hcp. A 87-years-old male patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: EP9605, Expiration date was not reported), dose 1 via intramuscular, administered in arm right on 05Apr2021 (age at vaccination 87 years) as single dose and second dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: ER7449, Expiration date was not reported), dose 2 via intramuscular, administered in arm right on 03May2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 06Jun2021, paralysed arm on an unspecified date, on an unspecified date scar from vaccine no. 1, hematoma from the neck to the shoulder, small painful nodule, pain in the arm progressed. Reported stated, he was upset that anyone was interested in this case and found the photos to be more explicit than the words. omitted, the attached photo (picture of the patient''s arm). His desire to go on vacation was such that he insisted on giving the second injection to regain the freedom to travel. To reassure reporter he told him about the covid arm and when he only had 2 fingers left where he felt "like flowing water", he told reporter it''s the end", thought he was talking about the disease, not his life. Patient received treatment for small painful nodule, treated with Paracetamol 500mg and Voltaren Dolo. For pain in the arm progressed, he treated himself with Tramadol + Stilnox to sleep, and massage with Voltaren Dolo and hot water bottles which seemed to relieve him. The patient died on 06Jun2021. It was not reported if an autopsy was performed. The outcome of event scar from vaccine no. 1, hematoma from the neck to the shoulder, small painful nodule, pain in the arm progressed was not recovered. Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: death; Paralyzed arm


VAERS ID: 1540245 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-17
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Myocarditis, Pulmonary embolism, Thrombocytopenia, Thrombosis, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEJNJFOC20210807037

Write-up: LUNG EMBOLISM; THROMBOSIS; THROMBOCYTOPENIA; MYOCARDITIS; VENTRICULAR FIBRILLATION; This spontaneous report received from a physician via the regulatory authority, case reference number DE-PEI-202100149468, and concerned a 27 year-old male patient of unspecified race and ethnic origin. 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 administration not reported, batch number XD974 expiry date not reported), dose not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-JUL-2021, the patient experienced ventricular fibrillation. On unspecified dates, the patient developed lung embolism, thrombosis, thrombocytopenia, and myocarditis. The patient was hospitalized on an unspecified date. On 17-JUL-2021, the patient died from an unknown cause of death. An autopsy was performed on an unspecified date, the results of which were not reported. The action taken with COVID-19 vaccine Ad26.CoV2.S was not applicable. The outcome was reported as fatal for lung embolism, thrombosis, thrombocytopenia, myocarditis and ventricular fibrillation. This report was serious (death, life-threatening and caused/prolonged hospitalization).; Sender''s Comments: V0: This spontaneous report received from a Regulatory Authority (DE-PEI-202100149468) concerns a 27-year-old male patient of unspecified ethnicity who was found to have ventricular fibrillation, lung embolism, thrombosis, thrombocytopenia, and myocarditis 7 days after receiving the Janssen Covid-19 vaccine. The patient died from an unspecified cause on an unspecified date. No other pertinent information reported. Information regarding other potential etiologies was insufficient and precludes a complete and meaningful assessment. The relationship of capillary leak syndrome to vaccination is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1541179 (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: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: EUCREAS; TEMERIT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202101010579

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-CN20212437. A 67-year-old female patient received second dose of BNT162B2(COMIRNATY), via intramuscular of administration on 15Jul2021, as single dose(Batch/Lot number was not reported) for covid-19 immunisation. Medical history included type 2 diabetes and hypertension. Concomitant medications included metformin hydrochloride, vildagliptin (EUCREAS) taken for type 2 diabetes from an unknown date;nebivolol hydrochloride (TEMERIT)(strength 5 mg) taken for hypertension from an unknown date. The patient''s COVID-19 history and PCR testing history and allergic history were unknown. The patient experienced cardiorespiratory arrest on 16Jul2021 13:00 and died at 16Jul2021 13:45. The outcome of event was fatal. It was not reported if an autopsy was performed. The event was reported as serious due to fatal outcome. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiorespiratory arrest


VAERS ID: 1541675 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-18
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood glucose, Blood glucose abnormal, Blood lactate dehydrogenase, C-reactive protein, COVID-19, COVID-19 pneumonia, Cardiac failure, Cardiac failure congestive, Chest X-ray, Death, Renal failure, Renal function test, SARS-CoV-2 test, Urinary tract infection, Urine analysis, Vaccination failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic renal insufficiency; Diabetic polyneuropathy; Gross obesity; Ischemic heart disease; Pulmonary embolism; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210418; Test Name: Creatine kinase; Result Unstructured Data: Test Result:16860; Comments: Units: U/L; Test Date: 20210418; Test Name: blood glucose; Result Unstructured Data: Test Result:unknown results; Test Date: 20210418; Test Name: LDH; Result Unstructured Data: Test Result:1532; Comments: Units: U/L; Test Date: 20210418; Test Name: Chest X-ray; Result Unstructured Data: Test Result:no infiltration was seen; Comments: diaphragm was pressed up on both sides with a sharp contour, no infiltration was seen; Test Date: 20210418; Test Name: C-reactive protein; Result Unstructured Data: Test Result:185.1 mg/l; Test Date: 20210418; Test Name: renal function; Result Unstructured Data: Test Result:impaired; Test Date: 20210418; Test Name: COVID-19 antigen test; Test Result: Positive ; Test Date: 20210418; Test Name: urinary tests; Result Unstructured Data: Test Result:urinary infection considered
CDC Split Type: HUPFIZER INC2021781864

Write-up: congestive heart failure; COVID-19 pneumonia; cardiac decompensation; chronic renal insufficiency/exacerbated the patient''s underlying conditions.; death; COVID-19; urinary infection; blood glucose values; Vaccination failure; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-456121. A 66-year-old female patient received the first dose of BNT162b2 (COMIRNATY, concentrate for dispersion for injection, 30 micrograms of COVID-19 mRNA Vaccine, MAH: BioNTech Manufacturing GmbH/ Pfizer) on 05Mar2021 (batch number: EP2163) via unspecified route as a single dose and the second dose of BNT162b2 (COMIRNATY, batch number: EW9127) on 09Apr2021 at 11:16 at 0.3 ml as a single dose intramuscularly in the left arm, both doses for COVID-19 immunization. Medical history included type II diabetes mellitus, diabetic polyneuropathy, extreme obesity, chronic renal insufficiency since 2018, pulmonary embolism in 2018, and ischemic heart disease. Concomitant medications were not reported. On 18Apr2021 the patient was hospitalized due to increasing weakness and dyspnoea. Lab data included elevated CK (Creatine Kinase)(16860 U/L), LDH(lactate dehydrogenase) (1532 U/L), CRP(C-reactive protein) (185.1 mg/L) and impaired renal function were confirmed in laboratory tests. The diaphragm was pressed up on both sides due to extreme obesity, but no infiltration was seen on chest X-ray. Although, intensive therapy consultation described COVID-19 pneumonia, which exacerbated the patient''s underlying conditions. Based on urinary tests, urinary infection was considered. Diuretics were started parenterally with dexamethasone and LMWH with gastric protection. Parenteral antibiotic therapy was used. Insulin therapy was started due to blood glucose values. The patient received oxygen supplementation. During observation, in addition to the therapy used, the patient''s condition progressed, therefore an intensive consultation was requested. Based on the patient''s advanced chronic underlying diseases, no improvement was expected from Intensive Care Unit treatment. Continuation of initiated therapy was recommended. Despite the applied treatments, her condition continued to deteriorate, and the patient died among the symptoms of respiratory failure caused by cardiac decompensation on 21Apr2021, at 01:30 a.m. Autopsy was not done. Cause of death was congestive heart failure due to chronic ischemic heart disease and chronic renal insufficiency. The outcome of the events urinary infection and blood glucose values was unknown, while of other events was fatal. Sender''s comments: The patient died 12 days after the second dose of Comirnaty due to COVID-19 which worsened her congestive heart failure and other underlying diseases. COVID-19 antigen test was positive 9 days after the second dose, therefore vaccination failure is considered possible with Comirnaty. The case is serious due to fatal outcome. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: vaccination failure; death; COVID-19; COVID-19 pneumonia; cardiac decompensation; chronic renal insufficiency; Congestive heart failure


VAERS ID: 1541726 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Sudden death, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Cardiomyopathy (broad)

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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:160/90 mmHg
CDC Split Type: ITPFIZER INC202101004158

Write-up: AFTER 1ST DOSE IN THE NIGHT 3 EPISODES OF VOMITING IN THE MORNING THE DOCTOR ADMINISTERED 1 Vial OF PLASIL, Blood Pressure 160/90. DURING THE DAY OF 6 REMAINS ASYMPTOMATIC UNTIL 6.30 PM SUDDEN DEATH; AFTER 1ST DOSE IN THE NIGHT 3 EPISODES OF VOMITING IN THE MORNING THE DOCTOR ADMINISTERED 1 Vial OF PLASIL, Blood Pressure 160/90. DURING THE DAY OF 6 REMAINS ASYMPTOMATIC UNTIL 6.30 PM SUDDEN DEATH; AFTER 1ST DOSE IN THE NIGHT 3 EPISODES OF VOMITING IN THE MORNING THE DOCTOR ADMINISTERED 1 Vial OF PLASIL, Blood Pressure 160/90. DURING THE DAY OF 6 REMAINS ASYMPTOMATIC UNTIL 6.30 PM SUDDEN DEATH; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency (MA) -WEB, regulatory authority number IT-MINISAL02-764381. A 59-year-old male patient received bnt162b2 (COMIRNATY, Solution for Injection), dose 1 via intramuscular, administered in Deltoid Left on 05Jul2021 17:05 (Batch/Lot Number: FE2707, Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jul2021, the patient experienced after 1st dose in the night 3 episodes of vomiting in the morning the doctor administered 1 vial of plasil, blood pressure 160/90. during the day of 6 remains asymptomatic until 6.30 pm sudden death. Laboratory tests on an unspecified date included blood pressure measurement: 160/90 mmhg. The doctor administered 1 vial of plasil for vomiting. The patient died on 06Jul2021 at 06:30 pm. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected. ; Reported Cause(s) of Death: after 1st dose in the night 3 episodes of vomiting in the morning the doctor administered 1 vial of plasil, blood pressure 160/90. during the day of 6 remains asymptomatic until 6.30 pm sudden death; after 1st dose in the night 3 episodes of vomiting


VAERS ID: 1541806 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Cardiac failure, Haemoglobin, Oxygen saturation, Pancytopenia, Platelet count, Pyrexia, White blood cell count
SMQs:, Cardiac failure (narrow), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Myelodysplastic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-28
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210628; Test Name: Haemoglobin; Result Unstructured Data: Test Result:6.8 g/dl; Test Date: 20210628; Test Name: SpO2; Test Result: 80 %; Comments: After 10 L of oxygen was administered.; Test Date: 20210628; Test Name: Platelet; Result Unstructured Data: Test Result:1000; Comments: Unit: /micro L; Test Date: 20210624; Test Name: WBC; Result Unstructured Data: Test Result:900; Comments: Unit: /micro L; Test Date: 20210628; Test Name: WBC; Result Unstructured Data: Test Result:800; Comments: Unit: /micro L
CDC Split Type: JPPFIZER INC202100995987

Write-up: Pancytopenia; poor consciousness persisted; Pyrexia; The poor oxygenation was considered caused by cardiac failure; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21122390. A 79-years and 11-month-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration on 23Jun2021 (the day of vaccination) (at age of 79-years-old) as dose 1, single for COVID-19 immunization. Body temperature before vaccination was not reported. The patient''s family history and medical history were not reported. 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). Patient medical history and concomitant medications were not reported. On 28Jun2021 (5 days after the vaccination), the patient experienced pancytopenia. The course of the event was as follows: On 23Jun2021, after the vaccination, the patient presented with pyrexia from the night. On 24Jun2021, blood test showed a low white blood cell count at 900/micro L. Pyrexia and poor consciousness persisted thereafter. On 28Jun2021, in the morning, SpO2 was 80%, indicating no improvement with 10 L of oxygen, and the patient was intubated. White blood cell was 800/micro L, haemoglobin was 6.8 g/dL, and platelet was 1000/micro L, which showed pancytopenia. The poor oxygenation was considered caused by cardiac failure associated with anemia on an unknown date in 2021. Blood transfusion was performed but did not improve the patient''s condition. On 28Jun2021, the patient was confirmed dead. 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. It was not reported if an autopsy was performed. On 28Jun2021 (5 days after the vaccination), the outcome of the event (Pancytopenia) was fatal. The Outcome of all other events are unknown. Information about lot/batch number has been requested.; Reported Cause(s) of Death: Pancytopenia


VAERS ID: 1541860 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-10
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: Congestive cardiac failure; Hypertension; Renal failure
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: LSJNJFOC20210816481

Write-up: DEATH; This spontaneous report was received from a consumer and concerned a 57 year-old male patient. The patient''s height and weight were not reported. The patient''s concurrent conditions included hypertension, renal failure and congestive cardiac failure (CCF). The patient received COVID-19 vaccine Ad26.CoV2.S (suspension for injection, intramuscular, batch number and expiry date not reported), dose and administration date not reported for prophylactic vaccination. The company will conduct follow-up to try and obtain the batch number. No concomitant medications were reported. On an unspecified date, within 12 hours of vaccination, it was reported that the patient died. No cause of death was reported and it was 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 20210816486, 20210816511 and 20210816515.; Sender''s Comments: V0: This spontaneous report received from consumer and concerned a 57 year-old male who died within 12 hours of receiving the Janssen COVID-19 vaccine. Medical history includes hypertension, renal failure and congestive cardiac failure. 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: 1541944 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-15
   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 - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Magnetic resonance imaging
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: 2021-06-16
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: MRI; Result Unstructured Data: Test Result:unknown; Comments: MRI related to brainstem activity.
CDC Split Type: NLPFIZER INC202101004145

Write-up: Brain hemorrhage leading to death; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority NL-LRB-00646770. This consumer reported similar events for two patients. This is the first of two reports. A 56-year-old male patient received first dose of BNT162B2 (COMIRNATY, formulation: Solution for injection, Lot Number: unknown), via on an unspecified route of administration on 11Jun2021 as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. No previous COVID-19 infection. On 15Jun2021, 4 days after start the patient had brain hemorrhage leading to death. The patient then died due to the brain hemorrhage on 16Jun2021. The patient received treatment for Cerebral infarction is treated with keeping him in a coma. A day later they got him out of the coma, after which patient had another cerebral hemorrhage. Patient was declared brain dead after that. Reported stated that this happened to my cousin and good friend whom I saw four days before his vaccination. I hear around me that more and more people end up in hospital because of a brain hemorrhage after vaccination. The patient underwent lab test which included magnetic resonance imaging to measure the brain stem activity on an unknown date result as unknown. The outcome of cerebral infarction is fatal. It was reported unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : NL-PFIZER INC-202101011663 same reporter/drug/event, different patient; Reported Cause(s) of Death: Brain hemorrhage


VAERS ID: 1541957 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-21
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210814147

Write-up: DEATH; This spontaneous report received from a physician via a Regulatory Authority [PL-URPL-3-840-2021] concerned a 48 year old female with unspecified race and ethnic origin. 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: XE389, expiry: 10-OCT-2021) 0.5 (unspecified unit) dose, first dose, 1 total administered in left arm on 17-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUL-2021, the patient died from unknown cause of death. 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: 20210814147-Covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1545793 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-27
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase, Angiogram, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatine phosphokinase MB, Blood lactate dehydrogenase, Cardiogenic shock, Cardiomyopathy, Dyspnoea exertional, Echocardiogram, Ejection fraction, Fibrin D dimer, N-terminal prohormone brain natriuretic peptide, Platelet count, Troponin T
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Pulmonary hypertension (broad), Cardiomyopathy (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: GPt; Result Unstructured Data: Test Result:1396; Test Name: CT angio; Result Unstructured Data: Test Result:no pulmonary embolism; Comments: 1) No evidence of a central pulmonary embolism or at the level of the lobes and segment arteries. Phase identifiable aorta without a tangible dissection membrane. 2) Heart globally enlarged / dilated. Pronounced signs of stress on the right heart. Larger pleural effusions bilaterally (right$g left), a.e. as part of cardiac decompensation. 3) Pneumonic consolidations peribronchially-central in the right upper lobe as in bronchopneumonia. In addition, at least two cavernous formations / fusions in the right upper lobe (series 6, IMA 61) or in the right lower lobe apically (series 6, IMA 66; Test Name: GOT; Result Unstructured Data: Test Result:838; Comments: U/l; Test Name: CK; Result Unstructured Data: Test Result:208; Test Name: CK-MB; Result Unstructured Data: Test Result:6.87 ng/ml; Comments: norm <3.6145 pf / ml (<116); Test Name: LDH; Result Unstructured Data: Test Result:987; Test Date: 20210531; Test Name: echo; Result Unstructured Data: Test Result:Dilated cardiomyopathy; Comments: Dilated cardiomyopathy with severely impaired LV function in diffuse hypokinesia. Mitral valve regurgitation 2 . Tricuspid valve insufflation 1 ''. No right heart strain. No pericardial effusion.; Test Name: LVEF; Result Unstructured Data: Test Result:<20 %; Test Name: D-dimer; Result Unstructured Data: Test Result:19.2 mg/l; Test Name: Nt proBNP; Result Unstructured Data: Test Result:12; Test Name: platelet; Result Unstructured Data: Test Result:96.000; Test Name: troponin T; Result Unstructured Data: Test Result:0.80 ng/ml
CDC Split Type: DEPFIZER INC202100987803

Write-up: Cardiogenic shock; Cardiomyopathy; Acute kidney failure; Dyspnoea exertional; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100137304. A 39-years-old female patient received bnt162b2 (COMIRNATY; Solution for injection), via an unspecified route of administration on 28Apr2021 (at the age of 39-years-old) (Lot Number: EX3599) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history and patient''s concomitant medications were not reported. The patient experienced Cardiogenic shock, Cardiomyopathy, Acute kidney failure, Dyspnoea exertional on 27May2021. The patient underwent lab tests and procedures which included Alanine aminotransferase: 1396 on an unspecified date, Angiogram: No pulmonary embolism on an unspecified date 1) No evidence of a central pulmonary embolism or at the level of the lobes and segment arteries. Phase identifiable aorta without a tangible dissection membrane. 2) Heart globally enlarged / dilated. Pronounced signs of stress on the right heart. Larger pleural effusions bilaterally (right$g left), a.e. as part of cardiac decompensation. 3) Pneumonic consolidations peribronchially-central in the right upper lobe as in bronchopneumonia. In addition, at least two cavernous formations / fusions in the right upper lobe (series 6, IMA 61) or in the right lower lobe apically (series 6, IMA 66 , aspartate aminotransferase: 838 on an unspecified date U/l , blood creatine phosphokinase: 208 on an unspecified date, Blood creatine phosphokinase mb: 6.87 ng/ml on an unspecified date norm <3.6145 pf / ml (<116) , blood lactate dehydrogenase: 987 on an unspecified date, Echocardiogram: dilated cardiomyopathy on 31May2021 Dilated cardiomyopathy with severely impaired LV function in diffuse hypokinesia. Mitral valve regurgitation 2. Tricuspid valve insufflation 1''. No right heart strain. No pericardial effusion, ejection fraction: <20 % on an unspecified date, fibrin d dimer: 19.2 mg/l on an unspecified date, n-terminal prohormone brain natriuretic peptide: 12 on an unspecified date, platelet count: 96.000 on an unspecified date, Troponin t: 0.80 ng/ml on an unspecified date. The patient died on an unspecified date. It was unknown if an autopsy was performed or not. No follow-up attempts possible. No further information expected; Reporter''s Comments: Summary Reporter Comment: LVEF <20% Echo 31May2021 Dilated cardiomyopathy with severely impaired LV function in diffuse hypokinesia. Mitral valve regurgitation 2 . Tricuspid valve insufflation 1 ''. No right heart strain. No pericardial effusion. D-dimers 19.2 mg / l (norm <0.5 Thrombocytes 96,000 GOT 835 U / l (nomr <35) GPt 1396 (norm <35); Reported Cause(s) of Death: the patient experienced Dyspnoea exertional, Cardiogenic shock, Cardiomyopathy, Acute kidney failure


VAERS ID: 1545988 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-06-12
   Days after vaccination:57
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: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 13
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial calcification
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987716

Write-up: Multiple strokes with death as a result; This is a spontaneous report from a non-contactable consumer or other non-healthcare professional downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021139092, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100136554. An 84-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 16Apr2021 as dose 2, single for covid-19 immunization. Medical history included arteriosclerosis from an unknown date and unknown if ongoing. The patient was not concerned known of any allergies. Information on risk factors or previous illnesses included a lot of medication, including blood thinners, calcified arteries, otherwise in good condition according to age. The patient experienced multiple strokes with death as a result on 12Jun2021. The patient died on 25Jun2021. An autopsy was not performed. Cause of Death reported as Stroke. COMIRNATY/ Stroke/ Unclassifiable. No follow-up attempts are possible, information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Stroke


VAERS ID: 1545989 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-08
Onset:2021-04-12
   Days after vaccination:35
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: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Zenker diverticulum
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987642

Write-up: Severe stroke resulting in death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB DE-PEI-CADR2021140007 and Safety Report Unique Identifier DE-PEI-202100137631. An 84-years-old male patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 08Mar2021 as second dose, single for COVID-19 immunization. Medical history included ongoing Zenker diverticulum. The patient''s concomitant medications were not reported. On 12Apr2021, the patient experienced severe stroke resulting in death. The patient died on 28Apr2021. It was not reported if an autopsy was performed. Reaction: Accident cerebrovascular. Source of assessment: RA Result of assessment: D. Unclassifiable Sender Comment: Are you or the person concerned known of any allergies? If yes, which? No information on risk factors or previous illnesses Zenker''s diverticulum, otherwise completely normal findings. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Accident cerebrovascular


VAERS ID: 1545993 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-07-05
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D018A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Coma scale, Computerised tomogram, Computerised tomogram head, Dysarthria, Headache, Illness, Magnetic resonance imaging, Monoplegia, Seizure, VIth nerve paralysis, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Glasgow Coma Scale; Result Unstructured Data: Test Result:deterioration < 8 points; Test Name: Computerised tomography; Result Unstructured Data: Test Result:cerebral bleeding evidence; Comments: suspected Subarachnoid hemorrhage; Test Name: Computerised tomography; Result Unstructured Data: Test Result:progressing cerebral oedema; Comments: on account of increased cerebral pressure.; Test Date: 20210706; Test Name: cranial computed tomography; Result Unstructured Data: Test Result:cerebral sinus vein thrombosis; Test Date: 20210706; Test Name: magnetic resonance tomography; Result Unstructured Data: Test Result:evidence of cerebral sinus thrombosis; Comments: and a brain oedema, convulsion.
CDC Split Type: DEPFIZER INC202100988686

Write-up: Thrombosis of venous sinuses; Brain oedema; Intra-cerebral hemorrhage; Seizure; abducens paralysis right; paralysis of arm; Vomiting; feeling of sickness; Headache; acute neurological symptoms with dysarthria; This is a spontaneous report from a non-contactable consumer or other non-Healthcare Professional downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021141885. A 36-years-old male patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Dose: 0.3 mL, Lot number: 1D018A, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Jun2021 (age at vaccination was unknown) as dose 2, 0.3ml single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient did not have any allergies. Information on risk factors or previous diseases was reported as none. The patient previously took first dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 12May2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. On 05Jul2021, the patient was referred to hospital on account of vomiting, feeling of sickness. Headache, acute neurological symptoms with dysarthria, subsequently in hospital paralysis of arm and abducens paralysis right. Computerised tomography with cerebral bleeding evidence, suspected subarachnoid hemorrhage on an unspecified date and cranial computed tomography with Clinical Target Volume on 06Jul2021 with urgent suspicion of a cerebral sinus vein thrombosis. On 06Jul2021, the patient experienced thrombosis of venous sinuses, brain oedema, intra-cerebral hemorrhage and seizure. On 06Jul2021, magnetic resonance tomography with evidence of cerebral sinus thrombosis and a brain oedema, convulsion. On 06Jul2021, papillademae. Emergency medical flight on 07Jul2021 at 6:10 am. Intubation and respiration, external ventricular drain apparatus, with Glasgow Coma Scale deterioration < 8 points on an unspecified date. Right computerised tomography with evidence of progressing cerebral oedema on account of increased cerebral pressure on an unspecified date. Hemicraniectomy was done on 07Jul2021. Anti-convulsive treatment, cerebral oedema treatment, antibiotic screening, anti-coagulation. Progressive sinus venal thrombosis despite decompressive measures, maximal brain pressure therapy, anti-coagulation and intensive therapy. Subsequently, fatal cerebral congestion bleeding and progressive cerebral oedema with irreversible brain pressure. The patient died on 09Jul2021. Death with unfavorable cerebral prognosis on 09Jul2021. An autopsy was not performed. This report was reported as serious-death. The outcome of the events thrombosis of venous sinuses, brain oedema and intra-cerebral hemorrhage was reported as fatal. The outcome of the event seizure was reported as not resolved. The outcome of the other events was unknown. Sender comment: Do you or the person concerned have any allergies? If so, which ones? None Information on risk factors or previous diseases none. No follow-up attempts are needed. No further information expected.; Reported Cause(s) of Death: Brain oedema; Intra-cerebral hemorrhage; Thrombosis of venous sinuses


VAERS ID: 1546001 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-25
Onset:2021-04-11
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7812 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100987538

Write-up: Infarct myocardial; This is a spontaneous report received from a non-contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is DE-PEI-CADR2021150259, Safety report unique identifier DE-PEI-202100150004. A 51-year-old male patient received first dose of BNT162B2 (COMIRNATY) Lot number ER7812, on 25Mar2021 at single dose for COVID-19 immunisation. Medical history included smoker. Concomitant medication was not reported. On 11Apr2021 the patient experienced Infarct myocardial which resulted in death. Sender Comment: Information on risk factors or previous illnesses smoker, professional soldier Relatedness of drug to reactions/events Source of assessment: RA Result of Assessment: D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1546048 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-03
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Malnutrition; Pancolitis
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Positive
CDC Split Type: ESJNJFOC20210813142

Write-up: ASYMPTOMATIC COVID-19; This spontaneous report received from a physician via a Regulatory Authority [NLP, ES-AEMPS-950071] concerned a 69 year old female of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s past medical history included: pancolitis, and malnutrition. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD955 and expiry: UNKNOWN) 0.5 ml, duration 1 day, 1 total administered on 03-MAY-2021 for covid-19 vaccination. The drug start period and drug last period were 62 days. No concomitant medications were reported. On 03-JUL-2021, the patient experienced asymptomatic covid-19. Laboratory data included: SARS-CoV-2 PCR test (NR: not provided) Positive. On 05-JUL-2021, the patient died from multiple organ failure, intestinal ischemia, and septic shock. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of asymptomatic covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210813142-COVID-19 VACCINE AD26.COV2.S.- Asymptomatic covid-19. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: MULTIPLE ORGAN FAILURE; INTESTINAL ISCHEMIA; SEPTIC SHOCK


VAERS ID: 1546066 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-28
   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 EK9788 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Coma, Confusional state, Death, Leukocytosis, Pneumonia, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 8
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: XERISTAR; NEURONTIN; XELEVIA; ACETYLSALICYLIC ACID; OMEPRAZOLE; PAZITAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthrosis; Cavernoma (left stable cerebral cavernoma); Cholecystectomy; COVID-19; Neuropathy (cranial neuropathy VI); Spinal canal stenosis (lumbar canal stenosis); TIA; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 PCR; Test Result: Negative
CDC Split Type: ESPFIZER INC202100987891

Write-up: bilateral pneumonia; loss of speech; comatose state; leucocytosis; vomit; Death; This is a spontaneous report from a contactable consumer or other non Health Professional downloaded from the Regulatory Authority-WEB ES-AEMPS-956110. A 88-year-old non-pregnant female patient received second dose of bnt162b2 (COMIRNATY solution for injection, Batch/Lot number: EK9788), via an unspecified route of administration on 28Jan2021 as dose 2, single for COVID-19 immunisation. The medical history of the patient included Cavernoma, Neuropathy from 2013 to unknown date, TIA from 2016 to unknown date, TIA from 2020 to unknown date, Cholecystectomy, Type 2 diabetes mellitus, Arthrosis, Spinal canal stenosis and COVID-19. The concomitant medications of the patient included duloxetine hydrochloride (XERISTAR), gabapentin (NEURONTIN), sitagliptin phosphate (XELEVIA), acetylsalicylic acid (ACETYLSALICYLIC ACID), omeprazole (OMEPRAZOLE), paracetamol, tramadol hydrochloride (PAZITAL). The patient was not pregnant at the time of vaccination. The patient previously received the first dose of COMIRNATY (solution for injection, Batch/Lot number: EM0477) on 07Jan2021 as single dose for COVID-19 immunisation. On 28Jan2021, the patient experienced vomit, loss of speech, comatose state, leucocytosis and the patient experienced bilateral pneumonia on 03Feb2021. The patient was hospitalized from 03Feb2021 to an unknown date for vomit and bilateral pneumonia. The patient underwent lab tests and procedures which included COVID-19 PCR: negative on an unspecified date. Therapeutic measures were taken as a result of bilateral pneumonia that included bronchodilators and antibiotic is started broad spectrum antibiotic but in the face of a fatal short-term prognosis, it was decided to apply measures of comfort and sedation. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: vomit; bilateral pneumonia; loss of speech; comatose state; leucocytosis


VAERS ID: 1546084 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210812235

Write-up: ICTUS; This spontaneous report received from a health care professional concerned a 36 year old male of unspecified race and ethnic origin. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration and batch number were not reported, expiry: unknown) dose, start therapy date were not reported,1 total administered 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 ictus and two weeks after vaccination the patient died due to ictus. 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). This case, from the same reporter is linked to 20210806771.; Sender''s Comments: V0:20210812235-COVID-19 VACCINE AD26.COV2.S-Ictus. 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: ICTUS


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