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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: 1515811 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD4555 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute myocardial infarction, Inappropriate schedule of product administration
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   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: Coronary artery stenosis; Coronary sclerosis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100939680

Write-up: fresh myocardial infarction in the posterior wall of the left ventricle; first dose on 06May2021; second dose on 17Jun2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 55-year-old male patient received second dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 (Batch/Lot Number: FD4555) as dose 2, single for covid-19 immunisation. Medical history included ongoing Coronary sclerosis and Coronary artery stenosis. The patient''s concomitant medications were not reported. Patient received first dose of bnt162b2 on 06May2021 with Batch/lot number: EY7015. On 24Jun2021 the patient experienced Acute myocardial infarction, true posterior wall infarction death. The patient died on 24Jun2021 from Acute myocardial infarction, true posterior wall infarction. The autopsy determined cause of death was reported to be: Acute myocardial infarction, true posterior wall infarction. Post-mortem findings: Cause of death: Fresh myocardial infarction pathology. Fresh myocardial infarction in the posterior wall of the left ventricle. Acute pulmonary congestion. First degree hepatic congestion. External description of corpse: A 180 cm tall corpse in normal DC. The skin is pale greyish-white, with blotchy blue-violet death marks on the back. Lying venous catheter in the left lateral neck region. The skin of the thorax shows some current marks (after resuscitation). Sender''s comments: No further information available. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: fresh myocardial infarction in the posterior wall of the left ventricle


VAERS ID: 1515822 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / 2 - / -

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: Mitral valve insufficiency
Preexisting Conditions: Medical History/Concurrent Conditions: Mitral valve prolapse (no regular medication use).
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100939704

Write-up: death NOS/ lifeless in bed; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 33-years-old female patient received second dose of BNT162B2 (COMIRNATY, lot number: FD6840), via an unspecified route of administration on 06Jul2021 at single dose for COVID-19 immunisation. Medical history included mitral valve insufficiency (continuing) and mitral valve prolapse (no regular medication use). Concomitant medications were not reported. The patient previously received first single dose of COMIRNATY on 08Jun2021 for COVID-19 immunisation. On 17Jul2021 the patient experienced death NOS. Found lifeless in bed on 17Jul2021, autopsy ordered. Autopsy report pending for cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: death NOS/ lifeless in bed


VAERS ID: 1515829 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Herpes zoster
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), 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: AUPFIZER INC202100963299

Write-up: Cerebrovascular accident; Herpes zoster; This is a spontaneous report from a contactable other health professional via the Regulatory authority report number is 588772. A 90-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 cerebrovascular accident and herpes zoster on 05Jun2021. Onset Time in Days: 10 days. The 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 possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cerebrovascular accident; Herpes zoster


VAERS ID: 1515830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-05-13
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AUPFIZER INC202100963302

Write-up: Cerebrovascular accident; This is a spontaneous report from a contactable other health professional via the Regulatory Authority report. A 64-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 cerebrovascular accident on 13May2021. 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: Cerebrovascular accident


VAERS ID: 1515849 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-28
Onset:2021-01-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ 6797 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Bacterial test positive, Blood creatinine, Blood creatinine increased, Blood urea, Blood urea increased, Cardiac arrest, Dermatitis allergic, General physical health deterioration, Hepatitis A, Malaise, Mycobacterium tuberculosis complex test, Platelet count, Platelet count decreased, Rash, Red blood cell count, Red blood cells urine, Red blood cells urine positive, Sepsis, Somnolence, Urinary sediment present, Urine analysis, White blood cell count, White blood cell count increased, White blood cells urine, White blood cells urine positive
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Liver infections (narrow), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (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), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-03-04
   Days after onset: 34
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: VIGANTOL [COLECALCIFEROL]; ALLERGO-COMOD; FRAXIPARINE MULTI; NOLPAZA; ZODAC; CALCICHEW D3
Current Illness: Alzheimer''s disease (according to Mini-Mental State Exam - moderate dementia); Asymptomatic bacteriuria (with identification Klebsiella Pneumoniae); Cerebral atherosclerosis; Hypertension arterial (that time without therapy); Incontinence of urine; Ischaemic heart disease (myocardial infarction can''t be excluded (2004)); Non-smoker; Omalgia (according to X-ray, sclerotic focus in the great tubercle of humerus (14x8.5 mm)); Sinus bradycardia (with heart rate 38-45/min with transitional loss of consciousness, on ECG without ischemic changes)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicectomy; Cholecystectomy; Choledocholithiasis (state after endoscopic retrograde cholangiopancreatography March 2016); Conjunctivitis allergic; Delivery; Endoscopic retrograde cholangiopancreatography (with the extraction of concrement); Gastric ulcer surgery; Humerus fracture; Hysterectomy; Myocardial infarction; Osteoporosis; Urinary infection
Allergies:
Diagnostic Lab Data: Test Date: 20210301; Test Name: ASAT; Result Unstructured Data: Test Result:0.67 ukat/L; Test Date: 20210304; Test Name: ASAT; Result Unstructured Data: Test Result:1.68 ukat/L; Test Date: 20210301; Test Name: Creatinine; Result Unstructured Data: Test Result:104 umol/l; Test Date: 20210304; Test Name: Creatinine; Result Unstructured Data: Test Result:198 umol/l; Test Date: 20210301; Test Name: Urea; Result Unstructured Data: Test Result:7 mmol/L; Test Date: 20210304; Test Name: Urea; Result Unstructured Data: Test Result:17.5 mmol/L; Test Name: infectious hepatitis; Test Result: Negative ; Test Name: TBC; Test Result: Negative ; Test Date: 20210301; Test Name: Platelet count; Result Unstructured Data: Test Result:149 x10 9/l; Test Date: 20210301; Test Name: Platelet count; Result Unstructured Data: Test Result:246 x10 9/l; Test Date: 20210304; Test Name: Platelet count; Result Unstructured Data: Test Result:45 x10 9/l; Test Date: 20210301; Test Name: RBC count; Result Unstructured Data: Test Result:4.95 x10 12/l; Test Date: 202103; Test Name: Red blood cells urine; Result Unstructured Data: Test Result:11-20; Test Date: 202103; Test Name: Epithelial cells urine; Result Unstructured Data: Test Result:5-10; Test Date: 202103; Test Name: Urine analysis; Result Unstructured Data: Test Result:3; Comments: identification of bacteria; Test Date: 20210301; Test Name: White blood cell count; Result Unstructured Data: Test Result:8.8 x10 9/l; Test Date: 20210304; Test Name: White blood cell count; Result Unstructured Data: Test Result:15.3 x10 9/l; Test Date: 202103; Test Name: White blood cells urine; Result Unstructured Data: Test Result:21-40
CDC Split Type: CZPFIZER INC2021905564

Write-up: condition aggravated/ generalized worsened health condition/ health condition was worsened; allergic facial exanthema; allergic facial exanthema; Sepsis; Heart arrest; sleepy; malaise; white blood cell count: 15.3 on 04Mar2021; Creatinine: 198 umol/l on 04Mar2021; urea: 17.5 mmol/l on 04Mar2021; Platelet count: 45 x10 9/l on 04Mar2021; Red blood cells urine: 11-20 in Mar2021; Urine analysis: 3 identification of bacteria; White blood cells urine: 21-40 in Mar2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 74-year-old female patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 28Jan2021 (Lot Number: EJ 6797) as single dose for covid-19 immunisation. Medical history included Endoscopic retrograde cholangiopancreatography with the extraction of concrement from Mar2016 and not ongoing; Cholecystectomy from an unknown date and not ongoing (state after cholecystectomy); ongoing arterial hypertension III. grade according to WHO, that time without therapy; ongoing brain atherosclerosis; Appendicectomy (state after appendectomy) not ongoing; ongoing Omalgia on the right side, according to X-ray - state after surgical neck fracture in the past, sclerotic focus in the great tubercle of humerus (14x8.5 mm), sharply defined, analgetics with effect; state after surgery of stomach from 2011 and not ongoing; ongoing Alzheimer''s disease according to Mini-Mental State Exam - moderate dementia; ongoing Incontinence of urine; 3 childrens, deliveries without complications and not ongoing; ongoing Ischaemic heart disease (myocardial infarction can''t be excluded (2004)); ongoing Sinus bradycardia with heart rate 38-45/min with transitional loss of consciousness, on ECG without ischemic changes, probably due to therapy with beta-blocators in Apr2019; Hysterectomy (state after hysterectomy) not ongoing; choledocholithiasis, state after endoscopic retrograde cholangiopancreatography in March 2016 with the extraction of concrement and not ongoing; ongoing Non-smoker; ongoing Asymptomatic bacteriuria with identification Klebsiella Pneumoniae from Mar2019; not ongoing Urinary infection etiology - e.coli; Osteoporosis; Conjunctivitis allergic; she did not drink alcohol. Concomitant medications included colecalciferol (VIGANTOL [COLECALCIFEROL]) taken for osteoporosis from 19Mar2020 to 26Feb2021; cromoglicate sodium (ALLERGO-COMOD) taken for Conjunctivitis allergic from 12Jan2021 to 16Feb2021; nadroparin calcium (FRAXIPARINE MULTI) taken for Ischaemic heart disease from 30Mar2019 to 01Mar2021, then from 01Mar2021 to 04Mar2021; pantoprazole sodium sesquihydrate (NOLPAZA) taken for Gastric ulcer surgery from 01Oct2010 to 28Feb2021; cetirizine hydrochloride (ZODAC) taken for Allergic conjunctivitis from 14Nov2020 to 17Feb2021; calcium carbonate, colecalciferol (CALCICHEW D3) taken for osteoporosis from 08Apr2020 to 28Feb2021. The patient experienced condition aggravated (death, hospitalization, disability, medically significant, life threatening) on 29Jan2021, allergic facial exanthema (death, hospitalization, disability, medically significant, life threatening) on 29Jan2021. The patient experienced Sepsis (death) and Heart arrest (death) on an unspecified date. It was reported that: the patient experienced the following adverse reaction after the administration of the 1st dose of COMIRNATY vaccine: allergic exanthema on the face, generalized worsened health condition. On 29Jan2021, it appeared allergic exanthema on the face with no reaction on antihistaminics, the patient received Prednison. The next days she still had exanthema, she was malaise and sleepy. On 18Feb2021 it had to be given the second dose, but the patient''s health condition was worsened, so the second dose was not administrated. The health condition was still worsening during the next few days and the patient died on 04Mar2021. An autopsy was not performed. The patient underwent lab tests and procedures which included aspartate aminotransferase (ASAT): 0.67 ukat/l on 01Mar2021, 1.68 ukat/l on 04Mar2021; Creatinine: 104 umol/l on 01Mar2021, 198 umol/l on 04Mar2021; urea: 7 mmol/l on 01Mar2021, 17.5 mmol/l on 04Mar2021; infectious hepatitis: negative on an unspecified date; Platelet count: 149 x10 9/l on 01Mar2021, 246 x10 9/l on 01Mar2021, 45 x10 9/l on 04Mar2021; red blood cell count: 4.95 x10 12/l on 01Mar2021; Red blood cells urine: 11-20 in Mar2021; Epithelial cells urine: 5-10 in Mar2021; Urine analysis: 3 identification of bacteria in Mar2021; white blood cell count: 8.8 x10 9/l on 01Mar2021, 15.3 on 04Mar2021. White blood cells urine: 21-40 in Mar2021; TBC negative on an unspecified date. Therapeutic measures were taken as a result of allergic facial exanthema. The outcome of events condition aggravated/ generalized worsened health condition/ health condition was worsened, allergic facial exanthema, Sepsis and Heart arrest was fatal; of the other events was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sepsis; Heart arrest; allergic facial exanthema; condition aggravated/ generalized worsened health condition/ health condition was worsened; allergic facial exanthema


VAERS ID: 1515872 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100941122

Write-up: sudden death due to cardiac arrest; This is a spontaneous report received by Pfizer from Biontech (manufacturer for bnt162b2 (COMIRNATY), from a non-contactable physician. A 52-year-old male patient received bnt162b2 (COMIRNATY) on an unspecified date as single dose (lot: unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has died due to sudden cardiac arrest 5 weeks after COMIRNATY administration. According to the physician no autopsy was performed, thus causal relation could hardly be assessed. The outcome of the event was fatal. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: Based on the temporal relationship, the association between the fatal event sudden cardiac arrest with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1515899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-10-28
Onset:2021-05-01
   Days after vaccination:185
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER GR26607 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood test, C-reactive protein, Circulatory collapse, Computerised tomogram, Computerised tomogram thorax, Confusional state, Cyanosis, Dizziness, Dyspnoea, Heart rate irregular, Muscular weakness, Pneumocystis jirovecii pneumonia, Pneumocystis test, Renal failure, Respiratory failure, Sepsis, Septic shock, Tremor
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Dementia (broad), Parkinson-like events (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), Cardiac arrhythmia terms, nonspecific (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-05-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ANAFRANIL; ANAFRANIL; FOLIMET; LITAREX [LITHIUM CITRATE]; METHOTREXATE PARANOVA; TRUXAL [CHLORPROTHIXENE HYDROCHLORIDE]
Current Illness: Fall (Acute admission due to fall at home)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic depression; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Arterial blood gases; Result Unstructured Data: Test Result:No results reported; Test Date: 20210503; Test Name: Blood test; Result Unstructured Data: Test Result:Affected infection count; Test Name: CT scan; Result Unstructured Data: Test Result:Bilateral infiltration; Test Date: 20210503; Test Name: Computerized tomogram thorax; Result Unstructured Data: Test Result:Multiple infiltrates. Signs of pneumonia.; Test Date: 20210503; Test Name: C-reactive protein; Result Unstructured Data: Test Result:Increasing; Test Date: 20210507; Test Name: Pneumocystis test; Result Unstructured Data: Test Result:Positive for Pneumocystis pneumonia
CDC Split Type: DKPFIZER INC202100915827

Write-up: Sepsis; Respiratory failure. The patient was intubated; Confused; Heart rate irregular; Shaking; Pneumocystis jiroveci pneumonia; Blue around the lips (sign of cyanosis); Difficulty breathing; Dizziness; Muscle weakness; Kidney failure; Circulatory failure; Septic shock; This is a spontaneous report from a contactable physicians and consumer downloaded from the regulatory authority, regulatory authority number DK-DKMA-WBS-0072312. A 74-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: ER2659) as dose 2, single for COVID-19 immunization; adalimumab (IMRALDI), subcutaneous from 28Oct2020 (Batch/Lot Number: GR26607) to 22Apr2021, at 40 mg, once every 14 days for rheumatoid arthritis. Historical vaccine included BNT162B2 (COMIRNATY), via an unspecified route of administration on 04Mar2021 (Batch/Lot Number: ET3674) as dose 1, single for COVID-19 immunization. Medical history included fall (had acute admission due to fall at home), chronic depression and rheumatoid arthritis. No medical history of pneumonia has been described in the last 10 years. Concomitant medications included clomipramine hydrochloride (ANAFRANIL) taken for depression from 2016 to 2021; clomipramine hydrochloride (ANAFRANIL RETARD) taken for depression from 1988 to 2021; folic acid (FOLIMET) taken for rheumatoid arthritis from 2005 to 2021; lithium citrate (LITAREX) taken for depression from 2019 to 2021; methotrexate (METHOTREXATE PARANOVA) taken for rheumatoid arthritis from 2005 to 2021; and chlorprothixene hydrochloride (TRUXAL) taken for depression from 1988 to 2021. On 02May2021 the patient developed Pneumocystis jiroveci pneumonia together with Blue lips, Difficulty breathing, Dizziness and Muscle weakness. On 03May2021 the patient was confused, had an irregular heart rate and was shaking. On 07May2021 the patient developed respiratory failure and on 16May2021 the patient developed sepsis. In May2021, at unknown date, but after 14 days of treatment at the hospital, the condition of the patient got worse with beginning kidney failure and circulatory failure. At admission there was sign of pneumonia and the patient was started up with tazocin (PIPERACILLIN and Tazobactam). Despite treatment, progression in the condition was observed and the patient became increasingly oxygen-demanding. The patient was transferred to intensive department and had to be intubated. Changed to treatment with Sulfotrim (SULFAMETHOXAZOLE AND TRIMETHOPRIM) (intravenous) as usual instructions, but the patient was still oxygen-demanding and on a respirator. After 14 days of treatment the patient developed kidney failure. She shows no signs of waking up despite that she had come out of sedation after tracheostomy. There was circulatory failure and she was given increasing doses of Noradrenaline. The treatment seems hopeless due to the severely affected patient and prolonged treatment. Active treatment was discontinued after conversation with the patient''s daughter. Reported causes of death: Pneumocystis jiroveci pneumonia, Kidney failure, Circulatory failure, Septic shock, sepsis. Only normal confirmation of death was performed postmortem. The other physician stated that no autopsy has been performed and he didn''t think that an inquest had been performed. The death has not been reported to the police, as the vaccine was first suspected of causing the events on 17Jun2021, approximately 1 month after the death. Tests results: Pneumocystis test (07May2021): Positive for Pneumocystis pneumonia (Pneumocystis (DNA) detected from oral mouthwash samples), Computerized tomogram thorax (03May2021): Multiple infiltrates. Signs of pneumonia. C-reactive protein (03May2021): increasing, Blood test (03May2021): affected infection count, arterial blood gases (May2021): No result reported, CT scan: Bilateral infiltration. The patient died on 19May2021. An autopsy was not performed. The ADRs were by the reporter reported as resulting in hospitalization on 03May2021 and being life-threatening and then fatal on 19May2021. Causality: Both drugs were reported as being suspected of causing the ADR. The other physician stated that the most obvious explanation for the pneumonia would be due to treatment with Imraldi. He believes that there is no causal relationship between the vaccine and the pneumonia and death. Additionally, he stated that healthy people very rarely get this type of pneumonia and underlined that the patient was on this immunosuppressive medication (Imraldi). On the other hand, the original reporter (physician) had another opinion. The fact that the patient has been vaccinated against covid-19 came out of a conversation on 17Jun2021, after the patient''s death. Hereafter, the original reporter (physician) reported Comirnaty as suspect drug as well - even though she was not convinced about a causal relationship between the vaccine and ADR. As a causal relationship between the vaccine and the ADR cannot be ruled out, the case is medically confirmed. Sender Comment: COMMENT FROM DKMA: Duplicate case DK-DKMA-WBS-0075521 (DK-DKMA-ADR 25575778) has been merged with this master case before submission to EV.; Reported Cause(s) of Death: cyanosis; Difficulty breathing; Dizziness; Muscle weakness; irregular heart rate; shaking; respiratory failure; sepsis; confused; Septic shock; Pneumocystis jiroveci pneumonia; Circulatory failure; Kidney failure


VAERS ID: 1515916 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1433 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SELO-ZOK; ALPRAZOLAM KRKA; OLANZAPIN ACCORD; ATORVASTATIN 1A FARMA; QUETIAPIN ACCORD; MIRTAZAPIN
Current Illness: Depression; Hypercholesterolemia; Hypertension; Paranoid type schizophrenia; Smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified (not known with current heart disease, but is described in an earlier anamnesis.); Mental disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKPFIZER INC202100939670

Write-up: cardiac arrest; This is a spontaneous report downloaded from the Medicines Agency (MA) -WEB [DK-DKMA-WBS-0078255]. The case was received from a contactable physician via The Danish Medicines Agency (DKMA). A 68-year-old female patient received first dose of bnt162b2 (COMIRNATY,(tozinameran (INN), Batch number: FC1433) via intramuscular on 04Jul2021 as dose 1, single for COVID-19 immunisation. There is no information regarding past medication. Patient concurrent conditions included smoker, depression, hypertension, hypercholesterolemia and paranoid type schizophrenia. Patient medical history included heart disease, unspecified (not known with current heart disease, but is described in an earlier anamnesis). Concomitant medication included metoprolol succinate (SELO-ZOK) tablet at 100 mg, 1x/day for hypertension from 06Nov2014; alprazolam (ALPRAZOLAM KRKA) tablet at 0.5 mg, 1x/day for mental disorder from 24Mar2021; olanzapine (OLANZAPIN ACCORD) tablet at 20 mg, 1x/day for an unspecified indication from 24Mar2021; atorvastatin calcium trihydrate (ATORVASTATIN 1A FARMA) tablet for hypercholesterolaemia from 07Oct2015 at 135 mg, 1x/day; quetiapine fumarate (QUETIAPIN ACCORD) tablet for schizophrenia from 24Mar2021 at 300 mg, 1x/day; mirtazapine (MIRTAZAPIN "2CARE4") tablet for depression from 22Sep2015 at 7.5 mg, 1x/day. On 14Jul2021 the patient developed cardiac arrest. The patient died on 14Jul2021. An autopsy was not performed. The ADRs were by the reporter reported as being fatal. No treatment or medical procedure due to the ADR was reported. The ADR cardiac arrest was fatal. Reported cause of death: cardiac arrest. There is no information regarding test results. Causality: The reporter states that it was not known that the patient has a heart disease, however the reporter has found it stated in an anamnesis.Brighton scale criteria: time onset first reaction was 10 day. acute reaction was no. rapid progression was no. duration of reaction was no answer. Skin and mucous membrane symptoms was none. Airway symptoms was none. Cardiovascular symptoms was none. Gastrointestinal symptoms was none. Blood pressure: min. no value. max. no value. S-tryptase, acute: no value. S-tryptase, base: no value. Temperature, max: no value. Sender Comment: Version 001 was not submitted to EV. Version 002, should be considered as version 1 No follow-up attempts possible. No further information expected. =; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1515976 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram head, 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: 2021-07-03
   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: Diabetes mellitus; Hypertension arterial
Preexisting Conditions: Medical History/Concurrent Conditions: Dyslipidemia; Hypothyroidism; Traffic accident
Allergies:
Diagnostic Lab Data: Test Date: 20200630; Test Name: CRANIAL Computerised tomogram; Result Unstructured Data: Test Result:without ventricular septal defects...; Comments: ...according to the usual protocol: No images are observed that suggest acute intra- or extra-axial bleeding. The ventricular system is normal in size and shape. Focal intraparenchymal lesions are not identified at both the infra- and supratentorial levels. Centered midline. Wide and free base cisterns. Bone and soft tissues without significant alterations. Diagnosis: Study without findings that suggest acute pathology at this time.
CDC Split Type: ESPFIZER INC2021905384

Write-up: Death sudden; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. A 53-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in Arm on Thursday 01Jul2021 (Lot Number: FC3098) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Hypertension arterial, ongoing diabetes mellitus, hypothyroidism from an unknown date, dyslipidaemia from an unknown date, road traffic accident on 30Jun2020. The patient''s concomitant medications were not reported. The patient previously took bnt162b2 (COMIRNATY) Lot number: FC3098 for covid-19 immunisation on 10Jun2021, pitavastatin calcium (ALIPZA 2mg, film-coated tablets), insulin glulisine (APIDRA 100iu/ml SOLUTION INJECTABLE IN CARTRIDGE), ramipril 2,5mg tablets and acetylsalicylic acid (ADIRO 100mg tablets gastro-resistant). The patient experienced death sudden on Saturday 03Jul2021.it was unknown whether an autopsy was done. It was reported that he was found dead in his home, discarding the suicide. At the date of notification (05Jul2021) the pharmacist was unaware of the causes of death as no access to the data related to the autopsy performed. He had a traffic accident the day before vaccination with a computed tomography, which results are: cranial Computerised tomogram WITHOUT / WITH CONTRAST: Description of the Exploration: Findings: A head Computerised tomogram is performed without ventricular septal defects according to the usual protocol: No images are observed that suggest acute intra- or extra-axial bleeding. The ventricular system is normal in size and shape. Focal intraparenchymal lesions are not identified at both the infra- and supratentorial levels. Centered midline. Wide and free base cisterns. Bone and soft tissues without significant alterations. Diagnosis: Study without findings that suggest acute pathology at this time. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death sudden


VAERS ID: 1516030 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-20
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Capillary leak syndrome
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210759328

Write-up: CAPILLARY LEAK SYNDROME; This spontaneous report received from a physician via a Regulatory Authority concerned a 50 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 21C14-04 expiry: UNKNOWN) 0.5 ml, 1 total administered on 17-JUN-2021 for covid-19 immunisation. No concomitant medications were reported. The drug start period (latency) was 4 days. On 20-JUN-2021, the patient experienced capillary leak syndrome, and was hospitalized (date unspecified). On 14-JUL-2021, the patient died from capillary leak syndrome. It was unknown if autopsy was performed. Action taken with covid-19 vaccine ad26.cov2.s was not applicable This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: This spontaneous report received from a physician via a Regulatory Authority concerns a 50-year-old female patient who developed capillary leak syndrome 4 days after receiving the Janssen COVID-19 vaccine. She died 24 days after the hospitalization. It was unknown if autopsy was performed. The patient''s past medical history included covid-19. No additional information is provided. Information regarding other potential etiologies was insufficient; considering the temporal relationship, the event is assessed to have an indeterminate relationship with vaccination.; Reported Cause(s) of Death: CAPILLARY LEAK SYNDROME


VAERS ID: 1516032 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210761689

Write-up: DEATH; This spontaneous report received from a health care professional concerned a 33 year old male of unknown race and ethnicity The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry date: Unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The reporter heard from a lady during break in the store that the patient died after receiving vaccine, on an unspecified date. The cause of death was unknown. 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: 20210761689-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: 1516064 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Fluid retention, Pneumonia, Pulmonary oedema, Renal failure, Skin weeping
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Severe cutaneous adverse reactions (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), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 35
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202100939759

Write-up: Pneumonia; Kidney failure; Blister; Skin oozing; Pulmonary oedema; Fluid retention; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority. A 76-year-old male patient received bnt162b2 (COMIRNATY) via an unspecified route of administration on 16Jun2021 (Batch/Lot Number: UNKNOWN) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced blister, skin oozing, pulmonary oedema, fluid retention, kidney failure, and pneumonia in Jun2021. All considered serious due to death. The patient died on 06Jul2021. It was not reported if an autopsy was performed. 08Jul2021 initial consumer: 16Jun2021 received the 2nd dose of Comirnaty (Pfizer-BionTech) vaccine. Large cellular fluid blotch on left footpad after a few days. Was sent home, despite a leak of cell fluid in his system, treatment error. Followed up a few days later with a similar, but larger, right tibial plateau. Delivered to hospital 27Jun2021 by ambulance as person was bleeding heavily with cell fluids out of body in the morning. Cellular fluids spread throughout the body, lungs and abdomen. It is not known what caused it, according to doctors. Pneumonia and loss of kidney function. Person died 06Jul2021. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: blister; skin oozing; pulmonary oedema; fluid retention; kidney failure; pneumonia


VAERS ID: 1516066 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coronary artery occlusion, Hyperhidrosis, Myocardial infarction, Palpitations, Visual impairment
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-16
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: FIPFIZER INC202100939771

Write-up: Myocardial infarction; Palpitations; Left anterior descending coronary artery occlusion; Visual disturbance; sweating; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB FI-FIMEA-20213648. A 64-years-old male patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 05May2021 as single dose for covid-19 immunisation. Medical history included hypertension. Concomitant medications included antihypertensive (name unknown) for hypertension. Patient experienced palpitations, sweating, visual disturbance which, however, were not considered as requiring first aid, experienced left anterior descending coronary artery occlusion, myocardial infarction, symptoms began approximately 5 days after vaccination, on 10May2021. The patient died on 16May2021. An autopsy was performed that revealed a rupture of the fatty plaque of the left protruding coronary artery and a blockage of the fat and blood in the vein, which was likely to cause myocardial infarction. 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; Palpitations; Left anterior descending coronary artery occlusion; Visual disturbance; sweating; Autopsy-determined Cause(s) of Death: A rupture of the fatty plaque of the left protruding coronary artery and a blockage of the fat and blood in the vein, which was likely to cause myocardial infarction


VAERS ID: 1516099 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Bradypnoea, Cerebellar haemorrhage, Coma, Decreased appetite, Gait disturbance, Headache, Hydrocephalus, Malaise, Nausea, Retinal haemorrhage, Scan brain, Visual impairment
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Respiratory failure (narrow), Hypoglycaemia (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: URAPIDIL; ESIDREX; METFORMINE [METFORMIN]; INDAPAMIDE; PERINDOPRIL; LERCANIDIPINE HYDROCHLORIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Brain scan; Result Unstructured Data: Test Result:Evidence of a left cerebellar intra-parenchymal ha; Comments: Evidence of a left cerebellar intra-parenchymal haemorrhage with tetraventricular flooding causing hydrocephalus with compression of the pre-pontic cistern and onset of tonsillar involvement. Terson''s syndrome with left retinal haemorrhage. No haemostasis disorder on the biological assessment.
CDC Split Type: FRPFIZER INC202100915625

Write-up: Cerebellar haemorrhage; acute hydrocephalus; difficulty walking and speaking/dysphasia; difficulty walking and speaking.; comatose state; bradypnoea; left retinal haemorrhage; Asthenia; visual disturbances; headache; Malaise; Nausea; loss of appetite; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority. A 64-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular, administered in left deltoid on 11Jun2021 (Batch/Lot Number: FC1526) as dose 2, single for COVID-19 immunisation. Medical history included diabetes and hypertension arterial. Concomitant medications included urapidil; hydrochlorothiazide (ESIDREX); metformin (METFORMINE); indapamide; perindopril; lercanidipine hydrochloride; all taken for an unspecified indication, start and stop date were not reported. From 12Jun2021, feeling of malaise with nausea, loss of appetite. On 13Jun2021, persistence of symptoms with asthenia, intermittent visual disturbances, headache. The patient also had difficulty walking and speaking (also reported as dysphasia). The patient was admitted to the emergency department due to the onset of a comatose state. A brain scan was carried out because of the appearance of bradypnoea and the absence of neurological improvement: Evidence of a left cerebellar intra-parenchymal haemorrhage with tetraventricular flooding causing hydrocephalus with compression of the pre-pontic cistern and onset of tonsillar involvement. Terson''s syndrome with left retinal haemorrhage. No haemostasis disorder on the biological assessment. Collegial decision not to operate due to poor prognosis. In total, cerebellar haemorrhage and acute hydrocephalus following the second injection of Comirnaty. Outcome of events was fatal. The patient died on 18Jun2021. 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: acute hydrocephalus; difficulty walking and speaking/dysphasia; difficulty walking and speaking; left retinal haemorrhage; malaise; nausea; loss of appetite; Asthenia; visual disturbances; headache; comatose state; Bradypnoea; Cerebellar haemorrhage


VAERS ID: 1516226 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-08
Onset:2021-05-06
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 RA / OT

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: 2021-05-23
   Days after onset: 17
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 17 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Lung cancer metastatic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100939827

Write-up: CVA; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority report. A 75-years-old male patient received BNT162B2 (PFIZER), dose 1 intramuscular, administered in Arm Right on 08Apr2021 (Batch/Lot Number: EW2239) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included Lung cancer metastatic, atrial fibrillation.The patient''s concomitant medications were not reported. Appearance on 06May2021, i.e. 28 days after his first injection, of a superficial and deep left sylvian infarction, in a context of atrial fibrillation and metastatic pulmonary cancer, whose thrombotic phenomena were rather attributable to paraneoplastic hypercoagulability. He presented a sudden severe neurological aggravation evoking a cerebrovascular recurrence in the basilar territory. Hospitalized from 06May2021 to 23May2021 in the neurological department. Outcome of event was fatal.The patient died on 23May2021. It was not reported if an autopsy was performed.Conclusion: Sylvian stroke at Day 28 (D28) post-vaccination in a 75-year-old patient in a context of atrial fibrillation and metastatic lung cancer. Hospitalization and death of the patient. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Deep and superficial left sylvian stroke


VAERS ID: 1516253 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood calcium, Blood electrolytes, Blood parathyroid hormone, Blood pressure measurement, Blood thyroid stimulating hormone, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Echocardiogram, Ejection fraction, Electrocardiogram, Magnetic resonance imaging head, Oxygen saturation, Renal function test, Vitamin D
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: 2021-07-03
   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: LEVOTHYROX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation (reduced by Cordarone); Cardiogenic shock; Dyslipidemia; Epilepsy; Hashimoto''s disease; Heparin-induced thrombocytopenia type II; Hypercalcemia; Ischemic stroke; Myocardial infarction; TSH increased
Allergies:
Diagnostic Lab Data: Test Name: calcium; Result Unstructured Data: Test Result:2.77; Test Date: 20210701; Test Name: calcium; Result Unstructured Data: Test Result:2.63; Test Name: Ionogram; Result Unstructured Data: Test Result:normal; Test Name: PTH; Result Unstructured Data: Test Result:normal; Test Date: 20210703; Test Name: blood pressure; Result Unstructured Data: Test Result:11/7; Test Name: TSH; Result Unstructured Data: Test Result:17; Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:37.2; Test Date: 20210623; Test Name: Computed tomography thorax-abdomen-pelvis; Result Unstructured Data: Test Result:disappearance of pulmonary condensations; Comments: disappearance of the previously described pulmonary parenchymal condensations and a right trochanteric fracture sequela.; Test Date: 20210624; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:inferolateral wall akinesia with LVEF at 27 percen; Comments: inferolateral wall akinesia with (ejection fraction )LVEF at 27 percent and dilated (left atrium) OG. Non-dilated Left Ventricule (LV), no pulmonary arterial hypertension (PAH), no peri-cardiac effusion and no valvulopathy.; Test Date: 2008; Test Name: lvef; Test Result: 40 %; Test Name: electrocardiogram; Result Unstructured Data: Test Result:regular sinus rhythm; Comments: regular sinus rhythm without repolarization disorder.; Test Date: 20210629; Test Name: brain MRI; Result Unstructured Data: Test Result:ischemic sequelae of the left sylvian territory; Comments: ischemic sequelae of the left sylvian territory, posterior junctional territories and cerebellar hemispheres. Post-traumatic sequelae of the left anterior temporal pole, lacunar leukopathy of the corona radiata and stability of the lateral ventricles volume.; Test Name: oxygen saturation; Test Result: 96 %; Test Date: 20210703; Test Name: oxygen saturation; Test Result: 98 %; Test Name: renal function; Result Unstructured Data: Test Result:normal; Test Name: Vitamin D; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC202100939791

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. A 59-years-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01Jul2021 as dose 2, single for COVID-19 immunisation. Medical history included Dyslipidemia, AC/FA in 2008 reduced by Cordarone, Hospitalization in intensive care unit in 2008 for 3 months for cardiogenic shock with functional myocardial infarction (MI) secondary to anemia and Atrial fibrillation (AF) with left atrial and left ventricle (LV) thrombus responsible for other embolic complications =$g digestive, cerebral, splenic, lower limbs and left parieto-occipital ischemic stroke secondary to hemorrhage due to HIT type 2. Ejection fraction (LVEF) of 2008 40%. Substituted Hashimoto''s hypothyroidism. Epilepsy sequelae of the stroke. Recurrent ischemic stroke corona radiata in Mar2009. HIT type 2 diagnosed on hemorrhagic transformation of the ischemic stroke and parietal hematoma of the small intestine. Autoimmune test performed in 2009 negative. History of the adverse event: Control brain MRI is performed on 29Jun2021 showing ischemic sequelae of the left sylvian territory, posterior junctional territories and cerebellar hemispheres. Post-traumatic sequelae of the left anterior temporal pole, lacunar leukopathy of the corona radiata and stability of the lateral ventricles volume. A Computed tomography thorax-abdomen-pelvis (TAP CT) scan was performed on 23Jun2021 showing disappearance of the previously described pulmonary parenchymal condensations and a right trochanteric fracture sequela. A cardiac ultrasound was also performed on 24Jun2021 showing inferolateral wall akinesia with (ejection fraction )LVEF at 27 percent and dilated (left atrium) OG. Non-dilated Left Ventricule (LV), no pulmonary arterial hypertension (PAH), no peri-cardiac effusion and no valvulopathy. The electrocardiogram remained in regular sinus rhythm without repolarization disorder. On the biological level, taking into account an elevated TSH of 17, Levothyrox is increased to 150 microg/day (usual dose of the patient at home) with weekly control of the thyroid balance. Biological workup also revealed hypercalcemia at 2.77 corrected with ionogram and normal renal function. PTH normal. Vitamin D normal. After endocrine advice, hypercalcemia possibly related to hypothyroidism: an increase in IV hydration was instituted, which led to a decrease in corrected calcemia to 2.63 on 01Jul2021. A pic line was placed on 02Jul2021 in order to continue IV hydration more easily. Concomitant medication included levothyroxine sodium (LEVOTHYROX). The patient experienced cardio-respiratory arrest 48 hours after vaccination on 03Jul2021. Vigilance also improved as well as interactions with the entourage. Bronchial secretions remain clear and fluid. Saturation remains above 96% in room air. However, on 03Jul2021 at 23:45, while the patient was seen and aspirated at 23H00 with a saturation of 98%, a temperature of 37.2, and a BP of 11/7, the patient was found in cardiorespiratory arrest who despite intensive resuscitation of 45 min did not recover. The patient died on 03Jul2021. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1516303 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100940268

Write-up: death; This is a spontaneous report from a non-contactable consumer via medical information team. A (young) patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. Relevant medical history was none. Concomitant medications were not reported. Patient died on unspecified date. It was not reported if an autopsy was performed. Death cause was not provided. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death


VAERS ID: 1516304 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-06-21
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE 2296 / 1 RA / OT

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

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: Medical History/Concurrent Conditions: Resuscitation
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC202100940736

Write-up: Maternal exposure During Pregnancy; Death; This case is a spontaneous report from a contactable physician. This physician reported information for both mother and baby. This is a baby report. A 39-year-old pregnant female received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: FE 2296), Intramuscular administered in right arm on 12Apr2021 as dose 1, single for covid-19 immunization. Medical history included neonatal resuscitation from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The female was pregnant when received the vaccine and give birth to a baby on 11May2021. The 5-weeks-old male baby experienced death on 21Jun2021. The pregnant female delivery by emergency caesarean section in a context of severe pre-eclampsia 1 month after vaccination on 11May2021 at 25 weeks + 1 day, child of 650 grams, 34 cm, deceased on 21Jun2021 despite neonatal resuscitation. Birth on 11May2021 of a male child, weighing 655 g. The patient died on 21Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Sender''s Comments: Linked Report(s) : FR-PFIZER INC-2021896158 mother case; Reported Cause(s) of Death: death


VAERS ID: 1516316 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-23
Onset:2021-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER7141 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Haemorrhagic stroke, Hypertension, Inappropriate schedule of product administration
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-25
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZEROCREAM; FYBOGEL; THEICAL D3; ATORVASTATIN; LEVOTHYROXINE SODIUM; LANSOPRAZOLE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Migraine; Thyroid stimulating immunoglobulin (two TSI''s (diagnosed around three years or so ago))
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934471

Write-up: Haemorrhagic stroke; frailty; hypertension; Dose 1 on 18Dec2020/ Dose 2 on 23Feb2021; This is a spontaneous report from a contactable consumer received from the Regulatory Authority report. A 92-year-old male patient (reporter''s father) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Feb2021 (Batch/ Lot Number: ER7141), at the age of 92-year-old, as single dose for COVID-19 immunisation. Medical history included migraine from an unknown date and thyroid stimulating immunoglobulin (TSI) from 2018. Do note he had had at least two TSI''s (diagnosed around three years or so ago) and there might have been more (but symptoms of migraine overlapped with TSI symptoms). Consultant had asked the reporter on more than one occasion how reporter differentiated - knew one to be different from the other given the overlap - when caring for reporter''s father. Concomitant medications included paraffin, liquid, white soft paraffin (ZEROCREAM); plantago ovata (FYBOGEL); calcium carbonate, colecalciferol (THEICAL D3); atorvastatin; levothyroxine sodium; lansoprazole and nutritional supplement (Vitabiotics Ultimate Vitamin C, 500mg). The patient previously received first dose of BNT162B2 on 18Dec2020 (Batch no. EJ0553-L450) for COVID-19 immunization. After the first vaccine the patient had chills, leg cramps and headache which lasted a couple of days. After the second vaccine the patient did not complain of side effects. On 25Feb2021, the patient experienced haemorrhagic stroke, frailty and hypertension with fatal outcome. The patient died on the 25Feb2021. Cause of death was brainstem haemorrhagic stroke and hypertension and frailty. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Haemorrhagic stroke; Frailty; Hypertension


VAERS ID: 1516521 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
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: 2021-05-16
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210512; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100908770

Write-up: SARS-CoV-2 infection; SARS-CoV-2 infection; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority report. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 12May2021 (at the age of 67-year-old) as dose 2, single for COVID-19 vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. Unsure if patient had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. On 12May2021, the patient experienced sars-cov-2 infection. The patient underwent lab tests and procedures which included COVID-19 virus test: Positive on 12May2021. The patient died on 16May2021. Death 4 days after second dose SARS-CoV-2 infection. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: SARS-CoV-2 infection


VAERS ID: 1516673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-08-01
Onset:2021-04-02
   Days after vaccination:244
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   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: Test Name: COVID-19 virus test; Test Result: Negative; Comments: No - Negative COVID-19 test.
CDC Split Type: GBPFIZER INC202100908975

Write-up: Death; This is a spontaneous report from a contactable consumer received from the Medicines and Healthcare products Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202107161731524740-OWTKX, Safety Report Unique Identifier GB-MHRA-ADR 25665364. The 32-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on Aug2020 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not have symptoms associated with COVID-19. It was unsure if patient was enrolled in clinical trial. On 02Apr2021 the patient experienced death. The patient died on 02Apr2021. It was not reported if an autopsy was performed. The patient underwent lab tests and procedures which included sars-cov-2 test resulted as negative on No - Negative COVID-19 test. It was not reported if an autopsy was performed. The outcome of the 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: The patient died on 02Apr2021


VAERS ID: 1516862 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Chest pain, Dyspnoea, Fibrin D dimer, Myocardial infarction, Platelet count, Pulmonary embolism, Suicide attempt, Thrombocytopenia
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Suicide/self-injury (narrow), Systemic lupus erythematosus (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), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: Medical History/Concurrent Conditions: Clot blood
Allergies:
Diagnostic Lab Data: Test Name: D-dimer; Result Unstructured Data: Test Result:UNKNOWN; Comments: results currently pending; Test Date: 20210717; Test Name: platelet counts; Result Unstructured Data: Test Result:Normal; Test Name: Thombocytopenia; Result Unstructured Data: Test Result:UNKNOWN
CDC Split Type: GBPFIZER INC202100908737

Write-up: shortness of breath; resuscitation attempts; chest pain; myocardial infarction; Pulmonary embolism; Cardiac arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107171520080490-HFPSV. A 57-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 09Jul2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included thrombosis. The patient''s concomitant medications were not reported. Patient previously took first dose of BNT162B2 for COVID-19 immunisation. The patient experienced shortness of breath, resuscitation attempts, pulmonary embolism, chest pain, myocardial infarction on an unspecified date, cardiac arrest on 17Jul2021. Patient suffered acute onset shortness of breath and chest pain one week post vaccine. Quickly collapsed and was found to be in VF cardiac arrest. Resuscitation attempts unsuccessful and patient died shortly afterwards. Patient has not tested positive for COVID-19 since having the vaccine. Unsure if patient is enrolled in clinical trial. Report was related to possible blood clots or low platelet counts. Patient had acute shortness of breath and chest pain followed by cardiac arrest. (out of hospital cardiac arrest) differential diagnosis includes myocardial infarction and PE". "Not yet diagnosed, will be referred to coroner. Platelets normal" and no platelet count <150 - 109/L on 17Jul2021 was platelet count measured. D-dimer $g4000 was unknown dimer measured but results currently pending. Anti-PF4 antibodies identified reported as unknown. The patient underwent lab tests and procedures which included fibrin d dimer: unknown results currently pending, platelet count: normal on 17Jul2021, thrombocytopenia: unknown. The patient died on 17Jul2021 and cause was unknown. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1517007 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC8289 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-19
   Days after onset: 39
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: FLUOXETINE; FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anxiety; Folic acid supplementation; Pregnancy (2 previous successful pregnancies carried to full term)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test; Test Name: Scans; Result Unstructured Data: Test Result:all fine
CDC Split Type: GBPFIZER INC202100934473

Write-up: Late miscarriage; Maternal exposure during pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202107211054152390-AX5K3, Safety Report Unique Identifier GB-MHRA-ADR 25685292. A 40-year-old female pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration on 10Jun2021 (Lot Number: Fc8289) at the age of 40-year-old as single dose for COVID-19 immunisation. Medical history included pregnancy (2 previous successful pregnancies carried to full term), anxiety, folic acid supplementation. Scans were completed for this pregnancy prior to vaccine where all fine. Patient had not had symptoms associated with COVID-19. Patient was not currently breastfeeding. Patient was not enrolled in clinical trial. Concomitant medications included fluoxetine taken for anxiety; folic acid taken for folic acid supplementation. The patient experienced late miscarriage on 19Jul2021, maternal exposure during pregnancy 10Jun2021. Patient was exposed to the medicine second-trimester (13-28 weeks). The case was reported as serious due to hospitalization, disability, medically significant, and death. The patient underwent lab tests and procedures which included COVID-19 virus test: negative covid-19 test on an unspecified date. The patient died on 19Jul2021. It was not reported if an autopsy was performed. Outcome of events was fatal. Patient had not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: Maternal exposure during pregnancy; Late miscarriage


VAERS ID: 1517009 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-30
Onset:2021-06-01
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM4965 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100934286

Write-up: Heart attack; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107211240582940-VR6I8, Safety Report Unique Identifier GB-MHRA-ADR 25688638. A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EM4965), via an unspecified route of administration on 30Apr2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The patient experienced heart attack on 01Jun2021 with outcome of fatal. The patient died on 01Jun2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. No follow up attempts are possible. No further information is expected. Reported Cause(s) of Death: Heart attack


VAERS ID: 1517015 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-23
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Brain death, Cardiomegaly, Cerebral haemorrhage, Coma, Hypertension, SARS-CoV-2 test, Thrombosis
SMQs:, Cardiac failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 25
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: 20210714; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202100934035

Write-up: coma; blood off her brain; high blood pressure; blood clots; Brain death; Heart enlarged; This is a spontaneous report from a contactable consumer from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107220650206510-T4DO4. Safety Report Unique Identifier: GB-MHRA-ADR 25690667. A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine), dose 1 via an unspecified route of administration on 16Jun2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient had no medical history and concomitant medications, nothing and no medications. Patient had not had symptoms associated with COVID-19. The patient experienced coma on an unspecified date, heart enlarged on 23Jun2021, brain death on 18Jul2021. Colapsed into a coma, fighting for her life, had received neurosurgery to drain blood off her brain, high blood pressure abd blood clots and swollen heart muscles. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 14Jul2021 No - Negative COVID-19 test. Case was reported as serious, life threatening. Outcome of Heart enlarged was not recovered and the other events were unknown. Patient had brain death on 18Jul2021. It was unknown if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Brain death


VAERS ID: 1517023 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-07
Onset:2021-05-15
   Days after vaccination:128
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-01
   Days after onset: 47
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms started Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Positive ; Comments: Yes - Positive COVID-19 test
CDC Split Type: GBPFIZER INC202100941407

Write-up: Malaria; This is a spontaneous report from a contactable consumer received from the regulatory authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202107221531222680-IV3NF, Safety Report Unique Identifier GB-MHRA-ADR 25693504. A 39-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 07Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included suspected COVID-19 (Unsure when symptoms started, Unsure when symptoms stopped). The patient''s concomitant medications were not reported. The patient experienced malaria (death) on 15May2021. The patient underwent lab tests and procedures which included COVID-19 virus test: positive (Yes - Positive COVID-19 test) on an unspecified date. The patient died on 01Jul2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. The outcome of the 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: malaria


VAERS ID: 1517066 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-25
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bradycardia foetal
SMQs:, Congenital and neonatal arrhythmias (broad), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-09
   Days after onset: 15
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202100942017

Write-up: Bradycardia foetal; This is the second of two reports. This is a fetus report. The first report was received from the regulatory authority. Regulatory authority report number is GB-MHRA-ADR 25687333.Safety Report Unique Identifier: GB-MHRA-ADR 25687333. A contactable consumer reported that the pregnant mother of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 15May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The fetus medical history was not reported. The fetus concomitant medications were not reported. The mother received the second vaccine on 15May2021, to which she was pregnant at the time, and shortly after having this vaccine, the fetus died of bradycardia. It was first noted on 25May2021 that the fetus was dying due to this heart condition, subsequently death was then confirmed on 09Jun2021, with indications that this had taken place within days of 25May2021. The mother stated that she felt that it was too coincidental, considering the fact that the baby suddenly died of heart problems after having this vaccine, which left the mother in a situation where she had to have the child removed due to the fact that she had not miscarried, which has left her extremely traumatized. The patient died on 09Jun2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : 202100934067 Maternal case; Reported Cause(s) of Death: Bradycardia foetal


VAERS ID: 1517093 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-04-26
   Days after vaccination:95
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6134 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210426; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: HRPFIZER INC202100917799

Write-up: without symptoms of COVID-19 disease; without symptoms of COVID-19 disease; death; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number HR-HALMED-300047831.A 96-years-old female patient received first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EJ6796 and Expiry date: Unknown), via an intramuscularly on 31Dec2020 at a dose of 0.3 ML, single dose, second dose intramuscularly on 21Jan2021 (Lot Number: EJ6134 and Expiry date: Unknown) at a dose of 0.3 ML single dose for COVID-19 immunization. The patient''s medical history included living in nursing home. The patient''s concomitant medications were not reported. On 26Apr2021, the patient experienced without symptoms of COVID-19 disease, vaccination failure and hospitalized. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Apr2021.The patient died on 30Apr2021. The outcome of event death was fatal and rest all other events was unknown. F/U (20Jul2021): Conclusion of Previously Completed Investigation: For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1517098 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-27
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Colon neoplasm (colon tumor); COVID-19 (hospitalized); Deep vein thrombosis; Diabetes; Hypertension; Pulmonary embolism
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202100922300

Write-up: On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; This is a spontaneous report from a contactable physician from the regulatory authority, regulatory authority number HU-OGYI-602521 A 87-years-old female patient (resident of a social care institute) received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 21Apr2021 09:00 (Batch/Lot Number: ET6956) as dose 2, 0.3 ml single for covid-19 immunisation. Medical history included Deep vein thrombosis, Diabetes, Hypertension, Atrial fibrillation, COVID-19 from Mar2021 to Mar2021 hospitalized, Colon neoplasm/colon tumor, Pulmonary embolism; all not ongoing. The patient''s concomitant medications were not reported. On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea where the symptoms were no longer observed. On 28Apr2021, the patient was transported to the social care institute, where she died on 03May2021. Autopsy was requested, further information is expected about the cause of death. According to the reporter, the patient death could be related to the the patient underlying diseases, age, and consequences of the recent coronavirus infection. Sender Comment: The 87-year-old patient died 12 days after the second dose of Comirnaty. Autopsy was requested, further information is expected about the cause of death. The causal relationship between the reported death and Comirnaty is not assessable due to lack of information. The case is serious due to hospitalization and fatal outcome. Batch/Lot Number: ET6956 No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; On 27Apr2021, the patient was hospitalized due to nausea, vomiting and diarrhea/ death; On 27Apr2021, the patient was hospitalized due to nausea, vomiting and dia


VAERS ID: 1517100 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-24
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac insufficiency; Decompensation cardiac; Erysipelas; Hypertension; Vertebrobasilar insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC2021906474

Write-up: Death; Marasmus; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number HU-OGYI-650721. A 84-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 15Jun2021 (Lot Number: FD1921) as 0.3 ml single dose for covid-19 immunisation. Medical history included hypertension, vertebrobasilar insufficiency, atrial fibrillation and cardiac insufficiency. The patient was already receiving treatment in the hospital from 09Apr2021 for erysipelas and cardiac decompensation. As her general condition gradually deteriorated, they decided to transfer the patient to the comfort care. The patient''s concomitant medications were not reported. The patient took the first dose of Comirnaty on 11May2021 (lot/batch no: FA5829) for Covid-19 immunisation. On 24Jun2021 at 00:30 the patient passed away among the symptoms of marasmus. The patient died on 24Jun2021. An autopsy was not performed. Sender Comment: As the event is related to the patient''s primary cardiovascular diseases, the causal relationship is not related between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts are possible. No further information expected. Sender''s Comments: Based on the information currently available,the relation between suspect product BNT162B2 or comirnaty and the events death were unrelated because of patient had history of serious cardiovascular disorders. Reported Cause(s) of Death: Death


VAERS ID: 1517129 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-18
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW8904 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dyspnoea, Multiple organ dysfunction syndrome
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   Days after onset: 46
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: VESITIRIM; AMLODIPINE; NASOFAN; SALAMOL EASI-BREATHE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergic rhinitis; Hypertension; Interstitial lung disease; Overactive bladder; Permanent cardiac pacemaker insertion
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202100920525

Write-up: Multi organ failure; Increased breathlessness; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number IE-HPRA-2021-079310, Safety Report Unique Identifier IE-HPRA-2021-079310. This is a report received from the Regulatory Authority (RA). A 71-year-old male patient received first dose BNT162B2 (COMIRNATY) via an unspecified route of administration on 15Apr2021 (Lot Number: EW8904) as 0.3ml single dose for COVID-19 immunisation. Medical history included permanent pacemaker from 2017, interstitial lung disease, hypertension, allergic rhinitis, and overactive bladder. Concomitant medications included VESITIRIM (Manufacturer Unknown) taken for hypertonic bladder from 15Jan2021 to 03Jun2021; GENERIC (Manufacturer Unknown) taken for hypertension from 15Jan2021 to 03Jun2021; NASOFAN NASAL SPRAY (Manufacturer Unknown) taken for rhinitis allergic from 15Jan2021 to 03Jun2021; SALAMOL EASI-BREATHE CFC-FREE INHALER (Manufacturer Unknown) taken for interstitial lung disease from 15Apr2021 to 03Jun2021. On 18Apr2021, the patient experienced increased breathlessness. On 13May2021, the patient was admitted to hospital. Following admission to hospital, the patient was treated with intravenous antibiotics and steroids but deteriorated further. The patient was subsequently admitted to the intensive care unit (ICU) with eventual multi organ failure. The patient died on 03Jun2021. It was not reported if an autopsy was performed. The outcome of events was fatal. No follow-up attempts are possible. No further information is expected. Reported Cause(s) of Death: Multiorgan failure; Increased breathlessnes


VAERS ID: 1517130 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-29
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure, Chronic obstructive pulmonary disease, Malaise, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac 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), Cardiomyopathy (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: 2021-03-31
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC202100915945

Write-up: COPD; cardiac failure; renal failure; Felt unwell after the second dose; This is a spontaneous report from a contactable consumer from the Regulatory Authority. The regulatory authority number IE-HPRA-2021-079416. An 87-year-old male patient received BNT162B2 (COMIRNATY) via an unspecified route of administration on 24Mar2021 (lot number and expiry date: unknown) as dose 2, single, for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). The patient was taking unspecified concomitant medications (patient was taking many different medicines). The patient previously received first dose of BNT162B2 (COMIRNATY) in Feb2021, for COVID-19 immunisation. On 29Mar2021, after the second dose, the patient felt unwell and was seen by his General Practitioner. It was reported that the patient was well before vaccination. On 31Mar2021, the patient passed away at home. No autopsy was performed. The cause of death in the death certificate included COPD, cardiac failure, and renal failure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Reported Cause(s) of Death: COPD; cardiac failure; renal failure


VAERS ID: 1517151 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3098 / 2 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939291

Write-up: Therapy-resistant hyperpyrexia sleepy state up to coma; Therapy-resistant hyperpyrexia sleepy state up to coma; Therapy-resistant hyperpyrexia sleepy state up to coma; This is a spontaneous report from a contactable Physician from the Regulatory Authority IT-MINISAL02-753463. A 75-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via intramuscular on the right arm on 24Jun2021 at 20:08 (Batch/Lot Number: FC3098; Expiration date:30Sep2021) at the age of 75-year-old as 0.3 mL dose for COVID-19 immunization. Medical history and concomitant medication were not reported. On 24Jun2021, the patient who had manifested therapy-resistant hyperpyrexia sleepy state up to coma. On an unspecified date, the patient died. The events of sopor, hyperpyrexia and coma caused death. An autopsy was unknown performed. The outcome of events was fatal. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: Therapy-resistant hyperpyrexia sleepy state up to coma.


VAERS ID: 1517156 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-13
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute leukaemia, Decreased appetite, Fatigue, Leukaemia, Motor dysfunction, Nausea, Pain in extremity, Pyrexia, Speech disorder, Tremor
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Haematological malignant tumours (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939391

Write-up: He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-753682. A 72-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on an unspecified date (Batch/Lot Number: Unknown) as Dose 1, 0.3 mL single for covid-19 immunisation. Medical history included diabetes mellitus. The patient''s concomitant medications were not reported. The patient experienced he started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia. Events onset date was reported as 13Apr2021. additional information reported: Actions taken (First aid and hospitalization with death 10 days after hospitalization) - Impact on quality of life (10/10) - COVID 19 COMIRNATY VACCINE (PFIZER): Administration site (right shoulder) Booster dose number (1). The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: He started with pain in his arm and flu-like exhaustion for days like this, after loss of appetite, nausea, tremors, high fever, motor and speech problems, eventually leading to fulminant leukemia.; He started with pain in his arm and flu-like exhaus


VAERS ID: 1517179 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-05-28
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma, Vertebrobasilar stroke
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   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: Bilateral pneumonia; Chronic cor pulmonale; Hypertensive heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100939416

Write-up: Stroke basilar artery which caused irreversible coma; Stroke basilar artery which caused irreversible coma; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-755100. An 88-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 12May2021 11:46 (Lot Number: FA5831) as 0.3 ML, single for covid-19 immunisation. Medical history included chronic cor pulmonale, bilateral pneumonia, hypertensive heart disease, all above from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced stroke basilar artery (vertebrobasilar stroke) which caused irreversible coma on 28May2021, the events caused patient death. The patient died on 04Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Stroke basilar artery which caused irreversible coma; Stroke basilar artery which caused irreversible coma


VAERS ID: 1517180 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-23
Onset:2021-05-06
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3599 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute kidney injury, Blood culture, Body temperature, Candida sepsis, Candida test, Coagulopathy, Computerised tomogram head, Dysphagia, Haematology test, Haemoglobin, Haemoglobinuria, Hemiparesis, Investigation, Ischaemic stroke, Pancytopenia, Platelet count, Prothrombin time, Speech disorder, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Haemolytic disorders (narrow), Agranulocytosis (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (narrow), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (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), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Proteinuria (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Sepsis (narrow), Opportunistic infections (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 31
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: TRAZODONE; TIROSINT; IRON; DIBASE; LANSOPRAZOLE; CONTRAMAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Duodenoenterostomy; Hypothyroidism; Parenteral nutrition; Trisomy 21; Ulcer (Appearance of a left parasternal swelling investigated by ultrasound, MRI and biopsy)
Allergies:
Diagnostic Lab Data: Test Name: PTT; Result Unstructured Data: Test Result:never had changes in coagulation; Comments: much less thromboembolic episodes; Test Date: 20210513; Test Name: PTT; Result Unstructured Data: Test Result:1.58; Comments: impaired; Test Name: blood culture; Result Unstructured Data: Test Result:confirmed a Candida plus a bacterium; Test Name: body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210506; Test Name: Candida Albicans; Test Result: Positive ; Test Date: 20210530; Test Name: Brain computerised tomography; Result Unstructured Data: Test Result:stroke was documented; Test Date: 20210506; Test Name: hematochemicals; Result Unstructured Data: Test Result:pancytopenia; Test Date: 20210513; Test Name: hematochemicals; Result Unstructured Data: Test Result:worsening of pancytopenia; Test Date: 20210513; Test Name: hemoglobin; Result Unstructured Data: Test Result:36; Test Date: 20210513; Test Name: GB; Result Unstructured Data: Test Result:3.32; Test Date: 20210513; Test Name: GR; Result Unstructured Data: Test Result:2.46; Test Date: 20210513; Test Name: Platelet count; Result Unstructured Data: Test Result:66,000; Test Name: PT; Result Unstructured Data: Test Result:never had changes in coagulation; Comments: much less thromboembolic episodes; Test Date: 20210506; Test Name: Urine analysis; Result Unstructured Data: Test Result:hyperchromic urine; Comments: hyperchromic urine
CDC Split Type: ITPFIZER INC202100939419

Write-up: CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; impaired coagulation; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; This is a spontaneous report from a contactable physician downloaded from the regulatory authority, regulatory authority number IT-MINISAL02-755208. A 49-year-old male patient received bnt162b2 (COMIRNATY), first single dose intramuscularly on 23Apr2021 (Batch/Lot Number: EX3599) for covid-19 immunisation. Medical history included trisomy 21 from an unknown date and unknown if ongoing, parenteral nutrition from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, duodenoenterostomy from an unknown date and unknown if ongoing , ulcer from an unknown date and unknown if ongoing (Appearance of a left parasternal swelling investigated by ultrasound, MRI and biopsy). Concomitant medications included trazodone hydrochloride; levothyroxine sodium (TIROSINT); ferrous gluconate (IRON); colecalciferol (DIBASE); lansoprazole; tramadol hydrochloride (CONTRAMAL). The patient previously took ceftriaxone sodium (ROCEFIN) and experienced allergy, azithromycin and experienced intolerance, metoclopramide (PLASIL) and experienced oculogyric crisis. The patient experienced candida sepsis, impaired speech and swallowing, hemoglobinuria, acute renal failure and pancythopenia (death) on 06May2021. The patient experienced ischemic stroke with hemiparesis days before death on unspecified date. The patient experienced impaired coagulation on 13May2021. The patient received treatment for the events. The patient died on 06Jun2021. The autopsy was not ordered. The physician said that the clinical situation was very compromised even before the vaccination: for 10 years he was no longer fed by mouth and had passed from SNG to percutaneous endoscopic gastrostomy then to jejunectomy and then to NPT, already attempted in the first months but then promptly replaced due to frequent sepsis of the CVC. This last time he had gone better: since September he had CVC without major problems except the appearance of a left parasternal swelling investigated by ultrasound, MRI and biopsy (all negative, it looked like sternochondritis of NDD) which eventually turned into a trophic ulcer that it was added to that of the button of the dismissed jejunostomy. Numerous repeatedly negative sore swabs were performed except the last positive for Candida Albicans (06May2021). The analyzes of that day (patients for the rest stationary and ''''asymptomatic '''' except hyperchromic urine) showed pancytopenia and initial renal insufficiency. On 13May2021, physician requested new hematochemicals that had shown worsening of pancytopenia (GB 3.32, GR 2.46, Hb /, 36, PLT 66,000) and the appearance of impaired coagulation PTT 1.58. It was reported by family members that the patient had woken up the previous morning with blood on his mouth. He was hospitalized and I know from internist colleague that the blood culture confirmed a Candida plus a bacterium, during the hospitalization he developed a low-grade fever with an episode at 38 degrees C. They immediately replaced him with the CVC, positioned CV. The situation was complex but it had gone through far worse situations. During the daily visit of the family he spoke, gesticulated normally, however on Sunday 30May2021 the doctor informed the relatives who had noticed that he did not move a little arm and right leg (until the late evening of 29May2021 no motor problems). From that moment on he presented right hemiplegia, dysarthria with the absence of the swallowing reflex and emission of indistinct sounds only. After that he presented labored breathing, he was aspirated and in the afternoon of 06Jun2021 he passed away. On a very fragile ground it seems that vaccination has triggered a chain reaction that involved blood crasis, coagulation and kidney function. Each time, before replacing the PEG or jejunostomy, the patient always performed blood chemistry including PT and PTT but never had changes in coagulation, much less thromboembolic episodes. Septic episodes, on the other hand, were usual but not in the last 7 years, in which he had enjoyed stable clinical conditions even if in very precarious balance. The reporter added the stroke was documented by cranial CT on 30May2021; the health file was emptied therefore it is impossible to provide documentation of the haematiochemicals and imaging. Sender''s comments: 08Jul2021 RLFV: request to the reporter (who declares that the vaccine may have contributed) clinical report on the case. The reporter specifies that he is not currently in possession of the hospital clinical documentation. 08Jul2021 RLFV feedback from the reporter who is reported in the description of the case. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWING. HAEMOGLOBINURIA, ACUTE RENAL FAILURE. PANCYTHOPENIA.; CANDIDA SEPSIS, DAYS BEFORE DEATH ISCHEMIC STROKE WITH HEMIPARESIS, IMPAIRED SPEECH AND SWALLOWI


VAERS ID: 1517185 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003655 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-05
   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: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST and PYREXIA in a 53-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3003655) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 01-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 02-Jul-2021, the patient experienced CARDIAC ARREST (seriousness criteria death and medically significant) and PYREXIA (seriousness criterion death). The patient died on 05-Jul-2021. The reported cause of death was Arrest cardiac and Fever. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: Although, a temporal association exist, based on the available information, it is not possible to exclude other underlying cause as the patient experienced fever prior to cardiac arrest. In addition, the exact temperature and other diagnostic findings were not provided. Hence, details provided is not sufficient to adequately assess causality. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received included no new information; Sender''s Comments: Although, a temporal association exist, based on the available information, it is not possible to exclude other underlying cause as the patient experienced fever prior to cardiac arrest. in addition, the exact temperature and other diagnostic findings were not provided. Hence, details provided is not sufficient to adequately assess causality. No further information is expected. Reported Cause(s) of Death: Arrest cardiac; Fever.


VAERS ID: 1517199 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Arterial rupture, Computerised tomogram, Echocardiogram, Investigation
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TALOFEN; DEURSIL; METFORMIN HYDROCHLORIDE; DOBETIN; LEDERFOLIN; LASIX; TIXTELLER; NORMIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm; Cirrhosis liver
Allergies:
Diagnostic Lab Data: Test Name: CT scan; Result Unstructured Data: Test Result:unknown results; Test Name: CT scan; Result Unstructured Data: Test Result:had no problems; Test Name: echo; Result Unstructured Data: Test Result:unknown results; Test Name: impact on quality of life; Result Unstructured Data: Test Result:10
CDC Split Type: ITPFIZER INC202100939466

Write-up: ruptured aorta; This is a spontaneous report from a contactable consumer from the Regulatory Authority [IT-MINISAL02-756578]. A 76-year-old male patient received the first dose of BNT162B2 (COMIRNATY), via intramuscular in the left arm on 24Jun2021 (Lot number: FC1526) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included exotoxic cirrhosis and aortic aneurysm treated with prosthesis years ago (in place by echo and CT scan made a month and a half ago). Concomitant medications included TALOFEN, DEURSIL, metformin hydrochloride, DOBETIN, LEDERFOLIN, LASIX, TIXTELLER, NORMIX. The patient after taking the first dose of Pfizer on 24Jun2021, had a ruptured aorta that had no problems a month before from CT. Compensation of previous cirrhosis. It was reported that the patient who died on 04Jul2021. Lab data included CT scan and echo that both with unknown results on unspecified date; CT scan had no problems a month ago; impact on quality of life was 10/10 on unspecified date. The outcome of the event was fatal. It was not reported if an autopsy was performed. Reporters comment: Exotoxic cirrhosis Aortic aneurysm treated with prosthesis years ago (in place by echo and CT scan made a month and a half ago). Senders comment: attached file of the er for all the details and to examination diagnostic and instrumental. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: ruptured aorta


VAERS ID: 1517217 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002917 / UNK - / OT

Administered by: Unknown       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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of CARDIO-RESPIRATORY ARREST in a 49-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002917) for COVID-19 vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular). On 16-Jul-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced CARDIO-RESPIRATORY ARREST (ECG); (seriousness criteria death and medically significant). The patient died on 16-Jul-2021. The reported cause of death was cardio-respiratory (ecg). It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment information provided. Action taken with mRNA-1273 in response to the event was Not Applicable Company Comment: Very limited information regarding the serious unexpected event of Cardio-respiratory arrest has been provided at this time insufficient for causality assessment. Further information (translation) has been requested. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Additional information was received from regulatory authority and contains no new information; Sender''s Comments: Very limited information regarding the serious unexpected event of Cardio-respiratory arrest has been provided at this time insufficient for causality assessment. Further information (translation) has been requested.


VAERS ID: 1517218 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002543 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Coombs positive haemolytic anaemia, Dyspnoea, Thrombocytopenia
SMQs:, Haemolytic disorders (narrow), Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of THROMBOCYTOPENIA, COOMBS POSITIVE HAEMOLYTIC ANAEMIA and DYSPNOEA in an 84-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3002543) for COVID-19 vaccination. No Medical History information was reported. On 01-Jun-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) .5 milliliter in total. On 01-Jun-2021, the patient experienced THROMBOCYTOPENIA (seriousness criteria death and medically significant), COOMBS POSITIVE HAEMOLYTIC ANAEMIA (seriousness criteria death and medically significant) and DYSPNOEA (seriousness criterion death). The patient died on 10-Jun-2021. The reported cause of death was Thrombocytopenia, Hemolytic autoimmune anemia DCP and Dyspnea. It is unknown if an autopsy was performed. For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported No treatment information was provided. The patient developed Haemolytic autoimmune anaemia ICP and Haemolytic autoimmune anaemia DCP. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Thrombocytopenia; Hemolytic autoimmune anemia DCP; Dyspnea


VAERS ID: 1517236 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202100916579

Write-up: three people in apparent good health, about 50, died 24 h after the administration of the Comirnaty vaccine; This is a spontaneous report from a contactable physician through a company representative. The physician reported safety information for three patients. This is the second out of three cases. A adult patient of an unspecified gender received bnt162b2 (COMIRNATY, Solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported by the physician that in the last two weeks (the last case yesterday at the time of report), on an unknown date, three people in apparent good health, about 50, died 24 hours after the administration of the Comirnaty vaccine. The event occurred after using the product. Autopsies was performed and they are waiting for the results of autopsies. The patient died on an unspecified date after vaccination. The clinical outcome of the event was fatal.; Sender''s Comments: Limited information of dose -event relationship post vaccination and other alternate explanation preclude a comprehensive causality assessment, however the causal role of BNT162B2 cannot be excluded for the reported event. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate; Reported Cause(s) of Death: death


VAERS ID: 1517246 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Hepatic function abnormal, Respiratory disorder, Vomiting
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-11
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Late effects of cerebral infarction
Allergies:
Diagnostic Lab Data: Test Date: 202107; Test Name: blood examination; Result Unstructured Data: Test Result:abnormal hepatic function
CDC Split Type: JPPFIZER INC202100908630

Write-up: Respiratory condition aggravated; Vomiting; Abnormal hepatic function; This is a spontaneous report from a contactable physician received through the COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 75-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination, but not specified. 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 bedridden condition due to late effects of cerebral infarction. On 08Jul2021 at 14:00 (the day of vaccination), the patient received a single dose of BNT162b2 (COMIRNATY Solution for injection, Lot number and expiration date were not reported) in the arm left as dose number unknown, single, with route of administration unspecified, for COVID-19 immunization. On 10Jul2021 (one day after the vaccination), the patient experienced vomiting. On 11Jul2021, the respiratory condition was aggravated. On 11Jul2021 (2 days after the vaccination), the patient experienced death. The events resulted in death. The outcome of the event was fatal. It was unknown whether the treatment was provided. The reporting physician assessed the event as serious (death). It was unknown if the autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The reported event was as follows: On 08Jul2021 at 14:00, the patient received a dose of BNT162b2 vaccination. On 10Jul2021, the patient experienced vomiting. On 11Jul2021, the respiratory condition was aggravated. On the same day, at 19:35 (3 days after vaccination), the patient was confirmed to die at the hospital where he was transferred to. The causality between the event and BNT162b2 vaccination was unknown. The blood examination at the hospital, where the patient was transferred to, showed abnormal hepatic function in Jul2021.; Reported Cause(s) of Death: vomiting; respiratory condition aggravated; Abnormal hepatic function


VAERS ID: 1517250 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-14
Onset:2021-07-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Body temperature, Cardio-respiratory arrest, Hypercapnia, Respiratory arrest, SARS-CoV-2 test
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 (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness: Atrial fibrillation
Preexisting Conditions: Medical History/Concurrent Conditions: Bacteraemia (Hospitalized from 26Jul2021); Carbon dioxide narcosis; Cellulitis (Hospitalized from 26Jul2021); Urinary tract infection
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210222; Test Name: SARS-CoV-2 test; Test Result: Positive.
CDC Split Type: JPPFIZER INC202100909733

Write-up: carbon dioxide narcosis; cardio-respiratory arrest; respiratory arrest; Apnoea; This is a spontaneous report initial from a contactable physician and follow-up report from a contactable pharmacist received from the Regulatory Authority. The Regulatory authority report number is v21120038. An 82-year-old female patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5249, Expiration date 30Sep2021) at the age of 82-year-old via an unspecified route of administration on 14Jul2021 at 13:48 (the day of vaccination), as dose 2, single for COVID-19 immunization. Medical history included urinary tract infection. Body temperature before vaccination was 36.8 degrees centigrade. The patient had no particular family history. Concomitant medication included ELIQUIS orally for atrial fibrillation in order to prevent cerebral infarction. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 15Jul2021 at 04:30 (14 hours/42 minutes after the vaccination), the patient experienced respiratory arrest. On 28Jun2021 (before the vaccination), the patient was admitted to the hospital. On 15Jul2021 (one day after the vaccination), the outcome of the events was fatal. It was unknown if autopsy was performed. The course of the event was as follows: On 22Feb2021, the patient originally had a history of hospitalization for COVID-19 positive at another hospital. The patient was being admitted to the institution for advanced age or some kind of neurological disease, and her level of care needed was 4. On 28Jun2021, the patient was admitted to the hospital for cellulitis and bacteraemia. From 28Jun2021 to 12Jul2021, during hospitalization, ceftriaxone (CTR) 2g/day was administered for 14 days. The responsible bacteria was group G Streptococcus. 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 carbon dioxide narcosis. On 14Jul2021 at 13:48, the patient was vaccinated, and no adverse reaction was noted after that. On 15Jul2021, at night, presumably 3 or 4 o''clock, the patient was found in cardiac arrest by a nurse on patrol. It was informed that the patient was in respiratory arrest. A monitor had not been placed. The patient was found under condition of cardio-respiratory arrest. The patient''s death was confirmed at 5:33 by the physician. The reporting physician commented as follows: The patient suddenly had respiratory arrest just before the discharge and after the vaccination, and thus, the involvement of BNT162b2 vaccination was suspected.; Reported Cause(s) of Death: Apnoea; carbon dioxide narcosis; respiratory arrest; Respiratory arrest.


VAERS ID: 1517251 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac failure acute, Cardio-respiratory arrest, Foaming at mouth, Loss of consciousness, Malaise, Pyrexia, Unresponsive to stimuli
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: EFIENT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac valvulopathy (underwent surgery 3 times for cardiac valvulopathy at hospital A); Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade
CDC Split Type: JPPFIZER INC202100909738

Write-up: cardio-respiratory arrest; unconscious/lost consciousness; did not respond to verbal stimulation; foamed at the mouth; Cardiac failure acute; feverish; malaise; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21120106. An 86-year and 11-month female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 10Jul2021 (Batch/Lot Number: FC3661; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Medical history included cardiac valvulopathy: The patient underwent surgery 3 times for cardiac valvulopathy at hospital A. She was still regularly visiting the hospital. The patient regularly visited hospital for the treatment of cardiac disease. Concomitant medication included prasugrel hydrochloride (EFIENT) tablet 5 mg. The patient received the first dose of Comirnaty on 19Jun2021. Body temperature before second vaccination was 36.5 degrees centigrade. On 10Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Lot# FC3661, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 12Jul2021, in the evening, (2 days after the vaccination), the patient experienced acute cardiac failure. On 12Jul2021 at 19:23, (2 days after the vaccination), the outcome of the events (Cardiac failure acute and cardio-respiratory arrest) was fatal. The course of the event was as follows: On 19Jun2021, the patient received the first dose of BNT162b2. On 10Jul2021, early in the morning, the patient had edema in her limbs and visited the emergency unit of hospital A. On 10Jul2021, in the afternoon, the patient received the second dose of BNT162b2. No changes were noted in the patient''s conditions while she was in the vaccination site and also after she went back home. On 11Jul2021, the patient was feverish and had malaise, but she was able to eat meals and drink water. On 12Jul2021, at 18:00, the patient''s family member found her unconscious in her room.. She foamed at the mouth. lost consciousness, and did not respond to verbal stimulation. Her family member asked for ambulance, and she was transferred to hospital B (The patient''s physician was in hospital A, but since they considered that the patient''s conditions required to be urgently treated, she was transferred to hospital B).At 18:56, when the ambulance arrived at the hospital, the patient had cardio-respiratory arrest. Resuscitative maneuver was performed, but no response was noted. At 19:23, the patient was confirmed dead at hospital B. The cause of death was acute cardiac failure. The reporting physician classified the events (Cardiac failure acute and cardio-respiratory arrest) as serious (death) and considered the causality of the event to BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was also unassessable. The outcome of feverish, malaise, lost consciousness, foamed at the mouth and did not respond to verbal stimulation was unknown.; Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1517252 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Body temperature, Hypophagia, Pyrexia, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-16
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia Alzheimer''s type; Disuse syndrome (the patient has been hospitalized since 02Feb2019); Hospitalisation
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: Body temperature; Result Unstructured Data: Test Result:37.1 Centigrade; Comments: before vaccination; Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result :at the maximum of 37.9 Centigrade; Comments: on the following day of the second vaccination
CDC Split Type: JPPFIZER INC202100909741

Write-up: Apnoea; respiratory arrest; oral intake became impossible; transient pyrexia at the maximum of 37.9 degrees centigrade; This is a spontaneous report from a contactable physician received from the regulatory authority, regulatory authority report number is v21120085. A 94-year and 3-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021), via an unspecified route of administration on 13Jul2021 10:32 as dose 2, single (at the age of 94 years old) for COVID-19 immunisation. Medical history included dementia Alzheimer''s type and disuse syndrome; from an unknown date, for which the patient has been hospitalized since 02Feb2019. The patient''s concomitant medications were not reported. On 16Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA2453, Expiration date 31Aug2021) for COVID-19 immunisation and experienced transient pyrexia at the maximum of 37.3 degrees centigrade. Family history was not reported. Body temperature before vaccination was 37.1 degrees centigrade. On 16Jul2021 at 08:45 (2 days 22 hours 13 minutes after the vaccination), the patient experienced apnoea. The course of the event was as follows: The patient has been hospitalized in the reporting hospital since 02Feb2019 due to disuse syndrome caused by dementia Alzheimer''s type. On 16Jun2021, the patient received the first dose of COMIRNATY. On the following day, the patient experienced transient pyrexia at the maximum of 37.3 degrees centigrade only and had no other appreciable event. On 13Jul2021, the patient received the second dose of COMIRNATY. On the following day (14Jul2021), the patient experienced transient pyrexia at the maximum of 37.9 degrees centigrade. From the same time, oral intake became impossible and the patient was managed with infusion; however, respiration and hemodynamics were stable. On the following day in the morning (15Jul2021), the patient was able to eat breakfast. However, subsequently at bedtime, the patient was found to have respiratory arrest and death was confirmed. 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 dementia Alzheimer''s type. The patient underwent lab tests and procedures which included body temperature: 37.1 centigrade on 13Jul2021 before vaccination, body temperature: at the maximum of 37.9 centigrade on 14Jul2021 on the following day of the second vaccination. Therapeutic measures were taken as a result of oral intake became impossible. On 16Jul2021 (3 days after the vaccination), the outcome of the event Apnoea and respiratory arrest was fatal. The outcome of the other events was unknown. The patient died on 16Jul2021. It was not reported if an autopsy was performed. The reporting physician commented as follows: The patient had advanced dementia with independence in activities of daily living for the elderly with dementia rank IV. Considering the patient''s age, risk of sudden turn for the worse and death was generally high; thus, causality between the vaccination and the event was unknown.; Reporter''s Comments: The patient had advanced dementia with independence in activities of daily living for the elderly with dementia rank IV. Considering the patient''s age, risk of sudden turn for the worse and death was generally high; thus, causality between the vaccination and the event was unknown.; Reported Cause(s) of Death: Apnoea; respiratory arrest


VAERS ID: 1517253 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-30
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Body temperature, Computerised tomogram, Imaging procedure, Interstitial lung disease, Oxygen saturation, SARS-CoV-2 test
SMQs:, Interstitial lung disease (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-08
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Antibody qualitative test; Test Result: Negative ; Test Date: 20210617; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 2021; Test Name: CT; Result Unstructured Data: Test Result:Bilateral diffuse crazy paving appearance; Comments: Bilateral pulmonary diffuse crazy paving appearance was observed; Test Date: 2021; Test Name: Imaging procedure; Result Unstructured Data: Test Result:aggravation; Comments: aggravation of bilateral interstitial pneumonia image were observed; Test Date: 20210630; Test Name: Imaging procedure; Result Unstructured Data: Test Result:bilateral pneumonia image were found; Test Date: 20210630; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Test Date: 2021; Test Name: SARS-CoV-2 PCR test; Test Result: Negative ; Test Date: 2021; Test Name: SARS-CoV-2 PCR test; Test Result: Negative
CDC Split Type: JPPFIZER INC202100909745

Write-up: Interstitial pneumonia; This is a spontaneous report from a contactable primary physician received from the Regulatory Agency (RA). Regulatory authority report number is v21120141. A 92-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 17Jun2021 14:00 (Batch/Lot Number: EY5423; Expiration Date: 31Aug2021) (at the age of 92 years old) as dose 2, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# was not provided). The patient experienced interstitial pneumonia on 30Jun2021. The patient was hospitalized for interstitial pneumonia from 30Jun2021 to an unknown date. On 30Jun2021 at unknown time (thirteen days after the vaccination), the patient experienced Interstitial pneumonia. On 30Jun2021 (thirteen days after the vaccination), the patient was admitted to the hospital. On 08Jul2021 (twenty-two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 30Jun2021, SpO2 decreased and bilateral pneumonia image were found and the patient was admitted to a hospital. The administration of antibacterial drugs was begun for Pneumonia bacterial, but there was no effect. Respiratory status of the patient worsened, and steroids were added. After that, Respiratory failure and aggravation of bilateral interstitial pneumonia image were observed. On 08Jul2021, the patient died. Search for the cause with such as bronchoscopy was not performed because it was not mentioned in the informed consent with the family. Bilateral pulmonary diffuse crazy paving appearance was observed on the Computerised tomogram image. Findings of the images were not typical Pneumonia bacterial or Pneumonia aspiration, and they matched with COVID-19 pneumonia. SARS-CoV-2 PCR was performed twice, and the results were negative. The result of antibody qualitative test was also negative. The patient''s body temperature was 36.4 C on 17Jun2021 before vaccination. 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 the complication of Pneumonia bacterial. The reporting physician commented as follows: "I cannot diagnose as COVID-19 pneumonia, but I reported because the pneumonia images after the vaccination of Comirnaty matched with COVID-19 pneumonia." The patient died on 08Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Interstitial pneumonia


VAERS ID: 1517256 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-13
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Pleural effusion, Sudden cardiac death
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-13
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100909756

Write-up: Sudden cardiac death; bilateral pleural effusion; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120037. A 93-year-old female patient received second dose of bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on 08Jul2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history included cardiac failure. Body temperature before vaccination and family history were not reported. Concomitant medications were not reported. On an unknown date, the patient previously received the first dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN for COVID-19 immunisation. On 08Jul2021 at an unknown time (the day of vaccination), the patient received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN. On 13Jul2021 at 10:01 (5 days after the vaccination), the patient experienced sudden cardiac death. On 13Jul2021 at 10:01 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 08Jul2021, the patient received the second dose of COVID-19 VACCINE - MANUFACTURER UNKNOWN. Afterwards, the patient had no fever. However, the patient did not take meals and was almost bedridden. On 13Jul2021 at 08:00, the patient''s breathing was hard when her eldest son went to observe her. He removed her sputum with a tissue. At 08:30, the patient was not breathing; therefore, the son called a care manager. The care manager requested an ambulance. At 09:00, the son performed cardiopulmonary resuscitation (CPR) on the patient. At 09:12, an emergency medical team arrived and performed CPR on the patient. At 09:20, a doctor car contacted them. An intubation was performed, and adrenaline was administered. At 09:38, the patient arrived at a hospital. Asystole persisted. The resuscitation was finished. At 10:01, the patient''s death was confirmed. A computerised tomogram (CT) showed bilateral pleural effusion and no pericardial fluid. The reporting physician classified the event as serious (death) and assessed the causality between the event and COVID-19 VACCINE - MANUFACTURER UNKNOWN as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: No particular abnormalities were observed before the vaccination.; Reported Cause(s) of Death: Sudden cardiac death


VAERS ID: 1517297 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac tamponade, Oxygen saturation
SMQs:

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Attention deficit hyperactivity disorder; Autism spectrum disorder; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination; Test Date: 20210707; Test Name: SpO2; Test Result: 77 %
CDC Split Type: JPPFIZER INC202100910825

Write-up: Cardiac tamponade; Acute aortic dissection; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120190. A 56-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 06Jul2021 at 12:00 (Batch/Lot Number: EW0207; Expiration Date: 30Sep2021) as dose 1, single for COVID-19 immunisation. Body temperature before vaccination was 36.4 degrees centigrade. The patient had no notable family history. Medical history included underlying conditions (autism spectrum disorder, attention deficit/hyperactivity disorder (AD/HD), epilepsy). The patient''s concomitant medications were not reported. The patient was on inpatient treatment at the reporting hospital since 21May2020 for drug adjustment for significant behaviour disorder and emotional disturbance and for epilepsy that were due to autism spectrum disorder and AD/HD. On 07Jul2021 at 17:20 (1 day after the vaccination), the patient experienced cardiac tamponade and acute aortic dissection. On 07Jul2021 (1 day after the vaccination), the outcome of the events was fatal. It was not reported whether autopsy was done. The course of the events was as follows: On 06Jul2021 (the day of vaccination), no specific serious problem was noted before the vaccination, and no side effects had been noted after the vaccination. On 07Jul2021 at 17:00 (1 day after the vaccination), the patient was screaming and moving actively at her room. At 17:20, there was a room visit as she stopped screaming and became silent, and she was found lying on the floor with complexion ill, loss of spontaneous respiration, cyanosis, and SpO2 77%. Cardiac massage, intravenous route securing, endotracheal intubation, automated external defibrillator (AED), and BOSMIN intramuscular injection were performed. While continuing resuscitation, an ambulance was called at 17:37, and the patient was urgently transported from the reporting hospital to Medical Center at 17:55. Thereafter, the patient underwent resuscitation at Medical Center but was unresponsive, and after waiting for her family to arrive, she was confirmed dead at 20:01. The cause of death was diagnosed as cardiac tamponade and acute aortic dissection. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162b2 as unassessable. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: Assessment of the diagnosis of the symptoms and causal relationship were not possible. No follow-up attempts are possible. No further information is expected.; Reporter''s Comments: Assessment of the diagnosis of the symptoms and causal relationship were not possible.; Reported Cause(s) of Death: Cardiac tamponade; Acute aortic dissection


VAERS ID: 1517311 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-15
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0201 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: MEMARY; TAKELDA; DIGOXIN; FUROSEMIDE; FUROSEMIDE; SPIRONOLACTONE; NEUQUINON; JUVELA N; AMITIZA; ELIQUIS; FERROMIA; METOANA; FEBURIC; SENNOSIDE A+B CALCIUM; BROTIZOLAM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Cardiac failure chronic; Diabetes mellitus; Mitral valve insufficiency; Oedema lower limb; Tricuspid valve disease
Allergies:
Diagnostic Lab Data: Test Name: blood pressure; Result Unstructured Data: Test Result:The usual systolic blood pressure was 100 to 120,; Comments: and the usual diastolic blood pressure was 50 to 70; Test Name: BNP level; Result Unstructured Data: Test Result:had improved with adjustment of medications
CDC Split Type: JPPFIZER INC202100911349

Write-up: Intra-cerebral haemorrhage; This is a spontaneous report from a contactable other healthcare professional received via COVID-19 Adverse Event Self-Reporting Solution. A non-pregnant 91-year-old female patient received bnt162b2 (COMIRNATY), intramuscular administered in left arm on 29Jun2021 13:30 (Batch/Lot Number: EW0201; Expiration Date: 30Sep2021) (at the age of 91-year-old) as DOSE 2, SINGLE for covid-19 immunisation. 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. The patient had no allergies to medications, food, or other products. Medical history included cardiac failure chronic, oedema both lower limbs, diabetes mellitus, mitral valve insufficiency, tricuspid insufficiency, and atrial fibrillation. Concomitant medications included memantine hydrochloride (MEMARY); acetylsalicylic acid, lansoprazole (TAKELDA); digoxin; furosemide 40 mg; furosemide 20 mg; spironolactone; ubidecarenone (NEUQUINON); tocopheryl nicotinate (JUVELA N); lubiprostone (AMITIZA); apixaban (ELIQUIS); ferrous sodium citrate (FERROMIA); anagliptin, metformin hydrochloride (METOANA); febuxostat (FEBURIC); and sennoside a+b calcium; brotizolam. Historical vaccine includes first dose of bnt162b2 (COMIRNATY, Lot# EY0779, Expiration date 31Aug2021) (at the age of 91-year-old) via intramuscular route of administration in the arm right for COVID-19 immunization. On 15Jul2021 (16 days after the vaccination), the patient experienced intra-cerebral haemorrhage. The event resulted in hospitalization (duration of hospitalization was 3 days). The outcome of the event was fatal. The reporter classified the event as serious (hospitalization and death). The patient died on 17Jul2021. The cause of death was reported as cerebral haemorrhage. It was unknown if an autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was reported as follows: The patient had been receiving treatment for cardiac failure chronic and oedema both lower limbs. The BNP level, wheezing on exertion, and oedema lower limbs had improved with adjustment of medications, and course was stable. The usual systolic blood pressure was 100 to 120, and the usual diastolic blood pressure was 50 to 70, and the patient did not use an antihypertensive drug. On 15Jul2021 (16 days after the vaccination), in the afternoon, the patient started to have headache, and she took oral acetaminophen (CALONAL). The patient had supper and was active. However, before dawn, the patient had depressed level of consciousness from delirium-like movement, and did not respond to a call. The patient was emergently transferred to the hospital. The patient was diagnosed with intra-cerebral haemorrhage. On 17Jul2021 (18 days after vaccination), the patient died at the hospital where she was transferred to.; Reported Cause(s) of Death: Intra-cerebral haemorrhage


VAERS ID: 1517312 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

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

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ECARD LD; CADUET
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100911430

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 84-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received candesartan cilexetil hydrochlorothiazide and amlodipine besilate, atorvastatin calcium hydrate (CADUET 3) within 2 weeks of vaccination and still ongoing. 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 osteoarthritis and hypertension. On 22Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# FA5765, Expiration date 30Sep2021) at the age of 84 years old. On 13Jul2021 at 10:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) (at the age of 84 years old) via intramuscular route of administration in the arm left for COVID-19 immunization. On 16Jul2021 (2 days/13 hours/30 minutes after the vaccination), the patient experienced death. The event resulted in emergency room/department or urgent care, and death. The outcome of the event was fatal without treatment. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19: Unknown. The reported event was as follows: On 16Jul2021 (2 days/13 hours/30 minutes after the second dose of the vaccination), in the morning, the patient was confirmed to have died. An autopsy was performed by the police but results were not available.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1517314 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-17
Onset:2021-07-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

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: JPPFIZER INC202100911620

Write-up: Shock; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120701. A 70-year-old male patient (70-year and 5-month-old male) received the second dose of bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 17Jul2021 (received at the age of 70-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. 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). Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY, Batch/Lot number was not reported) on an unknown date in 2021 for COVID-19 immunisation. On 17Jul2021 at 13:00, the patient experienced shock. The course of the event was as follows: On 17Jul2021 (the day of vaccination), the patient was found to collapse in the garden of his home by his neighbor, and an ambulance was called. When the ambulance service arrived, the neighbor was performing chest compression. The patient had skin warm. At 14:02, the patient was emergently transferred to the reporting hospital. Although resuscitation was tried, no response was obtained, and the patient was confirmed to die at 14:17. The patient died on 17Jul2021 14:17. The family wished the investigation of the cause of death. On 18Jul2021 (one day after vaccination), an autopsy was performed. An inquest was performed by the police, and the postmortem certificate was made. 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. The reporting physician commented as follows: The autopsy showed that macroscopic organic disease which led to death was unknown. The death due to shock was definite. It was concluded that the causality between the event and BNT162b2 vaccination could not be ruled out. Information on batch number has been requested.; Reported Cause(s) of Death: Shock


VAERS ID: 1517316 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-09
Onset:2021-07-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Fall, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SELECTOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Glomerulonephritis chronic; Hypertension; Pollinosis
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100911744

Write-up: Acute aortic dissection; lost consciousness and fell down; lost consciousness and fell down; This is a spontaneous report from a contactable physician received from the regulatory authority. The Regulatory authority report number is v21120220.?? A 70-year-old and 4-months female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021), via an unspecified route of administration in the left arm (also reported as left shoulder) on 09Jul2021 10:10 (the day of vaccination, at the age of 70-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic glomerulonephritis, hypertension, and pollinosis. Concomitant medication included celiprolol hydrochloride (SELECTOL) taken for an unspecified indication from 09Jul2021 10:10 and ongoing. On 18Jun2021 at 10:05, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot no.: FA2453, Expiration date: 31Aug2021) at single dose for COVID-19 immunization. On 12Jul2021 at 10:10 (3 days after the vaccination), the patient experienced acute aortic dissection. On 12Jul2021 (3 days after the vaccination), the outcome of the event was death. The course of the event was as follows: On 09Jul2021, the patient received BNT162b2 on the left shoulder. No particular problem was seen during 30-minute observation period, and the patient went back home. On 10Jul2021 and 11Jul2021, no change was noted in the patient''s physical conditions, and she spent time as usual. On 12Jul2021, since the patient''s mother had to be seen by a doctor, the patient drove their car to hospital A. While the patient was present in the medical examination, she suddenly lost consciousness and fell down. Cardiopulmonary resuscitation was immediately performed, but the heart beat did not reappear and the patient died. Information was obtained from the patient''s oldest daughter about the patient''s conditions after going back home on 09Jul2021. Information was also obtained from the document prepared by hospital A about the patient''s conditions after developing the event. The patient underwent lab tests and procedures which included Body temperature before vaccination on 09Jul2021 was 36.6 degrees centigrade. Therapeutic measure was taken as a result of the events. The patient died on 12Jul2021. Cause of death included acute aortic dissection, lost consciousness and fell down. It was unknown if an autopsy was performed. The reporting physician classified the event as serious (death) and considered that the causality of the event to BNT162b2 was unassessable. The reporting physician did not mention other possible cause of the event such as any other diseases.; Reported Cause(s) of Death: Acute aortic dissection; lost consciousness and fell down; lost consciousness and fell down


VAERS ID: 1517325 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-14
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5947 / 1 LA / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100916260

Write-up: Acute myocardial infarction; This is a spontaneous report from a contactable physician received via COVID-19 Self-Reporting. The patient was a non-pregnant 83-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications 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 cerebral infarction, hypertension, and diabetes mellitus. On 29Jun2021 at 14:15 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC5947, Expiration date 30Sep2021) intramuscular in the arm left for COVID-19 immunization. On 14Jul2021 at 01:00 (14 days 10 hours 45 minutes after the vaccination), the patient experienced acute myocardial infarction. The event resulted in life-threatening and death. The outcome of the event was fatal with treatment including coronary angiography and catheter intervention. Since the vaccination, the patient has not been tested for COVID-19. The reporting physician classified the event as serious (death and life-threatening). Sender''s Comments: The event acute myocardial infarction is considered not related to BNT162B2. The event is more likely an intercurrent medical condition for this elderly patient with underlying cerebral infarction, hypertension, and diabetes. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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: Acute myocardial infarction


VAERS ID: 1517326 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Cardiac failure acute, Decreased appetite, Malaise, Vomiting
SMQs:, Cardiac failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   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: Medical History/Concurrent Conditions: Dementia; Hypertension; Interstitial pneumonia; Pneumonia
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100916884

Write-up: Cardiac failure acute; general malaise; low back pain; inappetence; vomiting; This is a spontaneous report from a contactable physician received via COVID-19 Self-Reporting. The patient was a 95-year-old male. On 13Jul2021 at 13:45 (at the age of 95 years old) (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EW0207, Expiration date 30Sep2021) via intramuscular route of administration in the arm left as single dose for COVID-19 immunisation. Medical history included interstitial pneumonia, pneumonia, hypertension, and dementia. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescription drugs (details unknown) 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. The patient historical vaccine included, on 08Jun2021 at 13:45, the patient received the first dose of BNT162b2 (COMIRNATY, Lot# FA7338, Expiration date 30Sep2021) via intramuscular route of administration in the arm left for COVID-19 immunisation. On 14Jul2021 at 08:00 (18 hours/15 minutes after the vaccination), the patient experienced cardiac failure acute. The event resulted in death. The reported event was as follows: On 14Jul2021, the following day of the vaccination, the patient had low back pain, inappetence, vomiting, and general malaise, and house visit by a physician was requested. At the house visit by a physician, a drip infusion of fluid replacement was performed. Shortly after the completion of the drip infusion, the condition was aggravated, and the patient died. Therapeutic measures were taken as a result of events with treatment including a drip infusion of fluid replacement. Since the vaccination, the patient has not been tested for COVID-19. The physician office visit included for the events low back pain, inappetence, vomiting, and general malaise. The reporting physician assessed the events as serious (death). Autopsy was not performed. The outcome of the events was fatal. No follow-up attempts are possible. No further information is expected. Sender''s Comments: Based on available information, a possible contributory role of the subject product, Comirnaty vaccine, cannot be excluded for the reported events of Cardiac failure acute, low back pain, inappetence, vomiting, and general malaise. The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate. Reported Cause(s) of Death: Cardiac failure acute


VAERS ID: 1517328 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Bronchitis, Shock haemorrhagic
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hypovolaemic shock conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-14
   Days after onset: 20
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: Test Name: Body temperature; Result Unstructured Data: Test Result:unknown; Comments: before vaccination; Test Date: 20210624; Test Name: fever/pyrexia; Result Unstructured Data: Test Result:low grade fever; Test Date: 20210714; Test Name: fever/pyrexia; Result Unstructured Data: Test Result:38; Comments: degrees
CDC Split Type: JPPFIZER INC202100917998

Write-up: Shock haemorrhagic; Bronchitis; This is a spontaneous report from a contactable postmortem physician received from the regulatory authority. Regulatory authority report number is v21120365. A 76-year and 8-month-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021), via an unspecified route of administration on 24Jun2021 15:30 at the age of 76 years old as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient family history was unknown. It was unknown if there were any 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). Body temperature before vaccination was unknown. On 24Jun2021, the patient experienced bronchitis. On 14Jul2021 (twenty days after the vaccination), the patient experienced shock haemorrhagic; around at night, death. The course of the event was as follows: On 24Jun2021 (the day of the vaccination), after the vaccination, the patient started to have low grade fever. On 14Jul2021, the patient visited a local internal medicine doctor, was found pyrexia of 38 degrees, and was diagnosed as Bronchitis. After that, the patient died on 14Jul2021. On 16Jul2021, a postmortem was performed, and it was diagnosed as Shock haemorrhagic based on Pleural haemorrhage due to Aortic aneurysm rupture. Outcome of event bronchitis was unknown. The patient died on 14Jul2021. The reporting physician classified the event as serious (fatal) and assessed that the event was unrelated to BNT162b2. Other possible cause(s) of the event such as any other diseases was unknown. The reporting physician did not provide any further comment.; Sender''s Comments: Based on the available information there is not a reasonable possibility of a causal relation between the reported event" Shock haemorrhagic" and suspect drug BNT162B2.; Reported Cause(s) of Death: Shock haemorrhagic; Autopsy-determined Cause(s) of Death: Shock haemorrhagic; Pleural haemorrhage; Aortic aneurysm rupture


VAERS ID: 1517329 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-04
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, C-reactive protein, C-reactive protein increased, Cardiac arrest, Coma scale, Computerised tomogram, Foaming at mouth, Hypopnoea, Loss of consciousness, Osteomyelitis, Oxygen saturation, Pneumonia, Pyrexia, Unresponsive to stimuli
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 (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Osteonecrosis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Cardiac failure chronic; Renal failure (being treated with Dialysis at the time of vaccination)
Preexisting Conditions: Medical History/Concurrent Conditions: Dialysis
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: BP; Result Unstructured Data: Test Result: 97/43 mmHg; Test Date: 20210702; Test Name: body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination; Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result: 38.6 Centigrade; Test Date: 20210704; Test Name: JCS; Result Unstructured Data: Test Result: 3-300; Test Date: 20210704; Test Name: CT; Result Unstructured Data: Test Result: showed pneumonia image on the right lower lung; Test Date: 20210704; Test Name: CRP; Result Unstructured Data: Test Result: 472; Comments: unit illegible; Test Date: 20210704; Test Name: SpO2; Test Result: 93%; Comments: 8 L/m RM.
CDC Split Type: JPPFIZER INC202100918002

Write-up: Osteomyelitis of toes; foaming at the mouth; unconscious; pneumonia image on the right lower lung; no reaction to pain stimulation; body temperature was 38.6 degrees Celsius; blood pressure was 97/43 mmHg; shallow spontaneous respiration was observed.; mild increase of C-reactive protein to 472; Cardiac arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120290. The report was also received from a healthcare professional via a representative. An 86-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 02Jul2021 (Lot Number: EW0207; Expiration Date: 30Sep2021) as dose 2, single for COVID-19 immunisation. Medical history included ongoing cardiac failure chronic and ongoing renal failure (being treated with dialysis at the time of vaccination). Body temperature before vaccination was 36.6 degrees centigrade (02Jul2021). The patient family history was not provided. Heart disorder, renal disease, Dialysis at the time of vaccination, antithrombogenic drug were reported on the vaccine screening questionnaire. On an unknown date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# and Expiration date were not provided) for COVID-19 immunisation. On 02Jul2021 (the day of vaccination) at unspecified time in the afternoon, 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 04Jul2021 at 04:00 (two days after the vaccination), the patient experienced Other Reactions. On 04Jul2021 (two days after the vaccination), the patient was admitted to the hospital. On 04Jul2021 (two days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient was under the treatment for Cardiac failure chronic and Renal failure (Dialysis). On 04Jul2021 (two days after the vaccination) at 04:00, the family of the patient found the patient foaming at the mouth and being unconscious and called an ambulance. At 05:45, the patient was transferred to the hospital. On arrival, Scale was 3-300 (no reaction to pain stimulation), body temperature was 38.6 degrees Celsius, blood pressure was 97/43 mmHg, oxygen saturation (SpO2) was 93% (8 L/m RM), shallow spontaneous respiration was observed. Blood test showed mild increase of C-reactive protein to 472 (unit illegible), Computerised tomogram showed pneumonia image on the right lower lung. The patient was admitted to the hospital and received the respiratory treatment with BiBAP. After that, Cardiac arrest was observed. The reporting physician classified the event as serious (fatal) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases were Cardiac failure chronic, Renal failure, Osteomyelitis of toes and Pneumonia. The reporting physician did not provide any further comment. On 04Jul2021, the patient died due to cardiac arrest, while unknown outcome for the remaining events. It was unknown if an autopsy was performed. Reported Cause(s) of Death: Cardiac arrest.


VAERS ID: 1517330 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-15
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardio-respiratory arrest, Computerised tomogram, Pneumonia, SARS-CoV-2 test
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-18
   Days after onset: 3
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:
Preexisting Conditions: Medical History/Concurrent Conditions: Lung cancer (surgery on the right lung, radiotherapy to the left lung); Lung operation; Radiotherapy to lung
Allergies:
Diagnostic Lab Data: Test Date: 20210708; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before vaccination; Test Date: 20210715; Test Name: CT; Result Unstructured Data: Test Result:right pneumonia; Test Name: coronavirus antigen test; Test Result: Negative
CDC Split Type: JPPFIZER INC202100918012

Write-up: Sudden death after pneumonia/right pneumonia; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120366. An 85-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 08Jul2021 09:30 (at the age of 85 years) (Batch/Lot Number: FA7338; Expiration Date: 30Sep2021) as single dose for COVID-19 immunization. Medical history included lung cancer, for which the patient had undergone surgery on the right lung and radiotherapy to the left lung. The patient''s concomitant medications were not reported. The patient was an 85-year and 10-month-old male. Body temperature before vaccination was 36.2 degrees Centigrade. On 18Jul2021 (10 days after the vaccination) at around 02:00, the patient experienced sudden death after pneumonia. The outcome of the event was fatal. The clinical course was reported as follows: On 15Jul2021 (8 days after the vaccination, as reported) in the morning, the patient presented to the reporting hospital with chief complaint of hyperthermia and dyspnoea. The patient was diagnosed with right pneumonia by computerised tomogram (CT), and he was admitted to the reporting hospital for treatment. The result of coronavirus antigen test was negative. On 17Jul2021 (9 days after the vaccination), the symptoms that the patient had had at the time of admission were resolving. However, on 18Jul2021 (10 days after the vaccination), in the early hours, sudden cardio-respiratory arrest developed. The patient died on 18Jul2021. It was unknown if 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 acute pneumonia.; Reported Cause(s) of Death: Sudden death after pneumonia; Cardio-respiratory arrest


VAERS ID: 1517331 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-07-10
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic rupture, Body temperature, Cardio-respiratory arrest, Computerised tomogram, Fall
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), Acute central respiratory depression (broad), Accidents and injuries (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: THYRADIN S; CALBLOCK; TAMSULOSIN; BENZBROMARONE; CANDESARTAN; URALYT [POTASSIUM CITRATE;SODIUM CITRATE DIHYDRATE]; FLUTIDE [FLUTICASONE PROPIONATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic aneurysm (father); Bronchial asthma; Hypertension; Neoplasm malignant (mother); Papillary thyroid cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: before vaccination; Test Name: CT scans; Result Unstructured Data: Test Result:no significant changes; Test Name: CT scans; Result Unstructured Data: Test Result:aortic rupture
CDC Split Type: JPPFIZER INC202100918014

Write-up: Cardio-respiratory arrest; aortic rupture; fell down; This is a spontaneous report from a contactable physician (specialized in respiratory medicine) received from the Medical Devices Agency. A 69-year-old male patient received BNT162B2 (COMIRNATY) at the age of 69-years-old, via an unspecified route of administration on 16Jun2021 15:30 (Batch/Lot Number: EY0779; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunization. The patient was a 69-year-old male. Body temperature before vaccination was 36.1 degrees centigrade. The patient had family histories of aortic aneurysm (father) and neoplasm malignant (mother). The patient must not use alcohol and iodine. Medical history included bronchial asthma, hypertension, and papillary thyroid cancer. Concomitant medications included levothyroxine sodium (THYRADIN S), azelnidipine (CALBLOCK), tamsulosin (manufacture name not reported), benzbromarone (manufacture name not reported), candesartan (manufacture name not reported), potassium citrate/sodium citrate dihydrate (URALYT), and fluticasone propionate (FLUTIDE 100). On 08Jul2021, the patient made regular visit the outpatient otolaryngology department of the reporting hospital. CT scans including the chest showed no significant changes. On 10Jul2021, the patient was with his wife and his condition did not change. At 16:30 on the same date (24 days and 1 hour after the vaccination), the patient suddenly fell down and was taken to another hospital by ambulance. The patient was already in the condition of cardio-respiratory arrest when an emergency medical team arrived. Afterwards, resuscitation was continued; however, the heartbeat did not resume, and the patient''s death was confirmed on the same date, 10Jul2021. It was reported that a CT was performed after the patient''s death and revealed aortic rupture, which might be due to a cardiac massage. 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 reporting physician commented as follows: The patient regularly visited the otolaryngology department of the reporting hospital for pharyngeal cancer, the respiratory medicine department of the hospital for bronchial asthma, and the nephrology department of the hospital for hypertension; however, all the courses were favorable and stable. Although many days had passed since the vaccination, no other findings corresponding to the cause of death were found. Therefore, the reporting physician considered that a causal relationship could not be ruled out, and this case was reported.; Reported Cause(s) of Death: Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: aortic rupture, which might be due to a cardiac massage


VAERS ID: 1517332 (history)  
Form: Version 2.0  
Age: 95.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-07-01
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspartate aminotransferase, Asthma, Body temperature, C-reactive protein, Cardiac failure, Dyspnoea, Pyrexia, SARS-CoV-2 antibody test, Vomiting, White blood cell count
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-07
   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: AMLODIPINE; LANSOPRAZOLE; EBRANTIL [URAPIDIL]; UBRETID; URSO [URSODEOXYCHOLIC ACID]; BELSOMRA; ROZEREM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bedridden; Dementia; Diabetes mellitus; Hepatitis C; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: GOT; Result Unstructured Data: Test Result:37; Test Date: 20210701; Test Name: Body temperature; Result Unstructured Data: Test Result:pyrexia Centigrade; Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:38 Centigrade; Test Date: 20210701; Test Name: CRP; Result Unstructured Data: Test Result:0; Test Date: 20210705; Test Name: CRP; Result Unstructured Data: Test Result:0.5; Test Date: 20210701; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: Test Result:negative; Test Date: 20210701; Test Name: WBC; Result Unstructured Data: Test Result:4000; Test Date: 20210705; Test Name: WBC; Result Unstructured Data: Test Result:6000
CDC Split Type: JPPFIZER INC202100918020

Write-up: suspected cardiac failure; shortness of breath; asthma; small amount of vomiting; pyrexia; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was 95-year-old female. The patient age at vaccination was 95-year-old. Medical history included dementia, diabetes mellitus (DM), hepatitis C, and osteoporosis. The patient was bedridden. Concomitant medications included amlodipine (manufacture name not reported), lansoprazole (manufacture name not reported), urapidil (EBRANTIL), distigmine bromide (UBRETID), ursodeoxycholic acid (URSO), suvorexant (BELSOMRA), and ramelteon (ROZEREM). On 22Jun2021, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not reported) via an unspecified route of administration as DOSE 1, SINGLE for COVID-19 immunization. On 01Jul2021 (9 days after the vaccination), the patient developed pyrexia. WBC was 4000, and CRP was 0. SARS-CoV-2 antibody test showed negative. Cooling was performed in response to the event. On 05Jul2021 (13 days after the vaccination), as pyrexia of 38 degrees Centigrade persisted, acetaminophen (CALONAL) was prescribed. WBC was 6000, CRP was 0.5 and GOT was 37. On 06Jul2021 (14 days after the vaccination), while she was having conversation, she developed shortness of breath, symptoms of asthma, and she had small amount of vomiting. Given those symptoms, cardiac failure was suspected. On 07Jul2021 at 04:00 (15 days after the vaccination), the patient died. It was unknown whether autopsy was performed. The outcome of the event Cardiac failure was fatal and unknown for the other events. The reporting physician''s opinion was as follows: Eight days passed after the vaccination from pyrexia, it was considered that there was no causal relationship between the patient''s death and BNT162b2. Information on the lot/batch number has been requested.; Sender''s Comments: The patient was an 95-year-old female with multiple underlying diseases and was bedridden. Based on the temporal association, the reported events more likely represented intercurrent illnesses, 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: suspected cardiac failure


VAERS ID: 1517333 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-06
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY3860 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   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: Angina pectoris; Atrioventricular block; Bypass surgery; Dyslipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210625; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202100918021

Write-up: Loss of consciousness; Incontinence; dead; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120289. A 74-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot Number: EY3860; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration on 25Jun2021 17:00 (at the age of 74years) as dose 1, single for Covid-19 immunization. Medical history included atrioventricular block, angina pectoris, bypass surgery, hypertension, and dyslipidaemia from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.5 degrees centigrade. On 06Jul2021 at 18:24 (11 days after the vaccination), in the evening, around 30 minutes after the patient started to take a bath, the patient''s family member found him incontinent and unconsciousness in the bath. However, the patient did not seem to be drown. He was urgently transferred to Emergency Room and then confirmed dead. The patient''s family member stated that when the patient took a bath, decrease in his level of consciousness had often been seen, and that he preferred to take a long bath with hot water. The outcome of event incontinent was unknown. The patient died on 06Jul2021. It was unknown whether an autopsy was performed. The reporting physician classified the events as serious (death) and assessed causality to be unassessable to BNT162b2. The reporting physician did not mention other possible cause of the event such as any other diseases. The reporting physician commented as follows: It had been 12 days since the vaccination, and the causality was therefore not considered as explicit.; Reporter''s Comments: It had been 12 days since the vaccination, and the causality was therefore not considered as explicit.; Reported Cause(s) of Death: Loss of consciousness; dead


VAERS ID: 1517335 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-19
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Body temperature, C-reactive protein increased, Investigation, KL-6, SARS-CoV-2 test, Serum ferritin
SMQs:, Interstitial lung disease (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-27
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210613; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210621; Test Name: Body temperature; Result Unstructured Data: Test Result:38.4 Centigrade; Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:39.5 Centigrade; Comments: at 22:00; Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:over 39 Centigrade; Test Date: 202106; Test Name: CRP; Result Unstructured Data: Test Result:above 36; Test Date: 202106; Test Name: KL6; Result Unstructured Data: Test Result:above 800; Test Date: 20210621; Test Name: SARS-CoV2 ID-NOW COVID-19 (PCR) test; Test Result: Negative ; Test Date: 202106; Test Name: Ferritin; Result Unstructured Data: Test Result:1800; Test Date: 20210622; Test Name: A-DROP score; Result Unstructured Data: Test Result:3
CDC Split Type: JPPFIZER INC202100918040

Write-up: Acute respiratory distress syndrome; This is a spontaneous report from a contactable physician received from the Agency. The regulatory authority report number is v21120244. An 89-year and 8-month-old male patient received BNT162B2 (COMIRNATY; solution for injection; lot number: EY5422; expiration date: 31Aug2021), via an unspecified route of administration on 13Jun2021 (at the age of 89-years-old) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The family history was not provided. The patient''s body temperature on 13Jun2021 before vaccination was 36.5 degrees Centigrade. On 13Jun2021 (the day of vaccination), the patient received the first dose of BNT162B2. The clinical course of the event was as follows: On 19Jun2021 at 06:00 (6 days after the vaccination), the patient experienced acute respiratory distress syndrome (ARDS). On 21Jun2021 (8 days after vaccination), SARS-CoV2 ID-NOW COVID-19 (PCR) test were negative. On 21Jun2021 (8 days after vaccination), in the morning, the patient''s body temperature was 38.4 degrees Celsius. On 22Jun2021 (9 days after vaccination), the patient''s the body temperature was 39 degrees Celsius or higher. At 22:00 (9 days and 22 hours after vaccination), since the body temperature was 39.5 degrees Celsius, the patient visited the reporting hospital. Organizing pneumonia (OP) was observed in the left lower lobe. The A-DROP score was 3. After the hospitalization, in spite of the treatment, inflammation, cellular destruction, and respiratory failure rapidly progressed. On 27Jun2021 (14 days after vaccination), the patient died due to acute respiratory distress syndrome (ARDS). It was not reported if an autopsy was performed or not. 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. The reporting physician commented as follows: The course of acute interstitial pneumonia (AIP) was especially rapid. No aspiration or chronic diseases were pointed out. The ferritin was 1800, the KL6 was above 800, and the CRP was above 36.; Reported Cause(s) of Death: Acute respiratory distress syndrome


VAERS ID: 1517336 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-16
Onset:2021-07-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, Computerised tomogram, Malaise
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: 2021-07-18
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:could not identify the cause of death.
CDC Split Type: JPPFIZER INC202100918049

Write-up: Cardio-respiratory arrest; feeling unwell; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21120702. The 90-year and 11-month-old female patient received on 16Jul2021 at unknown time (the day of vaccination), the second dose of BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown, Solution for injection, Lot number unknown, Expiration date not reported) via an unspecified route of administration as dose 2, single (at the age of 90 years) for COVID-19 immunisation. Body temperature before vaccination and family history were not reported. The patient''s concomitant medications were not reported. It was unknown whether there were 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 an unknown date at unknown time, the patient previously received the first dose of BNT162B2 (Manufacturer Unknown, Solution for injection, Lot number not reported, Expiration date not reported). On 17Jul2021 at 23:00 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: The patient had been visiting another hospital regularly since before, but the disease was unknown. On 16Jul2021 (the day of vaccination), the patient received the second coronavirus vaccination. On 17Jul2021 (1 day after the vaccination), the patient was sleeping because of feeling unwell since this morning (things like body temperature measurement were not done). Around 22:30, the family saw the patient going to the toilet. At that time, a retching sound was heard. Around 23:00, as the patient became silent, the family went to see his condition; he was found lying next to the toilet, and an ambulance was called. The patient was in a state of cardio-respiratory arrest when the emergency crews arrived. He was transported to the reporting hospital. Return of spontaneous was not obtained even with resuscitation, and death was confirmed. Postmortem computerised tomography (CT) could not identify the cause of death. On 18Jul2021 (2 days after the vaccination), the outcome of the event cardio-respiratory arrest was fatal and unknown outcome for the event feeling unwell. The patient died on 18Jul2021. It was not reported whether autopsy was done. 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: The patient was in a state of cardio-respiratory arrest on arrival at the reporting hospital. The postmortem examination determined the cause of death as endogenous death of unknown cause. The reporting physician commented as follows: The cause of death was unidentified. Because the patient was at a very old age of 90, it was unknown to what level there was a causal relationship with the vaccination. However, the physician reported this case because also the causal relationship with the vaccine-induced side effects could not be denied considering the complaint of physical deconditioning in the morning on the next day of the second vaccination.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1517337 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-29
Onset:2021-07-04
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Death, Magnetic resonance imaging
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diffuse large B-cell lymphoma (Five years ago)
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: CT; Result Unstructured Data: Test Result: No abnormality for brain tumour; Test Date: 20210621; Test Name: MRI; Result Unstructured Data: Test Result: No abnormality for brain tumour
CDC Split Type: JPPFIZER INC202100918086

Write-up: Death; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. An 80-year-old male patient received bnt162b2 (COMIRNATY), intramuscular administered in left arm on 29Jun2021 14:30 (Batch/Lot Number: FA5765; Expiration Date: 30Sep2021) (at the age of 80-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications 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. Medical history included diffuse large b-cell lymphoma from 2016 (Five years ago). The patient''s concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021), via intramuscular in the left arm for COVID-19 immunization and seven days after the vaccination, the patient could not stand up because of pain of lower extremities. On 04Jul2021 at 21:00 (5 days after the vaccination), the patient died. The cause of death was reported as "Unknown." The course of the event was reported as follows: Seven days after the first dose of the vaccination, the patient could not stand up because of pain of lower extremities. The patient received computerised tomography on 18Jun2021 and magnetic resonance imaging on 21Jun2021 at another hospital, where the patient''s primary care physician saw his brain tumour (diffuse large B-cell lymphoma). The results of examinations revealed no abnormality for brain tumour. The patient died 5 days after the second vaccination. It was unknown if the patient received treatments for the event. The reporting physician assessed the event as serious (Death). Autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19.; Sender''s Comments: The event of death is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but consider also possible contributory effects from patient''s medical history, elderly age, and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1517338 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-18
Onset:2021-05-24
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Decreased activity, Urinary tract infection
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-06
   Days after onset: 43
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 INC202100918174

Write-up: urinary tract infection; decreased activities of daily living (ADL); This is a spontaneous report from a contactable physician received from Medical Devices Agency.The patient was an 81-year-old male. Body temperature before vaccination was not reported. Family history was not reported. 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) were unknown since the patient was not vaccinated at the reporting hospital. On 18May2021 (the day of vaccination), the patient received the first dose of BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown, 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 24May2021 (6 days after the vaccination), the patient experienced decreased activities of daily living (ADL). On 06Jul2021 (49 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: Before the vaccination, the patient was able to walk normally. On 18May2021, the patient received the first dose of COVID-19 vaccine at another hospital. 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 urinary tract infection. The reporting physician commented as follows: The patient received the vaccine at another hospital. Outcome of the event urinary tract infection was unknown, and decreased activities of daily living (ADL) was fatal. The patient died on 06Jul2021. It was unknown if autopsy was done. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: decreased activities of daily living (ADL)


VAERS ID: 1517339 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-04
Onset:2021-07-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5422 / 1 - / -

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: 2021-07-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Arteriosclerosis obliterans; Diabetes mellitus; Hyperlipidaemia; Late effects of cerebral infarction
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210704; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccinaiton
CDC Split Type: JPPFIZER INC202100918339

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21120243. A 65-year-old (also reported as 65-year and 6-month-old) male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: EY5422, expiration date: 31Aug2021), via an unspecified route of administration on 04Jul2021 (at the age of 65-years-old -as reported) at dose 1, single for COVID-19 immunization. Body temperature before vaccination on 04Jul2021 was 36.7 degrees Centigrade. Medical history included late effects of cerebral infarction, diabetes mellitus, hyperlipidaemia, arteriosclerosis obliterans, which were all ongoing. He was receiving drugs at his nearby hospital for late effects of cerebral infarction, diabetes mellitus, hyperlipidaemia, arteriosclerosis obliterans, and others. The patient''s family history was not provided. On 04Jul2021 (the day of vaccination), the patient received the first dose of BNT162B2 (COMIRNATY). On 05Jul2021 at 10:25 (reported as one day after the vaccination), the patient experienced cardio-respiratory arrest. When the home-visiting nurse visited the patient''s home, he experienced cardio-respiratory arrest. On 05Jul2021 (reported as one day after the vaccination), the outcome of the event was fatal. The patient died on 05Jul2021 due to cardio-respiratory arrest. An autopsy was performed with the intervention of the local police. 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.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1517340 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-05
Onset:2021-07-01
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fall, Nausea, Oxygen saturation, Oxygen saturation decreased, Pyrexia, Somnolence, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stent insertion (5 years ago); Arrhythmia; Atrial fibrillation paroxysmal; Deep vein thrombosis; Parkinson''s syndrome; Thoracic aortic aneurysm
Allergies:
Diagnostic Lab Data: Test Date: 20210705; Test Name: Body temperature; Result Unstructured Data: Test Result:35.1 Centigrade; Comments: before vaccination; Test Date: 20210706; Test Name: Body temperature; Result Unstructured Data: Test Result:37.3 Centigrade; Test Date: 20210707; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Test Date: 20210706; Test Name: SpO2; Test Result: 87 %; Test Date: 20210707; Test Name: SpO2; Test Result: 96 %
CDC Split Type: JPPFIZER INC202100918354

Write-up: Sudden death; queasy; tendency for somnolence; pyrexia of 37.3 degrees centigrade / low grade fever; SpO2 87%; the patient fell in a toilet; This is a spontaneous report from a contactable physician received from the Pharmaceuticals and Medical Devices Agency (PMDA). Regulatory authority report number is v21120376. The patient was a 94-year and 2-month-old female. Body temperature before vaccination was 35.1 degrees Centigrade. Family history was not reported. Medical history included deep vein thrombosis, Parkinson''s syndrome, thoracic aortic aneurysm, stent-graft insertion for thoracic aortic aneurysm, arrhythmia, and paroxysmal atrial fibrillation (Paf). On 07Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY; Lot number: EY5420, Expiration date: 31Aug2021) intramuscular, single, for COVID-19 immunization. Concomitant medication included apixaban (ELIQUIS) taken orally for deep vein thrombosis, start date was not reported and ongoing. On 05Jul2021 at 11:10 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection; at the age of 94-years-old; Lot number FA5765, Expiration date 30Sep2021) intramuscular as a single dose for COVID-19 immunization. On 10Jul2021 at 19:53 (5 days 8 hours 43 minutes after the vaccination), the patient experienced sudden death. On 10Jul2021 (5 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: The patient had medical history of Parkinson''s syndrome, deep vein thrombosis, thoracic aortic aneurysm, etc., for which visited medical care has been provided. On 07Jun2021, the patient received the first dose of BNT162b2 intramuscularly and developed no pyrexia, etc. On 05Jul2021, the patient received the second dose of BNT162b2 intramuscularly. On 06Jul2021, a helper confirmed that the patient had pyrexia of 37.3 degrees centigrade and SpO2 87%. Home visiting nurse received a contact and on 07Jul2021, the nurse visited the patient. Body temperature was 36.6 degrees centigrade and SpO2 was 96%. The patient had tendency for somnolence to some extent. On 10Jul2021 at around noon, the patient called the eldest daughter and told that the patient had queasy. When the patient was visited, the patient fell in a toilet and the reporting clinic was contacted. On 10Jul2021 at 19:53, death was confirmed. The patient died a sudden death on 10Jul2021. An autopsy was not performed. Outcome of the other events 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 cause of the event such as any other diseases was as follows: Five years have passed since the patient had stent-graft insertion for thoracic aortic aneurysm. The patient had a history of Paf; thus, there was a possibility that the patient had lethal arrhythmia. The reporting physician also commented as follows: Since the patient had surgery for thoracic aortic aneurysm, arrhythmia, and deep vein thrombosis, it was considered that the patient died due to cardiovascular factor. Family member did not wish to have anatomy, etc.; however, family member requested to report the adverse reactions.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1517344 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-25
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Endocarditis, Myocarditis, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-03
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic leukaemia in remission
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202100918787

Write-up: Acute myocarditis; pericarditis; endocarditis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The Regulatory authority report number is v21120912. The patient was a 71-year and 7-month-old male. Body temperature before vaccination was not provided. The family history was not provided. The underlying disease: The patient was receiving chemotherapy for chronic neutrophilic leukemia, treating with VIDAZA, the last dose was performed on the 6th cycle between 25May2021 and 02Jun2021. The chronic neutrophilic leukemia was assessed as almost remission. Concomitant drugs included unspecified oral antihypertensive drug. On 16Jun2021 at 12:30 (the day of vaccination), at age of 71-year-old, the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY0779, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25Jun2021 (8 days after the vaccination), the patient experienced acute myocarditis, pericarditis, and endocarditis. On 30Jun2021 (14 days after the vaccination), the patient was admitted to the hospital. On 03Jul2021 (16 days after the vaccination), the outcome of the events was fatal. The action taken for VIDAZA was post-therapy. The course of the event was as follows: In Aug2020, the patient visited the department of hematology of the hospital. The patient was diagnosed with chronic neutrophilic leukemia, and chemotherapy with VIDAZA was performed. The condition in almost remission was maintained. On 16Jun2021 (the day of vaccination), at 12:30, the patient received the first dose of BNT162b2 vaccination (Pfizer product, Lot#EY0779) at hospital. On 25Jun2021 (8 days after vaccination), the patient had pyrexia. On 30Jun2021 (13 days after vaccination), the patient was admitted to the department of hematology. An antibiotic was being administered. On 03Jul2021 (16 days after vaccination), in the morning, the patient suddenly had cardiac arrest in the ward, and he died. Since the cause of death was unknown, after an autopsy imaging was performed, no particular abnormalities were observed, and an autopsy was performed. The pericardia fluid increased to 250 mL or more, and the cardiac weight increased to 580 g. An image of significant eosinophilic inflammatory cell infiltration was histologically observed in the both ventricles of the heart. Thus, acute myocarditis was diagnosed on the autopsy. The inflammation extended to the epicardium and endocardium. It was assumed that myocarditis progressed to pump failure or lethal arrhythmia. 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 as follows: Recently, the patient was administered VIDAZA. However, it was the 6th cycle. No particular abnormalities were observed until the 5th cycle. Other oral medications such as an antihypertensive drug were not changed. The reporting physician commented as follows: Although the causality between myocarditis and BNT162b2 vaccination was unknown, the timing was close, and thus, this case was reported. Of note, in this case, in the future, consultation would be made with the specialists of pathology or infectious pathology via the Regulatory Authority. It was to be consulted how far additional investigation could be made from paraffin block or formalin-soaked specimens. Reported Cause(s) of Death: Acute myocarditis; pericarditis; endocarditis; Autopsy-determined Cause(s) of Death: Acute myocarditis.


VAERS ID: 1517345 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210710; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210713; Test Name: autopsy imaging; Result Unstructured Data: Test Result:no abnormalities; Comments: The AI showed no abnormalities which led to the direct cause of death.; Test Date: 20210713; Test Name: Troponin T; Test Result: Positive ; Comments: the cardiac blood showed that troponin T positive
CDC Split Type: JPPFIZER INC202100918789

Write-up: Cardiac death; This is a spontaneous report from a contactable physician received from Medical Devices Agency. The patient was a 65-year and 5-month-old (at vaccination) male. Body temperature before vaccination was 36.5 degrees centigrade. The patient had medical history of hypertension. The patient had no allergic history. There was no history of vaccination within 2 weeks. Concomitant medication was unknown. On 10Jul2021 at 18:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FD0889, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 12Jul2021 at 13:00 (2 days after the vaccination), the patient experienced cardiac death. The outcome of the event was fatal. The course of the event was as follows: On 10Jul2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 12Jul2021 (2 days after vaccination), the patient was found to collapse in the factory of his working place. On 13Jul2021, at 11:50, an autopsy imaging (AI) and an autopsy were performed at the reporting hospital. The AI showed no abnormalities which led to the direct cause of death. Since the cardiac blood showed that troponin T positive, the cause of death was determined as cardiac death. The estimated time of death was around 13:00 on 12Jul2021. 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. The reporting physician commented as follows: The causality between the death and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: Cardiac death; Autopsy-determined Cause(s) of Death: cardiac death


VAERS ID: 1517359 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-06
Onset:2021-07-09
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Myocardial infarction, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   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: PLAVIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Obstructive arteriosclerosis of lower extremities; Parkinson''s syndrome
Allergies:
Diagnostic Lab Data: Test Name: whole body CT after the death; Result Unstructured Data: Test Result:no haemorrhagic lesions in the brain; Comments: The whole body CT after the death (AI) showed no haemorrhagic lesions in the brain nor fracture . No abnormalities were observed in the major blood vessels.
CDC Split Type: JPPFIZER INC202100918919

Write-up: Sudden death; myocardial infarction was suspected; This is a spontaneous report from a contactable physician received from Medical Devices Agency. The patient was an 83-year and 4-month-old (at vaccination) female. The patient had medical histories of Parkinson''s syndrome, obstructive arteriosclerosis of lower extremities and hypertension. The patient''s activity of daily living (ADL) was reported as able to move with a walker. The concomitant medication included ongoing clopidogrel bisulfate (PLAVIX) taken orally. On 06Jul2021 at 13:30 (the day of vaccination), the patient received the first 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 09Jul2021 at 19:30 (3 days after the vaccination), the patient experienced sudden death. The outcome of the event was fatal. It was unknown if autopsy was performed. The course of the event was as follows: On 09Jul2021, at 19:30 (3 days after vaccination), the patient was found to collapse at her room, and an ambulance was called. When the patient was transferred to the emergency hospital, she was in cardio-respiratory arrest. Although resuscitation was performed, no return of spontaneous circulation was obtained, and the patient died. The whole body CT after the death (AI) showed no haemorrhagic lesions in the brain nor fracture. No abnormalities were observed in the major blood vessels. Cardiogenic disease such as myocardial infarction was suspected. 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. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown; however, the patient experienced sudden death on Day 3 after the vaccination, and this case was reported. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Sudden death; myocardial infarction was suspected


VAERS ID: 1517371 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-24
Onset:2021-03-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9605 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Alanine aminotransferase, Amylase, Aspartate aminotransferase, Bilirubin conjugated, Blood albumin, Blood alkaline phosphatase, Blood bilirubin, Blood chloride, Blood cholesterol, Blood cholinesterase, Blood creatine phosphokinase, Blood creatinine, Blood glucose, Blood lactate dehydrogenase, Blood potassium, Blood pressure measurement, Blood sodium, Blood triglycerides, Blood urea, Blood uric acid, Body temperature, C-reactive protein, Cerebral haematoma, Cerebral haemorrhage, Cerebral ventricular rupture, Computerised tomogram, Dysarthria, Fibrin, Fibrin D dimer, Gamma-glutamyltransferase, Glycosylated haemoglobin, Haematocrit, Haemoglobin, Headache, Heart rate, Hepatitis B surface antigen, Hepatitis C RNA, Hepatitis C virus test, High density lipoprotein, Imaging procedure, Low density lipoprotein, N-terminal prohormone brain natriuretic peptide, Nausea, Oxygen saturation, Platelet count, Protein total, Prothrombin time, Red blood cell count, Respiratory rate, White blood cell count
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-29
   Days after onset: 2
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: URSODEOXYCHOLIC ACID; BEZAFIBRATE
Current Illness: Dyslipidaemia; Hepatitis C
Preexisting Conditions: Medical History/Concurrent Conditions: Appendicitis; Common cold (treated on 11Feb2018 in a hospital)
Allergies:
Diagnostic Lab Data: Test Date: 20210328; Test Name: APTT ratio; Result Unstructured Data: Test Result:1.03; Test Date: 20210328; Test Name: ALT; Result Unstructured Data: Test Result:15 IU/l; Test Date: 20210328; Test Name: Amylase; Result Unstructured Data: Test Result:95 IU/l; Test Date: 20210328; Test Name: AST; Result Unstructured Data: Test Result:45 IU/l; Test Date: 20210328; Test Name: bilirubin direct; Test Result: 0.06 mg/dl; Test Date: 20210328; Test Name: Alb; Result Unstructured Data: Test Result:5.3 g/dl; Test Date: 20210328; Test Name: ALP; Result Unstructured Data: Test Result:545 IU/l; Test Date: 20210328; Test Name: bilirubin total; Test Result: 0.43 mg/dl; Test Date: 20210328; Test Name: Chloride; Result Unstructured Data: Test Result:101 mEq/l; Test Date: 20210328; Test Name: Cholesterol total; Test Result: 229 mg/dl; Test Date: 20210328; Test Name: Cholinesterase; Result Unstructured Data: Test Result:399 IU/l; Test Date: 20210328; Test Name: CPK; Result Unstructured Data: Test Result:139 IU/l; Test Date: 20210328; Test Name: Creatinine; Test Result: 0.59 mg/dl; Test Date: 20210328; Test Name: blood glucose; Test Result: 240 mg/dl; Test Date: 20210328; Test Name: LDH; Result Unstructured Data: Test Result:409 IU/l; Test Date: 20210328; Test Name: K; Result Unstructured Data: Test Result:3.3 mEq/l; Test Date: 20210327; Test Name: BP; Result Unstructured Data: Test Result:185/116; Test Date: 20210328; Test Name: BP; Result Unstructured Data: Test Result:160/133; Test Date: 20210328; Test Name: Na; Result Unstructured Data: Test Result:140 mEq/l; Test Date: 20210328; Test Name: Triglycerides; Test Result: 118 mg/dl; Test Date: 20210328; Test Name: BUN; Test Result: 21.7 mg/dl; Test Date: 20210328; Test Name: Uric acid; Test Result: 4.5 mg/dl; Test Date: 20210324; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before the vaccination; Test Date: 20210328; Test Name: CT scan; Result Unstructured Data: Test Result:Cerebral hemorrhage (diffuse hemorrhage in the rig; Comments: Cerebral hemorrhage (diffuse hemorrhage in the right hemisphere, intraventricular perforation); Test Date: 20210328; Test Name: CRP; Test Result: 0.12 mg/dl; Test Date: 20210328; Test Name: Fibrin; Test Result: 358.7 mg/dl; Test Date: 20210328; Test Name: D-dimer; Result Unstructured Data: Test Result:1.2 ug/ml; Test Date: 20210328; Test Name: Gamma-GTP; Result Unstructured Data: Test Result:18 IU/l; Test Date: 20210328; Test Name: HbA1c; Test Result: 5.8 %; Test Date: 20210328; Test Name: Haematocrit; Test Result: 38.5 %; Test Date: 20210328; Test Name: Hb; Result Unstructured Data: Test Result:13.0 g/dl; Test Date: 20210327; Test Name: HR; Result Unstructured Data: Test Result:64; Comments: irregular; Test Date: 20210328; Test Name: HR; Result Unstructured Data: Test Result:55; Comments: irregular; Test Date: 20210328; Test Name: HBsAg; Result Unstructured Data: Test Result:negative; Test Date: 20210328; Test Name: HCV (quantitative); Result Unstructured Data: Test Result:5.14; Test Date: 20210328; Test Name: HCV (Qualitative); Test Result: Positive ; Test Date: 20210328; Test Name: HDL; Test Result: 67.8 mg/dl; Test Name: Brain imaging; Result Unstructured Data: Test Result:revealed a large hematoma with ventricular rupture; Comments: revealed a large hematoma with ventricular rupture; Test Date: 20210328; Test Name: LDL; Test Result: 119.3 mg/dl; Test Date: 20210328; Test Name: NT-proBNP; Result Unstructured Data: Test Result:155.8 pg/mL; Test Date: 20210327; Test Name: SPO2; Test Result: 97 %; Comments: Room air; Test Date: 20210328; Test Name: SPO2; Test Result: 95 %; Comments: Room air; Test Date: 20210328; Test Name: Platelet count; Result Unstructured Data: Test Result:216000 /mm3; Test Date: 20210328; Test Name: Protein total; Result Unstructured Data: Test Result:8.7 g/dl; Test Date: 20210328; Test Name: PT-INR; Result Unstructured Data: Test Result:0.88; Test Date: 20210328; Test Name: RBC; Result Unstructured Data: Test Result:4070000 /mm3; Test Date: 20210327; Test Name: RR; Result Unstructured Data: Test Result:20; Test Date: 20210328; Test Name: RR; Result Unstructured Data: Test Result:19; Test Date: 20210328; Test Name: WBC; Result Unstructured Data: Test Result:9700 /mm3
CDC Split Type: JPPFIZER INC202100968282

Write-up: Cerebral haemorrhage; Brain imaging revealed a large hematoma with ventricular rupture; Brain imaging revealed a large hematoma with ventricular rupture; developed dysarthria with complaints of headache and nausea; developed dysarthria with complaints of headache and nausea; developed dysarthria with complaints of headache and nausea; This case was initially received on 29MAR2021 and it was previously submitted under unique case identification number. However, due to human error, this master case was erroneously nullified. Therefore a new master has been created with the same information under manufacturer number. All subsequent follow-up will be reported under this manufacturer report number. This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution; and also via a Pfizer sales representative. A 72-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, Lot number: EP9605; Expiration Date: 30Jun2021) at the age of 72 years, dose 1 intramuscular on 24Mar2021 15:30 as dose 1, single for COVID-19 immunization. The patient was a non-pregnant and it was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was also was unknown whether the patient received any other medications within 2 weeks of vaccination. It was unknown the patient had been diagnosed with COVID-19 or had tested positive for COVID-19 prior to vaccination. It was unknown whether the patient had side effect history or received other vaccines prior to the COVID vaccine. It was also unknown whether the patient had side effect history after receiving any vaccines. The degree of care which the patient needed was unknown. The degree of independence in activities of daily living (ADL) was unknown. Her swallowing function and whether she was able to take orally were unknown. Abnormalities noted before and after vaccination were unknown. Medical history included ongoing hepatitis C, ongoing dyslipidaemia, appendicitis, common cold (treated on 11Feb2018 in a hospital). The patient did not have any histories of allergy, smoking or alcohol intake. The patient''s concomitant medications included ursodeoxycholic acid and bezafibrate both taken orally from an unknown date to 28Mar2021. The patient body temperature before vaccination was 36.2 degrees Centigrade (24Mar2021). On 27Mar2021 at 21:00 (3 days after the vaccination), the patient has gone to bed. On 27Mar2021 23:30, the patient was found to have following abnormalities: headache, queasy and inarticulateness. The patient experienced cerebral hemorrhage and was in need of treatment in an emergency room/department or urgent care. Medical checkup conducted when members of an ambulance crew arrived showed that JCS II-20, RR 20, Spo2 97% (room air), BP 185/116 and HR 64 irregular. The event resulted in hospitalization. On the same day at 23:30, the patient complained of headache, nausea, Dysarthria. On 28Mar2021 (4 days after the vaccination), the patient was transported to the reporter''s institution at 00:42. Clinical course and therapeutic measures taken while she was transported were unknown. Physical examination conducted when the patient was arrived at the hospital showed that JCS III-100, BP 160/133, HR 55 irregular, RR 19, Spo2 95% (room air), MMT: rt-upper 5, rt-lower 5, It-upper 0, It-lower 1. The patient underwent lab test included computerized tomogram scan results on 28Mar2021 which showed that it was cerebral hemorrhage (diffuse hemorrhage in the right hemisphere, intraventricular perforation), and the patient has been diagnosed with cerebral hemorrhage. Surgery or life-prolonging treatment for the event was not desired, so the patient was followed up. On 28Mar2021, therapeutic measures were taken as a result of cerebral hemorrhage. Therapeutic measures for the event included transfusion (hemostatic agent, intracranial pressure-lowering agent and antihypertensive). On 28Mar2021, the patient visited the hospital and underwent lab tests and procedures which included APTT ratio (activated partial thromboplastin time ratio): 1.03, ALT: 15 iu/l, Amylase: 95 iu/l, AST: 45 iu/l, bilirubin direct: 0.06 mg/dl, blood albumin: 5.3 g/dl, ALP: 545 iu/l, bilirubin total: 0.43 mg/dl, Chloride: 101 meq/l, Cholesterol total: 229 mg/dl, Cholinesterase: 399 iu/l, Blood creatine phosphokinase (CPK): 139 iu/l, Creatinine: 0.59 mg/dl, blood glucose: 240 mg/dl, Blood lactate dehydrogenase (LDH): 409 iu/l, Blood potassium (K): 3.3 mEq/L, Blood sodium (Na): 140 mEq/L, Triglycerides: 118 mg/dl, blood urea nitrogen (BUN): 21.7 mg/dl, Uric acid: 4.5 mg/dl, CRP: 0.12 mg/dl, Fibrin: 358.7 mg/dl (150-350), D-dimer: 1.2 ug/ml (0-1.0), Gamma-GTP: 18 iu/l, HbA1c: 5.8 %, Haematocrit: 38.5%, Haemoglobin: 13.0 g/dl, Hepatitis B surface antigen (HBsAg): negative, HCV (quantitative): 5.14, HCV (Qualitative): positive, HDL: 67.8 mg/dl, LDL: 119.3 mg/dl, NT-proBNP: 155.8 pg/mL, Platelet count: 216000 /mm^3 (11.7-33.6), Protein total: 8.7 g/dl, PT-INR (Prothrombin time): 0.88, RBC: 4070000 /mm^3, WBC: 9700 /mm^3. On 29Mar2021 at 10:52 (5 days after the vaccination), the patient''s death has been confirmed in spite of the treatment with infusion of hemostatic agents, cerebral hypotensive agents, and antihypertensive agents. Surgery or life-prolonging treatment for the event was not desired, so the patient was followed up. An autopsy was not performed. The patient died due to cerebral haemorrhage. Diagnostic imaging at the time of her death or autopsy was not conducted. It was inferred that there was no direct relationship to vaccination. The reporting physician considered that the patient died of cerebral haemorrhage. The reporting physician''s considerations for the causal relationship between vaccination and death (including evidence of assessment) was reported as unknown. No follow-up attempts are possible, and no information is required. Follow-up (30Mar2021): This is a follow-up report from a same contactable physician received from Medical Devices Agency. New information included: added relevant medical history, added lab data. The reporter''s comment: base on the results of clinical lab test, no coagulation abnormal was observed. Follow-up attempts are completed. No further information is expected. Follow-up (01Apr2021): New information received from the same contactable physician via a Pfizer sales representative includes: causality assessment from the reporter, concomitant medication updated, therapeutic measures for the events updated, patient medical history was updated, laboratory information, clinical information details. A 72-year-old female patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunization. Medical history included hepatitis c, dyslipidemia, both from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. Three days after the first shot of tozinameran, she developed dysarthria with complaints of headache and nausea. Brain imaging revealed a large hematoma with ventricular rupture. Her platelet count was 216,000/mm3. She died 5 days after receiving tozinameran. The outcome of the events was


VAERS ID: 1517406 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0889 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-15
   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: PREDONINE [PREDNISOLONE]; DAIPHEN; BAYASPIRIN; TAKECAB; THYRADIN; DIOVAN; AMLODIPINE; DIART [AZOSEMIDE]; ALDACTONE [SPIRONOLACTONE]; LAGNOS; REFLEX [MIRTAZAPINE]; CONTOMIN [CHLORPROMAZINE HIBENZATE]; JARDIANCE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Hypothyroidism; Lung cancer
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021902203

Write-up: Pulmonary embolism (dyspnoea and respiratory failure); This is a spontaneous follow-up report from a non-contactable pharmacist via COVID-19 Adverse Event Self-Reporting Solution. An 84-year-old female patient received BNT162B2 (COMIRNATY; Lot Number: FD0889; Expiration Date: 30Sep2021), intramuscular, in left arm on 07Jul2021 (at the age of 84-years-old) as dose 2, single for COVID-19 immunization. Medical history included lung cancer, hypothyroidism, diabetes mellitus, and dyslipidaemia. There was no relevant past drug history. There were no known allergies. Concomitant medication included prednisolone (PREDONINE), sulfamethoxazole, trimethoprim (DAIPHEN), acetylsalicylic acid (BAYASPIRIN), vonoprazan fumarate (TAKECAB), thyroid (THYRADIN), valsartan (DIOVAN), amlodipine, azosemide (DIART), spironolactone (ALDACTONE), lactulose (LAGNOS JELLY), mirtazapine (REFLEX), chlorpromazine hibenzate (CONTOMIN), and empagliflozin (JARDIANCE). The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered at the nursing home/senior living facility. 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. Since the vaccination, the patient has not been tested for COVID-19. On 16Jun2021 at unknown time, the patient previously received the BNT162b2 (COMIRNATY, Solution for injection, Lot number EY3860, Expiration date 31Aug2021) intramuscularly in the left arm as dose 1, single for COVID-19 immunization. On 07Jul2021 at unknown time (the day of vaccination), the patient received the second dose of vaccine. On 15Jul2021 at 17:00 (8 days after the vaccination), the patient experienced pulmonary embolism (dyspnoea and respiratory failure). After changing position at the time of diaper changing, the patient experienced dyspnoea and respiratory failure. The cause was diagnosed as pulmonary embolism. The reporter stated that the adverse events resulted in doctor or other healthcare professional office/clinic visit and death on 15Jul2021. The death cause was pulmonary embolism. No autopsy was performed. Treatment was not given for the adverse events. The reporting pharmacist assessed the event as serious (death). The causality of the events was not reported. The outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the temporal relation, the association between pulmonary embolism and suspect drug cannot be completely ruled out. The contribution of patient''s age cannot be completely ruled out in the occurrence of the events. 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: Pulmonary embolism


VAERS ID: 1517409 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cardiac death, Pyrexia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-30
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DILTIAZEM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac valvulopathy
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021902546

Write-up: Acute cardiac death; The patient vomited several times; A high fever persisted; This is a spontaneous report from a physician via COVID-19 Adverse Event Self-Reporting Solution and also via Medical Devices Agency. The patient was a 72-year-old male. The most recent COVID-19 vaccine was administered at the hospital. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included diltiazem (DILTIAZEM). There was no relevant past drug history. There were no known allergies. Other medical history included cardiac valvulopathy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Jun2021 at 14:30, the patient previously received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscularly in the right arm for COVID-19 immunisation. On 22Jun2021 at 14:30 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EX3617, Expiration date 31Aug2021) intramuscularly in the right arm for COVID-19 immunisation. On 30Jun2021 at 17:00 (8 days after the vaccination), the patient experienced acute cardiac death. The reporter stated that the adverse event resulted in death. The death cause was acute cardiac death. No autopsy was performed. Treatment was not given for the adverse event. The reporting physician assessed the event as serious (death). The causality of the event was not reported. Upon follow-up it was reported that patient''s body temperature before vaccination was 36.4 degrees centigrade. On 22Jun2021 at unknown time (the day of vaccination), a high fever persisted after the COVID-19 vaccination. On 29Jun2021 at night (7 days after the vaccination), the patient vomited several times. The course of the events was as follows: On 22Jun2021 (the day of vaccination), a high fever persisted after the COVID-19 vaccination. The patient could not eat from 28Jun2021, and on 29Jun2021 at night, the patient vomited several times. On 01Jul2021 at 20:40, postmortem examination was performed (details was not reported). The reporting physician assessed the causality between the event (acute cardiac death) and BNT162b2 as unassessable. The seriousness and causality of the other events were not reported. Other possible causes of the events such as any other diseases were unknown. The reporting physician commented as follows: On 01Jul2021 at 20:40, postmortem examination was performed.; Reported Cause(s) of Death: Acute cardiac death


VAERS ID: 1517411 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature
SMQs:, Acute central respiratory depression (broad), Hostility/aggression (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: ATELEC; FUROSEMIDE; MEVALOTIN
Current Illness: Hypertension (receiving treatment)
Preexisting Conditions: Medical History/Concurrent Conditions: Subarachnoid haemorrhage
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021902813

Write-up: Asphyxia; This is a spontaneous report from a contactable physician received from the Regulatory Authority (Regulatory Authority report number: V21119846). The patient was a 74-year and 5-month-old female. Body temperature on 24Jun2021 (before vaccination) was 36.5 degrees Centigrade. The family history was not provided. The patient had medical history of ongoing hypertension, for which she was receiving treatment; and subarachnoid haemorrhage (not ongoing). The concomitant medications included oral cilnidipine (ATELEC), furosemide, pravastatin sodium (MEVALOTIN) and unspecified hypertension medication; all were ongoing. On 24Jun2021 at 10:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number: EY0779; Expiration date: 31Aug2021) as dose 1, single, with route of administration unspecified, for COVID-19 immunization. On 27Jun2021 (3 days after the vaccination), the patient experienced asphyxia. On 27Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 24Jun2021 (the day of vaccination), at 10:00, the patient received the first dose of BNT162b2 vaccination. At the time of vaccination, no side reactions were observed. On 26Jun2021 (2 days after vaccination), it was confirmed that the patient was fine by her neighbor. On 30Jun2021 (6 days after vaccination), the patient was found dead leaning forward in the kitchen sink. It was specified that the patient died on 27Jun2021 (3 days after vaccination) on the inquest by the police. The cause of death was 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 as follows: The patient had medical history of subarachnoid haemorrhage (past history), a disease which could cause vomiting. The reporting physician commented as follows: A large amount of pieces of meats which the patient seemed to have eaten were removed from the oral cavity of the dead body. Since there was no incidence, no autopsy was performed. The causality between the event and BNT162b2 vaccination was unknown.; Reported Cause(s) of Death: Asphyxia


VAERS ID: 1517421 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Condition aggravated, Heart rate decreased, Loss of consciousness, Myelodysplastic syndrome, Septic shock
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic cytopenias affecting more than one type of blood cell (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), Toxic-septic shock conditions (narrow), Blood premalignant disorders (narrow), Acute central respiratory depression (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 (narrow), Respiratory failure (broad), Hypoglycaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ROMIPLATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic stenosis; Atrial fibrillation; Cancer of transverse colon; Cardiac failure; Colon adenoma (after polypectomy); ESBL producing bacteria test positive; Gastric cancer; Idiopathic thrombocytopenic purpura (ROMIPLATE was administrated); Lung cancer; Myelodysplastic syndrome; Polypectomy; Radiotherapy; Spondylosis; Tuberculosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021903086

Write-up: pulse rate decreased, and the patient had cardiac arrest; pulse rate decreased, and the patient had cardiac arrest; Loss of consciousness; Septic shock; Myelodysplastic syndrome aggravation; Myelodysplastic syndrome aggravation; This is a spontaneous report from a contactable pharmacist received from Medical Devices Agency. The patient was an 85-year and 1-month-old female. Body temperature before vaccination was not provided. The family history was not provided. The patient'' medical history included as follows: idiopathic thrombocytopenic purpura, for which she was administered romiplostim (ROMIPLATE) 250 ug/week, myelodysplastic syndrome, cardiac failure, atrial fibrillation, aortic stenosis, after radiotherapy for lung cancer, colon adenoma (after polypectomy), after surgery for gastric cancer, cancer of transverse colon, cervical spondylotic myelopathy, ESBL producing Escherichia carrier, and tuberculosis. On 02Jun2021, the patient previously received the first dose of COVID-19 Vaccine (manufacturer Unknown, Lot# not reported, Expiration date not reported) for COVID-19 immunization. On 23Jun2021 (the day of vaccination), the patient received the second dose of COVID-19 Vaccine (Manufacturer Unknown, Solution for injection, Lot number reported as unknown, Expiration date reported as unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 25Jun2021 at 08:00 (2 days and 8 hours after the vaccination), when the patient got in a car, she suddenly lost consciousness. At 09:00 (2 days and 9 hours after vaccination), an ambulance was called, and the patient was transferred to the reporting hospital. The patient was admitted to the hospital. Since the patient was suspected to have septic shock, administration of meropenem hydrate (MEROPENEM) was initiated. Diltiazem hydrochloride 6 mg/hour and noradrenaline 0.5 mg/hour were continuously administered. At around 17:00 (2 days and 17 hours after vaccination), the pulse rate decreased, and the patient had cardiac arrest. On 25Jun2021 at 17:36 (2 days, 17 hours, and 36 minutes after vaccination), death was confirmed. The direct cause of death on the death certificate: Septic shock (the cause: myelodysplastic syndrome) (the blood culture on hospitalization showed no bacteria). The date of discharge from the hospital was reported as 25Jun2021. It was not reported if an autopsy was performed. The reporting pharmacist classified the events as serious (hospitalization and death) and assessed that the events were unrelated to COVID-19 Vaccine. Other possible cause of the events such as any other diseases was myelodysplastic syndrome. The reporting pharmacist commented as follows: The patient had septic shock after the second dose of COVID-19 vaccination. It was considered that the septic shock was caused by aggravation of myelodysplastic syndrome. It was considered that the events were unrelated to COVID-19 Vaccine; however, this case was reported as adverse events after the vaccination. Pfizer is a marketing authorization holder of COVID-19 Vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 Vaccine has submitted the same report to the regulatory authorities.; Sender''s Comments: Based on close temporal relationship the role of the usage of the COVID-19 vaccine in triggering/contributing to the events loss of consciousness, septic shock, cardiac arrest, pulse rate decreased, myelodysplastic syndrome aggravation cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: pulse rate decreased, and the patient had cardiac arrest; Septic shock; Myelodysplastic syndrome aggravation; Myelodysplastic syndrome aggravation; pulse rate decreased, and the patient had cardiac arrest; Loss of consciousness


VAERS ID: 1517456 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-31
Onset:2021-06-04
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Computerised tomogram, Intestinal obstruction, Peritonitis
SMQs:, Gastrointestinal obstruction (narrow), Gastrointestinal perforation (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210531; Test Name: Body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: before vaccination; Test Date: 20210604; Test Name: CT; Result Unstructured Data: Test Result:intestinal obstruction
CDC Split Type: JPPFIZER INC2021904404

Write-up: Intestinal obstruction; Peritonitis; This is a spontaneous report from a contactable physician received from Medical Devices Agency. A 91-year-old male patient received BNT162B2 (COMIRNATY) at the age of 91-years-old, via an unspecified route of administration on 31May2021 14:30 (Batch/Lot Number: EY0779; Expiration Date: 31Aug2021) as dose 1, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient was a 91-year-old male. Body temperature before vaccination was 36.2 degrees centigrade. Family history 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). On 04Jun2021 (4 days after the vaccination), the patient experienced intestinal obstruction and peritonitis, the patient was admitted to the hospital, the outcome of the events was fatal. The course of the event was as follows: After the vaccination, the patient had abdominal pain and diarrhoea. The symptoms tended to alleviate. On 03Jun2021, mild abdominal pain recurred, and the patient had bloating. Since there was no improvement, on 04Jun2021, the patient visited a hospital. As a result of CT, diagnosis of intestinal obstruction was made, for which the patient was hospitalized. Subsequently, on the same day, the patient developed peritonitis and died. The patient died on 04Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Intestinal obstruction; Peritonitis


VAERS ID: 1517461 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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 INC2021905756

Write-up: Death; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. It was reported that on unknown date in 2021 (the day of vaccination), the patient received a single dose of BNT162b2. On unknown date in 2021 (unknown days after the vaccination), the patient experienced death. The course of the event was as follows: On unknown date in 2021, the patient died shortly after s/he went home. The outcome of event was fatal. It was not reported if an autopsy was performed.; Sender''s Comments: The reported event of death with unknown cause is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Different patient, different AE, same reporter, same drug; Reported Cause(s) of Death: death


VAERS ID: 1517474 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-30
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 2021-06-30
   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 INC2021908099

Write-up: Sudden death; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 83-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 22Jun2021 (the day of vaccination, Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 30Jun2021 (8 days after the vaccination), the patient experienced sudden death. The patient died on 30Jun2021. It was not reported if an autopsy was performed. The reported event was as follows: On 22Jun2021 (the day of vaccination), the patient received the first dose of BNT162b2 vaccination. On 30Jun2021 (8 days after vaccination), the patient experienced sudden death. The patient had no underlying diseases and he died suddenly. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1517607 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-15
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Nasopharyngitis, 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: 2021-04-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCORTISONE; NIFEDIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Left ventricular hypertrophy; Polymyalgia rheumatica; Subclinical hypothyroidism
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100915914

Write-up: mild cold/Common cold; Death, acute/Sudden death; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency. A 74-year-old male patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), via an unspecified route of administration on 12Apr2021 as dose 1, single for COVID-19 immunisation. Medical history included subclinical hypothyroidism, hypertension, left ventricular hypertrophy and polymyalgia rheumatica from an unknown date. Concomitant medications included hydrocortisone and nifedipine, both taken for an unspecified indication, start and stop dates were not reported. The patient experienced Death, acute/Sudden death on 15Apr2021 and mild cold/common cold on an unspecified date. The clinical course was as follows: Patient was found collapsed in a shower cabinet. He was alone and found a couple of minutes later. Resuscitation was unsuccessful. Cause of death remains unknown: possible arrhytmia, myocardial infarct, cerebral hemorrhage. No autopsy is done. As far as known patient had no side effects after vaccination. On the day of his death patient had symptoms of a common cold, no fever. The outcome of the event Death, acute/Sudden death was fatal, while of mild cold/common cold was unknown. The patient died on 15Apr2021. An autopsy was not performed. Reporter Comment: Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Additional information ADR: Acute death Previous COVID-19 infection: No 14Jul2021 Follow up received: 1. Natural death. I don''t know what is listed. differential diagnosis arrhythmia, myocardial infarction, massive brain haemorrhage (GP told me), 2. No known side effects, 3. I thought a mild cold, not a fever, 4. Collapsed in shower cubicle, tap was not on yet. He was alone, was found a few minutes later., 5. Polymyalgia rheumatica, subclinical hypothyroidism, hypertension, left ventricular hypertrophy, 6. 1x recording due to a torn knee ligament for which OK, 7. High Blood Pressure $g Nifedipine. polymyalgia rheumatica $g hydrocortisone, low dose, 8. Vital man, lived independently with wife, 9. No deteriorating health, except rheumatism complaints since 1 yr, which got better. No other complaints, vital., 10. No, not tested, 11. No autopsy done Assessor Lareb: FU received. No autopsy, cause of death remains unknown. Cold reaction added. Medical history added. Comedication added. Summary edited. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected; Reporter''s Comments: summary: BioNTech/Pfizer vaccine (Comirnaty) Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no Passing away Additional information ADR: Acute death COVID-19 Previous COVID-19 infection: No; Reported Cause(s) of Death: Death, acute


VAERS ID: 1517608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-12
Onset:2021-04-26
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Oedema peripheral
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Anaphylactic reaction (broad), 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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: NOVORAPID
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100915727

Write-up: cardiac arreststil; Fat ankles, death; Fat legs, death; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency. This serious spontaneous report from a consumer professional concerned a female aged 74 years. A 74-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 12Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medication included insulin aspart (NOVORAPID). The patient had no previous COVID-19 infection. The patient experienced fat ankles, death and fat legs, death on 26Apr2021 with fatal outcome; and cardiac arreststil on 12May2021 with fatal outcome. The patient died on 12May2021. It was not reported if an autopsy was performed. Reporter''s comment: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Previous COVID-19 infection: No. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: BioNTech/Pfizer vaccine (Comirnaty). Past drug therapy BioNTech/Pfizer vaccine (Comirnaty): no. Previous COVID-19 infection: No.; Reported Cause(s) of Death: Fat ankles, death; Fat legs, death; cardiac arreststil


VAERS ID: 1517613 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Malaise, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ANTIGRIPPINE [ASCORBIC ACID;CAFFEINE;PARACETAMOL]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC202100948822

Write-up: Myalgia; Not feeling well; Fatigue; Pain in the joints; Cold shivers; This is a spontaneous report received from a contactable consumer or other non hcp downloaded from the Medicines Agency. A 65-years-old male patient received a dose of bnt162b2 (COMIRNATY, Batch/Lot Number: Unknown), via an unspecified route of administration on 15Jun2021 as Dose number unknown, Single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ascorbic acid, caffeine, paracetamol (ANTIGRIPPINE) taken for an unspecified indication, start and stop date were not reported. On 16Jun2021, the patient experienced myalgia, not feeling well, fatigue, pain in the joints, cold shivers. The patient died on an unspecified date. Therapeutic measures were taken as a result of myalgia, not feeling well, fatigue, pain in the joints, cold shivers. The patient died on an unspecified date. It was not reported if an autopsy was performed. The patient was treated with Ibuprofen. The clinical outcome of event was fatal. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reporter''s Comments: Past drug therapy BioNTech/Pfizer vaccin (Comirnaty): unknown Previous COVID-19 infection: No; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1517647 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC2021908105

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient 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: death


VAERS ID: 1517648 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC2021908116

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient 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: death


VAERS ID: 1517649 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC2021908122

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient 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: death


VAERS ID: 1517650 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC2021908123

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. 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: death


VAERS ID: 1517651 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC2021908124

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Med safe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 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: death


VAERS ID: 1517652 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC2021908125

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Med safe. Regulatory authority report number is unknown. A patient of unspecified age and gender received BNT162B2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about Lot/Batch number cannot be obtained.; Reported Cause(s) of Death: death


VAERS ID: 1517653 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC2021908126

Write-up: death; This is a spontaneous report from a contactable other health care professional via the Medsafe. Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. 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: death


VAERS ID: 1517654 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NZPFIZER INC2021908127

Write-up: death; This is a spontaneous report from a contactable other health care professional via the . Regulatory authority report number is unknown. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 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: death


VAERS ID: 1517694 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-03
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Embolism, Infarction, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension (Patient was taking medications for the treatment of hypertension.); Post-traumatic epilepsy (Patient was taking medications for the treatment of post-traumatic epilepsy)
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLJNJFOC20210758721

Write-up: FEVER 38.0 - 38.4 C LASTING UP TO 48 HOURS; SUSPICION OF INFARCTION/EMBOLISM; SUSPICION OF INFARCTION/EMBOLISM; This spontaneous report received from a physician via a Regulatory Authorityconcerned a 47 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension, and post-traumatic epilepsy. The patient was on medication for treatment of hypertension, and post-traumatic epilepsy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD975 expiry: 27-OCT-2021) 0.5 dose (units unspecified), 1 total administered on 27-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021; 20:30, the patient experienced suspicion of infarction/embolism (coded as Infarction), suspicion of infarction/embolism (coded as embolism). On an unspecified date, the patient experienced fever 38.0 - 38.4 c lasting up to 48 hours. On 03-JUN-2021, the subject died from infarction, and embolism. 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 suspicion of infarction/embolism (Infarction) and suspicion of infarction/embolism (embolism) on 03-JUN-2021, and the outcome of fever 38.0 - 38.4 c lasting up to 48 hours was not reported. This report was serious (Death, and Other Medically Important Condition).; Covid-19 vaccine ad26.cov2.s- Suspicion of infarction/embolism(Embolism), Suspicion of infarction/embolism(Infarction). This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE -Covid-19 vaccine ad26.cov2.s-Fever 38.0 - 38.4?C lasting up to 48 hours. This event(s) is labeled per RSI and is therefore considered potentially related.; Reported Cause(s) of Death: INFARCTION; EMBOLISM


VAERS ID: 1517701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-07
Onset:2021-06-21
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2172 / 2 - / OT

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: 2021-06-24
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PTPFIZER INC202100949261

Write-up: stroke; This is a spontaneous report from a contactable consumer downloaded from the Medicines Agency. A 69-years-old male patient received BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number: EY2172; CAUL (Additional information on drug): 22021), dose 2 intramuscular on 07May2021 as dose 2, 0.3ml single for COVID-19 immunisation. The indication verbatim was reported as indicated for active immunization to prevent COVID-19 caused by the SARS-CoV-2 virus. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (COMIRNATY; Solution for injection; Batch/Lot Number: EW2243; (CAUL (Additional information on drug): 17621), dose 1 Intramuscular on 09Apr2021 as dose 1, 0.3 ml single for COVID-19 immunisation. On 21Jun2021, the patient experienced stroke. The adverse reaction (ADR) started 45 days after the administration of the 2nd dose of the suspected vaccine. The notifier was contacted in order to obtain additional information, but no response was obtained, so the clinical history, concomitant medication and results of complementary diagnostic tests are unknown. The patient was hospitalized and died 3 days later. The patient died due to Stroke on 24Jun2021. It is unknown whether an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Stroke


VAERS ID: 1517765 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-01
   Days after onset: 30
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202100915865

Write-up: HEAVY TO BREATHE; GENERAL FEELING OF ILLNESS; TIREDNESS; This is a spontaneous report from a contactable consumer professional downloaded from the Medicines Agency. This consumer reported different events for the same patient after different vaccine doses. This is the first of two reports. Both cases are serious. An 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY, solution for injection) via an unspecified route of administration on Apr2021 (Lot Number: Unknown) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. A few days after the first vaccination in Apr2021, patient experienced general feeling of illness (general malaise), tiredness (fatigue) and heavy to breathe (difficulty breathing). The second dose was given in May2021 (as reported). The outcome of the events was fatal. The case was reported as serious, death. The patient died in May2021. An autopsy was performed and results were not provided. No follow-up attempts are possible. Information on batch number cannot be obtained.; Reported Cause(s) of Death: HEAVY TO BREATHE; GENERAL FEELING OF ILLNESS; TIREDNESS


VAERS ID: 1517801 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-24
Onset:2021-03-12
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Aphasia, Cerebral ischaemia, Computerised tomogram head, Facial paralysis, Muscular weakness
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-01
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210312; Test Name: CT angiography; Result Unstructured Data: Test Result:without occlusion or stenosis of cerebral vessels.; Comments: without occlusion or stenosis of cerebral vessels.; Test Date: 20210312; Test Name: CT brain; Result Unstructured Data: Test Result:without early focal changes and sign of dense arte; Comments: without early focal changes and sign of dense artery, CT angiography without occlusion or stenosis of cerebral vessels.; Test Date: 20210313; Test Name: CT brain; Result Unstructured Data: Test Result:developed ischaemia on the right frontoparietal an; Comments: developed ischaemia on the right frontoparietal and frontotemporal and in the basal ganglia.
CDC Split Type: SKPFIZER INC2021904877

Write-up: Focal cerebral ischaemia; his right oral corner hung /expressive aphasia/right hemiparesis /left hemiplegia developed; right upper limb weakened; his right oral corner hung /expressive aphasia/right hemiparesis /left hemiplegia developed; This is a spontaneous report from a contactable physician downloaded from the Medicines Agency. Case is a spontaneous serious case report sent by a physician. A 97-year-old male patient received bnt162b2 (COMIRNATY), via intramuscular on 24Feb2021 (Batch/Lot Number: Unknown) as DOSE 2, SINGLE for covid-19 immunisation. Concomitant therapy, medical history and additional details were not reported and have been requested. The patient experienced focal cerebral ischaemia on 12Mar2021. On 12Mar2021, the patient stopped talking, his right oral corner hung and his right upper limb weakened. Clinically on admission the patient had the expressive aphasia, he understood everything, but he had right hemiparesis with a central lesion of facial nerve (CN VII). Two hours later, left hemiplegia developed. The patient was transferred to the Geriatric Department, where he died shortly after. CT of the brain (12Mar2021): without early focal changes and sign of dense artery, CT angiography without occlusion or stenosis of cerebral vessels. CT of the brain (13Mar2021): developed ischaemia on the right frontoparietal and frontotemporal and in the basal ganglia. NUL - Focal cerebral ischemia right fronto-temporally and in the basal ganglia, clinically aphasia, right-sided hemiparesis. Causality assessment assessed by the pathologist was not yet available. The patient died in Mar2021. It was not reported if an autopsy was performed. The outcome of event focal cerebral ischaemia was reported as fatal, outcome of other event was unknown. No follow-up attempts possible. No further information expected. Information on batch number cannot be obtained.; Reported Cause(s) of Death: Focal cerebral ischaemia


VAERS ID: 1517802 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-28
Onset:2021-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Guillain-Barre syndrome, Paraesthesia, Paraesthesia oral, Pneumonia
SMQs:, Peripheral neuropathy (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-07
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic obstructive pulmonary disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKPFIZER INC2021904912

Write-up: Paraesthesia of limbs; Paraesthesia tongue; Weakness; Pneumonia; Guillain-Barre syndrome; This is a spontaneous report from a contactable consumer downloaded from the- Medicines Agency. This is the first of two reports reporting different events for different vaccine doses for the same patient. A 71-year-old male patient received BNT162B2 (COMIRNATY) intramuscular on 28Apr2021 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease. The patient''s concomitant medications were not reported. The patient previously received first dose of COMIRNATY (lot number were not reported) and experienced weakness and pain in upper extremity. The patient experienced guillain-barre syndrome on 01May2021 with outcome of fatal, pneumonia on an unspecified date with outcome of fatal, paraesthesia of limbs and paraesthesia tongue on 02May2021 with outcome of unknown, weakness on an unspecified date with outcome of unknown. The patient was hospitalized for paraesthesia of limbs and paraesthesia tongue from 02May2021. The patient died on 07May2021. An autopsy was performed and results were not provided. After the second dose, the patient was weaker. On the fourth day the patient had paraesthesia of upper and lower extremities and tongue. Emergency services was called on 02May2021 in the morning. The patient was hospitalized on Department of Neurology. The patient experienced Guillain-Barre syndrome. He could not cough as usual. Mucus accumulated in his lungs and he got severe pneumonia. On the third day of the hospitalization, the patient was transferred to the Department of Anesthesiology and Intensive Medicine, where he was in artificial sleep. The patient died on 07May2021. Autopsy was done. Guillain-Barre syndrome and pneumonia were assessed as cause of death. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Guillain-Barre syndrome; pneumonia


VAERS ID: 1517803 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-04-04
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-31
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: 2021-04-04
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SKPFIZER INC2021904956

Write-up: Death; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Medicines Agency. An 89-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01Apr2021 (Batch/Lot Number: Unknown), dose 1 on 03Mar2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported, after being vaccinated with the second dose of experimental gene therapy Comirnata from Pfizer / Biontech, in the 3rd and 4th phases of the clinical trial, the patient died within 72 hours (on 04Apr2021). It was the direct cause of her death. Her health was probably excellent, she could be part of the experiment. Ask for more information from the MD, who agreed and evaluated the health status of people in DSS. Cause of death and information about autopsy were not reported. Causality assessment assessed by the pathologist is not yet available. The primary source assessed death of the patient as a direct cause. No follow-up attempts are possible, information on batch number cannot be obtained.; Reporter''s Comments: The primary source assessed death of the patient as a direct cause.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1517812 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-09
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Headache, Myalgia, Pyrexia, Sepsis
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: TWMODERNATX, INC.MOD20212

Write-up: Sepsis (Sepsis); fatigue; headache; muscle ache; fever; This regulatory authority case was reported by a consumer and describes the occurrence of SEPSIS (Sepsis (Sepsis)), FATIGUE (fatigue), HEADACHE (headache), MYALGIA (muscle ache) and PYREXIA (fever) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, the patient experienced SEPSIS (Sepsis (Sepsis)) (seriousness criteria death and medically significant), FATIGUE (fatigue) (seriousness criterion death), HEADACHE (headache) (seriousness criterion death), MYALGIA (muscle ache) (seriousness criterion death) and PYREXIA (fever) (seriousness criterion death). The reported cause of death was Fatigue, Sepsis, Fever, Muscle ache and Headache. It is unknown if an autopsy was performed. Concomitant medication was not provided by reporter. No treatment information was provided. Company Comment A 73-year-old male patient experienced sepsis, fatigue, headache, myalgia and pyrexia 6 days following vaccination with mRNA-1273 and subsequently died. Very limited information regarding these events has been provided at this time. No information regarding patient''s medical history nor concomitant medicatons was provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Sender''s Comments: A 73-year-old male patient experienced sepsis, fatigue, headache, myalgia and pyrexia 6 days following vaccination with mRNA-1273 and subsequently died. Very limited information regarding these events has been provided at this time. No information regarding patient''s medical history nor concomitant medicatons was provided. It is also unknown if an autopsy was performed. Causality is confounded with patient''s advanced age.; Reported Cause(s) of Death: fatigue; sepsis; fever; muscle ache; headache


VAERS ID: 1518329 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-07-12
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Dyspnoea
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), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100909570

Write-up: Cardiac arrest; Shortness of breath; This is a spontaneous report from a contactable other health care professional. A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Jun2021 (at the age of 69-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included cardiac disorder. The patient concomitant medications were not reported. On 12Jul2021, the patient experienced cardiac arrest and shortness of breath. The event cardiac arrest assessed as serious (death, medically significant). On 12Jul2021, the patient died. An autopsy was not performed. The outcome for shortness of breath was unknown as reported. Case comment: Based on available information, a possible contributory role of bnt162b2 vaccine can not be excluded for the reported event of Cardiac arrest due to temporal relationship and current known drug safety profile. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product was 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, would be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. No further information was available at the time of this report.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1518330 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FB0927 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Fibrin D dimer, Fibrin D dimer increased, Vomiting
SMQs:, Acute pancreatitis (broad), Haemorrhage laboratory terms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-09
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210709; Test Name: Fibrin D-dimer; Result Unstructured Data: Test Result:$g20
CDC Split Type: ZAPFIZER INC202100909601

Write-up: Died; Chest pain; D-Dimer $g20; Vomiting; This is a spontaneous report from a contactable other healthcare professional. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: FB0927, Expiry date was not reported) (at the age of 69-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension. The patient''s concomitant medications were not reported. On 09Jul2021, the patient experienced chest pain in the morning; vomiting and had a d-dimer $g20. On the same day, the patient died (cause: not reported). Laboratory test on 09Jul2021 included Fibrin D dimer was $g20. An autopsy was not performed. The outcome of the events chest pain, vomiting and d-dimer $g20 was unknown. No further details were provided at the time of this report. ; Sender''s Comments: Based on the limited information in the case report, a meaningful medical assessment is not possible and a causal relationship between event death and suspect product BNT162B2 cannot be completely ruled out. The 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: 1518331 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-30
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Asthenia, Blood iron, Blood iron increased, Chest pain, Death, Dizziness, Dyspnoea, HIV test, Haematocrit decreased, Haemoglobin decreased, Mean cell haemoglobin concentration, Mean cell haemoglobin concentration decreased, Mean cell volume, Mean cell volume increased, Monocyte count, Monocyte count increased, Pain, Platelet count, Platelet count decreased, Productive cough, Red blood cell count, Red blood cell count decreased, Red blood cell sedimentation rate, Red blood cell sedimentation rate increased, Red cell distribution width, Red cell distribution width increased, Reticulocyte count, Reticulocyte count decreased, Serum ferritin, Serum ferritin increased, White blood cell count, White blood cell count decreased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (narrow), Haematopoietic leukopenia (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-10
   Days after onset: 10
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Renal impairment
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: HIV; Result Unstructured Data: Test Result:negative; Test Date: 20210708; Test Name: red blood cell count low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: hemoglobin low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: haematocrit low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: MCV high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: red cell distribution width high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: MCHC low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: Platelet count low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: monocytes high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: iron high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: ferritin high; Result Unstructured Data: Test Result:high; Test Date: 20210708; Test Name: white blood cell count low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: reticulocyte count low; Result Unstructured Data: Test Result:low; Test Date: 20210708; Test Name: ESR high; Result Unstructured Data: Test Result:high
CDC Split Type: ZAPFIZER INC202100909620

Write-up: Death; Symptomatic anaemia; Red blood cell count low; Hemoglobin low; Haematocrit low; MCV high; Red cell distribution width high; MCHC low; Platelet count low; Monocytes high; Iron high; Ferritin high; White blood cell count low; Reticulocyte count low; ESR high; Chest pain; Difficulty breathing; Body pain; Weakness; Productive cough; Dizziness; This is a spontaneous report from a contactable physician. A 85-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: Not reported) via unspecified route of administration, administered on an unspecified date for covid-19 immunization. Medical history included renal impairment. The patient''s concomitant medications were not reported. On 30Jun2021, the patient experienced body pain, weakness, productive cough, dizziness, chest pain, difficulty breathing, had symptomatic anemia. On 08Jul2021, the lab results red blood cell count low, hemoglobin low, hematocrit low, MCV high, red cell distribution width high, MCHC low, Platelet count low, monocytes high, iron high, ferritin high, white blood cell count low, reticulocyte count low, ESR high. On 30Jun2021 patient underwent HIV test: negative. The patient died on 10Jul2021. An autopsy was not performed. Outcome of the events was unknown except death which is fatal. No further information was available in the time of this report. ; Sender''s Comments: As there is limited information in the case provided, the causal association between the event death and the suspect drug BNT162b2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1518337 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-07
Onset:2021-06-30
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202100942000

Write-up: Thrombocytopenia; Death; This is a spontaneous report from a contactable physician. An 81-year-old female patient received BNT162b2 (COMIRNATY) first single dose administration on 07Jun2021 at 12:29 (Batch/Lot Number: FA7812; Expiration Date: 30Sep2021) for covid-19 immunization at age of 81-year-old. The patient''s medical history and concomitant medications were not reported. The patient developed thrombocytopenia (hospitalization) on 30Jun2021. The patient is reported to have died on 02Jul2021. The cause of death was not reported. It was not reported if an autopsy was performed. Outcome of the event thrombocytopenia was unknown.; Sender''s Comments: The information available in this report is limited, and does not allow a medically meaningful assessment of the case. The event die is assessed as related to the suspect drug per company guidance. A contributory role of BNT162B2 to event thrombocytopenia cannot be excluded based on temporal association and available information. The case will be re-assessed when relevant information, particularly the cause of death, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1519184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-07-05
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, 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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Esophageal varices; Hepatic cirrhosis
Preexisting Conditions: Comments: The patient was in compromised health. It was reported that the patient was not pregnant
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESJNJFOC20210763703

Write-up: DEATH; NON-THROMBOCYTOPENIC HEMORRHAGIC STROKE; This spontaneous report received from a consumer via a company representative concerned a 7 decade old (reported in her 60''s) female of an unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included cirrhosis, and esophageal varices. The patient''s pre-existing medical condition included that she was in compromised health. It was reported that the patient was not pregnant. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry: unknown) dose, start therapy date were not reported, frequency time was 1 total administered on an unspecified date in JUN-2021 (reported as died about 15 days after receiving the vaccination) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUL-2021, the patient was hospitalized for 1 day due to a stroke and she was died at 08:00 on unspecified date. The hospital did not link the death to the vaccine, they have diagnoses for stroke as a non-thrombocytopenic hemorrhagic stroke. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of non-thrombocytopenic hemorrhagic stroke was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender''s Comments: V0 20210763703-COVID-19 VACCINE AD26.COV2.S-Death, non-thrombocytopenic hemorrhagic stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


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