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From the 1/7/2022 release of VAERS data:

Found 21,745 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

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Case Details

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VAERS ID: 1265040 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-03
Onset:2021-04-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood electrolytes, Chest pain, Dyspnoea, Electrocardiogram, Full blood count, Laboratory test, Pulmonary embolism, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-05
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: APIXABAN; EPLERENONE; IRBESARTAN; LERCANIDIPINE; FLUVASTATIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Hypertrophic cardiomyopathy (for at least 7 years which was well controlled); Sleep apnoea syndrome; Struma nodosa
Allergies:
Diagnostic Lab Data: Test Date: 20210305; Test Name: blood electrolytes; Result Unstructured Data: Test Result:normal; Test Date: 20200720; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm and a 1st degree AVB; Comments: regular sinus rhythm and a 1st degree AVB; Test Date: 20210305; Test Name: complete blood count; Result Unstructured Data: Test Result:normal; Test Date: 20210305; Test Name: biological assessment; Result Unstructured Data: Test Result:normal: Complete blood count, blood electrolyte; Comments: normal: Complete blood count, blood electrolytes, no renal failure
CDC Split Type: FRPFIZER INC2021447019

Write-up: Suspicion of infection with COVID-19; shortness of breath, dyspnea; chest pain; Suspicion of pulmonary embolism; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-PO20211802, Safety Report Unique Identifier FR-AFSSAPS-2021039411. An 87-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection; Batch/Lot Number: EW2239), intramuscularly (IM), administered in the right arm on 03Apr2021 as 0.3 mL, single for COVID-19 immunisation. The patient''s medical history included struma nodosa, atrial fibrillation paroxysmal, hypertrophic cardiomyopathy (for at least 7 years which was well controlled), and sleep apnoea syndrome. Concomitant medications included apixaban, eplerenone, irbesartan, lercanidipine, and fluvastatin; all taken for unspecified indications, start and stop dates were not reported. The patient has not had COVID-19 and has not been tested. He has had a history of hypertrophic cardiomyopathy for at least 7 years which was well controlled and paroxysmal atrial fibrillation. The last cardiological assessment dated from 20Jul2020 with an ECG showing a regular sinus rhythm and a 1st degree AV block. The last biological assessment of 03Mar2021 was normal: Complete blood count, blood electrolytes, no renal failure. On 03Apr2021, the patient had the injection of the first dose of COMIRNATY vaccine lot EW2239 IM in the right arm. On 04Apr2021, at the start of the night, the patient presented with shortness of breath, dyspnea and chest pain. The ED was called. 05Apr2021 at 1 am, the patient''s death was noted. The suspicion of pulmonary embolism was raised. On 06Apr2021, the patient''s wife and several family members have tested positive for COVID-19. The patient himself was not tested and did not have symptoms suggestive of COVID-19. However, according to those around him, the patient was unusually tired a few days before receiving the vaccine injection. Request for additional information was made (as reported). The outcome of shortness of breath, dyspnea and chest pain was unknown. The patient died on 05Apr2021 due to suspicion of pulmonary embolism and suspicion of infection with COVID-19. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Suspicion of pulmonary embolism; Suspicion of infection with COVID-19


VAERS ID: 1265041 (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: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Antibody test, Blood pressure measurement, Death, Discomfort, Malaise, Oxygen saturation, Vaccination site pain
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; COVID-19; Depressive disorder; Stroke; Urothelial carcinoma
Allergies:
Diagnostic Lab Data: Test Date: 20210402; Test Name: rapid post-mortem antigenic test; Result Unstructured Data: Test Result:negative; Test Date: 20210401; Test Name: BP; Result Unstructured Data: Test Result:18; Test Date: 20210402; Test Name: BP; Result Unstructured Data: Test Result:15; Test Date: 20210401; Test Name: oxygen saturation; Result Unstructured Data: Test Result:Normal
CDC Split Type: FRPFIZER INC2021446929

Write-up: Death NOS/recognition of the patient''s death; not feeling "very well"; general discomfort; pain in the arm around the injection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB FR-AFSSAPS-RE20211000, Safety Report Unique Identifier FR-AFSSAPS-2021035193. A 96-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: ET7205 and expiration date not provided), intramuscular, administered in Arm Left first dose on 01Apr2021 16:30 at single dose for covid-19 immunisation. The patient''s medical history included Depressive disorder, Urothelial carcinoma, COVID-19 in Nov2020, Arterial hypertension, and Stroke in 2018. The patient''s concomitant medications were not reported. On 01Apr2021, the patient received the vaccine and no reaction noted immediately after injection. Around 7PM the patient complains of general discomfort with pain in the arm around the injection. BP measurement at 18, normal oxygen saturation. Prescription of paracetamol (unknown laboratory) 1 g. On 02Apr2021 around 4AM, patient not feeling "very well" and blood pressure at 15. At 6AM, recognition of the patient''s death/ death NOS. Performed a rapid post-mortem antigenic test: negative. The patient died on 02Apr2021. It was not reported if an autopsy was performed. The outcome of the event death was fatal and unknown for the remaining events. No follow-up attempts are possible. No information is expected.; Reported Cause(s) of Death: Death NOS/recognition of the patient''s death


VAERS ID: 1265043 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-03-09
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Bacterial sepsis, Bacterial test positive, Blood creatinine, Blood culture, C-reactive protein, Cell death, Computerised tomogram, Culture urine, Death, Hyperleukocytosis, Inflammation, Pulmonary arterial hypertension, Pyelonephritis, Troponin, White blood cell count
SMQs:, Malignancy related conditions (narrow), Pulmonary hypertension (narrow), Infective pneumonia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-10
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: ALT; Result Unstructured Data: Test Result:1607 IU/l; Test Name: AST; Result Unstructured Data: Test Result:3664 IU/l; Test Name: blood creatinine; Result Unstructured Data: Test Result:114 umol/l; Test Date: 20210309; Test Name: blood culture; Result Unstructured Data: Test Result:gram + cocci; Test Name: thoraco-abdomino-pelvic and skull CT scan; Result Unstructured Data: Test Result:no suspicious lesion; Comments: Heterogeneous enhancement of the right liver, more hypodense without individualizable mass; Test Name: c-reactive protein; Result Unstructured Data: Test Result:$g 100 mg; Test Date: 20210309; Test Name: c-reactive protein; Test Result: 160 mg; Test Date: 20210309; Test Name: urine culture; Result Unstructured Data: Test Result:E.coli in urine; Test Name: troponin; Result Unstructured Data: Test Result:10490 ng/L; Test Name: white blood cell count; Result Unstructured Data: Test Result:Hyperleukocytosis 18000 /mm3; Test Date: 20210309; Test Name: white blood cell count; Result Unstructured Data: Test Result:Hyperleukocytosis at 19,000 /mm3
CDC Split Type: FRPFIZER INC2021447046

Write-up: major inflammatory syndrome; suspicion of pyelonephritis; Hyperleukocytosis; severe cytolysis; chronic pulmonary arterial hypertension; Death unexplained; septic process by gram + cocci on blood cultures; E.coli in urine; This is as spontaneous report received from a contactable pharmacist downloaded from the regulatory authority-WEB. The regulatory authority report number is FR-AFSSAPS-RN20211082, Safety report unique identifier FR-AFSSAPS-2021038794. An 80-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 04Feb2021 (Batch/Lot Number: EJ6788) as a single dose for COVID-19 vaccination. The patient''s medical history and concomitant medications were not reported. Historical vaccine included COMIRNATY, first dose, lot number: EM0477, on 13Jan2021 for COVID-19 immunisation. The patient experienced death unexplained on 10Mar2021. The patient died on 10Mar2021, unexplained death. Further ADR description stated that the patient was hospitalized on 07Mar2021 for major inflammatory syndrome on suspicion of pyelonephritis. Biology report included: Hyperleukocytosis 18000/mm3, C-reactive protein (CRP)$g 100 mg/L, severe cytolysis (ALT at 1607 IU/L, AST=3664IU/L, Troponin$g 10490ng/L on probable sepsis, blood creatinine at 114umol/L..). On 09Mar2021, Hyperleukocytosis at 19,000/mm3, CRP at 160 mg/L, decrease in cytolysis and therefore septic process by gram + cocci on blood cultures and E.coli in urine treated with Tazocillin and Daptomycin. Performing a thoraco-abdomino-pelvic and skull CT scan: no suspicious lesion. Heterogeneous enhancement of the right liver, more hypodense without individualizable mass. Predominant global cardiomegaly in the right cavities and dilation of the trunk of the portal aorta to 38mm: hypothesis of chronic pulmonary arterial hypertension. It was not reported if an autopsy was performed. The outcome of death unexplained was fatal while unknown for other events. No follow-up attempts are possible. No further information is expected. Information on lot number obtained.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1265051 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-02-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, B-cell lymphoma, Body temperature, Chills, Haemophagocytic lymphohistiocytosis, Influenza, Lymphadenopathy, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Malignant lymphomas (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Haematological malignant tumours (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-09
   Days after onset: 48
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Coronary disease
Allergies:
Diagnostic Lab Data: Test Date: 20210311; Test Name: COVID-19 test nasal swab; Test Result: Negative ; Test Date: 20210219; Test Name: temperature; Result Unstructured Data: Test Result:39
CDC Split Type: FRPFIZER INC2021453304

Write-up: macrophage activation syndrome linked to B lymphoma possibly activated; macrophage activation syndrome linked to B lymphoma possibly activated; fever at 39; chills; adenopathy; asthenia; flu syndrome; This is a spontaneous report from a contactable consumer (patient) received via Regulatory Authority, sender''s case report number FR-COVAES-6b696838-e86e-48ae-86bf-8f9cf4a27df3. A 76-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 19Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included coronary disease and arterial hypertension. The patient''s concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 for COVID-19 immunisation. The patient experienced fever at 39, chills, lymphadenopathy, asthenia, flu syndrome. Death due to macrophage activation syndrome linked to B lymphoma possibly activated / accelerated by the vaccine. The events onset on 19Feb2021 and resulted in doctor or other healthcare professional office / clinic visit and emergency room / department or urgent care. Patient received treatment for the events included paracetamol. COVID-19 test nasal swab on 11Mar2021 was negative. The patient died on 09Apr2021. An autopsy was not performed. This case was reported as serious with seriousness criteria: death, Hospitalized for 10 days and Life-threatening. Outcome of the events was fatal. No follow-up attempts are possible, information on batch numbers cannot be obtained.; Reported Cause(s) of Death: fever at 39; chills; lymphadenopathy; asthenia; flu syndrome; macrophage activation syndrome linked to B lymphoma possibly activated; macrophage activation syndrome linked to B lymphoma possibly activated


VAERS ID: 1265495 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-28
Onset:2021-03-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741 / 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: 2021-03-30
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Angina pectoris; Dementia (in Alzheimer''s disease); Depressive episode; Gastritis; Hypertension; IHD; Transient cerebral ischaemia
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:not tested positive since having the vaccine; Test Date: 20201127; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBPFIZER INC2021449708

Write-up: Death; This is a spontaneous report from a contactable other healthcare professional. This is a report received from the Regulatory Agency (RA). Regulatory authority report number GB-MHRA-WEBCOVID-202104211121410910-NY1ZZ, Safety Report Unique Identifier GB-MHRA-ADR 25173874. A 91-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER1741) on 28Mar2021 at single dose for COVID-19 immunisation. Medical history included transient cerebral ischaemia from 24Feb2021, moderate depressive episode from 24Feb2021, hypertension, gastritis from 24Feb2021, dementia from 24Feb2021 (dementia in Alzheimer''s disease), Alzheimer from 24Feb2021, ischemic heart disease (IHD), angina from 24Feb2021. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medications were not reported. The patient previously took CALCI-D 1000mg/1000 units chewable tablets one daily from 19Jan2021, memantine 20mg tablets one daily from 19Jan2021, lansoprazole 30mg gastro-resistant capsules one once daily from 19Jan2021, folic acid 5mg tablets one daily from 19Jan2021 and from 27Jan2021 400microgram tablets one daily, clopidogrel 75mg tablets one once daily from 19Jan2021, atorvastatin 20mg tablets one daily from 19Jan2021, nitrofurantoin 100mg modified-release capsules one twice daily for three days for UTI in females from 12Feb2021 to 15Feb2021, mirtazapine 45mg tablets one tablet at night from 19Jan2021. The patient experienced death on 30Mar2021. It was reported that the patient was found deceased. She had second BNT162b2 vaccine two days before which could be coincidence. The report was not related to possible blood clots or low platelet counts. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 27Nov2020 and not tested positive for COVID-19 since having the vaccine. The patient died on 30Mar2021. The outcome of the event was fatal. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1265500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-04-12
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiogram, Anticoagulation drug level below therapeutic, Atrial fibrillation, Autoscopy, Cerebral infarction, Cerebral thrombosis, Cerebrovascular accident, Cognitive disorder, Computerised tomogram head, Confusional state, Delirium, Haemorrhage, Headache, Hemiparesis, Inappropriate schedule of product administration, International normalised ratio, Investigation, Off label use, Oxygen saturation, Oxygen saturation decreased, Pain, Platelet count, Platelet count decreased, Prothrombin time, Pulmonary haemorrhage, Pulmonary oedema, Renal impairment, SARS-CoV-2 test, Somnolence, Thrombocytopenia, Transient ischaemic attack, Vertebral artery stenosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tumour lysis syndrome (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-21
   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: BISOPROLOL; CEPHALEXIN [CEFALEXIN]; VITAMIN E [VITAMIN E NOS]; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anticoagulant therapy; Atrial fibrillation; Catheter placement; Hemiparesis; Non-smoker; Platelet count decreased (platelet count (usual normal range 150-450) as 131); Renal embolism; Renal impairment; Renal infarction; UTI; Comments: Self catheterises. UTIs. Atrial fibrillation Renal infarction (embolic) 2016, anticoagulated since then. Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: aPTT; Test Result: 24.7 s; Test Date: 20210412; Test Name: CTA; Result Unstructured Data: Test Result:some right vertebral artery stenoses; Comments: some right vertebral artery stenoses, but otherwise patent vessels; Test Date: 20210418; Test Name: CT head; Result Unstructured Data: Test Result:extensive clot in left MCA and established infarct; Comments: extensive clot in left MCA and established infarction; Test Date: 20210412; Test Name: INR; Result Unstructured Data: Test Result:subtherapeutic; Test Date: 20210414; Test Name: INR; Result Unstructured Data: Test Result:1.1; Test Date: 20210418; Test Name: Haemorrhage; Result Unstructured Data: Test Result:15.58; Comments: Haemorrhage was identified with Clinical note 15.58 on 18Apr2021: bleeding from lungs.; Test Date: 20210418; Test Name: saturations; Result Unstructured Data: Test Result:dropping; Test Date: 20210412; Test Name: Platelets; Result Unstructured Data: Test Result:less than 150 a - 109/l; Test Date: 20210413; Test Name: Platelets; Result Unstructured Data: Test Result:low; Test Date: 20210414; Test Name: Platelets; Result Unstructured Data: Test Result:132; Test Date: 20190702; Test Name: Platelets; Result Unstructured Data: Test Result:131; Test Date: 20210417; Test Name: Platelets; Result Unstructured Data: Test Result:130; Test Name: PT; Result Unstructured Data: Test Result:11.3; Test Date: 20210417; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021454985

Write-up: pain; 7 seconds; renal impairment; bleeding; cognitive impairment; hemiparesis; atrial fibrillation; confusion; delirium; pulmonary oedema; Drowsy; Dose 1 on 21Jan2021/dose 2 on 21Mar2021; Dose 1 on 21Jan2021/dose 2 on 21Mar2021; extensive clot in left MCA and established infarction; extensive clot in left MCA and established infarction; lungs bleeding/ Frothy blood on suctioning; dropping saturations; headache; stroke/ mild right hand weakness and word-finding difficulties; Low platelets; Subtherapeutic INR; platelet count less than 150 A - 109/L; TIA/episode of transient visual loss (? hemianopia); right vertebral artery stenoses; This is a spontaneous report from a contactable physician by Pfizer from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104211738274670-CRIYX, Safety Report Unique Identifier GB-MHRA-ADR 25176403. An 82-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: Not known) as single dose, dose 2 via an unspecified route of administration on 21Mar2021 (Batch/Lot Number: not known) as single dose for covid-19 immunisation; apixaban (APIXABAN), via unspecified route of administration from an unspecified date at an unspecified dose for an unspecified indication; Medical history included Atrial fibrillation; Renal impairment; Hemiparesis; Self catheterizes; UTIs; Renal infarction (embolic) from 2016 anticoagulated since then; platelet count (usual normal range 150-450) as 131 on 02Jul2019; currently was non-smoke. The patient did not have a history of, or concurrent, intracranial malignancy and did not have concurrent or recent intracranial infections. The patient hadn''t had recent surgical or medical interventions to the central nervous system (including lumbar puncture) and hadn''t had a recent trauma/head injury. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication included bisoprolol (BISOPROLOL) taken for atrial fibrillation; cephalexin [cefalexin] (CEPHALEXIN [CEFALEXIN]) taken for catheter management; vitamin e nos (VITAMIN E [VITAMIN E NOS]); warfarin (WARFARIN). The patient previously took heparin. The patient experienced stroke/ mild right hand weakness and word-finding difficulties (death) on 17Apr2021, atrial fibrillation (death) on an unspecified date, confusion (death) on an unspecified date, delirium (death) on an unspecified date, pulmonary oedema (death) on an unspecified date, headache (death) on 17Apr2021, pain (death) on an unspecified date, 7 seconds (autoscopy) (death) on an unspecified date, renal impairment (death) on an unspecified date, bleeding (death) on an unspecified date, cognitive impairment (death) on an unspecified date, hemiparesis (death) on an unspecified date, subtherapeutic INR (death) on 12Apr2021, low platelets (non-serious) on 13Apr2021, platelet count less than 150 a - 109/l (Medically Significant) on 12Apr2021, TIA/episode of transient visual loss (? hemianopia) on 12Apr2021, right vertebral artery stenoses on 12Apr2021, Drowsy on an unspecified date, extensive clot in left MCA and established infarction on 18Apr2021, lungs bleeding/ Frothy blood on suctioning on 18Apr2021, dropping saturations on 18Apr2021. The patient underwent lab tests and procedures which included CT head: shows extensive clot in left MCA and established infarction on 18Apr2021; INR: 1.1 on 14Apr2021; INR: subtherapeutic on 12Apr2021; platelet count: 132 on 14Apr2021; platelet count: less than 150 a - 109/l on 12Apr2021; platelet count: low platelets on 13Apr2021; platelet count after vaccine (usual normal range 150-450) and measured as 130 on 17Apr2021; platelet count before vaccine measured (usual normal range 150-450) as 131 on 02Jul2019; vascular imaging (CTA): showed some right vertebral artery stenoses, but otherwise patent vessels on 12Apr2021; No Infectious screen (eg HIV, hepatitis C/B, herpes zoster/ CMV); PT was "11.3". Activated Partial Thromboplastin Clotting Time (aPTT) was "24.7 seconds"; Haemorrhage was identified with Clinical note 15.58 on 18Apr2021: bleeding from lungs; dropping saturations on 18Apr2021; COVID-19 virus test: no - negative covid-19 test on 17Apr2021. Patient had not tested positive for COVID-19 since having the vaccine. The clinical course provided as follows: He had had a fatal stroke due to known atrial fibrillation. I''m doing the yellow card because it was so strange his INR suddenly going subtherapeutic after years of perfect control. Also platelets a bit low. I''ve discussed with the son who is happy for me to fill this in. Background of AF and renal impairment - hence was on warfarin. Had been 100% in target INR range of 2-3 since 2016. Son, who lives with him (and also wife, but she has cognitive impairment), are both confident he had not missed any doses of warfarin, had taken the recommended dosage, hadn''t started or stopped any other medications including vitamins and supplements, and had no dietary changes which may have caused his sub-therapeutic INR. Seen (by me) in clinic 14Apr2021 after episode of transient visual loss (? hemianopia) on 12Apr2021 - vascular imaging (CTA) at the time showed some right vertebral artery stenoses, but otherwise patent vessels. INR was 1.1. Platelets 132. New warfarin dosing instructions given the same day. Re-presented to ED 17Apr2021 morning: mild right hand weakness and word-finding difficulties, which were improving. NIHSS equal to 1, INR 1.1 again. Changed to apixaban, not for TPA in view of mild deficit. Discharged on apixaban. Re-presented later that day, diagnosed with confusion and delirium. Also headache. Further deterioration 18Apr2021 morning. CT head 18Apr2021 shows extensive clot in left MCA and established infarction. On assessment: Drowsy - localising to pain. Right hemiparesis. No reaction to painful stimuli on right, withdraws on left. No reaction to voice or visual threat. Bilaterally extensor plantars. End of life care initiated. The patient died on 21Apr2021. It was unknown if an autopsy was performed. The report relate to possible blood clots or low platelet counts. TIA then minor stroke then fatal stroke". This was diagnosed via Clinical (TIA and minor stroke) and CT (major stroke). The date of diagnosis First TIA was 12Apr2021, Major stroke was 17Apr2021. The platelet count was less than 150 A - 109/L on 12Apr2021. It was unknown of the D-dimer more than 4000 and if anti-PF4 antibodies were identified. The patient had had no any previous reactions to medications, especially heparin or anticoagulants. The patient did not have confirmed or suspected autoimmune or inflammatory disease, including vasculitis. The patient didn''t have history of, or current, malignancy. The lowest platelet count after vaccine (usual normal range 150-450) and measured as 130 on 17Apr2021. The last platelet count before vaccine measured (usual normal range 150-450) as 131 on 02Jul2019. The patient was not reviewed by a haematologist. Haemorrhage was identified with Clinical note 15.58 on 18Apr2021: Has now also developed bleeding from? pharynx, ? lungs, dropping saturations. Frothy blood on suctioning. No sign of pulmonary oedema, and this looks like blood. The last action taken in response to the events for apixaban was not applicable. The outcome of the event Low platelets was not recovered, of platelet count less than 150 A - 109/L, TIA/episode of transient visual loss (? hemianopia), right vertebral artery stenoses, Drowsy, extensive clot in left MCA and established infarction, lungs bleeding/ Frothy blood on suctioning, dropping saturations, Dose 1 on 21Jan2021/dose 2 on 21Mar2021 was unknown, of the other events 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: stroke/ mild right hand weakness and word-finding difficulties; atrial fibrillation; confusion; delirium; pulmonary oedema; headache; pain; 7 seconds; renal impairment; bleeding; cognitive impairment; hemiparesis; Subtherapeutic INR


VAERS ID: 1265510 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-13
Onset:2021-03-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Disease recurrence, Lethargy, Pulmonary embolism
SMQs:, Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-04-11
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ZOLOFT; NITRONG; EXELON PATCH 10; SALOSPIR; LASIX [FUROSEMIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lethargic (LETHARGIC EPISODES 2-3 DAYS DURATION); Pericarditis NOS (NO CARDIOLOGICAL PROBLEM DESPITE THE CONCOMITANT DRUGS ADMINISTRATION.); Vascular dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: GRPFIZER INC2021453391

Write-up: Death; Pulmonary embolism; lethargic episode; lethargic episode; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB, regulatory authority number GR-GREOF-20212503. This is a report received. An 83-year-old female patient received the second dose of BNT162B2 (COMIRNATY), intramuscularly on 13Mar2021 at single dose for COVID-19 immunisation. Medical history included vascular dementia presented the last 7 years, pericarditis from 1999 (no cardiological problem despite the concomitant drugs administration), and lethargy (lethargic episodes 2-3 days duration, during these episodes seemed half asleep with the ability to recognise the familiars, she was under feeding support, after these episodes she was functional). Concomitant medications included sertraline hydrochloride (ZOLOFT) for depression, glyceryl trinitrate (NITRONG), rivastigmine (EXELON PATCH 10) for vascular dementia and Alzheimer''s disease, acetylsalicylic acid (SALOSPIR) for anticoagulant therapy, and furosemide (LASIX). The patient experienced pulmonary embolism on 13Mar2021, and death on 11Apr2021. 2 days since the vaccination, patient presented another lethargic episode on 15Mar2021. After 15 days she stopped feeding and called physician. On 02Apr2021 she was admitted to hospital. This case was reported as serious with seriousness criteria death, hospitalization, medically significant, and life threatening. The patient died on 11Apr2021. Outcome of event lethargic episode was unknown. 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: pulmonary embolism


VAERS ID: 1265519 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-03-07
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0725 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein, COVID-19, Cardiopulmonary failure, Chest X-ray, Drug ineffective, SARS-CoV-2 test
SMQs:, Cardiac failure (narrow), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-22
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FRONTIN; MILURIT; EBRANTIL [URAPIDIL]; FENOSWISS; NORMODIPINE; ROSUVASTATIN; COVERCARD PLUS; ACETYLSALICYLIC ACID; NOOTROPIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carotid artery stenosis; Cholecystectomy; Diabetes; Diabetic nephropathy; Hypertension; Hypertensive encephalopathy; Ischemic heart disease; Vertebrobasilar insufficiency
Allergies:
Diagnostic Lab Data: Test Date: 20210310; Test Name: Chest X-ray; Result Unstructured Data: Test Result:bilateral multifocal infiltration, congestion and; Comments: bilateral multifocal infiltration, congestion and cardiomegaly; Test Date: 20210310; Test Name: C-reactive protein; Result Unstructured Data: Test Result:94.8 mg/l; Test Date: 20210307; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: HUPFIZER INC2021455369

Write-up: Cardiorespiratory insufficiency due to COVID-19; Cardiorespiratory insufficiency due to COVID-19; Cardiorespiratory insufficiency due to COVID-19; This is a spontaneous report downloaded from the Regulatory Authority-WEB (Regulatory Authority report number: HU-OGYI-201721). A contactable healthcare professional (contactable through Regulatory Authority only) reported that an 80-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: EL0725; Expiration date was not reported), intramuscularly on the right arm on 17Feb2021 as a single dose for COVID-19 immunization. Medical history included hypertension, cholecystectomy, carotid artery stenosis, diabetic nephropathy, vertebrobasilar insufficiency, ischemic heart disease, hypertensive encephalopathy and diabetes; all were not ongoing. Concomitant medications included alprazolam (FRONTIN), allopurinol (MILURIT), urapidil (EBRANTIL), fenofibrate (FENOSWISS), amlodipine besilate (NORMODIPINE), rosuvastatin, amlodipine besilate, indapamide, perindopril arginine (COVERCARD PLUS), acetylsalicylic acid and piracetam (NOOTROPIL). On 07Mar2021, the patient had tested positive to COVID-19 antigen test (symptoms described as dizzy, weak, and had headache and cough). The patient''s chest X-ray showed bilateral multifocal infiltration, congestion and cardiomegaly and C-reactive protein was 94.8 mg/l; both on 10Mar2021. On 22Mar2021, the patient had cardiorespiratory insufficiency. The patient had died on 22Mar2021, and the cause of death was cardiorespiratory insufficiency due to COVID-19. It was unknown if an autopsy was performed. The causal relationship between the reported death and Comirnaty was considered unlikely. Follow-up activities have been closed. No routine follow-up is possible for EV-WEB ICSRs.; Reported Cause(s) of Death: cardiorespiratory insufficiency due to COVID-19; cardiorespiratory insufficiency due to COVID-19; cardiorespiratory insufficiency due to COVID-19


VAERS ID: 1265520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-03-22
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Cardiac failure, Chest X-ray, Haematoma
SMQs:, Cardiac failure (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-30
   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: Appendectomy; Cardiomyopathy; Cerebral circulatory disorder; COPD; Decubitus; Glaucoma; Hypertension; Wheelchair user
Allergies:
Diagnostic Lab Data: Test Date: 20210324; Test Name: Chest X-ray; Result Unstructured Data: Test Result:fluid, bronchovascular leasions; Comments: dilated, calcified aorta, globally dilated heart, slight increase in venous pressure in the pulmonary circulation
CDC Split Type: HUPFIZER INC2021455489

Write-up: haematoma on leg; symptoms of cardiac decompensation; Acute exacerbation of chronic bronchitis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB, regulatory authority number HU-OGYI-206621. A 91-year-old female patient received the first dose of bnt162b2 (COMIRNATY), intramuscular on 17Mar2021 (Lot Number: Unknown) as 0.3 mL, single for COVID-19 immunisation. Medical history included hypertension, cardiomyopathy, appendectomy, vertebral circulatory disorder, COPD, glaucoma, decubitus, and the patient also have been in a wheelchair-user and on oxygen therapy for a while. Concomitant medications were not reported. The patient experienced acute exacerbation of chronic bronchitis on 24Mar2021, haematoma on leg on 22Mar2021, symptoms of cardiac decompensation on 22Mar2021 with fatal outcome. The patient died on 30Mar2021. It was not reported if an autopsy was performed. The clinical course was reported as follows: On 22Mar2021, the patient was taken to the GP because of a painful lump on her left leg, which looked like a haematoma, the patient probably punched her leg into something. She was referred to a hospital due to the haematoma and incipient decompensation symptoms. In admission status, subcutaneous suffusions were seen throughout the body, massive edema on both legs, surgically treated leg ulcer, lip- and acrocyanosis, chest deformed due to emphysema kyphosis, hypersonic percussion sound, congestive rash, congestive and bronchial murmurs, enlarged heart, normotension, negative nervous system status, slightly aggressive behavior due to hypoxia. Acute exacerbation of chronic bronchitis, exacerbated by chronic decompensated cor pulmonale was found in the background of the patient''s complaints. On 24Mar2021, chest X-ray showed fluid, bronchovascular leasions; dilated, calcified aorta; globally dilated heart; slight increase in venous pressure in the pulmonary circulation. Parenteral steroids, expectorants, bronchodilators, diuretics, oxygen inhalation and LMWH prophylaxis were used as therapy. The patient''s condition stabilized and showed a slight improvement, however, on 29Mar2021, recurrent symptoms of acute exacerbation of chronic spastic bronchitis, respiratory failure occurred, increased doses of parenteral steroids, and broad-spectrum antibiotics were initiated. The patient''s condition did not improve for adequate treatment, on 30Mar2021, the patient died at 05:30 am due to respiratory and circulatory insufficiency. Sender''s Comment: The reported events are neither listed nor expected adverse event of Comirnaty. TTO was 5 days, and the 91-year-old patient died 13 days after vaccination due to respiratory and circulatory insufficiency. The causal relationship between the events and Comirnaty is considered unlikely. The case is serious due to fatal outcome. No follow-up attempts are possible; information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: circulatory and respiratory insufficiency; circulatory and respiratory insufficiency


VAERS ID: 1265529 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER6166 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Foetal death
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021446854

Write-up: IUFD; This is a spontaneous report received from a contactable other HCP. This other hcp reported information for both mother and fetus/baby. This is a maternal report. A 21-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot Number: ER6166) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 for covid-19 immunization. The patient experienced iufd (Foetal death in utero, death, hospitalization) on an unspecified date. The mother reported she became pregnant while taking bnt162b2. The mother was 3 Trimester pregnant at the onset of the event. The patient died on an unspecified date. It was not reported if an autopsy was performed. Time range was one week. The clinical course was reported as follows: A pregnant woman at week 39 went to the emergency room because her water broke, noted that she did not feel fetal movements from the night denying contractions or bleeding. The anatomical scans during pregnancy were normal. In the emergency room, a fetus was found without a pulse, a normal amount of amniotic fluid, an estimated weight of 2700 grams. Are interested in performing a genetic test. No follow-up attempts are possible. No further information expected; Sender''s Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: IUFD


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