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From the 1/14/2022 release of VAERS data:

Found 22,193 cases where Vaccine targets COVID-19 (COVID19) and Patient Died

Government Disclaimer on use of this data



Case Details

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VAERS ID: 1760582 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-07-16
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Blood creatine phosphokinase, Blood creatinine, C-reactive protein, Chronic obstructive pulmonary disease, Gamma-glutamyltransferase, Myoglobin blood, N-terminal prohormone brain natriuretic peptide, Platelet count, Respiratory acidosis, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-03
   Days after onset: 18
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: ENALAPRIL EG; ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE;INDACATEROL MALEATE]; EUPANTOL; LERCANIDIPINE HYDROCHLORIDE; PAROXETINE HYDROCHLORIDE; ESIDREX; RIVAROXABAN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm; Alcohol use (Between 10 and 40 g per day); Chronic obstructive pulmonary disease; Chronic sinusitis; Depression; Embolism pulmonary; Ex-tobacco user; Hypercholesterolaemia; Hypertension arterial; Prevention
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:35 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: ASAT; Result Unstructured Data: Test Result:60 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: Creatine phosphokinase; Result Unstructured Data: Test Result:657 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: Creatinine; Result Unstructured Data: Test Result:81 umol/l; Test Date: 20210719; Test Name: C-reactive protein; Result Unstructured Data: Test Result:29.7 mg/l; Test Date: 20210719; Test Name: Gamma GT; Result Unstructured Data: Test Result:65 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: Myoglobin blood; Result Unstructured Data: Test Result:391 IU/l; Comments: Units:U/L; Test Date: 20210719; Test Name: NT-proBNP; Result Unstructured Data: Test Result:234.1 pg/mL; Test Date: 20210719; Test Name: Platelet count; Result Unstructured Data: Test Result:303000 /mm3; Test Name: COVID-19 PCR test; Test Result: Negative ; Test Date: 20210719; Test Name: Troponin; Result Unstructured Data: Test Result:57 ng/L; Test Date: 20210719; Test Name: White blood cell count; Result Unstructured Data: Test Result:18800 /mm3
CDC Split Type: FRPFIZER INC202101273108

Write-up: Chronic obstructive airways disease exacerbated / exacerbation of COPD; hypercapnic acidosis; This is a spontaneous report from a contactable physician downloaded from the regulatory authority. Regulatory Authority Report Number: FR-AFSSAPS-NY20214371. A 70-year-old male patient received the first dose of BNT162B2 (COMIRNATY, mRNA encoding the peak viral protein (S) of SARS-CoV-2) via intramuscular on 05Jun2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included hypercholesterolemia, chronic sinusitis, chronic obstructive pulmonary disease (COPD), abdominal aortic aneurysm, ex-tobacco user, depression, embolism pulmonary (since 2020), prevention, hypertension arterial and alcohol use (between 10 and 40 g per day). Concomitant medication included enalapril maleate (ENALAPRIL EG) taken for hypertension arterial, glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE;INDACATEROL MALEATE]) taken for COPD, pantoprazole sodium sesquihydrate (EUPANTOL) taken for prevention, lercanidipine hydrochloride taken for hypertension arterial, paroxetine hydrochloride taken for depression, hydrochlorothiazide (ESIDREX) taken for hypertension arterial and rivaroxaban taken for embolism pulmonary. On 16Jul2021, 42 day after the beginning of drug administration, 42 days after the last drug administration, the patient developed exacerbation of chronic obstructive pulmonary disease which led to death on 03Aug2021. On 16Jul2021, occurrence of exacerbation of chronic obstructive pulmonary disease. Evolution: Death. The patient was hospitalized in pneumology on 16Jul2021 for an exacerbation of COPD. The initial management consisted of corticosteroid therapy and probabilistic treatment with AUGMENTIN from 18Jul2021 without documentation for the moment with an increase in sputum. The Covid PCR test is negative. During the night of 18Jul2021 to 19Jul2021, respiratory deterioration with hypercapnic acidosis and acute respiratory distress refractory to aerosol therapy, transfer to discharge for further treatment. Failure of non-invasive ventilation and respiratory exhaustion, need to intubate the patient and place him under mechanical ventilation, relay of bi-antibiotic therapy with ROCEPHINE and ROVAMYCINE. Note that the patient was able to benefit from a dose of COVID vaccine and that the second was scheduled for 18Jul2021. The patient is transferred to the intensive care suites for treatment. Acute hypercapnic respiratory failure secondary to an exacerbation of COPD with no point of infectious call found. Pneumopathy acquired under mechanical ventilation with septic shock in E. Coli and S. maltophilia. Treatment with VFEND for bronchial aspergillosis. Inability to wean invasive ventilation during the stay. Illusory invasive ventilation weaning project in view of the underlying respiratory terrain. Multifactorial renal failure (sepsis, limb ischemia) occurred during the stay. Limb ischemia with rhabdomyolysis; therapeutic impasse with evolution towards a multi-visceral failure. Faced with multiorgan failure, namely acute renal failure, hyperkalaemia, respiratory, and hemodynamics, most likely due to vascular disease, in a context of COPD Gold IV at Day 14 of invasive ventilation with probable sepsis at the pulmonary starting point treated with BACTRIM, TAZOCILLINE and V- FEND for pulmonary aspergillosis, it was decided not to initiate other invasive therapies, namely no external cardiac massage and no extra-renal purification. This decision is made in agreement with the family. It is in this context the death occurs on 03Aug2021 at 2:58 p.m. Additional tests included On 19Jul2021, Platelet count (Platelet count): 303,000 per cubic millimeter. Leukocyte count (White blood cell count): 18800 per cubic millimeter. Creatinine (Creatinine): 81 micromole per liter. ASAT (ASAT): 60 enzyme unit per liter. Alanine aminotransferase (Alanine aminotransferase): 35 enzyme unit per liter. Blood myoglobin (Blood myoglobin): 391 enzyme unit per liter. Gamma GT (Gamma GT): 65 enzyme unit per liter. Creatine phosphokinase (Creatine phosphokinase): 657 enzyme unit per liter. Troponin (Troponin): 57 nanogram per liter. NT-proBNP (NT-proBNP): 234.1 picogram per milliliter. C-reactive protein (C-reactive protein): 29.7 milligram per liter. Autopsy was unknown. The outcome of chronic obstructive airways disease exacerbated was fatal. The outcome of other event was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1760583 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-08-20
   Days after vaccination:80
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, COVID-19, Computerised tomogram, Drug ineffective, Fibrin D dimer, Haemoglobin, Platelet count, Pulmonary embolism, SARS-CoV-2 test, White blood cell count
SMQs:, Lack of efficacy/effect (narrow), Interstitial lung disease (broad), Embolic and thrombotic events, venous (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Neurosyphilis (treated with corticosteroid therapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210820; Test Name: chest CT scan; Result Unstructured Data: Test Result:Typical bi-pulmonary parenchymal involvement; Comments: Typical bi-pulmonary parenchymal involvement with greater than 75% involvement without pulmonary embolism.; Test Date: 20210831; Test Name: Scanner; Result Unstructured Data: Test Result:Right upper segmental pulmonary embolism; Comments: Right upper segmental pulmonary embolism without evidence of acute pulmonary heart. Pejorative evolution of the parenchymal involvement.; Test Date: 20210820; Test Name: Fibrin D dimer; Result Unstructured Data: Test Result:2700 ug/ml; Test Date: 20210820; Test Name: Haemoglobin; Result Unstructured Data: Test Result:14 g/dl; Test Date: 20210820; Test Name: Platelet count; Result Unstructured Data: Test Result:354000 /mm3; Test Date: 20210820; Test Name: Test PCR covid-19; Test Result: Positive ; Comments: VARIANT DELTA; Test Date: 20210820; Test Name: White blood cell count; Result Unstructured Data: Test Result:29000 /mm3
CDC Split Type: FRPFIZER INC202101273098

Write-up: Drug ineffective; COVID-19; pulmonary embolism; Acute Respiratory Distress Syndrome; This is a spontaneous report received from a contactable physician downloaded from the regulatory authority report number is FR-AFSSAPS-NY20214412. A 65-year-old male patient received the second dose of BNT162B2 (COMIRNATY, mRNA encoding the peak viral protein (S) of SARS-CoV-2) via intramuscular in Jun2021 (Lot Number: Unknown ) as single dose for COVID-19 immunization. Medical history included neurosyphilis treated with corticosteroid therapy. Concomitant medication was not specified. The patient died on 07Sep2021. ospitalization in intensive care unit for pneumopathy and then pulmonary embolism. Need for ECMO. Recurrent pneumothorax. Fatal outcome. Death 17 days later. CU hospitalization for COVID acute respiratory distress syndrome (ARDS) documented with DELTA variant and complicated by mechanically ventilated acquired pneumonia and pulmonary embolism. Need for extracorporeal membrane oxygenator (ECMO). Recurrent pneumothorax. Unfavourable evolution. Patient died on 07Sep2021 from refractory ARDS. Additional examinations: On 20Aug2021, PCR covid-19 test: positive. Thoracic Angioscan (CT Scan): Typical bi-pulmonary parenchymal involvement with greater than 75% involvement without pulmonary embolism. Leukocyte count: 29000 per cubic millimeter. emoglobin: 14 gram per deciliter. latelet count: 354000 per cubic millimeter. -Dimer: 2700 microgram per milliliter. T scan: right upper segmental pulmonary embolism without signs of acute pulmonary heart disease. Pejorative course of parenchymal involvement. Autopsy was unknown. The outcome of events was fatal. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: COVID-19; Acute Respiratory Distress Syndrome; Embolism pulmonary; Drug ineffective


VAERS ID: 1760600 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-10
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Vaccination failure
SMQs:, Lack of efficacy/effect (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Down''s syndrome; Drug allergy; Edema Quincke''s; Epilepsy; Pervasive developmental disorder; Pneumopathy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRJNJFOC20211002082

Write-up: VACCINATION FAILURE; This spontaneous report received from a physician via a Regulatory Authority (JANSSEN Vaccines, FR-AFSSAPS-RN20212825) on 01-OCT-2021 and concerned a 64 year old male of unknown race and ethnicity. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: drug allergy, pervasive developmental disorder, edema quincke''s, epilepsy, pneumopathy, and down''s syndrome. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported and expiry: Unknown) 1 dosage forms, 1 total, administered on 18-JUN-2021 for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 10-AUG-2021, the patient experienced vaccination failure. On 01-SEP-2021, the patient died from covid-19 pneumonitis. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Reported Cause(s) of Death: COVID-19 PNEUMONITIS


VAERS ID: 1760614 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-09-05
   Days after vaccination:101
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Blood pressure measurement, Body temperature, COVID-19, Heart rate, Oxygen saturation, Physical examination, Respiratory rate, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-07
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210905; Test Name: cardiopulmonary auscultation; Result Unstructured Data: Test Result:patient with bilateral congestion; Test Date: 20210906; Test Name: cardiopulmonary auscultation; Result Unstructured Data: Test Result:Some rhonchi with 2 bases; Test Date: 20210906; Test Name: Arterial blood pressure; Result Unstructured Data: Test Result:15/8; Test Date: 20210905; Test Name: temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Test Date: 20210906; Test Name: temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Test Date: 20210905; Test Name: heart rate; Result Unstructured Data: Test Result:100; Test Date: 20210906; Test Name: heart rate; Result Unstructured Data: Test Result:100; Comments: / min, regular; Test Date: 20210906; Test Name: Desaturation; Result Unstructured Data: Test Result:Desaturation this morning; Comments: requiring high concentration mask; Test Date: 20210905; Test Name: pulsed oxygen saturation; Test Result: 91 %; Comments: under 3l O2; Test Date: 20210906; Test Name: abdomen examination; Result Unstructured Data: Test Result:Sensitive abdomen left iliac fossa, defenseless; Test Date: 20210905; Test Name: physical examination; Result Unstructured Data: Test Result:Sleepy patient ++, no marbling; Test Date: 20210906; Test Name: physical examination; Result Unstructured Data: Test Result:sleepy and weak; Test Date: 20210906; Test Name: Respiratory rate; Result Unstructured Data: Test Result:48; Comments: / min polypneic 48 / min with slight draft and thoraco-abdominal swing; Test Date: 20210905; Test Name: COVID-19 PCR test; Test Result: Positive ; Comments: variant unknown
CDC Split Type: FRPFIZER INC202101273312

Write-up: vaccination failure confirmed; COVID-19 confirmed by positive COVID PCR test, variant unknown; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority -WEB FR-AFSSAPS-TO20218095. An 89-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot Number: Unknown) on 27May2021 and the first dose of BNT162B2 (Lot Number: Unknown) on 15Apr2021, both via intramuscular at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient experienced vaccination failure confirmed and COVID-19 confirmed by positive COVID PCR test, variant unknown on 05Sep2021. Duration was reported as 3 days. Seen by the doctor on call in the residential care. The patient underwent lab tests and procedures on 05Sep2021 which included COVID-19 PCR test: positive (variant unknown), physical examination: sleepy patient ++, no marbling, cardiopulmonary auscultation: patient with bilateral congestion, pulsed oxygen saturation 91% (under 3l O2), temperature 37.7 Centigrades, heart rate: 100. Discussion with the team, no hospitalization given the significant previous dependence. Therapeutic measures were taken as a result of events and included treatment with corticosteroid therapy and antibiotic therapy administered intramuscularly (IM). On 06Sep2021, worsening of the general condition in 48h. Doctor on duty introduced CST IM + ceftriaxone sodium (ROCEPHINE) IM. Desaturation this morning requiring high concentration mask. Algique to mobilization. The patient underwent lab tests and procedures on 06Sep2021 which included physical examination: sleepy and weak, temperature: 37.2 Centigrade, arterial blood pressure: 15/8, respiratory rate: 48 / min (polypneic 48 / min with slight draft and thoraco-abdominal swing), regular heart sounds: 100/min, cardiopulmonary auscultation: some rhonchi with 2 bases, abdomen examination: sensitive abdomen left iliac fossa, defenseless. Therapeutic measures were taken as a result of events and included treatment with continuation CST IM, stop ceftriaxone sodium IM, stop ceftriaxone sodium IM, continuation O2 with high concentration mask, introduction fentanyl (DUROGESIC) 25mg, introduction of hyoscine (SCOPODERM), introduction midazolam (HYPNOVEL) 10 mg subcutaneously over 24h. Family warned palliative treatment no harsh treatment no hospitalization. The patient died on 07Sep2021. Patient''s death from COVID 19 on 07Sep2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: vaccination failure confirmed; COVID-19 confirmed by positive COVID PCR test, variant unknown


VAERS ID: 1760615 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-03
Onset:2021-08-23
   Days after vaccination:173
Submitted: 0000-00-00
Entered: 2021-10-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-29
   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: Dementia Alzheimer''s type (very advanced)
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic psychosis
Allergies:
Diagnostic Lab Data: Test Date: 20210823; Test Name: Test SARS-CoV-2; Test Result: Positive ; Comments: Variant Delta
CDC Split Type: FRPFIZER INC202101278480

Write-up: Drug Ineffective; Symptomatic Covid-19; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority -WEB - [FR-AFSSAPS-TO20218132]. A 96-year-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 03Mar2021 (Batch/Lot Number: EP9598) as dose 2, single for covid-19 immunisation. Medical history included ongoing Dementia in very advanced Alzheimer''s disease and Chronic psychosis from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. It was reported that on 23Aug2021 Symptomatic Covid-19 (also reported as Drug Ineffective). The Sars-Cov-2 test carried out on 23Aug2021: positive with the presence of the Delta variant. On-site medical care respond to current recommendations. The patient died on 29Aug2021 (also reported as EVOLUTION: death on 29Aug2021/ Pneumonie covid-19). An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Pneumonie covid-19


VAERS ID: 1760698 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-09-17
   Days after vaccination:212
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-17
   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: Asthma bronchial; Atrial fibrillation; Cardiac insufficiency; Coronary disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Sudden death unexplained; This case was received via Regulatory Authority (Reference number: DE-PEI-202100194215) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death unexplained) in an 89-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 214012) for Prophylactic vaccination. Concurrent medical conditions included Asthma bronchial, Coronary disease, Cardiac insufficiency and Atrial fibrillation. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. The patient died on 17-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. Treatment information was not provided. Company comment: This case concerns a 89-year-old female patient with medical history of asthma, coronary artery disease, cardiac insufficiency and atrial fibrillation, who experienced the unexpected and fatal event of Sudden death unexplained. The event occurred approximately 1 day after third dose of Spikevax. Autopsy is not reported. The rechallenge was not applicable. The medical history of asthma, coronary artery disease, cardiac insufficiency and atrial fibrillation remain as confounders. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 89-year-old female patient with medical history of asthma, coronary artery disease, cardiac insufficiency and atrial fibrillation, who experienced the unexpected and fatal event of Sudden death unexplained. The event occurred approximately 1 day after third dose of Spikevax. Autopsy is not reported. The rechallenge was not applicable. The medical history of asthma, coronary artery disease, cardiac insufficiency and atrial fibrillation remain as confounders. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1760884 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-17
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004217 / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-17
   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: DEMODERNATX, INC.MOD20213

Write-up: Acute myocardial infarction; This case was received via regulatory authority (Reference number: DE-PEI-202100194284) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) in a 52-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3004217) for Prophylactic vaccination. No Medical History information was reported. On 15-Jul-2021, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Jul-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (Acute myocardial infarction) (seriousness criteria death and medically significant). The patient died on 17-Jul-2021. The cause of death was not reported. An autopsy was performed, but no results were provided. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: This case concerns a 52-year-old, male patient with no relevant medical history, who experienced the unexpected event of Acute Myocardial Infarction. The event occurred approximately 3 days after the first dose of Spikevax and had a fatal outcome. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a 52-year-old, male patient with no relevant medical history, who experienced the unexpected event of Acute Myocardial Infarction. The event occurred approximately 3 days after the first dose of Spikevax and had a fatal outcome. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1761177 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
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: The patient was healthy, active and had no health problems.
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRJNJFOC20211003738

Write-up: DIED DUE TO THE VACCINE; This spontaneous report received from a consumer concerned a male of unspecified age, race and ethnic origin. The patient''s height, and weight were not reported. The patient was healthy, active and had no health problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date was not reported,1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient died due to the vaccine. On an unspecified date, it was confirmed by examination (autopsy) as the cause of death. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to the vaccine on an unspecified date. This report was serious (Death).; Sender''s Comments: V0. 20211003738-COVID-19 VACCINE AD26.COV2.S- Died due to the vaccine. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: DIED DUE TO THE VACCINE; Autopsy-determined Cause(s) of Death: DIED DUE TO THE VACCINE


VAERS ID: 1761185 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-04
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Interchange of vaccine products, Off label use
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-08
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: BRPFIZER INC202101288092

Write-up: after 4 days he died; Dose 1 and Dose 2 of CORONAVAC, Dose 3 of COMIRNATY; Dose 1 and Dose 2 of CORONAVAC, Dose 3 of COMIRNATY; This is a spontaneous report from a contactable consumer (patient''s daughter). A male patient of an unspecified age received BNT162b2 (COMIRNATY, Solution for injection), dose 3 via an unspecified route of administration on 04Sep2021 as single dose for COVID-19 immunisation. Medical history included ''He did not have comorbidities, nor any kind of disease. Historic vaccine included Coronavac on 08Feb2021 the first dose and on 08Mar2021 the second dose of Coronavac both for COVID-19 immunization. The patient''s concomitant medications were not reported. As reported, the patient''s daughter stated ''I come through this request an investigation or notification about the happening with the event that occurred with the death of the patient on 08Sep2021, of this current year. An unknown country is a villainy, with good people dying with the lack of prepare of a regulatory authority, deciding that elderly people take vaccines wildly''. Her father took two doses of Coronavac and full vaccinated. Her father had the booster dose on September 4th 2021, he took the Pfizer one and after 4 days he passed away. The patient died on 08Sep2021. It was not reported if an autopsy was performed. The lot number for the vaccine, [BNT162b2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: after 4 days he died


VAERS ID: 1761483 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Computerised tomogram, Dyspnoea, Electrocardiogram, General physical health deterioration, Troponin, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Anaphylactic reaction (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-20
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ALDACTONE [SPIRONOLACTONE]; AMLODIPIN SANDOZ ECO; ASPIRIN CARDIO; ATOZET; JANUVIA; REVATIO; TOREM [TORASEMIDE]; TRACLEER [BOSENTAN]; VI-DE 3; LANTUS; ANORO ELLIPTA; DAFALGAN; DOMPERIDON MEPHA; LAXIPEG
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD (COPD GOLD 1, Risk class B with severe emphysema); Emphysema (COPD GOLD 1, Risk class B with severe emphysema); Hospitalisation; Non ST segment elevation myocardial infarction (NSTEMI type 2 on 30Mar2021 with known coronary 3-vascular disease); Papillary urothelial carcinoma (Multilocular papillary urothelial carcinoma of the urinary bladder pT1 and pTis); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: CT scan; Result Unstructured Data: Test Result:A central or paracentral pulmonary artery embolism; Comments: A central or paracentral pulmonary artery embolism could be excluded; Test Date: 20210415; Test Name: ECG; Result Unstructured Data: Test Result:No newrepolarisation disturbances; Comments: No new repolarisation disturbances; Test Date: 20210415; Test Name: Troponin; Result Unstructured Data: Test Result:Decreased
CDC Split Type: CHPFIZER INC202101287573

Write-up: Dyspnoea; Thoracic pressure sensation; A non-sustained, asymptomatic ventricular tachycardia occurred in the emergency unit; General condition reduction; This is a spontaneous report received from a contactable physician via a regulatory authority. Regulatory authority report number CH-SM-2021-15815. A 73-year-old male patient received bnt162b2 (COMIRNATY), first dose intramuscular on 15Apr2021 (at age of 73-year-old) (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Non ST segment elevation myocardial infarction from 30Mar2021 (NSTEMI type 2 on 30Mar2021 with known coronary 3-vascular disease), chronic obstructive pulmonary disease (COPD) (COPD GOLD 1, Risk class B with severe emphysema), emphysema (COPD GOLD 1, Risk class B with severe emphysema), Papillary urothelial carcinoma (Multilocular papillary urothelial carcinoma of the urinary bladder pT1 and pTis), type 2 diabetes mellitus, hospitalisation from 30Mar2021 to 12Apr2021 (Hospitalisation for decompensation of his underlying disease of cor pulmonale with severe pulmonary hypertension). Concomitant medications included medication at hospital admission on 15Apr2021, since unknown date until 20Apr2021, unless otherwise stated: oral administration; Fixed medication: spironolactone (ALDACTONE); amlodipine besilate (AMLODIPIN SANDOZ ECO); acetylsalicylic acid (ASPIRIN CARDIO); atorvastatin calcium/ ezetimibe (ATOZET); sitagliptin phosphate (JANUVIA); sildenafil citrate (REVATIO); torasemide (TOREM); bosentan (TRACLEER); colecalciferol (VI-DE 3); insulin glargine (LANTUS); umeclidinium bromide/ vilanterol trifenatate (ANORO ELLIPTA); paracetamol (DAFALGAN); domperidone (DOMPERIDON MEPHA) (it also reported "10 mg max. 3x/day"); macrogol 400 (LAXIPEG). It reported that the patient was actively immunised against COVID-19 disease caused by SARS-CoV-2 for the first time with Comirnaty (Tozinameranum) mRNA-Covid-19 vaccine on 15Apr2021. Two to three hours after vaccination, the patient presented to the emergency department due to dyspnoea and a pulling thoracic pressure sensation. Previously, the patient had been hospitalised from 30Mar2021 to 12Apr2021 for decompensation of his underlying disease of cor pulmonale with severe pulmonary hypertension. In the emergency unit on 15Apr2021, a severely hypoxaemic patient presented with oxygen 12L/min, which could be rapidly reduced in the course of adequate oxygenation at rest. A central or paracentral pulmonary artery embolism could be excluded by chest CT. The ECG did not show any new repolarisation disturbances and the troponin level decreased compared to previous values. A non-sustained, asymptomatic ventricular tachycardia occurred in the emergency unit, which was treated with 2g magnesium i.v. and the patient was briefly transferred to the intensive care unit. In the course, the respiratory situation continued to improve spontaneously and the oxygen requirement was reduced to the original values at home, so that the patient could be transferred to the pneumological ward the following day. On transfer, an afebrile patient presented in a reduced general condition. In view of the severity of the underlying disease with advanced cor pulmonale with severe pulmonary hypertension and emphysema, the attending physicians were unable to make any further optimisations during the inpatient stay, even though the therapy had already been fully developed. The smallest efforts triggered dyspnoea in the patient with an increase in basic oxygen therapy. The patient wished to be discharged to his home environment instead of a possible follow-up care facility. On 20Apr2021, the patient could be discharged home from hospital in a slightly improved but still reduced general condition. The patient died at home on the same day (20Apr2021). No more detailed information is available on the exact cause of death. According to the responsible pulmonologists, the underlying disease with severe pulmonary hypertension and emphysema possibly explains the sudden but not entirely unexpected death of the patient. The outcome for Dyspnoea and Thoracic pressure sensation was fatal, for a non-sustained, asymptomatic ventricular tachycardia occurred in the emergency unit was unknown, for general condition reduction was recovering. A causal relationship between Comirnaty and Dyspnea and Chest discomfort was assessed as possible. A regulatory authority assessed this case as serious with fatal outcome and hospitalization. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Pulmonary hypertension; Emphysema; Disease progression


VAERS ID: 1762397 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: Artificial cardiac pacemaker wearer; Mitral valve insufficiency; Paroxysmal atrial fibrillation; Triple vessel disease
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aneurysm; Endovascular aortic aneurysm repair (Condition after endovascular aneurysm surgery in symptomatic infrarenal abdominal aortic aneurysm.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101278582

Write-up: Found dead; Inappropriate schedule of vaccine administered; This is a spontaneous report from a non-contactable physician downloaded from the WEB DE-DCGMA-21191695 and sender''s (Case) Safety Report Unique Identifier DE-PEI-202100196553. A 71-year-old male patient received bnt162b2 (COMIRNATY, Strength 0.3ml), dose 2 intramuscular on 10Jun2021 (Lot Number: FA5833) (at age of 71-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient took the first dose of bnt162b2 (COMIRNATY) on 29-APR-2021 (lot: EX3510) (at age of 71-year-old) for covid-19 immunization. Medical history included cardiac Artificial cardiac pacemaker wearer from Dec2018 and ongoing, Abdominal aneurysm from an unknown date and not ongoing; ongoing Triple vessel disease; ongoing Mitral valve insufficiency; Paroxysmal atrial fibrillation from Jan2021 and ongoing; Endovascular aortic aneurysm repair from 26Feb2021 and ongoing. Condition after endovascular aneurysm surgery in symptomatic infrarenal abdominal aortic aneurysm. The patient''s concomitant medications were not reported. The patient was found dead on 16Jun2021, inappropriate schedule of vaccine administered (non-serious) on 10Jun2021 with outcome of unknown. The patient died on 16Jun2021. 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: Found dead


VAERS ID: 1762399 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Myocardial ischaemia
SMQs:, Other ischaemic heart disease (narrow)

Life Threatening? Yes
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: Adipositas; Alcohol abuse; Amphetamine abuse; Coronary artery disease; Hyperlipidaemia; Hypertension; Hyperuricaemia; Nicotine abuse
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101278756

Write-up: Ischaemia myocardial; This is a spontaneous report received from a not-contactable physician downloaded from the Regulatory Authority-WEB DCGMA number DE-DCGMA-21192512, Safety Report Unique Identifier: DE-PEI-202100196057. This report was forwarded via RA (Regulatory Authority). A 35-year-old male patient received the second dose of BNT162B2 (COMIRNATY, 0.3 ml) via intramuscular on 10Jul2021 (Lot Number: FC1440) at the age of 35-year-old as single dose for COVID-19 immunization. Medical history included adipositas, hyperuricaemia, nicotine abuse, alcohol abuse, amphetamine abuse, hypertension, coronary artery disease and hyperlipidaemia, all unknown ongoing. Concomitant medication was not reported. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on 29May2021 (Batch/Lot number: 1C009A) as single dose for COVID-19 immunization. On 12Jul2021, the patient experienced ischaemia myocardial. The patient died on 12Jul2021. Autopsy was not performed. The outcome of ischaemia myocardial was fatal.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1762418 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-21
Onset:2021-09-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCRP9 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anemia; Myeloproliferative neoplasm
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101278123

Write-up: Multiple organ failure; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-PEI-202100197091. An 85-year-old male patient received the second dose of BNT162B2 (COMIRNATY) at 85-year-old, via an unspecified route of administration on 21Sep2021 (Batch/Lot Number: SCRP9) at single dose for COVID-19 immunisation. Medical history included myeloproliferative neoplasm, and anaemia. The patient''s concomitant medications were not reported. Patient previously received the first dose of BNT162B2 (COMIRNATY) at 85-year-old, via an unspecified route of administration on 31Aug2021 for COVID-19 immunisation. The patient experienced multiple organ failure on 23Sep2021. This report was serious - death. The patient died on 23Sep2021. It was not reported if an autopsy was performed. Event assessment: Comirnaty/ event /Regulatory Authority /Result of Assessment: B. Indeterminate. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Multiple organ failure


VAERS ID: 1762419 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Apoplexy; Diabetes mellitus; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101278167

Write-up: Pulmonary embolus; General physical condition decreased; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-202100197135. A 24-year-old male patient received BNT162B2 (COMIRNATY), dose 2 via an unspecified route of administration on 21May2021 (Batch/Lot Number: unknown) as single dose for COVID-19 immunisation. Medical history included hypertension, apoplexy from 2012 and diabetes mellitus. The patient''s concomitant medications were not reported. Historical vaccine included 1st dose of BNT162B2 on 30Apr2021 for COVID-19 vaccination. The patient experienced pulmonary embolus and general physical condition decreased, both on 23May2021. Time Interval between beginning of drug administration and start of reaction was 2 days. The patient died on an unspecified date. It was not reported if an autopsy was performed. Outcome of the events was fatal. Relatedness of drug to reaction/event: Source of assessment: Regulatory Authority, Result of Assessment D. Unclassifiable. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: General physical condition decreased; Pulmonary embolus


VAERS ID: 1762456 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-21
Onset:2021-08-16
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE9174 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   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: Medical History/Concurrent Conditions: Communication disorder; COVID-19; Immobile; Living in care
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: Test Result:above 40 Centigrade; Comments: High fever above 40 degrees C
CDC Split Type: DEPFIZER INC202101272639

Write-up: Pyrexia / High fever above 40 degrees C; Unknown cause of death; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021181185, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100193389. An 83 years-old female patient received BNT162B2 (COMIRNATY, Lot. FE9174) on 21Jul2021, at single dose, for COVID-19 immunisation. The patient''s weight was 80 kg, and height was 165 cm. Concomitant medications were unknown. On 16Aug2021 the patient died. Unknown cause of death was reported. The patient experienced also pyrexia on an unspecified date. The patient''s outcome was: not recovered/not resolved for pyrexia, fatal for unknown cause of death. No autopsy was done. This report is serious - death. Sender''s comments: Information on risk factors or pre-existing conditions severe care, immobile and hardly responsive. Reportedly had Covid19 in Dec2020. Died on 16Aug2021. The time relationship is thus given. / High fever above 40 degrees C. Result of Assessment: Comirnaty/ all event(s): Regulatory Authority: D. Unclassifiable. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1762457 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F030A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Interchange of vaccine products, Myocardial infarction, Off label use
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Ex-smoker (non-smoker for 10 years); Overweight
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Smoker (Smoker for years)
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272646

Write-up: Sudden death 17 days after the 2nd vaccination with Cominarty; Off label use; Interchange of vaccine products; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, DE-PEI-CADR2021181351, Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100193808. A 68 years-old male patient received the second dose of BNT162B2 (COMIRNATY, Lot. 1F030A) on 13Jul2021, at single dose, for COVID-19 immunisation. The patient''s medical history and concurrent conditions included: overweight, smoker. The patient''s weight was 120 kg, and height was 188 cm. No concomitant medications were reported. On 31Jul2021, the patient experienced infarct myocardial. The patient''s outcome was: fatal for infarct myocardial. This report is serious - death. Sender Comment: No known of any allergies reported Information on risk factors or previous illnesses: obesity high blood pressure smoker for years, non-smoker for 10 years Between the first and the second vaccination, my father was in the emergency room because of severe pain in his leg. Thrombosis was suspected, but the doctors couldn''t find anything. After the administration of Ibuflam, the pain subsided and he was no longer in pain. 17 days after the 2nd vaccination my father died suddenly and unexpectedly and was on 31Jul2021 dead in bed. The doctor who did the inquest suspected heart failure or cardiac arrest or a heart attack. An autopsy was not made. Relatedness of drug to reaction(s)/event(s) Regulatory Authority D. Unclassifiable Historical vaccine: Vaxzevria, event: pain in leg. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1762458 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Coronary artery embolism, Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatism
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101278154

Write-up: arrythmia/Blood clots that led to heart attack 3 days after 2nd vaccination with Biontech; Blood clots that led to heart attack 3 days after 2nd vaccination with Biontech; Blood clots that led to heart attack 3 days after 2nd vaccination with Biontech; This is a spontaneous report from a non-contactable consumer downloaded from the WEB, regulatory authority number DE-PEI-CADR2021182989, Sender''s (Case) Safety Report Unique Identifier: DE-PEI-202100196240. A 77-year-old female patient received 2nd dose of BNT162B2 (COMIRNATY) at single dose via an unknown route on 21Jun2021 at 77-year-old for COVID-19 immunisation. Medical history included rheumatism. No aware of allergies. Concomitant drug was not provided. Serious events were reported as "blood clots that led to heart attack 3 days after 2nd vaccination with BioNTech" with onset date of 21Jun2021 and seriousness criteria of death. Patient was suspected acute embolus of the coronary artery related to arrythmia. Outcome of the events was fatal (also reported stop date of arrhythmia, Myocardial infarction, Coronary artery embolism was 24Jun2021). This report was serious due to death.; Reported Cause(s) of Death: Blood clots that led to heart attack 3 days after 2nd vaccination with Biontech; Blood clots that led to heart attack 3 days after 2nd vaccination with Biontech; Blood clots that led to heart attack 3 days after 2nd vaccination with Biontech


VAERS ID: 1762459 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-08-30
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH SCPT7 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, 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), Cardiac arrhythmia terms, nonspecific (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-30
   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: Hypertension; Venous insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101278145

Write-up: Arrhythmia; sudden cardiac arrest; This is a spontaneous report from a non-contactable consumer downloaded from the WEB [DE-PEI-CADR2021183481]. Sender''s Safety Report Unique Identifier is DE-PEI-202100196938. A 41-year-old male patient received BNT162B2 (COMIRNATY, Lot#: SCPT7, Strength: 0.3 mL) at single dose on 24Aug2021 for COVID-19 immunisation. Medical history included hypertension; venous insufficiency. Concomitant medications were not reported. On 30Aug2021, the patient experienced arrhythmia and died the same day. It was sudden cardiac arrest with attempted resuscitation without success. It was unknown if an autopsy was performed. The outcome of events was fatal. This report was serious - death. Sender Comment: Are allergies known for you or the person concerned? If yes, which? no Information about risk factors or pre-existing conditions: Hypertension, well adjusted venous insufficiency / Sudden cardiac arrest with attempted resuscitation without success ; Reported Cause(s) of Death: sudden cardiac arrest; Arrhythmia


VAERS ID: 1762477 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101293190

Write-up: suspicion of pulmonay embolism; third dose COMIRNATY; third dose COMIRNATY; This spontaneous report was received from a not-contactable physician and based on information received by Pfizer from Biontech [manufacturer control number: 89606], license party for Comirnaty. An 88-year-old female patient (Unknown pregnant) received the third dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient previously received the second dose and the first dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On an unspecified date, the patient experienced suspicion of pulmonay embolism (patient complained of shortness of breath before death). The patient died on an unspecified date. Autopsy was not reported. The outcome of pulmonary embolism was fatal. The outcome of other events was unknown. No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Pulmonary embolism


VAERS ID: 1762614 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-05
Onset:2021-08-13
   Days after vaccination:189
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL8723 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Chest X-ray, Diarrhoea, Dyspnoea, Oxygen saturation, Oxygen saturation decreased, SARS-CoV-2 test, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-17
   Days after onset: 4
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: Atrial fibrillation paroxysmal; Cardiac assistance device user; Dementia Alzheimer''s type; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210814; Test Name: Thorax X-ray; Result Unstructured Data: Test Result: pneumonia; Comments: RIGHT BASAL INFILTRATE, LEFT BASAL PLEURITIS; Test Date: 20210814; Test Name: Oxygen saturation; Result Unstructured Data: Test Result: low; Test Date: 20210814; Test Name: SARS-CoV-2 PCR test; Test Result: Positive.
CDC Split Type: ESPFIZER INC202101285121

Write-up: COVID-19 pneumonia; Vaccination failure; Oxygen saturation low; Dyspnea; diarrhoea; This is a spontaneous report from a contactable pharmacist from the Regulatory Authority. The regulatory authority number ES-AEMPS-976741. A non-pregnant 97-year-old female patient received the bnt162b2 (COMIRNATY), dose 2 on 05Feb2021 (Lot Number: EL8723; Expiration Date: 31May2021), dose 1 on 15Jan2021 (Lot Number: EM0477; Expiration Date: 30Apr2021), both dose via an unspecified route of administration, administered in arm as a single dose for covid-19 immunization. The patient was no pregnant at time of vaccination. Medical history included Dementia Alzheimer''s type, Atrial fibrillation paroxysmal, Hypertension arterial, Pacemaker carrier. The patient''s concomitant medications were not reported. On 13Aug2021 the patient presented diarrhoea. On 14Aug2021, the patient experienced covid-19 pneumonia, vaccination failure, oxygen saturation low, dyspnea. All events assessed as serious (death, hospitalization). The patient underwent lab tests and procedures which included chest x-ray pneumonia (right basal infiltrate, left basal pleuritis) on 14Aug2021, oxygen saturation low on 14Aug2021, SARS-CoV-2 PCR test positive on 14Aug2021. The patient died on 17Aug2021. It was unknown if an autopsy was performed. The outcome of the events was fatal. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477 (dose 1) and lot EL8723 (dose 2). A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, and stability. Concluded that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root causes were identified as the complaint was not confirmed. No follow-up attempts are possible, no information is expected. Reported Cause(s) of Death: COVID-19 pneumonia; Vaccination failure; Oxygen saturation low; Dyspnea; Diarrhoea


VAERS ID: 1762632 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4509 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain injury, Brain oedema, Diabetes mellitus, Dyspnoea, Fatigue, Inappropriate schedule of product administration, Ketoacidosis, Malaise, SARS-CoV-2 test, SARS-CoV-2 test negative, Thirst
SMQs:, Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Medication errors (narrow), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OPAMOX; SERONIL; OLANZAPINE ACCORD; MELATONIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Eating disorder (in adolescence); Mood disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210911; Test Name: covid-19 virus test; Test Result: Negative
CDC Split Type: FIPFIZER INC202101278353

Write-up: severe fatigue; malaise; constant thirst; Mild shortness of breath on exertion; Inappropriate schedule of vaccine administered; SARS-CoV-2 test negative; Ketoacidosis; Diabetes; Brain injury; Brain oedema; This is a spontaneous report received from a contactable physician downloaded from the WEB. The regulatory authority report number FI-FIMEA-20215020. A 23-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 03Sep2021 (at age of 23 years old) (Lot Number: FG4509) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included mood disorder, eating disorder (in adolescence) and a school bullying at the background. Historical Vaccine included first dose of bnt162b2 (COMIRNATY), dose 1 in Arm Left on 01Jul2021 (Lot Number: FE2296) for covid-19 immunisation. Concomitant medication(s) included oxazepam (OPAMOX); fluoxetine hydrochloride (SERONIL) taken for mental disorder; olanzapine (OLANZAPINE ACCORD) taken for mental disorder; melatonin (MELATONIN) taken for initial insomnia, all start and stop date were not reported. The patient experienced diabetes (death) on 03Sep2021; brain injury (death) on 03Sep2021; brain oedema (death) on 03Sep2021; sars-cov-2 test negative (death) on 03Sep2021; ketoacidosis (death) on 03Sep2021; severe fatigue, malaise, constant thirst, mild shortness of breath on exertion, inappropriate schedule of vaccine administered, above were non-serious on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Sep2021. The patient died on Sep2021. It was not reported if an autopsy was performed. Clinical course as reported: After the second coronary vaccine, experienced more than a week of severe fatigue, malaise, and constant thirst. Mild shortness of breath on exertion. Referred to 11Sep coronavirus test, which was negative. 12Sep upon hospitalization very poor condition, diagnosed with fresh diabetes and severe ketoacidosis, which resulted in severe cerebral edema and extensive brain damage within half a day. Today, the patient intensive care will be abandoned and presumably she will die. Relatives are wondering if the vaccine may have anything to do with the onset of diabetes, although this had apparently not been previously reported. 23Sep2021 follow-up doctor: In the future, the patient will have a forensic examination of the cause of death, so the death certificate will be made by a forensic doctor. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: diabetes; brain injury; brain oedema; sars-cov-2 test negative; ketoacidosis


VAERS ID: 1762646 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:2021-07-19
   Days after vaccination:66
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5831 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac disorder, Coma, Delirium, Encephalitis autoimmune, Fall, Fatigue, Infection, Investigation, Lumbar puncture, Metabolic disorder, Oedema peripheral, Orthostatic hypotension, SARS-CoV-2 test, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-26
   Days after onset: 38
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications: BETAXOLOL; ESOMEPRAZOLE; NORSET; DUTASTERIDE; KARDEGIC
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate; Chronic renal failure; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Name: orthostatic hypotension test; Test Result: Positive ; Comments: orthostatic hypotension test was positive; Test Name: lumbar puncture; Result Unstructured Data: Test Result:autoimmune encephalitis confirmed; Comments: autoimmune encephalitis confirmed by the presence of anti-NMDAR antibodies; Test Date: 20210716; Test Name: Covid polymerase chain reaction test; Test Result: Negative
CDC Split Type: FRPFIZER INC202101278957

Write-up: fatigue; fall; fainting; edema of the lower legs/pitting; cardiac decompensation; orthostatic hypotension; worsening asthenia; harmful delirium; comatose state; infectious and metabolic complications; metabolic complications; Encephalitis autoimmune; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-BX20218847. A 93-years-old male patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: FA5831, expiration date unknown) intramuscularly on 14May2021 for COVID-19 immunisation. Medical history included adenocarcinoma of prostate from an unknown date and unknown if ongoing, hypertension arterial from an unknown date and unknown if ongoing, chronic renal failure from an unknown date and unknown if ongoing. Patient previously received 1st single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT number: EW4815, expiration date unknown) intramuscularly in the left arm on 17Apr2021 for COVID-19 immunisation. Concomitant medications included betaxolol taken for an unspecified indication, start and stop date were not reported; esomeprazole taken for an unspecified indication, start and stop date were not reported; mirtazapine (NORSET) taken for an unspecified indication, start and stop date were not reported; dutasteride taken for an unspecified indication, start and stop date were not reported; acetylsalicylate lysine (KARDEGIC) taken for an unspecified indication, start and stop date were not reported. Autoimmune encephalitis discovered 2 months after dose 2. Patient was hospitalised on 16Jul2021, that was (i.e.) 2 months after dose 2, because of a few days of fatigue with a fall at home and fainting without loss of consciousness. On intake, the patient presented edema of the lower legs, showing pitting to varying degrees without any sign of deep vein thrombosis. Treatment with Lasilix due to suspected cardiac decompensation, offering a reduction in the edema. Regarding the falls, the orthostatic hypotension test was positive, leading to the fitting of compression stockings. During hospitalization, rapidly worsening asthenia followed by harmful delirium and a comatose state. The report showed autoimmune encephalitis confirmed by the presence of anti-NMDAR antibodies on lumbar puncture. Treatment with Vimpat and corticosteroids did not improve the patient''s state of alertness. The patient experienced infectious and metabolic complications on an unspecified date with seriousness criteria of death, encephalitis autoimmune on 19Jul2021 with seriousness criteria of hospitalized on 16Jul2021 and outcome of not recovered, fatigue on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, fall on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, fainting on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, edema of the lower legs/pitting on an unspecified date with seriousness criteria of 16Jul2021 and outcome of unknown, cardiac decompensation on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, orthostatic hypotension on an unspecified date with seriousness criteria of hospitalized on 16Jul2021 and outcome of unknown, worsening asthenia on an unspecified date with seriousness criteria of hospitalization and outcome of unknown, harmful delirium on an unspecified date with seriousness criteria of hospitalization and outcome of unknown, comatose state on an unspecified date with seriousness criteria of hospitalization and outcome of unknown. The patient was hospitalized for encephalitis autoimmune from 16Jul2021 to an unknown date. The patient was hospitalized for fatigue from 16Jul2021 to an unknown date. The patient was hospitalized for fall from 16Jul2021 to an unknown date. The patient underwent lab tests and procedures which included investigation: positive on an unspecified date orthostatic hypotension test was positive, lumbar puncture: autoimmune encephalitis confirmed on an unspecified date autoimmune encephalitis confirmed by the presence of anti-NMDAR antibodies, Covid polymerase chain reaction test was negative on 16Jul2021. Therapeutic measures were taken as a result of encephalitis autoimmune, fatigue, fall, fainting, edema of the lower legs/pitting, cardiac decompensation, orthostatic hypotension, worsening asthenia, harmful delirium, comatose state. The patient died on 26Aug2021. Cause of death was infectious and metabolic complications. It was not reported if an autopsy was performed. NB : Accountability "without prejudice to any investigations that may be carried out in the context of legal or amicable compensation procedures.". No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: infectious and metabolic complications; infectious and metabolic complications


VAERS ID: 1762654 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-09
Onset:2021-08-11
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, COVID-19 pneumonia, Drug ineffective, Dyspnoea, Lung disorder, Oxygen saturation, Oxygen saturation decreased, Pulmonary function test
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-22
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Dyslipidemia
Allergies:
Diagnostic Lab Data: Test Name: saturation; Test Result: 64 %; Comments: under 12 l oxygen; Test Name: pulm impairment; Test Result: 75 %; Comments: pulm impairment
CDC Split Type: FRPFIZER INC202101291875

Write-up: COVID-19; Severe desaturation 64% under 12 l oxygen; dyspnea; pulm impairment; vaccine failure; COVID-19 pneumonitis; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority -WEB, regulatory authority number FR-AFSSAPS-LY202110420. An 88-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: ER2659), via intramuscular on 09Mar2021 as dose 1, single for covid-19 immunization. Medical history included arterial hypertension, dyslipidaemia; both from an unknown date and unknown if ongoing. The concomitant medications were not reported. On an unspecified date, the patient had covid-19, severe desaturation 64% under 12 l oxygen with dyspnea and pulm impairment 75%. On 11Aug2021, the patient experienced covid-19 pneumonitis and vaccine failure. The patient underwent lab tests and procedures which included oxygen saturation: 64 % (under 12 l oxygen), pulmonary function test: 75 % (pulm impairment) on an unspecified date. Continuing care hospitalization on 22Aug2021. The patient died on 22Aug2021. The cause of death was unknown. It was not reported if an autopsy was performed. The outcome of all the events was unknown while covid-19 pneumonitis was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1762673 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-11
Onset:2021-09-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal haemorrhage, Platelet count, Rectal haemorrhage, Red blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-15
   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: METHOTREXATE; FOLIC ACID; SIMPONI; DIFFU K; BECILAN; BISOPROLOL; XATRAL; ZARZIO; RIFADINE; LOVENOX; DEXAMBUTOL; PIRILENE; RIMIFON
Current Illness: Bone tuberculosis (bone and lung tuberculosis); Thrombocytopenia
Preexisting Conditions: Medical History/Concurrent Conditions: Hospitalization (for tuberculosis: in geriatric ward)
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: platelet count; Result Unstructured Data: Test Result:42 x10 9/l; Test Date: 20210910; Test Name: platelet count; Result Unstructured Data: Test Result:42 x10 9/l; Test Date: 20210914; Test Name: platelet count; Result Unstructured Data: Test Result:97 x10 9/l; Test Date: 20210914; Test Name: red blood cells; Result Unstructured Data: Test Result:7.7 g/dl; Comments: anaemia
CDC Split Type: FRPFIZER INC202101278533

Write-up: upper digestive haemorrhage; rectorragia; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Agency (RA)-WEB FR-AFSSAPS-MP20217735.Safety Report Unique Identifier FR-AFSSAPS-2021133140. A 77-year-old male patient received the first dose of BNT162B2 (COMIRNATY, dilutable dispersion for injection) via intramuscular on 13Sep2021 (Lot Number: Unknown) as single dose for COVID-19 immunization. Medical history included thrombocytopenia and bone tuberculosis (bone and lung tuberculosis), both ongoing. The patient hospitalized for tuberculosis: in geriatric ward from 26Aug2021 to 10Sep2021 then from 10Sep2021 to 15Sep2021 in internal medicine, patient with thrombocytopenia at 42 G/L from 08Sep2021 to 10Sep2021. (normal coagulation test). Concomitant medication included rifampicin (RIFADINE [RIFAMPICIN]) for tuberculosis from 11Sep2021, levofloxacin (LOVENOX [LEVOFLOXACIN]) for tuberculosis from 12Sep2021, ethambutol dihydrochloride (DEXAMBUTOL) for tuberculosis from 11Sep2021, pyrazinamide (PIRILENE) for tuberculosis from 11Sep2021, isoniazid (RIMIFON) for tuberculosis from 11Sep2021, methotrexate from 2020, folic acid from 2020, golimumab (SIMPONI) from 2020, potassium chloride (DIFFU K), pyridoxine hydrochloride (BECILAN), bisoprolol, alfuzosin hydrochloride (XATRAL) and filgrastim (ZARZIO) from 11Sep2021 to 13Sep2021. On 15Sep2021, the patient experienced rectorragia. The platelet count was 97G/L on 14Sep2021. The patient received a transfusion of packed red blood cells on 14Sep2021. No melena or digestive disturbances on previous days. On 15Sep2021, the patient was found dead with extravasation of red digestive blood (massive rectorrhagia). The question of an upper digestive haemorrhage was also raised. Treatment included: From 11Sep2021 to 13Sep2021: Zarzio 30 MiU. Since 11Sep2021: Dexambutol in 500mg, Rifadine in 600mg, Pirilene in 2000mg and Rimifon in 300mg. Since more than 1 year: methotrexate 5mg/week, folic acid 5mg/week, Simponi S/C once/month. Since unknown: Diffu K, Becilan, bisoprolol 2.5mg, Xatral LP 40mg, Lovenox 0.4. The patient last took methotrexate on 30Aug2021 and then on 13Sep2021. Died during the night of 14/15Sep2021 due to massive haemorrhage. Autopsy was not preformed. The outcome of Bleeding rectal was fatal. The outcome of other event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtain. No further information is expected.; Reported Cause(s) of Death: gastrointestinal bleeding


VAERS ID: 1762674 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-20
Onset:2021-09-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Cardio-respiratory arrest, Coma scale, Oxygen saturation, 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), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-21
   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: Underweight
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210920; Test Name: Glasgow; Result Unstructured Data: Test Result:3; Comments: 14h46; Test Date: 20210920; Test Name: oxygen; Result Unstructured Data: Test Result:desaturation; Comments: major desaturation; Test Name: PCR COVID-19; Test Result: Positive
CDC Split Type: FRPFIZER INC202101278530

Write-up: PCR Covid +.; Cardio-respiratory arrest; This is a spontaneous report from a contactable pharmacist downloaded from the regulatory authority-WEB, regulatory authority number FR-AFSSAPS-MP20217736. A 77-year-old female patient received the first dose of BNT162B2 (COMIRNATY, Batch/Lot number was not reported) intramuscular on 20Sep2021 at age of 77-year-old at single dose for COVID-19 immunisation. Medical history included ongoing underweight. No other medical history. Lean, independent at home. No treatment. The patient''s concomitant medications were not reported. Paucisymptomatic. Usual thinness, living alone at home. Cardio-respiratory arrest 3 hours after the injection of Comirnaty (20Sep2021). Resuscitation by firefighters. On the arrival at the emergency room at 2:46 p.m.: Glasgowscale 3, spontaneous ventilation, O2 15L with major desaturation. Death at 1:40 am (21Sep2021). PCR COVID-19 + (unspecified date). The outcome of event cardio-respiratory arrest was fatal, the outcome of other event was unknown. The patient died on 21Sep2021. An autopsy was not performed. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: cardio-respiratory arrest


VAERS ID: 1762676 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-14
Onset:2021-08-24
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002919 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   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: Allergic asthma
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension (treated with monotherapy)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: Death sudden; This case was received via Regulatory Authority (Reference number: FR-AFSSAPS-NT20213597) on 27-Sep-2021 and was forwarded to Moderna on 27-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Death sudden) in a 48-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3002919 and 3003187) for SARS-CoV-2 vaccination. The patient''s past medical history included Hypertension (treated with monotherapy). Concurrent medical conditions included Allergic asthma. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Jul-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. The patient died on 24-Aug-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information was provided. Patient medical history included hypertension with monotherapy and allergic asthma. Company Comment: This case concerns a 48-year-old male patient with medical history of hypertension who experienced unexpected event of sudden death. The fatal event occurred 1 month 1 day after the administration of the second dose of mRNA-1273 (Spikevax). The re-challenge was not applicable as this is an event of death with unknown cause. Causality for the reported event was not provided by the reporter The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as serious per Regulatory Authority reporting as event is an important medical event Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Translated document received on 29-SEP-2021 included suspect product medicinal product name and substance name updated and text relevant medical history and concurrent condition updated.; Sender''s Comments: This case concerns a 48-year-old male patient with medical history of hypertension who experienced unexpected event of sudden death. The fatal event occurred 1 month 1 day after the administration of the second dose of mRNA-1273 (Spikevax). The re-challenge was not applicable as this is an event of death with unknown cause. Causality for the reported event was not provided by the reporter The benefit-risk relationship of the vaccine is not affected by this report. Event seriousness assessed as serious per Regulatory Authority reporting as event is an important medical event; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1762754 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-03-01
   Days after vaccination:28
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy artery, Biopsy skin, Blood bicarbonate, Blood lactic acid, Body temperature, C-reactive protein, Cardiac arrest, Factor II mutation, Factor V Leiden mutation, Giant cell arteritis, Haematemesis, Haemoglobin, Mean cell volume, Microbiology test, Myelocyte count, Normocytic anaemia, PCO2, PO2, Platelet count, Positron emission tomogram, Purpura, Spinal myelogram, Sputum test, Urine analysis, Weight, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Haematopoietic erythropenia (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), Congenital, familial and genetic disorders (narrow), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Vasculitis (narrow), Chronic kidney disease (broad), Respiratory failure (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: 2021-09-12
   Days after onset: 194
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: SIMVASTATIN; CORTANCYL; HYZAAR; XATRAL; AVODART; SYMBICORT; VENTOLINE [SALBUTAMOL]; PLAVIX
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Carpal tunnel syndrome; Cataract bilateral NOS; Dizziness (at the cerebellar level); Dyspnea exertional; Factor II mutation; Factor V Leiden mutation; Hip prosthesis insertion; Hypercholesterolaemia; Hypertension arterial; Ischemic stroke (put on Plavix revealed by dizziness at the cerebellar level); OA hip (Left hip osteoarthritis); Polymyalgia rheumatica (Pseudo Rhizomelic Arthritis treated with Prednisone); Surgery
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: Biopsy of the temporal artery; Test Result: Negative ; Test Date: 20210830; Test Name: Skin biopsy; Result Unstructured Data: Test Result:fund a neutrophilic infiltrate without sign of vas; Comments: fund a neutrophilic infiltrate without sign of vasculitis; Test Date: 20210911; Test Name: Bicarbonate; Result Unstructured Data: Test Result:6 mmol/L; Test Date: 20210911; Test Name: lactate; Result Unstructured Data: Test Result:12 mmol/L; Test Date: 202106; Test Name: fever; Result Unstructured Data: Test Result:fever; Test Date: 202106; Test Name: CRP; Result Unstructured Data: Test Result:160 mg/l; Comments: infectious / neoplastic assessment negative.; Test Date: 20210826; Test Name: CRP; Result Unstructured Data: Test Result:35 mg/l; Comments: re-increase of the CRP at 6 months of the Dose 2; Test Name: Factor II mutation; Result Unstructured Data: Test Result:mutation without thrombosis; Comments: mutation without thrombosis; Test Name: Factor v mutation; Result Unstructured Data: Test Result:mutation without thrombosis; Comments: mutation without thrombosis; Test Date: 20210826; Test Name: anemia; Result Unstructured Data: Test Result:8.3 g/dl; Test Date: 20210911; Test Name: anemia; Result Unstructured Data: Test Result:6.4 g/dl; Test Date: 20210826; Test Name: MCV; Result Unstructured Data: Test Result:94; Comments: fl; Test Name: bacteriological samples; Result Unstructured Data: Test Result:negativity; Comments: negativity of the bacteriological samples taken, except for an cytobacteriological examination of sputum of 10Sep2021 postive to S maltophilia at 104 and cytobacterioligical urine exam of 28Aug2021; Test Date: 20210826; Test Name: myelocyte; Test Result: 1.7 %; Test Date: 20210911; Test Name: PCO2; Result Unstructured Data: Test Result:12 mmHg; Test Date: 20210911; Test Name: pH; Result Unstructured Data: Test Result:7.30; Test Date: 20210826; Test Name: platelet; Result Unstructured Data: Test Result:223 x10 9/l; Test Date: 20210911; Test Name: Po2; Result Unstructured Data: Test Result:114 mmHg; Test Date: 202106; Test Name: PET CT; Result Unstructured Data: Test Result:Absence of pathological fixation of the vascular w; Comments: Absence of pathological fixation of the vascular walls; Test Date: 20210709; Test Name: Myelogram; Result Unstructured Data: Test Result:apparently normal marrow; Test Date: 20210910; Test Name: cytobacteriological examination of sputum; Result Unstructured Data: Test Result:postive with Stenotrophomonas maltophilia at 104; Comments: postive with Stenotrophomonas maltophilia at 104; Test Date: 20210828; Test Name: cytobacterioligical urine exam; Result Unstructured Data: Test Result:positive for E; Comments: untreated in the absence of functional urinary signs and leukocyturia; Test Date: 202106; Test Name: Weight; Result Unstructured Data: Test Result:loss of 3 kg
CDC Split Type: FRPFIZER INC202101278521

Write-up: Purpura NOS; spontaneous cardiac arrest due to asystole and death of the patient; Haematemesis; Anemia normocytic; Cranial arteritis; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-PC20214292. A 92-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included Hypertension arterial from 2012, OA hip (Left hip osteoarthritis), Dyspnea exertional, Hip prosthesis insertion from 2005, Hypercholesterolaemia, Polymyalgia rheumatica (Pseudo Rhizomelic Arthritis treated with Prednisone), Cataract bilateral NOS from 2005, ischaemic stroke from 2012 (put on Plavix revealed by dizziness at the cerebellar level), carpal tunnel syndrome, operated, dizziness (at the cerebellar level), Factor II and V mutation without thrombosis. Family history: Horton''s disease in his sister. Concomitant medications included simvastatin taken for an unspecified indication, start and stop date were not reported; prednisone (CORTANCYL) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (HYZAAR) taken for an unspecified indication, start and stop date were not reported; alfuzosin hydrochloride (XATRAL) taken for an unspecified indication, start and stop date were not reported; dutasteride (AVODART) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; salbutamol (VENTOLINE) taken for an unspecified indication, start and stop date were not reported; clopidogrel bisulfate (PLAVIX) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose bnt162b2 (COMIRNATY, Lot: unknown) in Jan2021 for COVID-19 immunisation and since January: mechanical pain in the left hip and difficulty getting up from a chair, clopidogrel bisulfate (PLAVIX) for ischaemic stroke and experienced dizziness, prednisone for Pseudo Rhizomelic Arthritis. The patient experienced anemia normocytic (death) on Aug2021 , haematemesis (death) on 11Sep2021 14:00, purpura nos (death, hospitalization) on Aug2021 , cranial arteritis (death) on Mar2021 , spontaneous cardiac arrest due to asystole and death of the patient (death) on 12Sep2021. - Mar2021: onset of symptoms of Horton''s disease.- Jun2021: diagnosis of giant cell arteritis (Horton), unproven in front of a clinical associating : Asthenia, loss of 3 kg, fever, bi-temporal headache, claudication of the jaw.CRP at 160 mg / L, infectious / neoplastic assessment negative.- PET CT: Absence of pathological fixation of the vascular walls.- Biopsy of the temporal artery on 04Jun2021 negative.Treated with corticosteroid therapy with good initial response but corticosteroid dependence at 40 mg / day.- mid Jul2021: cortisone-sparing treatment with Metoject 15 mg / week subcutaneously.-10Aug2021: episode of erysipelas of the right lower limb with favorable evolution after 10 days of treatment with Clamoxyl, the venous echo of the lower limbs was without abnormality. In addition, in the aftermath, the appearance of a right perimalleolar ulcer.Then a picture of purpura of the bilateral lower limbs appeared without fever during the decrease in corticosteroids in the aftermath of erysipelas around 30-35 mg of Cortancyl, in parallel with normocytic anemia of progressive worsening over several weeks, with an isolated episode of black stools, asthenia that continues to worsen progressively, no fever at home, no recurrence of headaches.New biology carried out during the follow-up on 26Aug2021 finding anemia at 8.3 g/dL, myelocyte 1.7%, MCV 94 fL platelet 223 x10 9/l, CRP 35 mg/L.On the hematological level:- Multifactorial aregenerative normocytic anemia (iron deficiency, inflammatory syndrome, probable digestive bleeding, underlying myelodysplasia) without other cytopenia. Iron supplementation with Ferinject 100 mg on 30Aug2021- Myelogram on 09Jul2021 showing an apparently normal marrow.- In terms of Horton''s disease:Ineffectiveness of METHOTREXATE, discontinuation of treatment discussion of the introduction of TOCILIZUMAB after elimination of any infectious process.- On the cutaneous and articular level:Immunological assessment looking for small vessel vasculitis: negative.Skin biopsy performed on 30Aug2021 fund a neutrophilic infiltrate without sign of vasculitis.Biological inflammatory syndrome associated with fever with progressive dyspnea NYHA III: negativity of the bacteriological samples taken (unknown date), except for an cytobacteriological examination of sputum of 10Sep2021 postive to S maltophilia at 104 and cytobacterioligical urine exam of 28Aug2021 positive for E blister untreated in the absence urinary functional sign and leukocyturia.-11Sep2021: hemorrhagic shock with anemia with Hb at 6.4 g /dl and clinically well tolerated hypotension: transfusion of 2 RCCs.Around 14:00, first episode of hematemesis, in a patient who remained normotensive. Second episode of hematemesis around 16:00 with the course of a patient who becomes polypneic with mottling all over the body. It is also hypotensive and tachycardic.Femoral arterial blood gas: lactate at 12 mmol/L, pH at 7.30, Bicarbonate 6 mmol/L, PCO2 12 mmHg and Po2 114 mmHg.Vascular filling with 500 ml of isotonic saline in free flow, then transfusion of 2 CGR, (Red Blood Cell Concentrate) allowing a notable clinical improvement with improvement of mottling and disappearance of agitation.-12Sep2021: spontaneous cardiac arrest due to asystole and death of the patient. Evolution: Death.In total: onset of symptoms of Horton''s disease 1 month after Dose 2 of the COMIRNATY vaccine. Then purpura of the lower limbs, normocytic anemia of progressive aggravation, deterioration of the general state and re-increase of the CRP at 6 months of the Dose 2 then digestive haemorrhage on ulcer and hemorrhagic shock leading to the death at 7 months. Therapeutic measures were taken as a result of events. Physician Office Visit for events.The patient died on 12Sep2021. It was not reported if an autopsy was performed. The outcome of events was fatal. The lot number for BNT162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: Cranial arteritis; Purpura NOS; Haematemesis; Anemia normocytic; spontaneous cardiac arrest due to asystole and death of the patient


VAERS ID: 1762762 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-03
Onset:2021-08-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE2707 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Blood pressure measurement, Body temperature, Coma scale, Computerised tomogram, Electrocardiogram, Lower respiratory tract congestion, Oxygen saturation, Oxygen saturation decreased, Pain, Pneumonia aspiration, Pyrexia, Rales, SARS-CoV-2 test, Somnolence, Specialist consultation
SMQs:, Cardiac failure (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-09
   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: MODOPAR; AMLOR; MOVICOL [MACROGOL 3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE]; ATHYMIL; NORMACOL [CALENDULA OFFICINALIS;RHAMNUS FRANGULA]; DOLIPRANE
Current Illness: Hospitalization (long-term care for difficult home maintenance due to loss of autonomy in advanced Parkinson''s)
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Bedridden; COVID-19; Deglutition disorder; Dementia with Lewy bodies; Disease Parkinson''s
Allergies:
Diagnostic Lab Data: Test Date: 2018; Test Name: blood pressure; Result Unstructured Data: Test Result:13/8 mmHg; Test Date: 20210808; Test Name: body temperature; Result Unstructured Data: Test Result:37.7 Centigrade; Comments: fever; Test Date: 20210809; Test Name: glasgow score; Result Unstructured Data: Test Result:3/15; Test Date: 20210505; Test Name: thoraco-abdomino-pelvic scanner; Result Unstructured Data: Test Result:presence of some pulmonary lesions; Comments: compatible with COVID-19 pneumonia.; Test Date: 2018; Test Name: ECG; Result Unstructured Data: Test Result:regular sinus rhythm ECG; Comments: with a fine QRS axis, cardiac echo: LV retained, no primary pulmonary hypertension, dry pericardium, difficult to assess or no valvular heart disease; Test Date: 20210809; Test Name: oxygen saturation; Test Result: 97 %; Comments: good O2 saturation; Test Date: 20200406; Test Name: SARS-CoV-2 test (PCR COVID-19); Test Result: Positive ; Test Date: 2018; Test Name: Cardiologist consultation; Result Unstructured Data: Test Result:hypertension well controlled
CDC Split Type: FRPFIZER INC202101278510

Write-up: Aspiration pneumonia; Acute respiratory distress syndrome; oxygen desaturation; bronchial congestion; somnolence; bronchial rales on auscultation; Fever; pain on mobilization; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number FR-AFSSAPS-PS20212155. A 70-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Lot Number: FE2707) intramuscular on 03Aug2021 at age of 70-year-old at single dose for COVID-19 immunisation. Medical history included bedridden, disease Parkinson''s, deglutition disorder (swallowing disorders), arterial hypertension, Lewy body dementia, COVID infection, tested on 06Apr2020 (also reported as "06Arp2021", pending clarification), hospitalization from 25Oct2017 to 09Aug2021 in long-term care for difficult home maintenance due to loss of autonomy in advanced Parkinson''s disease. Patient not communicating, asleep, questioning impossible. Eupneic, no cough or expectoration, clear pulmonary auscultation. Heart noise regular but muffled, no murmur. Soft painless calves, left foot edema, no nausea or vomiting, painless soft abdomen no bladder, clean oral cavity. In 2018: cardiology consultation: hypertension well controlled, Blood pressure 13/8 mmHg, regular sinus rhythm ECG with a fine QRS axis, cardiac echo: LV retained, no primary pulmonary hypertension, dry pericardium, difficult to assess or no valvular heart disease. Concomitant medications included benserazide hydrochloride, levodopa (MODOPAR) taken for an unspecified indication from an unspecified date; amlodipine besilate (AMLOR) taken for an unspecified indication from an unspecified date; macrogol 3350, potassium chloride, sodium bicarbonate, sodium chloride (MOVICOL) taken for an unspecified indication from an unspecified date; mianserin hydrochloride (ATHYMIL) taken for an unspecified indication from an unspecified date; calendula officinalis, rhamnus frangula (NORMACOL) taken for an unspecified indication from an unspecified date; paracetamol (DOLIPRANE) taken for an unspecified indication from an unspecified date. 05May2021: thoraco-abdomino-pelvic scanner: presence of some pulmonary lesions compatible with COVID-19 pneumonia. 03Aug2021: 1st injection Comirnaty after agreement of the family. 08Aug2021: that is 5 days after the injection, fever at 37.7 C, patient with pain on mobilization, analgesic treatment with paracetamol (PERFALGAN) 1g every 8 hours intravenously. 09Aug2021: that is 6 days after the injection, oxygen desaturation with bronchial congestion and bronchial rales on auscultation, oxygen therapy set up at 3L / min with good O2 saturation at 97%, antibiotic therapy started with ceftriaxone 1g intravenously, preventive anticoagulation with enoxaparin (LOVENOX) 4000 IU sc. Patient difficult to sample, inability to do the blood gases. 09Aug2021 afternoon: rapid worsening of the patient''s clinical condition with acute respiratory distress syndrome, somnolence with a Glasgow score of 3/15 and arterial hypotension, oxygen therapy with an oxygen mask in place, physiological serum in intravenously. The patient died at 4:20 p.m. Hospital report suggests possible aspiration pneumonia (onset date unknown). In total, respiratory distress occurred 5 days (pending clarification) after the first injection of the Comirnaty vaccine, progressing within 24 hours to death, in a 70-year-old patient with Parkinson''s disease, bedridden and with swallowing disorders. Aspiration pneumonia has been reported. The outcome of event acute respiratory distress syndrome was fatal, the outcome of other events was unknown. The patient died on 09Aug2021 4:20 p.m. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Acute respiratory distress syndrome


VAERS ID: 1762806 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-03-01
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Investigation, Noninfective encephalitis, Pneumonia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Noninfectious encephalitis (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-09-11
   Days after onset: 193
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: Investigation; Result Unstructured Data: Test Result:Encephalitis induced by covid vaccine confirmed; Comments: Encephalitis induced by Covid vaccine confirmed
CDC Split Type: GBPFIZER INC202101280753

Write-up: Renal failure; Pneumonia; Encephalitus inflammation of the brain causing myclonic jerks ; falls ; confusion and terrible body injuries; This is a spontaneous report from a contactable consumer (patient''s child). This report is received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-EYC 00261688 and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25997605. A 88-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), dose 1 parenteral on 21Jan2021 (Lot number was not reported) as single dose for COVID-19 immunisation (age at vaccination unspecified). The patient''s medical history and concomitant medications were not reported. The patient experienced encephalitis inflammation of the brain causing myoclonic jerks, falls, confusion and terrible body injuries. Jerking started on 01Mar2021. Everything fell out of the patient''s hands and was burning himself spilling hot drinks. Then he started falling causing terrible injuries. He went to hospital and broke his hip in there from these jerks making him fall. He had hip operation and then heart. He also experienced kidney failure and pneumonia, onset date not provided. He spent 5 weeks in hospital and ended up in a nursing home in May. He was admitted back to hospital end of June with hallucinations and still jerking. Every test was done to find the cause and it was confirmed: encephalitis induced by COVID vaccine. Seriousness criteria of this report included hospitalization, life-threatening, death. The patient died on 11Sep2021 due to noninfective encephalitis, recorded on the death certificate. It was not reported if an autopsy was performed. The outcome of events kidney failure and pneumonia was unknown. No follow-up attempts are possible; information about lot number cannot be obtained. No further information is expected. ; Reported Cause(s) of Death: Noninfective encephalitis


VAERS ID: 1763070 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 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: 2021-03-15
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101287275

Write-up: Myocardial infarct; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109281742054890-YOMIY, Safety Report Unique Identifier GB-MHRA-ADR 26005954. A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 (lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced myocardial infarct (death) on 15Mar2021. Patient is not enrolled in clinical trial. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. The outcome of the event was fatal. The patient died on 15Mar2021 due to event. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Myocardial infarct


VAERS ID: 1763071 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-08
Onset:2021-01-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Palpitations, SARS-CoV-2 test
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-01-30
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC202101287249

Write-up: Heart pounding; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202109282344087230-H7YRO, Safety Report Unique Identifier GB-MHRA-ADR 26007558. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Jan2021 (Batch/Lot Number: Not known) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient had not had symptoms associated with COVID-19. The patient experienced heart pounding on 08Jan2021. The seriousness criteria of the event was death and life-threatening. The clinical course was reported as That poisonous vaccine killed her the government is accountable. Patient had not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. The patient underwent lab tests and procedures which included SARS-CoV-2 test: no - negative COVID-19 test on an unspecified date. The outcome of the event was fatal. The patient died on 30Jan2021. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Heart pounding


VAERS ID: 1763152 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRJNJFOC20211002119

Write-up: DEATH; This spontaneous report received from a consumer via social media (News) and concerned a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. As per the reporter, "He was reading news about the case where person died from Janssen vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender''s Comments: V0: 20211002119-covid-19 vaccine ad26.cov2.s -death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1763153 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-09
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD6840 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Circulatory collapse, Hypotension, Nausea, Shock
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (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), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-09
   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: DIAPREL; PANTOPRAZOLE; METFORMIN; KALDYUM; FURON [FUROSEMIDE]; LETROX; METOPROLOL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HUPFIZER INC202101280806

Write-up: epigastric pain; shock; nausea; hypotension; cardiovascular failure; This is a spontaneous report from a contactable other healthcare professional downloaded from the regulatory authority, regulatory authority number HU-OGYI-755721. This serious, spontaneous case was reported by a physician on 10Sep2021, concerning the occurrence of epigastric pain, hypotension, nausea and shock after the use of BNT162b2 (COMIRNATY) concentrate for dispersion for injection (MAH: BioNTech Manufacturing). On 01Sep2021, the 76-year-old female patient received 0.3 ml Comirnaty concentrate for dispersion for injection (tozinameran; batch number: FD6840, expiry date: Oct2021, intramuscularly, in the left arm) for COVID-19 immunisation. On 09Sep2021, the patient experienced epigastric pain, nausea and hypotension. The patient was transferred to the emergency care unit in the hospital. The patient was diagnosed with shock. The patient experienced cardiovascular failure and died. The patient''s medical history details were not reported. The patient''s concomitant medicinal products were Letrox (levothyroxine sodium), metformin, Diaprel (gliclazide), pantoprazole, Furon (furosemide), Kaldyum (potassium chloride) and metoprolol. Further information is expected. Sender''s comments: According to Comirnaty, nausea is listed and therefore expected. The events epigastric pain, hypotension and shock are not listed and not expected. TTO is 8 days until death. Dechallenge and rechallenge were not applicable. The causal relationship between the suspected drug and the events is considered not assessable per lack of information. The case is considered serious due to fatal outcome.; Reported Cause(s) of Death: Circulatory collapse


VAERS ID: 1763178 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-19
Onset:2021-09-08
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Blood fibrinogen, Cavernous sinus thrombosis, Cerebral venous sinus thrombosis, Coma scale, Coma scale abnormal, Computerised tomogram head, Headache, Lumbar puncture, Platelet count, Seizure, Syncope, Visual impairment
SMQs:, Torsade de pointes/QT prolongation (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-19
   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: 20210908; Test Name: Angiogram; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided.; Test Date: 202109; Test Name: Fibrinogen; Result Unstructured Data: Test Result:Normal; Test Date: 20210915; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:Unknown results; Comments: Reduced GCS/coma.; Test Date: 20210908; Test Name: Brain CT; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided.; Test Date: 20210915; Test Name: Brain CT; Result Unstructured Data: Test Result:Unknown results; Comments: CT brain demonstrated left sided intracranial haemorrhage. Review of CT scan by neuroradiology detected CVST.; Test Date: 20210908; Test Name: Lumbar puncture; Result Unstructured Data: Test Result:Unknown results; Comments: Results not provided.; Test Date: 20210916; Test Name: Platelet count; Result Unstructured Data: Test Result:114; Comments: note heparin given already at this stage; Test Date: 20210917; Test Name: Platelet count; Result Unstructured Data: Test Result:91
CDC Split Type: IEPFIZER INC202101278766

Write-up: This is a spontaneous report from a contactable other healthcare professional via Regulatory Authority HPRA, downloaded from the Regulatory Authority-WEB (regulatory authority number IE-HPRA-2021-084778). A 20-year-old male patient received the second dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on 19Aug2021 (Lot number was not reported) as single dose for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (COMIRNATY) on 22Jul2021 for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced CVST (cerebral venous sinus thrombosis) on 15Sep2021, visual disturbance on 08Sep2021, collapse (syncope) on 15Sep2021, headache on 08Sep2021, seizure on 15Sep2021, cavernous sinus thrombosis on an unspecified date and reduced GCS/coma on 15Sep2021; all the events were serious as medically significant and due to hospitalization; the outcome of all the events was fatal. The patient underwent lab tests and procedures which included angiogram: unknown results on 08Sep2021 (Results not provided), blood fibrinogen: normal in Sep2021, coma scale: unknown results on 15Sep2021 (Reduced GCS/coma), computerised tomogram head: unknown results on 08Sep2021 (Results not provided), computerised tomogram head: unknown results on 15Sep2021 (CT brain demonstrated left sided intracranial hemorrhage. Review of CT scan by neuroradiology detected CVST), lumbar puncture: unknown results on 08Sep2021 (Results not provided), platelet count: 114 on 16Sep2021 (note heparin given already at this stage), platelet count: 91 on 17Sep2021. The patient died on 19Sep2021. An autopsy was performed and results were not provided. The cause of death was cavernous sinus thrombosis. On 19Sep2021, the patient died in hospital. An autopsy was directed and the preliminary indications from the clinical investigations were that the cause of death was cavernous sinus thrombosis. On 08Sep2021, the patient presented to hospital with headache and visual disturbance. Investigations performed included, CT brain, CT angiogram and lumbar puncture to rule out a suspected intracranial bleed (results not provided). On an unknown date, the patient was discharged. On 15Sep2021, the patient represented to hospital with collapse, seizure and reduced Glasgow coma scale (GCS). The patient was intubated and CT brain demonstrated left sided intracranial hemorrhage. The review of CT scan by the hospital neuroradiology detected cerebral venous sinus thrombosis (CVST) and the patient was transferred to another hospital. The management included heparin infusion and a catheter-directed thrombectomy. The patient remained in a coma and it was considered a salvage decompression craniotomy would not be beneficial and the patient passed away on 19Sep2021. HIT screen/anti-PF4 antibodies were not performed and the Consultant stated they did not think it was thrombosis with thrombocytopenia syndrome (TTS). Details of blood tests from initial hospitalisation were not available at the time of reporting. At the time of the reporting, a post-mortem was being performed. The provisional cause of death was due to CVST. It was unknown details of any underlying thrombophilia or other cause. Limited past medical history was available but not known by the reporter to have had any significant past medical history or concomitant medication. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: CAVERNOUS SINUS THROMBOSIS


VAERS ID: 1763190 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY4825 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Dry mouth, Palpitations, Toxic shock syndrome
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Toxic-septic shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Cardiomyopathy (broad), Dehydration (broad), Sepsis (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: IQPFIZER INC202101280838

Write-up: Palpitation; dry mouth; Toxic shock syndrome; This is a spontaneous report from a non-contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number IQ-IPHVC-300028181. A 55-year-old male patient received 2nd single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EY4825; 210126A, Expiration Date: Aug2021) intramuscularly on 09May2021 for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient''s concomitant medications were not reported. The patient experienced toxic shock syndrome on 09May2021 with seriousness criteria of death and outcome of fatal, palpitation on an unspecified date with outcome of unknown, dry mouth on an unspecified date with outcome of unknown. 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 is expected.; Reported Cause(s) of Death: Toxic shock syndrome


VAERS ID: 1763194 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD8831 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Computerised tomogram, Cough, Dyspnoea, Polymerase chain reaction, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-31
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210726; Test Name: CT scan; Result Unstructured Data: Test Result:70% COVID-19; Test Date: 20210716; Test Name: PCR; Test Result: Negative
CDC Split Type: IQPFIZER INC202101280927

Write-up: Suspected COVID-19, 70% covid 19; fever; cough; SOB; This is a spontaneous report from a non-contactable pharmacist. This is a report received from the regulatory authority. Regulatory authority report number IQ-IPHVC-300034362. A 43-year-old female patient received 1st single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: FD8831, expiration date: 30Oct2021) intramuscularly on 13Jul2021 at age of 43-year-old for COVID-19 immunisation. Patient was not pregnant at time of events onset. Medical history was none. No history of allergies or chronic diseases and not taken any drugs. Concomitant medications were not reported. After 3 days from given 1st dose of vaccin the, patient suffered from (fever, SOB, cough). The PCR was negative but after 10 days the symptoms was worse and the CT scan show 70% covid 19 then the patient was dead in 31Jul2021. The patient experienced suspected covid-19, 70% covid 19 on 26Jul2021, symptoms was worse on 26Jul2021, fever on 16Jul2021, cough on 16Jul2021; all serious as death with outcome of fatal. The patient underwent lab tests and procedures which included polymerase chain reaction was negative on 16Jul2021, computerised tomogram on 16Jul2021 showed 70% COVID-19 on 26Jul2021. Patient died on 31Jul2021. 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: Suspected COVID-19, 70% covid 19; fever; cough; SOB


VAERS ID: 1763200 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-15
Onset:2021-04-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, COVID-19, Cough, Dyspnoea, Fatigue, Incorrect route of product administration, Oxygen saturation, Oxygen saturation decreased, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug abuse and dependence (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Myocardial infarction (two attacks)
Allergies:
Diagnostic Lab Data: Test Date: 20210422; Test Name: body temperature; Result Unstructured Data: Test Result:pyrexia; Test Date: 20210424; Test Name: oxygen saturation; Result Unstructured Data: Test Result:decreased; Test Date: 202104; Test Name: COVID-19 PCR test; Test Result: Positive ; Test Date: 202104; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: IQPFIZER INC202101286451

Write-up: acute Dyspnoea; Oxygen saturation decreased; covid19/did PCR and the results positive; Pyrexia; Cough; Fatigue; Route of Administration: Subcutaneous; This is a spontaneous report from a non-contactable pharmacist. This is a report received from regulatory authority. The regulatory authority report number is IQ-IPHVC-300030171. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 Subcutaneous on 15Apr2021 (Batch/Lot number was not reported) (at age of 71-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension and two attacks of myocardial infarction. The patient''s concomitant medications included continuing with chronic drugs. The patient experienced covid19 (death, hospitalization) on 22Apr2021, pyrexia (hospitalization) on 22Apr2021 with outcome of recovered in Apr2021, cough (hospitalization) on 22Apr2021 with outcome of unknown, fatigue (hospitalization) on 22Apr2021 with outcome of unknown, acute dyspnoea (hospitalization) on 24Apr2021 with outcome of unknown, oxygen saturation decreased (hospitalization) on 24Apr2021 with outcome of unknown. Clinical course reported patient took the 1st dose Pfizer vaccine and after 7 days he complained covid19-like symptoms included pyrexia, cough, fatigue. He did PCR and the results positive in Apr2021 then he admitted to RCU because he was severe illness of covid. He stayed in RCU about 14 days then he discharged to negative result of PCR in Apr2021. Despite he discharged still complaining respiratory disorder such as acute dyspnoea, oxygen saturation decreased. Patient dead after 55 days of 1st dose of vaccination. The patient died on 09May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: covid19/did PCR and the results positive


VAERS ID: 1763204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-06
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Death, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   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: Asymptomatic COVID-19
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: positive
CDC Split Type: ITJNJFOC20211001082

Write-up: DEATH; DRAMATIC WORSENING OF HEALTH CONDITION FOLLOWING VACCINATION (SUSPECTED COVID-19 INFECTION); SUSPECTED COVID-19 INFECTION; This spontaneous report received from a company representative via social media (News article) concerned a 57 year old male patient (electrician) of unspecified race and ethnic origin. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: asymptomatic covid-19. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On unspecified date, the laboratory data of patient included COVID-19 virus test reported as positive. On 06-SEP-2021, the patient experienced suspected covid-19 infection. On the same day he was hospitalized in Intensive Care Unit (ICU) after showing positive signs for Covid-19. The patient got Janssen vaccine even though he was covid-19 positive. On 23-SEP-2021, doctors announced the news of his death, he died, after days of agony in the ICU following dramatic worsening of his health condition following vaccination (suspected covid-19 infection). The patient died from unknown cause of death. He was hospitalized for 17 days. It was not reported, if the autopsy was performed or not. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died due to unknown cause of death on 23-SEP-2021, and the outcome of dramatic worsening of health condition following vaccination (suspected covid-19 infection) and suspected covid-19 infection was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211001062.; Sender''s Comments: V0: 20211001082-COVID-19 VACCINE AD26.COV2.S.- Death, Dramatic worsening of health condition following vaccination (suspected covid-19 infection), suspected covid-19 infection. This events is considered unassessable. The events 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 events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH


VAERS ID: 1763374 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   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:
Preexisting Conditions: Medical History/Concurrent Conditions: Blood pressure high; Cardiovascular disorder; Clotting disorder; Overweight; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101273627

Write-up: CEREBRAL HEMORRAGIA; HEADACHE; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB IT-MINISAL02-790467 A 75-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation . Medical history included type 2 diabetes mellitus , overweight , cardiovascular disorder , hypertension, coagulopathy. The patient''s concomitant medications were not reported. The patient received the first dose of BNT162B2 vaccine on 10Apr2021. The patient experienced cerebral hemorrhage on 05May2021 with fatal outcome , headache (medically significant) on 02May2021 with outcome of unknown. The patient died on 05May2021. It was not reported if an autopsy was performed. Course of the event. headache on 02May2021; cerebral hemorrhage on 05May2021. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Cerebral haemorrhage


VAERS ID: 1763375 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-17
Onset:2021-08-25
   Days after vaccination:161
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP9598 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101273623

Write-up: Found by a passer-by lying on the ground during a training outing with a racing bike, with no signs of a disastrous fall. Alerted on 118, health workers tried to revive him.; This is a spontaneous report from a contactable consumer via Regulatory Authority, downloaded from the regulatory agency-WEB (regulatory authority report number is IT-MINISAL02-790496). An 80-year-old male patient received the second dose of BNT162B2 (COMIRNATY) intramuscular on 17Mar2021 (Lot Number: EP9598) at 0.3 mL single for COVID-19 immunisation. Relevant medical history was not reported. There were no concomitant medications. On 25Aug2021, the patient was "found by a passer-by lying on the ground during a training outing with a racing bike, with no signs of a disastrous fall. Alerted on 118, health workers tried to revive him". The reporter was not aware of the symptoms preceding the outcome and reported that the patient did not have coexisting medical conditions and was not taking concomitant therapies. The patient received treatment with adrenaline and oxygen, resuscitation for 15 minutes, then the death was ascertained. No autopsy was performed. Reporter''s comment: No previous illnesses. No follow-up attempts possible. No further information expected.; Reporter''s Comments: No previous illnesses; Reported Cause(s) of Death: Sudden death


VAERS ID: 1763376 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Paralysis, Renal impairment
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101278870

Write-up: renal dysfunction; Paralysis; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority. IT-MINISAL02-790654. A 92-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in arm left on an unspecified date (Batch/Lot number was not reported) as single dose, at an unspecified age, for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced renal dysfunction and paralysis both on 12Apr2021, seriousness criteria of the events reported as death and hospitalization. Actions taken (Hospitalization and analysis of adverse reactions). Impact on quality of life (10/10). The outcome of the events was fatal. The patient died in 2021. It was unknown if an autopsy was performed. Sender Comment: 23Sep2021 regulatory authority: requests for follow-up information from the reporter regarding autopsy report and vaccination date. Waiting. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: renal dysfunction; Paralysis


VAERS ID: 1763386 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-01
Onset:2021-02-17
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6136 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Cardiac disorder, Cerebrovascular accident, Renal failure, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Supraventricular tachyarrhythmias (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (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: 2021-07-15
   Days after onset: 147
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: Coronavirus infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101285136

Write-up: thrombosis; atrial fibrillation; Cerebrovascular accident; kidney insufficiency; heart disease; This is a spontaneous report from a contactable consumer downloaded from the regulatory authority-WEB IT-MINISAL02-791629. A 78-year-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration, administered in arm left on 01Feb2021 (Lot Number: EJ6136) as single dose for covid-19 immunisation. Medical history included COVID infection. The patient''s concomitant medications were not reported. The patient experienced atrial fibrillation, cerebrovascular accident and thrombosis on 17Feb2021; kidney insufficiency and heart disease in 2021 with outcome of unknown. Atrial fibrillation, cerebrovascular accident and thrombosis were reported as serious (death, hospitalization). The patient died on 15Jul2021 due to atrial fibrillation, cerebrovascular accident and thrombosis. It was not reported if an autopsy was performed. Outcome of atrial fibrillation, cerebrovascular accident and thrombosis was fatal, of kidney insufficiency and heart disease was unknown. Reporter''s comments: The adverse reaction led to another clinically relevant condition - Concomitant conditions: heart disease, kidney insufficiency, Previous coronavirus infection: yes - Reaction time: 10:00 - Posted by Covid19-file. No follow-up attempts are possible. No further information is expected. ; Reporter''s Comments: The adverse reaction led to another clinically relevant condition - Concomitant conditions: heart disease, kidney insufficiency, Previous coronavirus infection: yes - Reaction time: 10:00 - Posted by Covid19-file; Sender''s Comments: Linked Report(s) : IT-PFIZER INC-202101195563 same product, different patient/events; Reported Cause(s) of Death: Cerebrovascular accident; atrial fibrillation; thrombosis


VAERS ID: 1763388 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-06
Onset:2021-09-17
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG4686 / 1 - / -

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: Medical History/Concurrent Conditions: Atrial fibrillation; Prostatic hypertrophy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC202101285349

Write-up: Standstill cardiac (cardiac arrest); This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority-WEB. This is a report received from the regulatory Authority. Regulatory authority number IT-MINISAL02-791680. An 84-year-old male patient received first dose of BNT162B2 (COMIRNATY; Solution for injection; Lot Number: FG4686), via an unspecified route of administration on 06Sep2021 as dose 1, single for covid-19 immunisation. Medical history included benign prostatic hypertrophy from an unknown date and unknown if ongoing and atrial fibrillation from an unknown date and unknown if ongoing. Patient''s impact on quality of life with Comairnaty was 10/10 COVID 19 COMIRNATY VACCINE (PFIZER): Booster dose number (1). The patient''s concomitant medications were not reported. On 17Sep202, the patient experienced standstill cardiac (cardiac arrest). The patient died with standstill cardiac on an unspecified date. It was unknown if an autopsy was performed. Reporter''s comment: prostatic hypertrophy atrial fibrillation. Sender''s comments: 24Sep2021 Pharmacovigilance contacted reporter updated form requested medical report of GP. Waiting.; Reported Cause(s) of Death: cardiac arrest


VAERS ID: 1763400 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 2021-09-01
   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: ITPFIZER INC202101285625

Write-up: Sudden death; This is a spontaneous report from a contactable consumer, received via portal. A 12-year-old female patient received an unknown dose of BNT162B2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient been tested for COVID-19. It was unknown whether the patient received other vaccines within 4 weeks prior to the COVID vaccine. In Sep2021, the patient experienced sudden death. It was not reported if an autopsy was performed. People talking about the event that happened to a 12-year-old girl. They said the girl was found dead in her bed by her parents about 3 weeks ago, the day after vaccination with BNT162B2 (unknown dose). She confirmed that she had no further information and was unable to obtain it. Treatment was unknown. The outcome of event was fatal. No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1763406 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-15
Onset:2021-08-27
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300042721 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: SARS-CoV-2 infection; Vaccination failure; This case was received via Regulatory Authority (Reference number: AT-BASGAGES-2021-047228) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of COVID-19 (SARS-CoV-2 infection) and VACCINATION FAILURE (Vaccination failure) in a 94-year-old female patient who received mRNA-1273 (batch nos. 3000493 and 300042721) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Intramuscular) dosage was changed to 1 dosage form. On 27-Aug-2021, the patient experienced COVID-19 (SARS-CoV-2 infection) (seriousness criterion death) and VACCINATION FAILURE (Vaccination failure) (seriousness criterion death). The patient died on 27-Aug-2021. The reported cause of death was SARS-CoV-2 infection and Vaccination failure. It is unknown if an autopsy was performed. For mRNA-1273 (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter Treatment information was not provided. Company comment: This report concerns a 94 year old female patient with no relevant medical history who experienced fatal unexpected events of COVID-19 and vaccination failure. The events occurred approximately 5 and 6 months after vaccination with second and first dose of mRNA-1273 respectively. The re-challenge is assessed as not applicable as the events were fatal in nature and occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender''s Comments: This report concerns a 94 year old female patient with no relevant medical history who experienced fatal unexpected events of COVID-19 and vaccination failure. The events occurred approximately 5 and 6 months after vaccination with second and first dose of mRNA-1273 respectively. The re-challenge is assessed as not applicable as the events were fatal in nature and occurred after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Reported Cause(s) of Death: SARS-CoV-2 infection; Vaccination failure


VAERS ID: 1763505 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Platelet count, Platelet count decreased
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: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: platelets; Result Unstructured Data: Test Result:decreased
CDC Split Type: JPPFIZER INC202101269278

Write-up: death; Platelets decreased; This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 6 patients. This is the fourth of six reports. An elderly patient (reported as at age of 90s to 100s years) of an unspecified gender received a single unspecified dose number of BNT162b2 (COMIRNATY, solution for injection, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date at dose number unknown, single for COVID-19 immunisation, at the clinic. The patient medical history and concomitant medications were not provided. On an unknown date (unknown days after vaccination), the patient experienced platelets decreased. On an unknown date (unknown days after vaccination), the patient experienced death. The outcome of death was fatal, while the outcome of the other event was unknown. It was unknown if an autopsy was performed. The reporting physician commented that the causality between the events and BNT162b2 was unknown. The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender''s Comments: Based on the current limited available information, a possible contributory role of the suspect product BNT162B2 to the development of event death cannot be totally excluded/assessed. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : JP-PFIZER INC-202101268990 Same reporter, same events,different patient; Reported Cause(s) of Death: death


VAERS ID: 1763506 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-03
Onset:2021-07-07
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0207 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, Body temperature, Cardiac perforation, Cardio-respiratory arrest, Computerised tomogram
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: 2021-07-07
   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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none
Allergies:
Diagnostic Lab Data: Test Date: 20210703; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: Before vaccination; Test Date: 20210707; Test Name: CT; Result Unstructured Data: Test Result:aortic dissection and intrathoracic rupture
CDC Split Type: JPPFIZER INC202101276280

Write-up: cardio-respiratory arrest; Aortic dissection; intrathoracic rupture; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21127889. A 63-year and 4-month-old female patient received the second dose of BNT162b2 (COMIRNATY, solution for injection, Lot number: EW0207, Expiration Date: 30Sep2021) at single dose on 03Jul2021 at age of 63 years old for COVID-19 immunization. Body temperature before vaccination was 35.8 degrees Centigrade on 03Jul2021. Medical history and concomitant medication were none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient family history was not reported. On 07Jul2021 at 12:15 (4 days after the vaccination), the patient experienced cardio-respiratory arrest. The course of the event was as follows: The patient was in a state of cardio-respiratory arrest on arrival to the reporting physician''s hospital. Although cardiopulmonary resuscitation was performed, recovery was not obtained. Aortic dissection and intrathoracic rupture were considered as the cause of the death from the results of detailed examination including computerised tomography (CT) on 07Jul2021. On 07Jul2021 (4 days after the vaccination), the patient died. The outcome of events was fatal. The reporting physician classified the event cardio-respiratory arrest as serious (death) and assessed that the events was unrelated to BNT162b2. Other possible causes of the event such as any other diseases were aortic dissection and intrathoracic rupture. The reporting physician commented as follows: It was difficult to consider causality between the vaccination and the events.; Sender''s Comments: based on the known safety profile of vaccine and information available the event cardio-respiratory arrest was considered unrelated to the suspect drug.; Reported Cause(s) of Death: cardio-respiratory arrest; Aortic dissection; intrathoracic rupture


VAERS ID: 1763509 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-17
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma scale, Computerised tomogram, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-25
   Days after onset: 8
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210918; Test Name: JCS; Result Unstructured Data: Test Result:300; Test Date: 20210918; Test Name: Contrast enhanced CT scan; Result Unstructured Data: Test Result:right vertebral artery dissection; Comments: right vertebral artery dissection, and ruptured aneurysm was diagnosed; Test Date: 20210918; Test Name: head CT scan; Result Unstructured Data: Test Result:subarachnoid haemorrhage
CDC Split Type: JPPFIZER INC202101277992

Write-up: Subarachnoid haemorrhage; This is a spontaneous report from a contactable physician received from the regulatory authority. Regulatory authority report number is v21128027. A 55-year-old (reported as 55-year and 6-month-old) male patient received the second dose of COVID-19 vaccine (Manufacture unknown, Lot number and Expiration date were not reported) at 55-year-old, via an unspecified route of administration on 16Sep2021 at single dose for COVID-19 immunization. Body temperature before vaccination was not reported. Medical history, concomitant medications and family history were not provided. On an unspecified date, the patient previously received the first dose of COVID-19 vaccine (Manufacture unknown, Lot number and Expiration date were not reported), via an unspecified route of administration at single dose for COVID-19 immunization. On 17Sep2021 at around 12:00 (1 day after the vaccination), the patient experienced subarachnoid haemorrhage. On 25Sep2021 (9 days after the vaccination), the patient died of subarachnoid haemorrhage. It was not reported if an autopsy was performed. The course of the events was as follows: On 17Sep2021 at around 12:00, the patient was aware of headache. On 18Sep2021 at around 01:30, headache worsened, and an emergency service was requested. When arriving at a hospital, consciousness disturbed (JCS-300) appeared. At an emergency outpatient department, oral intubation and head CT scan were performed, and it revealed subarachnoid haemorrhage. Contrast enhanced CT scan showed right vertebral artery dissection, and ruptured aneurysm was diagnosed. Conservative therapy was chosen under a diagnosis of the most critical subarachnoid haemorrhage. On 18Sep2021, under whole-body management, dilatation of pupil was noted and spontaneous respiration disappeared, then DNAR (Do Not Attempt Resuscitation) was ordered. On 25Sep2021, the patient''s death was confirmed. The reporting physician classified the event as serious (fatal) and assessed the causality between the event and BNT162b2 as unassessable. It was unknown if there was other possible cause of the event. The reporting physician commented as follows: Occlusion of the opposite side of (left) vertebral artery was noted, and arteriosclerosis was intense. His medical background of arteriosclerosis was considered to be the cause of the right vertebral artery dissection, but the causal relationship between ruptured aneurysm and the vaccination could not be determined. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: subarachnoid haemorrhage


VAERS ID: 1763511 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-28
Onset:2021-07-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Ascites, Aspartate aminotransferase, Blood albumin, Blood albumin increased, Blood alkaline phosphatase, Blood chloride, Blood cholinesterase, Blood cholinesterase increased, Blood creatinine, Blood lactate dehydrogenase, Blood lactate dehydrogenase increased, Blood potassium, Blood pressure immeasurable, Blood pressure measurement, Blood sodium, Blood urea, Blood urea increased, Body temperature, Bradycardia, Cardiac arrest, Computerised tomogram, Condition aggravated, Cyanosis, Decreased appetite, Gamma-glutamyltransferase, Hepatic neoplasm, Hypotension, Localised oedema, Malaise, Oedema peripheral, Oxygen saturation, Oxygen saturation decreased, Pancreatic neoplasm, Platelet count, Pleural effusion, Ventricular fibrillation, Ventricular tachycardia
SMQs:, Torsade de pointes/QT prolongation (narrow), Acute renal failure (broad), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (narrow), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Liver tumours of unspecified malignancy (narrow), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (narrow), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-07-23
   Days after onset: 22
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? 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: Test Date: 20210721; Test Name: ALT; Result Unstructured Data: Test Result:23; Test Date: 20210721; Test Name: AST; Result Unstructured Data: Test Result:34; Test Date: 20210721; Test Name: Alb; Result Unstructured Data: Test Result:2.1; Test Date: 20210721; Test Name: Alb; Result Unstructured Data: Test Result:10.9; Test Date: 20210721; Test Name: ALP; Result Unstructured Data: Test Result:100; Test Date: 20210721; Test Name: Cl; Result Unstructured Data: Test Result:104; Test Date: 20210721; Test Name: ChE; Result Unstructured Data: Test Result:81; Test Date: 20210721; Test Name: Cr; Result Unstructured Data: Test Result:1.22; Test Date: 20210721; Test Name: LDH; Result Unstructured Data: Test Result:372; Test Date: 20210721; Test Name: K; Result Unstructured Data: Test Result:4.4; Test Date: 202107; Test Name: blood pressure; Result Unstructured Data: Test Result:60 to 90; Test Date: 20210721; Test Name: blood pressure; Result Unstructured Data: Test Result:immeasurable; Test Date: 20210721; Test Name: Na; Result Unstructured Data: Test Result:136; Test Date: 20210721; Test Name: BUN; Result Unstructured Data: Test Result:81.7; Test Date: 20210607; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination of the first dose; Test Date: 20210628; Test Name: body temperature; Result Unstructured Data: Test Result:35.8 Centigrade; Comments: before vaccination of the second dose; Test Date: 20210721; Test Name: CT; Result Unstructured Data: Test Result:thoracic and abdominal fluid retention; Comments: a presence of thoracic and abdominal fluid retention; Pancreas tumor and liver tumour were suspected.; Test Date: 20210721; Test Name: gamma GTP; Result Unstructured Data: Test Result:21; Test Date: 202107; Test Name: SpO2; Result Unstructured Data: Test Result:90 to 92 %; Comments: on 10 L of oxygen in a reservoir; Test Date: 20210721; Test Name: SpO2; Test Result: 89 %; Test Date: 20210721; Test Name: PLT; Result Unstructured Data: Test Result:40000
CDC Split Type: JPPFIZER INC202101282081

Write-up: oxygen saturation (SpO2) 89%; cyanosis peripheral; blood pressure immeasurable; general malaise/malaise and appetite impaired were aggravated; appetite impaired/ appetite impaired were aggravated; transition from bradycardia to ventricular tachycardia (VT) and then to ventricular fibrillation (VF), cardiac arrest was confirmed; ventricular tachycardia; ventricular fibrillation; cardiac arrest; thoracic and abdominal fluid retention; thoracic and abdominal fluid retention; Pancreas tumor and liver tumour were suspected; Pancreas tumor and liver tumour were suspected; cholinesterase (ChE), 81; blood urea nitrogen (BUN) 81.7; albumin (Alb) 10.9; lactate dehydrogenase (LDH), 372; Blood pressure (BP) was 60 to 90; Oedema on the trunk and upper and lower limbs; Oedema on the trunk and upper and lower limbs; Condition aggravated; This is a spontaneous report from a contactable physician (the head of the hospital) received from the regulatory authority. Regulatory authority report number is v21128067. A 89-year and 2-month-old female patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration at age of 89 years (as reported) on 28Jun2021 (Lot Number: EY5423; Expiration Date: 31Aug2021) as single dose for covid-19 immunisation. Medical history was none. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). The patient family history was not reported. The patient''s concomitant medications were not reported. Historical vaccination included first dose of BNT162b2 (COMIRNATY, Lot# FA4597, Expiration date 31Aug2021) via an unspecified route of administration on 07Jun2021 at age of 89 years (as reported) of vaccination, for COVID-19 immunization. Body temperature before vaccination was 36.7 degrees Centigrade at the first dose of BNT162b2 (07Jun2021) and 35.8 degrees Centigrade at the second dose of BNT162b2 (28Jun2021). On 28Jun2021 (the day of vaccination), the patient received the second dose. On an unknown date of Jul2021 (unknown days after the vaccination), the patient experienced general malaise and appetite impaired. On 21Jul2021 (23 days after the vaccination), the patient was immediately transported to the hospital. On 23Jul2021 (25 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: After receiving COVID-19 vaccines on 07Jun2021 and 28Jun2021, the patient became in a bedridden-like state. On 21Jul2021, malaise and appetite impaired were aggravated. Due to oxygen saturation (SpO2) 89%, cyanosis peripheral and blood pressure immeasurable, the patient was immediately transported to the hospital. Computerised tomogram (CT) findings revealed a presence of thoracic and abdominal fluid retention. Pancreas tumor and liver tumour were suspected. The laboratory data included blood urea nitrogen (BUN) 81.7; creatinine (Cr) 1.22; sodium (Na) 136; chlorine (Cl) 104; potassium (K), 4.4; albumin (Alb), 2.1, 10.9; platelet count (PLT), 40000; aspartate aminotransferase (AST), 34; alanine aminotransferase (ALT), 23; lactate dehydrogenase (LDH), 372; alkaline phosphatase (ALP), 100; gamma glutamyl transpeptidase (GTP), 21; and cholinesterase (ChE), 81. Drip infusion and oxygen therapy were performed under admission. Blood pressure (BP) was 60 to 90 and SpO2 was 90 to 92% on 10 L of oxygen in a reservoir (Jul2021). Oedema on the trunk and upper and lower limbs was noted (Jul2021). On 23Jul2021, after transition from bradycardia to ventricular tachycardia (VT) and then to ventricular fibrillation (VF), cardiac arrest was confirmed. The patient was admitted to the reporting physician''s hospital on 21Jul2021 and discharged dead on 23Jul2021. The reporting physician classified the events (general malaise and appetite impaired) as serious (death and hospitalization) and assessed 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 patient had lived her daily life before the vaccination. Condition aggravated (2021) after the vaccination was suspected. The outcome of general malaise and appetite impaired was fatal, blood pressure immeasurable was recovering, other events were unknown. The patient died on 23Jul2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: general malaise; appetite impaired


VAERS ID: 1763514 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0583 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal distension, Aortic dissection, Body temperature, Heat illness
SMQs:, Acute pancreatitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-08
   Days after onset: 11
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: METHOTREXATE; ALLOPURINOL; BENZBROMARONE; ROSUVASTATIN; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension; Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 20210728; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC202101285718

Write-up: Acute aortic dissection; I hear splashing in my stomach and do not feel it is empty; Heat illness was suspected; Epigastric bloating; This is a spontaneous report from a contactable physician via the regulatory authority. Regulatory authority report number is v21128088. A 62-year-old (62-year and 5-month-old) male patient received BNT162b2 (COMIRNATY, Solution for injection), dose 1 intramuscular on 28Jul2021 11:00 (lot Number: EY0583; Expiration Date: 31Oct2021) (at vaccination age of 62-year-old) as 0.3 ml for COVID-19 immunisation. Medical history included rheumatoid arthritis and hypertension. Family history was nothing in particular. Concomitant medications included methotrexate, allopurinol, benzbromarone, rosuvastatin, amlodipine. The patient experienced acute aortic dissection with seriousness of death on 08Aug2021 20:00, ''epigastric bloating'' with seriousness of important medically significant on 28Jul2021, ''heat illness was suspected'' with seriousness of important medically significant on 05Aug2021, ''I hear splashing in my stomach and do not feel it is empty'' with seriousness of important medically significant on 06Aug2021. The clinical course was as follows: Body temperature before vaccination was 36.3 degrees centigrade on 28Jul2021. On 28Jul2021 during the post-vaccination observation, the patient experienced no particular abnormality and went home. At night on the same day, the patient began to feel epigastric bloating. On 30Jul2021 (2 days after the vaccination), the outcome of epigastric bloating was recovering. On 05Aug2021 (8 days after the vaccination), heat illness was suspected. On 06Aug2021 (9 days after the vaccination), the patient complained, "I hear splashing in my stomach and do not feel it is empty." On 08Aug2021 around 20:00 (11 days after the vaccination), the patient experienced acute aortic dissection. On 08Aug2021 (11 days after the vaccination), the outcome of the event acute aortic dissection was fatal. The outcome of the other events was not reported. It was not reported whether autopsy was done. On 29Jul2021 (1 day after the vaccination), the symptom remained unimproved, and the patient visited the reporting clinic. The vital signs were normal. As the patient had not eaten yet, he received a transfusion and went home. On 30Jul2021 (2 days after the vaccination), the patient revisited the clinic. The epigastric bloating sensation was slightly alleviated. He received a transfusion again. On 05Aug2021 (8 days after the vaccination), the patient revisited the clinic. The temperature was high, and heat illness was suspected. He received a transfusion. On 06Aug2021 (9 days after the vaccination), the patient revisited the clinic. He complained, "I hear splashing in my stomach and do not feel it is empty." He received a transfusion, was prescribed oral medications, and went home. On 08Aug2021 (11 days after the vaccination), the patient was found lying down in the bathroom at home and was transported by ambulance. Emergency medical care was performed at the hospital, but his death was confirmed at 21:08 on the same day. Acute aortic dissection was diagnosed. Therapeutic measures were taken as a result of epigastric bloating, ''heat illness was suspected'', ''I hear splashing in my stomach and do not feel it is empty''. The patient died on 08Aug2021. It was not reported if an autopsy was performed. The reporting physician classified the event acute aortic dissection as serious (death) and assessed the causality between the event acute aortic dissection and BNT162b2 as unassessable. Other possible causes of the event acute aortic dissection such as any other diseases included hypertension and rheumatoid arthritis. The seriousness and causality of the other events were not provided. The reporting physician commented as follows: The causal relationship with the vaccine was unknown.; Reported Cause(s) of Death: Acute aortic dissection


VAERS ID: 1763515 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-09-16
Onset:2021-09-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG0978 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal hypokinesia, Maternal exposure during pregnancy, Umbilical cord abnormality
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? Yes
Died? Yes
   Date died: 2021-09-21
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101285757

Write-up: true knot of umbilical cord; fetal movement decreased; Maternal exposure during pregnancy; This is a spontaneous report from a contactable physician received from the Regulatory Agency. Regulatory authority report number is v21128064. This physician reported information for both mother and fetus. This is a fetus report. A fetus patient of an unspecified gender received the first dose of bnt162b2 (COMIRNATY), transplacental on 16Sep2021 15:30 (Lot number FG0978, Expiration date 30Nov2021) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced maternal exposure during pregnancy (death, congenital anomaly) on 16Sep2021, true knot of umbilical cord (death, congenital anomaly) on 21Sep2021, fetal movement decreased (death, congenital anomaly) on 16Sep2021. The patient was a fetus at gestational age 35 weeks. The patient''s mother was a 35-year and 6-month-old female (age at vaccination was 35 years and 6 months old). On 21Sep2021 in the morning (5 days after the vaccination), the patient experienced true knot of umbilical cord. The event resulted in intra-uterine death. The mother has been visiting another hospital regularly for medical examination. Expected date of delivery was 17Oct2021. Fetal movement was felt until 15Sep2021 (gestational week 35 day 3). However, since the mother received vaccine on 16Sep2021, fetal movement decreased. On 21Sep2021, the mother visited another hospital for pregnancy examination and was told to have intra-uterine death. The mother was referred to the reporting hospital and examined again but it was intra-uterine death as has been expected. On the same day, the mother was admitted to hospital and labor induction was performed. On 22Sep2021 (gestational week 36 day 3), the mother had vaginal delivery (stillbirth). True knot of umbilical cord was noted. The reporting physician classified the event as serious (congenital anomaly) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was true knot of umbilical cord. The reporting physician commented as follows: Direct cause of death was true knot of umbilical cord. Causality between worsening of blood flow due to true knot of umbilical cord and vaccination was unknown (assumed as probably unrelated). The outcome of the events was fatal. The patient died on 21Sep2021 due to events. It was not reported if an autopsy was performed. No follow-up attempts are needed. No further information is expected.; Sender''s Comments: Linked Report(s) : JP-PFIZER INC-202101285858 maternal case; Reported Cause(s) of Death: fetal movement decreased; Maternal exposure during pregnancy; true knot of umbilical cord


VAERS ID: 1763516 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-13
Onset:2021-07-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0203 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-21
   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: JANUVIA; HARNAL D; BETANIS; ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE;INDACATEROL MALEATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema; Laryngeal cancer; Surgery; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101285789

Write-up: acute myocardial infarction; Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority (RA). Regulatory authority report number is v21128107. A 77-years-old male patient received bnt162b2 (COMIRNATY), at the age of 77-years-old, dose 2 via an unspecified route of administration on 13Jul2021 10:00 (Lot Number: EW0203; Expiration Date: 30Sep2021) as SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus, emphysema, and the postoperative state of laryngeal cancer (Jan2011, as reported). Concomitant medications included sitagliptin phosphate (JANUVIA) 50, orally taken at 1 tablet in the morning; tamsulosin hydrochloride (HARNAL D) 0.2, orally taken at 1 tablet daily; mirabegron (BETANIS) 50, orally taken at 1 tablet in the morning; and glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER) inhalation, taken 1 DF daily; all for an unspecified indication, and start and stop date were not reported. On 22Jun2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number FA7338, Expiration date 30Sep2021). The patient experienced cardio-respiratory arrest on 21Jul2021 09:00, acute myocardial infarction on an unspecified date, both with fatal outcome. The clinical course was as follows: On 21Jul2021 at around 09:00 (8 days after the vaccination), the patient was found in a state of cardio-respiratory arrest at home. On 21Jul2021 (8 days after the vaccination), the outcome of the event was fatal. The reporting physician classified the event as serious (death) and assessed the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was myocardial infarction. An autopsy was performed. The reporting physician commented as follows: The diagnosis by the coroner was acute myocardial infarction.; Reported Cause(s) of Death: acute myocardial infarction; Cardio-respiratory arrest; Autopsy-determined Cause(s) of Death: acute myocardial infarction


VAERS ID: 1763517 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-09
Onset:2021-09-21
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood test, C-reactive protein, C-reactive protein increased, Death, White blood cell disorder
SMQs:, Haematopoietic leukopenia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: THYRADIN; TENELIA; MEVALOTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes mellitus; Dyslipidaemia; Thyroid function decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210908; Test Name: blood test; Result Unstructured Data: Test Result:no abnormalities; Comments: at the reporting hospital; Test Date: 20210921; Test Name: blood test; Result Unstructured Data: Test Result:abnormal WBC level; Comments: visited a different hospital; Test Date: 20210921; Test Name: CRP; Test Result: Positive ; Comments: visited a different hospital
CDC Split Type: JPPFIZER INC202101288734

Write-up: died; CRP was positive; Abnormal WBC level; This is a spontaneous report from a contactable physician. This report was received via a sales representative. A 69-year-old female patient received second dose of BNT162B2 (COMIRNATY), via intramuscular on 09Sep2021 as single dose, for covid-19 immunisation. The patient medical history included thyroid function decreased, diabetes mellitus and dyslipidaemia. Concomitant medications included thyroid (THYRADIN) for thyroid function decreased, teneligliptin hydrobromide (TENELIA) for diabetes mellitus, and pravastatin sodium (MEVALOTIN) for dyslipidaemia (all medications were administered for a long time). The patient previously took the first dose of BNT162b2 (COMIRNATY), via an unspecified route of administration as a single dose for COVID-19 immunisation. On 23Sep2021 (14 days after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 08Sep2021, blood test was performed at the reporting hospital and no abnormalities were noted. On 09Sep2021, the patient received the second dose of the vaccination. On 21Sep2021, since the patient could not consume meals, she visited a different hospital. The reporter was informed by the hospital that C-reactive protein (CRP) was positive and abnormal white blood cell (WBC) level was noted, and the patient died. The outcome of the event died was fatal, for other events was unknown. The patient was died on 23Sep2021. It was not reported if an autopsy was performed. The reporting physician classified the event (death) as serious (fatal outcome) and assessed that the event was probably related to BNT162B2. The reporting physician commented as follows: The blood test performed on 08Sep2021 did not show abnormalities, but considering the report of abnormal blood test results (21Sep2021), the causal relationship with BNT162B2 was suspected. The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: died


VAERS ID: 1763518 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-14
Onset:2021-09-28
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FF2018 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Hanging
SMQs:, Accidents and injuries (narrow), Hostility/aggression (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Depression; Hypertension; Hypothyroidism; Osteoporosis; Parkinson''s syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210914; Test Name: body temperature; Result Unstructured Data: Test Result:36.1 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC202101289067

Write-up: Hanging; This is a spontaneous report from a contactable physician received from the regulatory authority report number is v21128087. A 77-year and 8-month-old female patient received BNT162B2 (COMIRNATY), dose 1 via an unspecified route of administration on 14Sep2021 13:48 (Lot Number: FF2018; Expiration Date: 31Dec2021) (at age of 77-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension, angina pectoris, hypothyroidism, osteoporosis, depression, and Parkinson''s syndrome. The patient''s concomitant medications were not reported. Body temperature before vaccination was 36.1 degrees Centigrade. The patient family history was unknown. The patient had medical history of hypertension, angina pectoris, hypothyroidism, osteoporosis, depression, and Parkinson''s syndrome. The patient''s concomitant medications were not reported. On 28Sep2021 at around 10:00 (14 days after the vaccination), the patient experienced hanging. The course of the event was as follows: On 28Sep2021 at around 10:00 (the day reported), the patient was found hanging in her room. According to information from her family, the patient had felt rather depressed in the past few months because of physical deconditioning. The patient was immediately transported to a nearby hospital, and her death was confirmed. On 28Sep2021 (14 days after the vaccination), the outcome of the event was fatal. The reporting physician classified the event as serious (death) and assessed that the event was unrelated to BNT162b2. Other possible cause of the event such as any other diseases was depression. The reporting physician commented that the causal relationship with the vaccination was not confirmed.; Sender''s Comments: Based on the information available and a possible contributory role of the suspect BNT162B2 to the reported fatal event of hanging can be completely excluded/unrelated.The case will be reassessed once new information is available.; Reported Cause(s) of Death: Hanging


VAERS ID: 1763519 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-06-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Death
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: Renal disease
Allergies:
Diagnostic Lab Data: Test Date: 20210621; Test Name: body temperature; Result Unstructured Data: Test Result:36.2 Centigrade; Comments: Before second vaccination
CDC Split Type: JPPFIZER INC202101295475

Write-up: Unknown cause of death; This is a spontaneous report from a contactable physician received from the RA. Regulatory authority report number is v21128323. A 70-year and 0-month-old male patient received second dose of BNT162b2 (COMIRNATY, Solution for injection), via an unspecified route of administration on 21Jun2021 (Lot Number: FA5829; Expiration Date: 31Aug2021) (at the age of 70-year-old) as single dose for COVID-19 immunisation. Medical history included renal disease from an unknown date and unknown if ongoing. The family history was not provided. The patient''s concomitant medications were not reported. On an unknown date in 2021, the patient previously received first dose of BNT162b2 (COMIRNATY, Lot Number and Expiration date were not reported). Body temperature before second vaccination was 36.2 degrees centigrade. On 21Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY). On 24Jun2021, before dawn (3 days after the vaccination), the patient experienced unknown cause of death. On 24Jun2021 (3 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: on 24Jun2021 (3 days after vaccination), the patient was found dead at his home. The summary was unknown. An autopsy was not 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 unassessable. The reporting physician commented as follows: it was unassessable whether the event was caused by BNT162b2 vaccination or by the patient''s physical condition including his underlying disease.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1763533 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis
SMQs:, Cardiomyopathy (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: 2021-09-12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: This case was received via Takeda Pharmaceuticals (Reference number: 2021TJP095045) on 24-Sep-2021 and was forwarded to Moderna on 02-Oct-2021. This case was reported by a person involved in a vaccine recipient via the regulatory authority. On 29-Aug-2021, the patient received dose of this vaccine (number of doses unknown). On an unknow date, myocarditis developed. On 12-Sep-2021, the patient died. The outcome of myocarditis was reported as fatal. Follow-up investigation will be impossible due to non-cooperation of the reporter. Company Comment: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Reporter''s Comments: The event developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship. JP-TAKEDA-2021TJP095046:Original case: 2021TJP095046; Sender''s Comments: This case concerns a 45-year-old, male patient with no relevant medical history, who experienced the unexpected event of myocarditis. The event myocarditis exact occurrence unknown with respect with the unknown dose number of mRNA-1273 vaccine administration and had a fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Myocarditis


VAERS ID: 1763567 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Brain oedema, Cardiovascular insufficiency, International normalised ratio, Myocardial ischaemia, Pulmonary artery thrombosis, Pulmonary oedema, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Hyponatraemia/SIADH (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Other ischaemic heart disease (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DIGOXIN; VEROSPIRON; TRIFAS [TORASEMIDE]; WARFAREX; CARVEDILOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension (gr II, with high additional risk); Cardiac insufficiency (NYHA II); Chronic atrial fibrillation (with high thromboembolic risk); Mitral valve repair (reprothesis 2005, 2015); Rheumatic heart disease; Tricuspid valve incompetence (gr II); Valvular heart disease NOS (operated)
Allergies:
Diagnostic Lab Data: Test Name: INR; Result Unstructured Data: Test Result:1.92
CDC Split Type: MDPFIZER INC202101271841

Write-up: pulmonary artery thrombosis; ischemic cardiopathy; cerebral and pulmonary edema; cerebral and pulmonary edema; cardiovascular insufficiency; the patient was found suddenly dead at work; This is a spontaneous report from a contactable other healthcare professional via the Regulatory Authority. Regulatory Authority report number MD-MMDA-300003496. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 25May2021 (at the age of 56-year-old) (Lot Number: FA7812; Diluent batch number: 21-098-DX) as single dose for COVID-19 immunisation. Relevant medical history included chronic rheumatic cardiopathy, valvulopathy (operated), mitral valve prosthesis in 1990 (reprothesis 2005, 2015), tricuspid valve insufficiency (gr II), chronic atrial fibrillation (with high thromboembolic risk), arterial hypertension (gr II, with high additional risk) and cardiac insufficiency (NYHA II). Concomitant medications included digoxin (DIGOXIN); spironolactone (VEROSPIRON); torasemide (TRIFAS); warfarin sodium clathrate (WARFAREX); carvedilol; all taken for unspecified indications, start and stop dates were not reported. The patient was found suddenly dead at work (sudden death) on 26May2021. The patient underwent lab tests and procedures which included international normalised ratio: 1.92 on an unknown date. An autopsy was performed, and the reported causes of death were pulmonary artery thrombosis, ischemic cardiopathy, cerebral and pulmonary edema, cardiovascular insufficiency. The patient was under cardiosurgeon evidence with diagnosis: chronic reumatismal cardiopathy; operated valvulopathy; mitral valve prothesis 1990, reprothesis 2005, 2015; tricuspid valve insufficiency gr ii, chronic atrial fibrillation with high thromboembolic risk, arterial hypertension gr II high additional risk, cardiac insufficiency NYHA II. Long term treatment tablets digoxin, VEROSPIRON, TRIFAS, carvedilol, WARFAREX; "IP 56%", INR 1.92. Post vaccination reaction non manifested "during 30". On 26May2021 at 13:30 it was received a phone call from the patient who did not show signs of post vaccination reaction "communicated she feels well". At 14:05 informed that the patient was found suddenly dead at work. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: pulmonary artery thrombosis; ischemic cardiopathy; cerebral and pulmonary edema; cerebral and pulmonary edema; cardiovascular insufficiency


VAERS ID: 1763568 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-27
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina of effort (CF II); Atrial flutter (she was in intensive care unit with pulmonary edema, atrial flutter); Hypertension (gr II, very high additional risk); Intensive care; Ischemic heart disease; Permanent atrial fibrillation; Pneumonia (Sars-Cov-2 infection, complicated by post-Covid-19 pneumonia, and underwent stationary treatment); Pulmonary edema (she was in intensive care unit with pulmonary edema, atrial flutter); SARS-CoV-2 infection (Sars-Cov-2 infection, complicated by post-Covid-19 pneumonia, and underwent stationary treatment); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data:
CDC Split Type: MDPFIZER INC202101271843

Write-up: repeated myocardial infarction; This is a spontaneous report from a contactable physician via Regulatory Authority report number MD-MMDA-300003749. A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 27May2021 (at the age of 69-year-old) (Batch/Lot number was not reported) as single dose (dose number unknown) for COVID-19 immunisation. Relevant medical history included ischemic cardiopathy, angina pectoris of effort (CF II), permanent atrial fibrillation, hypertension (gr II, very high additional risk), type 2 diabetes mellitus, Sars-Cov-infection from Dec2020 to an unknown date (Sars-Cov-2 infection, complicated by post-Covid-19 pneumonia, and underwent stationary treatment), post-Covid-19 pneumonia, pulmonary oedema from Mar2021 to an unknown date (she was in intensive care unit with pulmonary edema, atrial flutter), atrial flutter from Mar2021 to an unknown date, intensive care from Mar2021 to an unknown date. Concomitant medications were not specified. The patient was consulted by the cardiologist who indicated treatment, which the patient was regularly taking. The patient experienced repeated myocardial infarction on 27May2021 with fatal outcome on the same day, 27May2021. On 27May2021, she was hospitalized with emergency and she died with the diagnosis of repeated myocardial infarction. An autopsy was not performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: repeated myocardial infarction


VAERS ID: 1763570 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-08-18
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Acute pulmonary oedema, Blood creatinine, Blood culture, Blood thromboplastin, C-reactive protein, COVID-19 pneumonia, Cardiac failure congestive, Cardiogenic shock, Chest X-ray, Chronic kidney disease, Computerised tomogram, Glomerular filtration rate, Haemoglobin, Heart rate, International normalised ratio, Lymphocyte count, Neutrophil count, Oxygen saturation, PCO2, PO2, Platelet count, Respiratory rate, SARS-CoV-2 test, Vaccination failure, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Lack of efficacy/effect (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-23
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATORVASTATIN; SPIRONOLACTONE; AMIODARONE; BROMAZEPAM; BUMETANIDE; METOLAZONE; IMDUR; OMEPRAZOLE; WARFARIN; ENTRESTO; SLOW-K; ALLOPURINOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Chronic heart failure (EF 45%); Chronic kidney disease stage 4; Coronary artery disease; Defibrillator/pacemaker insertion; Hypertension; Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: APTT; Result Unstructured Data: Test Result:1.29 to 54.9; Comments: High and rising on 18, 19, 20, 21 and 22Aug2021; Test Name: CREATININE; Result Unstructured Data: Test Result:246 to 147; Comments: HIGH but falling on 18, 19, 20, 21 and 22Aug2021; Test Name: Blood culture; Result Unstructured Data: Test Result:Staph epidermidis, Gram positive cooci; Comments: On 18, 19, 22 and 23Aug2021; Test Name: PTT; Result Unstructured Data: Test Result:21.6 to 67.4; Comments: High and rising on 18, 19, 20, 21 and 22Aug2021; Test Date: 20210818; Test Name: CXR; Result Unstructured Data: Test Result:Lungs clear, normal; Test Date: 20210819; Test Name: CT; Result Unstructured Data: Test Result:No active pulmonary lesion seen; Comments: normal CT; Test Name: C-REACTIVE PROTEIN; Result Unstructured Data: Test Result:25 to 73; Comments: VERY HIGH AND RISING on 18, 19, 20, 21 and 22Aug2021; Test Name: EGFR; Result Unstructured Data: Test Result:24 to 44; Comments: LOW on 18, 19, 20, 21 and 22Aug2021; Test Name: HEMOGLOBIN; Result Unstructured Data: Test Result:12.9 to 13.3; Comments: low on 18, 19, 20, 21 and 22Aug2021; Test Name: Heart rate; Result Unstructured Data: Test Result:120 to 130bpm; Test Date: 20210818; Test Name: Heart rate; Result Unstructured Data: Test Result:83 bpm; Test Name: INR; Result Unstructured Data: Test Result:1.9 to 5.9; Comments: High and rising on 18, 19, 20, 21 and 22Aug2021; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.63 fell to 0.28; Comments: Low and decreasing on 18, 19, 20, 21 and 22Aug2021; Test Name: NEUTROPHILS; Result Unstructured Data: Test Result:4.0 to 8.6; Comments: Normal, rose to high on 18, 19, 20, 21 and 22Aug2021; Test Name: SpO2; Test Result: 88 %; Comments: on 5ml/L NRM; Test Name: SpO2; Test Result: 86 %; Comments: on 5L/min NRB; Test Date: 20210818; Test Name: SpO2; Test Result: 95 %; Comments: on RA; Test Date: 20210821; Test Name: PCO2; Result Unstructured Data: Test Result:37 mmHg; Test Date: 20210822; Test Name: PCO2; Result Unstructured Data: Test Result:64 mmHg; Test Date: 20210821; Test Name: PH; Result Unstructured Data: Test Result:7.45; Test Date: 20210822; Test Name: PH; Result Unstructured Data: Test Result:7.23; Test Name: PLATELET COUNT; Result Unstructured Data: Test Result:220 to 193; Comments: Normal on 18, 19, 20, 21 and 22Aug2021; Test Date: 20210821; Test Name: PO2; Result Unstructured Data: Test Result:113 mmHg; Test Date: 20210822; Test Name: PO2; Result Unstructured Data: Test Result:59 mmHg; Test Name: Respiratory rate; Result Unstructured Data: Test Result:30/min; Test Date: 20210818; Test Name: SARS-CoV-2 PCR test; Result Unstructured Data: Test Result:Detected - CT 22; Test Name: WBC; Result Unstructured Data: Test Result:5.7-9.7; Comments: NORMAL on 18, 19, 20, 21 and 22Aug2021
CDC Split Type: MTPFIZER INC202101296436

Write-up: Nasal swab (RT-PCR) - positive; Nasal swab (RT-PCR) - positive; CKD worsened due to dehydration; Cardiogenic shock; Acute pulmonary edema; Congestive heart failure; This is a spontaneous report from a contactable physician. A 65-years-old male patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number: ET6956, Expiry date: Unknown) via intramuscularly, administered in Arm Left on 24Apr2021 as dose 1, single and dose 2 intramuscularly, administered in Arm Left on 15May2021 (Lot Number: EX8680, Expiry date: Unknown) as dose 2, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, cardiac failure chronic from an unknown date and unknown if ongoing EF 45%, coronary artery disease from 2012 to an unknown date, aortic valve replacement from 1996 to an unknown date, implantable defibrillator insertion from 2012 to an unknown date, chronic kidney disease and non-tobacco user from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin (ATORVASTATIN) 80mg nocte, spironolactone (SPIRONOLACTONE) 25mg BD, amiodarone (AMIODARONE) 200mg dly, bromazepam (BROMAZEPAM) 3mg TDS, bumetanide (BUMETANIDE) 1mg (2-2-1), metolazone (METOLAZONE) 1 tab prn, isosorbide mononitrate (IMDUR) 60mg dly, omeprazole (OMEPRAZOLE) 20mg BD, warfarin (WARFARIN), sacubitril valsartan sodium hydrate (ENTRESTO)24/6mg dly, potassium chloride (SLOW-K) 2 tabs dly and allopurinol (ALLOPURINOL) 200mg dly taken for an unspecified indication, start and stop date were not reported. The patient underwent a nasal swab (RT-PCR) that was positive on 18Aug2021 (new infection). Admitted on 18Aug2021. Initially patient was admitted onto a COVID ward, then transferred to CCU on the 23Aug2021. On admission SpO2 was 95% on RA; pulse 83 bpm; afebrile. Patient progressively worsened over the next few days. CKD worsened due to dehydration Prior to CCU transfer patient had an SpO2 of 86% on 5L/min NRB, RR - 30/min, and HR of 120 to 130bpm. Oxygen supplementation at 5L/min increased SpO2 to 88% on NRM. Patient became unresponsive on the 23Aug2021 and CPR was performed. Patient was subsequently intubated. Patient deceased in hospital on the 23Aug2021. Cause of death: Cardiogenic shock consequent to acute pulmonary oedema, congestive heart failure, aortic valve replacement, pneumonia and COVID-19 positive. Patient was treatment with Dexamethasone 6mg dly (19Aug2021-23Aug2021) till date of death. The patient underwent lab tests and procedures which included activated partial thromboplastin time: 1.29 to 54.9 on High and rising on 18, 19, 20, 21 and 22Aug2021, blood creatinine: 246 to 147 on HIGH but falling on 18, 19, 20, 21 and 22Aug2021, blood culture: staph epidermidis, gram positive cooci on unspecified date On 18, 19, 22 and 23Aug2021, blood thromboplastin: 21.6 to 67.4 on high and rising on 18, 19, 20, 21 and 22Aug2021, chest x-ray: lungs clear, normal on 18Aug2021, computerised tomogram: no active pulmonary lesion seen on 19Aug2021 normal CT , c-reactive protein: 25 to 73 on very high and raising on 18, 19, 20, 21 and 22Aug2021, glomerular filtration rate: 24 to 44 on low on 18, 19, 20, 21 and 22Aug2021, haemoglobin: 12.9 to 13.3 on low on 18, 19, 20, 21 and 22Aug2021, heart rate: 120 to 130bpm on an unknown date, heart rate: 83 bpm on 18Aug2021, international normalised ratio: 1.9 to 5.9 on High and rising on 18, 19, 20, 21 and 22Aug2021, lymphocyte count: 0.63 fell to 0.28 on low and decreasing on 18, 19, 20, 21 and 22Aug2021, neutrophil count: 4.0 to 8.6 on normal, rose to high on 18, 19, 20, 21 and 22Aug2021 , oxygen saturation: 88 % on 5ml/L NRM. Therapeutic measures were taken as a result covid-19 and vaccination failure. The patient died on 23Aug2021. An autopsy was not performed. The outcome of the event Chronic kidney disease was unknown and all other events were fatal. No follow-up attempts required. No more information are expected.; Sender''s Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiogenic shock


VAERS ID: 1763631 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-26
Onset:2021-09-07
   Days after vaccination:193
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP2166 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-12
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Exposure to SARS-CoV-2 (He was exposed to coronavirus (known route of infection) probably 05Sep2021. During hospitalization.); Multimorbidity (Summary: Multimorbid and had been hospitalized and treated for pyelonephritis and sepsis.); Pyelonephritis (Summary: Multimorbid and had been hospitalized and treated for pyelonephritis and sepsis.); Sepsis (Summary: Multimorbid and had been hospitalized and treated for pyelonephritis and sepsis.)
Allergies:
Diagnostic Lab Data: Test Date: 20210907; Test Name: COVID-19 antigen test; Test Result: Positive
CDC Split Type: NOPFIZER INC202101279026

Write-up: Covid-19 infection; Covid-19 infection; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB NO-NOMAADVRE-FHI-2021-Ug921q. An 89-year-old male patient received BNT162B2 (COMIRNATY, Solution for injection) intramuscularly for 1st single dose on 05Feb2021 (LOT/Batch number and expiration date unknown) and intramuscularly for 2nd single dose on 26Feb2021 (LOT number: EP2166, expiration date unknown) for COVID-19 immunisation. Medical history included sepsis from 05Sep2021, multimorbidity, exposure to SARS-CoV-2 from 05Sep2021, COVID-19 from 12Sep2021, pyelonephritis from 05Sep2021. Patient was multimorbid and had been hospitalized and treated for pyelonephritis and sepsis. He was exposed to coronavirus (known route of infection) probably 05Sep2021, during hospitalization. After transfer to short-term nursing home on 07Sep2021, he developed new symptoms consistent with covid-19 infection (cough, tingling, impaired general condition) and tested positive on antigen rapid test. The symptom picture developed rapidly with somatic delirium and fall and the patient was considered to be in the terminal phase shortly after transfer to a nursing home. Outcome of the events was fatal. The patient died 12Sep2021. Cause of death was reported as COVID-19 related. It was unknown if an autopsy was performed. COVID-19 antigen test on 07Sep2021 was positive. VOC (variant of concern) not known, but presumed to be Delta. Events latency with dose 2 was reported as 194 Days, with dose 1 was 215 Days. Reporters comments and additional relevant information: Reported as a case of vaccine failure. The patient was fully vaccinated with Comirnaty, first dose 05Feb2021, second dose 26Feb2021. He was exposed to coronavirus (known route of infection) probably 05Sep2021, during a hospitalization. He was multimorbid and had been hospitalized and treated for pyelonephritis and possible sepsis during hospitalization. After transfer to short-term nursing home 07Sep2021, he developed new symptoms consistent with covid-19 infection (cough, tingling, impaired general condition) and tested positive on antigen rapid test. The symptom picture developed rapidly with somatic delirium and fall and the patient was considered to be in the terminal phase shortly after transfer to a nursing home. The patient died 12Sep2021. regulatory authority: New information per telephone with reporter 23Sep2021: VOC (variant of concern) not known, but presumed to be Delta. Cause of death: covid-19 related. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and COVID-19 event as no relationship. The regulatory authority assessed the causal relationship between bnt162b2 (COMIRNATY) and Vaccination failure, as possible. The lot number for the vaccine, Comirnaty dose 1, was not provided and will be requested during follow up.; Reported Cause(s) of Death: Covid-19 infection; Covid-19 infection


VAERS ID: 1763644 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-13
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal disorder, Investigation, Maternal exposure during pregnancy, Trisomy 21, Ultrasound antenatal screen
SMQs:, Congenital, familial and genetic disorders (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? Yes
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: VITAMIN D [VITAMIN D NOS]; FOLATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Fetal investigations; Result Unstructured Data: Test Result:other fetal abnormalities; Comments: It was also proven that the fetus most likely had Downs syndrome; Test Name: Fetal nuchal translucency ultrasound; Result Unstructured Data: Test Result:clear thick nuchal fold
CDC Split Type: NOPFIZER INC202101292300

Write-up: Maternal exposure during pregnancy, first trimester; Fetal abnormalities, fetus had a clear thick nuchal fold and also other fetal abnormalities; Down''s syndrome; This is a spontaneous report from a non-contactable consumer (parent) via Regulatory Authority, downloaded from the Regulatory Authority-WEB (NO-NOMAADVRE-PASRAPP-2021-Ud2ar1; NO-NOMAADVRE-E2B_00050908). This consumer reported events for both mother and fetus. This is the fetus case. Only this case is serious. A fetus received BNT162B2 (COMIRNATY) dose 2 transplacental, administered to the 26-year-old mother intramuscular in the left arm, on 13May2021 (Batch/Lot number was not reported) as initial Pfizer dose single for COVID-19 immunisation. The fetus received the first dose for COVID-19 immunisation with COVID-19 vaccine NRVV AD (CHADOX1 NCOV-19) (VAXZEVRIA; Formulation: Suspension for injection) on 17Feb2021 (Batch/lot number: Unknown) transplacental via the mother (intramuscular in the right arm). The patient medical history was not reported. Concomitant medications included vitamin D taken for an unspecified indication, start and stop date were not reported; folic acid (FOLATE) taken for an unspecified indication, start and stop date were not reported. The patient experienced maternal exposure during pregnancy, first trimester on an unspecified, disorder fetal NOS in 2021 with fatal outcome and Down''s syndrome in 2021 with outcome unknown. The mother was revaccination with different COVID-19 vaccine and early foetal death occurred. The mother reported that the fetus died in the womb in week 11+4. The mother reported that it was discovered that the fetus had a clear thick nuchal fold and also other fetal abnormalities. It was also proven that the fetus most likely had Down''s syndrome. It was unknown if an autopsy was performed. Reporter Comment: Contact with healthcare professionals: Physician, Nurse. The patient reported that the fetus died in the womb in week 11+4. The patient reported that it was discovered that the fetus had a clear thick nuchal fold and also other fetal abnormalities. It was also proven that the fetus most likely had Downs syndrome. The Regulatory Authority did not provide a causality assessment. No follow-up attempts are possible. No further information expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: Contact with healthcare professionals: Physician, Nurse. The patient reported that the fetus died in the womb in week 11+4. The patient reported that it was discovered that the fetus had a clear thick nuchal fold and also other fetal abnormalities. It was also proven that the fetus most likely had Downs syndrome.; Sender''s Comments: Linked Report(s) : NO-PFIZER INC-202101272746 Mother/fetus case; Reported Cause(s) of Death: Disorder foetal NOS


VAERS ID: 1763664 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-08-07
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chronic obstructive pulmonary disease, Cough, Decreased appetite, Specialist consultation, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 0
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: AMOKSIKLAV [AMOXICILLIN;CLAVULANIC ACID]; DEXAVEN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210722; Test Name: Pulmonologist; Result Unstructured Data: Test Result:reslut unknown
CDC Split Type: PLPFIZER INC202101279012

Write-up: Cough aggravated; Weakness worsened; Appetite lost; suspected COPD; Sudden death; This is a spontaneous report received from a contactable Consumer or other non HCP downloaded from the RA. The regulatory authority report number is PL-URPL-DML-MLP.4401.2.665.2021. Report DML-MLP.4401.2.665.2021 was sent to hospital on 10Sep2021 by the patient''s wife. The reporter reported events for two doses of BNT162B2 vaccination. This case refers to dose 2. A 73-year-old male patient received 2nd single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) on 29May2021 at age of 73-year-old for COVID-19 immunisation. Body weight was 80 kg and height was 175 cm. Medical history was not reported. Patient previously received 1st single dose of BNT162B2 (COMIRNATY, Solution for injection, LOT/Batch number and expiration date unknown) on an unspecified date for COVID-19 immunisation and experienced asthenia, appetite lost, cough. Concomitant medications included amoxicillin, clavulanic acid (AMOKSIKLAV), dexamethasone sodium phosphate (DEXAVEN). The patient experienced side effects: Worsening of side effects after the first dose (severe cough, loss of appetite, weakness). In primary health care, suspected COPD, he made additional examinations and visits to specialists on the basis of referrals. On 22Jul2021, during a visit to a Pulmonologist, he was referred to a hospital at the Pulmonology Department. After a 2-week hospitalization, the patient suddenly died in hospital on 07Aug2021 at 3:40 pm. Health result was death. Date of death was 07Aug2021, no autopsy was performed. Consequences of the side effect: Visit to the doctor with doctor''s instructions referral to hospital, pulmonology department; hospitalization (2 weeks in the pulmonology department); death. The reporting person did not assess whether the side effect was serious. RA classified the report as severe (hospitalization or its extension, death). The data contained in the electronic report was all at the disposal - in the event of obtaining additional information, another version would be sent. Sender Comment: Related Report: PL-URPL-DML-MLP.4401.2.664.2021 (concerns first dose of vaccine). It cannot be assessed whether taking the second dose of Comirnaty caused the symptoms to worsen: severe cough, loss of appetite and weakness. It is possible that they were a sign of a progressive respiratory disease. The post-mortem examination was not performed, therefore the possible relationship between the patient''s vaccination and his sudden death cannot be determined. There is a blurred time relationship between the discovery of a side effect and the administration of the second dose of Comirnaty. The reporting person did not specify the severity of the side effect. Due to the hospitalization and death of the patient, classified the side effect as serious. Relatedness of drug to all reaction(s)/event(s) RA: unassessable No follow-up attempts possible. No further information expected. Information on lot number cannot be obtained.; Sender''s Comments: Linked Report(s) : PL-PFIZER INC-202101279007 1st/2nd dose of Comirnaty; Reported Cause(s) of Death: Weakness worsened; Appetite lost; suspected COPD; Cough aggravated


VAERS ID: 1763767 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-01-21
Onset:2021-01-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Dyspnoea, Fatigue, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-10
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Dementia; General physical condition decreased; Living in nursing home
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210119; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: PTPFIZER INC202101272855

Write-up: Prostration; COVID-19; Breathing difficult; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Agency-WEB [Regulatory Authority number PT-INFARMED-T202109-846], Safety Report Unique Identifier PT-INFARMED-T202109-846. An 88-year-old female patient received the 1st dose of bnt162b2 (COMIRNATY), intramuscular on 21Jan2021 (Batch/Lot number was not reported) as DOSE 1, 0.3 ML SINGLE for COVID-19 immunisation. Medical history included ongoing dementia, ongoing general physical health deterioration, ongoing living in residential institution. There were no concomitant medications. The patient experienced prostration (caused death) on 23Jan2021, COVID-19 (caused death) on 23Jan2021, breathing difficult (caused death) on 23Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Jan2021. Therapeutic measures were taken as a result of the events and included treatment with forced nasal oxygenation. The patient died due to the events on 10Feb2021. An autopsy was not performed. Reporter Comment: Concomitant Medication-No Medication Error Occurred?-No Other Information-No significant particular illnesses, with the exception of physical and mental degradation due to age, particularly dementia. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reporter''s Comments: Concomitant Medication-No Medication Error Occurred?-No Other Information-No significant particular illnesses, with the exception of physical and mental degradation due to age, particularly Dementia.; Reported Cause(s) of Death: COVID-19; Breathing difficult; Prostration


VAERS ID: 1763791 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-01
Onset:2021-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FG7898 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Immunisation, Off label use, Pulmonary oedema
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (narrow), 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), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: WARAN
Current Illness: Atrial fibrillation (waran treated); Chronic kidney disease stage 4; Lung transplant (due to lung fibrosis)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Pulmonary fibrosis (transplanted); Pulmonary oedema (in need of care at the ICU after second vaccine dose against covid-19 in Mar2021)
Allergies:
Diagnostic Lab Data:
CDC Split Type: SEPFIZER INC202101285409

Write-up: Pulmonary oedema; cardiac arrest; patient received 3rd dose (booster dose) of bnt162b2 in Sep2021; patient received 3rd dose (booster dose) of bnt162b2 in Sep2021; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number SE-MPA-2021-082736. A 71-year-old female patient received bnt162b2 (COMIRNATY) via an unspecified route of administration, dose 3 on unspecified date in Sep2021 (Batch/Lot Number: FG7898) at single dose at the age of 71-year-old for covid-19 immunisation. Medical history included pulmonary oedema from Mar2021, ongoing atrial fibrillation (waran treated), ongoing chronic kidney disease stage 4, covid-19 from Nov2020, ongoing lung transplant due to lung fibrosis, pulmonary fibrosis (transplanted). Concomitant medication included warfarin sodium (WARAN, 2.5 mg) taken for an unspecified indication, start and stop date were not reported. Patient previously received first dose of bnt162b2 on 26Feb2021 (batch/lot number: EP2166), and second dose on 19Mar2021 (batch/lot number: ET3620), both at single dose for covid-19 immunisation. The patient had pulmonary oedema in need of care at the ICU after second vaccine dose against covid-19 in Mar2021. Patient experienced pulmonary oedema on unspecified date in Sep2021, onset for the reaction was less than 24 hours. It was reported the night after the vaccination (third dose) she developed pulmonary oedema and had a cardiac arrest. The patient was resuscitated and admitted at the ICU where she had another cardiac arrest and passed away one day after the vaccination in Sep2021. It was not reported if an autopsy was performed. Reported cause of death was pulmonary oedema and cardiac arrest.; Reported Cause(s) of Death: Pulmonary oedema; Cardiac arrest


VAERS ID: 1763800 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Dehydration, Diarrhoea, Interchange of vaccine products, Investigation, Malaise, Off label use, Pleural mesothelioma, Pyrexia, Weight, Weight decreased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Medication errors (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological malignant tumours (narrow), Dehydration (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: ELIQUIS; METOPROLOL
Current Illness: Atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: investigation; Result Unstructured Data: Test Result:pleural mesothelioma; Test Date: 2021; Test Name: weight; Result Unstructured Data: Test Result:lost weight from 74kg to 62kg
CDC Split Type: SEPFIZER INC202101239811

Write-up: diarrhea (increase)/stomach problems/problems keeping his food; fever; general feeling of illness; lost weight from 74 to 62 kg; dehydrated; pleural mesothelioma; Off label use; Interchange of vaccine products; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority, regulatory authority number SE-MPA-2021-083841. A 74-year-old male patient received bnt162b2 (Lot Number: EX8680), via an unspecified route of administration on 13May2021 (at the age of 74-years-old) as dose 2 (initial Pfizer dose), single for covid-19 immunisation. The patient medical history included ongoing atrial fibrillation from an unknown date. Concomitant medications included apixaban (ELIQUIS); and metoprolol both were taken for an unspecified indication, start and stop date were not reported. The patient previously received moderna covid-19 vaccine on Apr2021 as dose 1 for covid-19 immunisation, and experienced diarrhea, fever and general malaise. On 14May2021, the patient experienced diarrhea aggravated, fever and general malaise. The patient already had persistent stomach problems in the form of diarrhea, and after dose 2 the problems increased. The patient had problems keeping his food and lost weight from 74 to 62 kg (in 2021). In 2021, approximately 2 weeks after dose 2, the patient was severely dehydrated and hospitalized. The patient was given antibiotics which reduced his stomach problems, and it was also seen that the patient had fluid in his lungs. Investigation later showed that the patient had pleural mesothelioma (in 2021). Therapeutic measure were taken as a result of stomach problems in the form of diarrhea. The patient died several months later (in 2021) and the reporter stated the cause of death as pleural mesothelioma. It was unknown if an autopsy was performed. The outcome of pleural mesothelioma was fatal; while the rest of the events was unknown. Report assessed as serious - hospitalization, and death (due to pleural mesothelioma). No follow-up attempts are possible. No further information expected.; Reported Cause(s) of Death: Pleural mesothelioma


VAERS ID: 1763818 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Arrhythmia, Condition aggravated, Heart rate, Lung disorder
SMQs:, Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (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: Atrial fibrillation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Heart rate; Result Unstructured Data: Test Result:Low
CDC Split Type: SEPFIZER INC202101273990

Write-up: Heart arrhythmia; Lung function impaired; Condition aggravated; This is a spontaneous report from a contactable consumer downloaded from the RA, regulatory authority number SE-MPA-2021-084932. Additional identifier SE-VISMA-1632079444651. An 88-year-old male patient received the second dose of BNT162B2 (COMIRNATY) on an unspecified date, in 2021, at single dose, for COVID-19 immunisation. Relevant medical history included atrial fibrillation from an unspecified date and ongoing. The patient previously, on 25Feb2021, received the first dose of BNT162B2 (COMIRNATY) at single dose, for COVID-19 immunisation. On an unspecified date, in 2021, the patient experienced heart arrhythmia. The man fainted a few times, heart rate was low from time to time, lung function was impaired, oxygen was added as much as possible, treated at the hospital, but died 20 days after second dose of vaccine (condition aggravated). Outcome: fatal. Cardiac arrhythmia and impaired lung function were the causes of death. It was unknown if autopsy was done. Report assessed as serious, death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Cardiac arrhythmia; Lung function decreased; Condition aggravated


VAERS ID: 1763820 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-16
Onset:2021-04-01
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration, Pneumonia, X-ray
SMQs:, Eosinophilic pneumonia (broad), Medication errors (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: X-ray; Result Unstructured Data: Test Result:"maybe" pneumonia was found; Comments: "maybe" pneumonia was found
CDC Split Type: SEPFIZER INC202101285433

Write-up: Inappropriate schedule of vaccine administered; Death; reporter stated that "maybe" pneumonia was found; This is a spontaneous report from a contactable consumer downloaded from the RA, regulatory authority number SE-MPA-2021-085637. A 99-year-old male patient received bnt162b2 (COMIRNATY), second dose via an unspecified route of administration on 16Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (COMIRNATY) on 04Mar2021 (batch/lot number was unknown) as single dose for covid-19 immunisation and experienced slightly worse related to his normal condition. Reporter stated that the man was old and fragile but could more or less take care of himself. The reporter stated that after the first dose of the vaccine the man became slightly worse related to his normal condition. The man was unable to go to the health center to take the second dose so it was given at home about 6 weeks after the first dose. Two days after the second dose the man was taken by ambulance to hospital, X-ray investigation was performed and the reporter stated that "maybe" pneumonia was found and furthermore the reporter stated that the pneumonia did not respond to antibiotics. The man died later after less than a week in hospital (in Apr2021), cause of death was not stated in the report. It was not reported if an autopsy was performed. Report was assessed as serious: death. The outcome for death was fatal, for other event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1763830 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-13
Onset:2021-09-13
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asphyxia, Body temperature increased, Cardiac failure acute, Cardiopulmonary failure, Pulmonary oedema, Pulse absent, Seizure
SMQs:, Cardiac failure (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Convulsions (narrow), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (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: 2021-09-13
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: UAPFIZER INC202101234120

Write-up: pulse absent; seizure; body temperature increased; Asphyxiation; cardiopulmonary failure; pulmonary oedema; acute coronary failure; The initial case was missing the following minimum criteria: reporter was unidentifiable. Upon receipt of follow-up information on 28Sep2021, this case now contains all required information to be considered valid. This is a spontaneous report received contactable reporters of consumer and a health care professional via the RA. A 19-years-old male patient received 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on 13Apr2021 15:05 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced seizure on 13Sep2021 20:15 , pulse absent on 13Sep2021 20:35 , asphyxiation on 13Sep2021, body temperature increased on 13Sep2021. The patient died on 13Sep2021. It was not reported if an autopsy was performed. On 13Sep2021 near 21:00 a team of emergency medical assistance has fixed the death of a 19-year-old man. Based on the results of the examination, the preliminary cause of death was established: a cardiopulmonary failure, pulmonary oedema, acute coronary failure. Additional investigations were taken. For this purpose, material was taken for histological and toxicological examination. The residual cause of death will be established after receiving of the results of laboratory investigations within a month. Outcome of seizure, pulse absent, asphyxiation, cardiopulmonary failure, pulmonary oedema, and acute coronary failure was fatal. Outcome of body temperature increased was unknown. According to the information to the RA, on 13Apr2021 about 15:05, the man was vaccinated against COVID-19 with the Comirnaty / Pfizer-BioNTech vaccine. More than 5 people were vaccinated from the same vial, they all feel good. Within 30 minutes of medical observation after vaccination, the patient had no complaints of well-being. This case is currently being reviewed by the RA.; Reported Cause(s) of Death: cardiopulmonary failure; pulmonary oedema; acute coronary failure; seizure; pulse absent; Asphyxiation


VAERS ID: 1764134 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002616 / 2 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Multiple organ dysfunction syndrome, Sickle cell anaemia with crisis
SMQs:, Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-03
   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: Drepanocytosis; Vaso-occlusive crisis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: FR-AFSSAPS-AM20212570) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of MULTIPLE ORGAN DYSFUNCTION SYNDROME and SICKLE CELL ANAEMIA WITH CRISIS in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3002616) for COVID-19 vaccination. Concurrent medical conditions included Drepanocytosis and Vaso-occlusive crisis. On 17-Jun-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In June 2021, the patient experienced SICKLE CELL ANAEMIA WITH CRISIS (seriousness criteria death and medically significant). On 02-Jul-2021, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (seriousness criteria death and medically significant). The patient died on 03-Jun-2021. The reported cause of death was Multi organ failure. It is unknown if an autopsy was performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company comment: This case concerns a 30-year-old, female patient with relevant medical history of Drepanocytosis and Vaso-occlusive crisis, who experienced the unexpected serious events of Multiple organ dysfunction syndrome and Sickle cell anaemia with crisis. The event of Multiple organ dysfunction syndrome occurred approximately 15 days after the second dose of Spikevax and the event of Sickle cell anaemia with crisis occurred around in the same month of second dose vaccination (event onset date unknown) had a fatal outcome, with death occurring approximately 15 days after the vaccination. The date of death is inaccurately reported prior to vaccination (on 03Jun2021 and second dose vaccination was on 17Jun2021) in the source document. The rechallenge was not applicable. The medical history of Drepanocytosis and Vaso-occlusive crisis remains confounders. The cause of death is reported as Multiple Organ Failure. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation document received on 30-Sep-2021 and included no new information.; Sender''s Comments: This case concerns a 30-year-old, female patient with relevant medical history of Drepanocytosis and Vaso-occlusive crisis, who experienced the unexpected serious events of Multiple organ dysfunction syndrome and Sickle cell anaemia with crisis. The event of Multiple organ dysfunction syndrome occurred approximately 15 days after the second dose of Spikevax and the event of Sickle cell anaemia with crisis occurred around in the same month of second dose vaccination (event onset date unknown) had a fatal outcome, with death occurring approximately 15 days after the vaccination. The date of death is inaccurately reported prior to vaccination (on 03Jun2021 and second dose vaccination was on 17Jun2021) in the source document. The rechallenge was not applicable. The medical history of Drepanocytosis and Vaso-occlusive crisis remains confounders. The cause of death is reported as Multiple Organ Failure. The benefit-risk relationship of mRNA-1273 (COVID-19 Vaccine Moderna) is not affected by this report.; Reported Cause(s) of Death: Multi organ failure


VAERS ID: 1764135 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-23
Onset:2021-08-29
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 214017 / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-13
   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: Psoriasis
Preexisting Conditions: Medical History/Concurrent Conditions: Vertebral artery thrombosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: FR-AFSSAPS-BS20211753) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of BASILAR ARTERY THROMBOSIS in a 50-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 214017) for COVID-19 vaccination. The patient''s past medical history included Vertebral artery thrombosis in 2009. Concurrent medical conditions included Psoriasis. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 29-Aug-2021, the patient experienced BASILAR ARTERY THROMBOSIS (seriousness criteria death and medically significant). The patient died on 13-Sep-2021. The reported cause of death was refusal of care by the patient. An autopsy was not performed. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Event as reported by the primary source was changed to basilar artery thrombosis. Treatment information was not provided. Company Comment: This case concerns a 50-year-old, male patient with relevant medical history of Vertebral artery thrombosis and Psoriasis, who experienced the unexpected event of Basilar artery thrombosis. The event occurred approximately 6 days after the first dose of Moderna Covid-19 vaccine and had a fatal outcome. The patient died on 13-Sep-2021. The reported cause of death was refusal of care by the patient. An autopsy was not performed. The medical history of Vertebral artery thrombosis is cofounding. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translation received on 30 Sep 2021 included: description as reported for cause of death has changed.; Sender''s Comments: This case concerns a 50-year-old, male patient with relevant medical history of Vertebral artery thrombosis and Psoriasis, who experienced the unexpected event of Basilar artery thrombosis. The event occurred approximately 6 days after the first dose of Moderna Covid-19 vaccine and had a fatal outcome. The patient died on 13-Sep-2021. The reported cause of death was refusal of care by the patient. An autopsy was not performed. The medical history of Vertebral artery thrombosis is cofounding. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter''s assessment. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Refusal of care by the patient


VAERS ID: 1764518 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-31
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Fatigue, Headache, Hospitalisation, Oxygen saturation, Polymerase chain reaction positive, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-23
   Days after onset: 23
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: BGJNJFOC20211007334

Write-up: Death; High temperature; Fatigue; Headache; Hospitalisation; PCR positive; O2 saturation; This spontaneous report received from a consumer via Regulatory Authority (EVHUMAN Vaccines, BG-BDA-21701) on 05-OCT-2021 concerned a 50 year old male of an unspecified race and ethnic origin. The patient''s weight was 96 kilograms, and height was not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch: unknown, expiry: unknown) dose was not reported, 1 total administered on 31-AUG-2021 for covid-19 immunisation. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was hospitalized and number of days hospitalized and discharge information was not reported. On 2021, the patient had oxygen(O2) saturation, hospitalization. PCR positive. On 31-AUG-2021, the patient experienced fatigue, headache and high temperature. On 23-Sep-2021, the patient passed away. 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 23-SEP-2021, and the outcome of o2 saturation, fatigue, headache, hospitalization, PCR positive and high temperature was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Reported Cause(s) of Death: DEATH


VAERS ID: 1765780 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3095 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Inappropriate schedule of product administration
SMQs:, Medication errors (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: Coronary disease; Depression; Diabetes mellitus; Hypercholesteraemia; Hypertension; Polytoxicomania
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272825

Write-up: 1st dose: 28Apr2021; 2nd dose 09Jun2021; Death; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB DE-DCGMA-21191570 and Sender''s (Case) Safety Report Unique Identifier DE-PEI-202100192436 A 74-Year-old Female patient received the second dose of bnt162b2 (COMIRNATY) Intramuscularly on 09Jun2021 at the age of 74-Year-old (Lot number: FC3095) as 0.3 ml single dose for COVID-19 immunisation. The patient''s medical history included Coronary disease, Hypertension, Diabetes mellitus, Polytoxicomania, Hypercholesteraemia, Depression, all from an unspecified date and unknown if ongoing. Concomitant medications were not reported. The patient previously received bnt162b2 (COMIRNATY) on 28Apr2021 at the age of 74-Year-old (lot: EA3599) as single dose for covid-19 immunisation. In Jun2021, the patient experienced Death. This report is serious due to death, life threatening. Result of assessment for the event /PEI / : D. Unclassifiable. It was unknown if Autopsy Done. The outcome of the event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1765820 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101304890

Write-up: death; This is a spontaneous report from a contactable physician. This case is received by Pfizer from Biontech (manufacturer control number: 90226]), license party for Comirnaty. A female patient of unspecified age received bnt162b2 (COMIRNATY) on an unspecified date as single dose (Dose number and lot numbers unknown) for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient died on an unspecified date. It was In general many side effects. It was not reported if Autopsy Done. The outcome of the event was fatal. Lot/batch number has been requested.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: death


VAERS ID: 1765835 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-14
Onset:2021-08-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002620 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-15
   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: SERTRALINA PENSA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression; Sleep apnoea syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: ESMODERNATX, INC.MOD20213

Write-up: Sudden death; This case was received via Regulatory Authority (Reference number: ES-AEMPS-1006801) on 28-Sep-2021 and was forwarded to Moderna on 28-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of SUDDEN DEATH (Sudden death) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 3002620) for COVID-19 immunisation. The patient''s past medical history included Sleep apnoea syndrome and Depression. Concomitant products included SERTRALINE HYDROCHLORIDE (SERTRALINA PENSA) for Depression. On 14-Aug-2021, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. The patient died on 15-Aug-2021. The reported cause of death was Sudden death. It is unknown if an autopsy was performed. mRNA-1273 (Spikevax) (Intramuscular) was withdrawn on 14-Aug-2021. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided by the reporter. This case concerns a 46 year old male with a history of Sleep apnea syndrome and depression and sertraline use who experienced the serious unlisted event of Sudden death, cause not reported, a day after the second dose of Spikevax vaccine. Re-challenge is not applicable for dose 2 and unknown for dose 1 as no information is reported. The history of sleep apnea syndrome and use of sertraline remain confounders as they could have affected the event and outcome. Benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Translated document received on 01-OCT-2021 includes dosage text (second Dose) and medical history, Reporter information updated; Sender''s Comments: This case concerns a 46 year old male with a history of Sleep apnea syndrome and depression and sertraline use who experienced the serious unlisted event of Sudden death, cause not reported, a day after the second dose of Spikevax vaccine. Re-challenge is not applicable for dose 2 and unknown for dose 1 as no information is reported. The history of sleep apnea syndrome and use of sertraline remain confounders as they could have affected the event and outcome. Benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1765993 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Chest pain, Condition aggravated, Echocardiogram, Electrocardiogram, Fatigue, Haematoma, International normalised ratio, International normalised ratio increased, Mobility decreased, Myocardial infarction, SARS-CoV-2 test, Troponin, Ultrasound abdomen
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Parkinson-like events (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-24
   Days after onset: 82
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: CABOZANTINIB S-MALATE; PREVISCAN [FLUINDIONE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Metastasis; Renal carcinoma (Renal carcinoma detected in Jul2015 (stage pT3c) and operated on 30Jul2015.); Stent placement; Surgery (Renal carcinoma detected in Jul2015 (stage pT3c) and operated on 30Jul2015.)
Allergies:
Diagnostic Lab Data: Test Date: 20210630; Test Name: coronarography; Result Unstructured Data: Test Result:subocclusive and repermeabilised lesion; Comments: subocclusive and repermeabilised lesion of the middle left anterior descending artery at the stent entry with good downstream quality and marked atheroma of the rest of the network with no significant lesion; Test Name: cardiac ultrasound; Result Unstructured Data: Test Result:hypokinesia; Comments: modest antero-apical hypokinesia, left ventricular ejection fraction preserved at more than 50% no pericardial detachment; Test Name: electrocardiography; Result Unstructured Data: Test Result:negative antero-septal T waves; Test Date: 20210630; Test Name: electrocardiography; Result Unstructured Data: Test Result:wide anterior T waves; Comments: wide anterior T waves with initial inferior mirror outline; Test Name: INR; Result Unstructured Data: Test Result:1.88; Test Date: 20210519; Test Name: INR; Result Unstructured Data: Test Result:2.26; Test Date: 20210608; Test Name: INR; Result Unstructured Data: Test Result:6.68; Test Date: 20210621; Test Name: INR; Result Unstructured Data: Test Result:1.56; Test Date: 20210708; Test Name: INR; Result Unstructured Data: Test Result:4.16; Test Date: 20210713; Test Name: INR; Result Unstructured Data: Test Result:6.19; Test Name: SARS-CoV-2 test; Test Result: Negative ; Test Date: 20210630; Test Name: Troponin; Result Unstructured Data: Test Result:1400 ng/L; Test Date: 20210610; Test Name: abdominal ultrasound; Result Unstructured Data: Test Result:no evidence of a deep haematoma
CDC Split Type: FRPFIZER INC202101262350

Write-up: Infarct myocardial; thoracic pain; International normalised ratio increased; Haematoma; Loss of mobility; Persistent fatigue; Resurgence of the pains linked to the disease (renal carcinoma); This is a spontaneous report from a contactable consumer downloaded from the regulatory authority number FR-AFSSAPS-LY202110890. A 74-year-old male patient received first dose of BNT162b2 (COMIRNATY), intramuscular on 02Jun2021 (Lot Number: FA8016) as single dose for COVID-19 immunisation. Medical history was reported as follow: renal carcinoma detected in Jul2015 (stage pT3c) and operated on 30Jul2015. Pulmonary and mediastinal metastatic evolution in Sep2016. Treatment with SUNITINIB from Sep2016 to Dec2019, stent placement on an unknown date. Concomitant medications included cabozantinib s-malate and fluindione (PREVISCAN, 20 mg, tablet), both taken for an unspecified indication, start and stop date were not reported. The clinical course was reported as follows: on 02Jun2021 vaccination with a first dose of the COMIRNATY. 24 hours after the vaccination (03Jun2021), onset of significant and persistent fatigue that caused loss of mobility and a resurgence of the pains linked to the disease (renal carcinoma), with onset of a giant haematoma on the torso. On 08Jun2021 increase in the international normalized ratio value to 6.68 (Normal value between 2 and 3). On 30Jun2021 in a context of a radiology treatment session for his disease, the patient presented with thoracic pain. Following the results of the electrocardiography and the coronarography, the patient was admitted to hospital (on 30Jun2021) for ongoing medical care for myocardial infarction. Rapid ongoing medical care: the left anterior descending artery was treated with a new active stent, with a good angiographic outcome, no recurrence of the thoracic pain. The patient underwent lab tests and procedures which included coronarography: subocclusive and repermeabilised lesion of the middle left anterior descending artery at the stent entry with good downstream quality and marked atheroma of the rest of the network with no significant lesion on 30Jun2021; cardiac ultrasound: modest antero-apical hypokinesia, left ventricular ejection fraction preserved at more than 50% no pericardial detachment on an unspecified date; electrocardiography: negative antero-septal t waves on an unspecified date and wide anterior T waves with initial inferior mirror outline on 30Jun2021 , international normalized ratio (INR, 2-3): 1.88 on an unspecified date, 2.26 on 19May2021, 6.68 on 08Jun2021, 1.56 on 21Jun2021, 4.16 on 08Jul2021 and 6.19 on 13Jul2021; SARS-CoV-2 test: negative on an unspecified date; troponin: 1400 ng/l on 30Jun2021; abdominal ultrasound: no evidence of a deep haematoma on 10Jun2021. Therapeutic measures were taken as a result of the events and included treatment with KARDEGIC, PLAVIX, PREVISCAN 20mg, BISOC 1.25mg, ATORVASTATINE 80mg, RAMIPRIL 2.5mg, PARACETAMOL, PANTOPRAZOLE 20mg, ACTISKENAN. The patient outcome of the events haematoma, thoracic pain and international normalized ratio increased was recovered, the outcome of loss of mobility was not recovered, the outcome of the other events was fatal. The patient died on 24Aug2021. 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: Infarct myocardial; fatigue; Resurgence of the pains linked to the disease (renal carcinoma)


VAERS ID: 1766050 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 3 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Computerised tomogram, Immunisation, Off label use, Oxygen saturation, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-16
   Days after onset: 99
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: FUMAFER; EPLERENONE; FUROSEMIDE; PREVISCAN [FLUINDIONE]; ABASAGLAR; DIFFU K; ALLOPURINOL; HUMALOG HD KWIKPEN; BISOPROLOL [BISOPROLOL FUMARATE]; PLAVIX; RAMIPRIL; XATRAL; ULTIBRO BREEZHALER [GLYCOPYRRONIUM BROMIDE;INDACATEROL MALEATE]; TAHOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: AFib; Appendectomy; Cardio-respiratory arrest (on acute thrombosis of the left common trunk with angioplasty); COPD; Dyslipidaemia; Hypertension arterial; Implantable defibrillator user; Ischaemic heart disease; Lung adenocarcinoma; Lung lobectomy; Non-insulin-dependent diabetes mellitus; Rheumatoid arthritis; Tabaquism; Triple vessel bypass graft
Allergies:
Diagnostic Lab Data: Test Date: 20210824; Test Name: CT scan; Result Unstructured Data: Test Result:sars-cov2 pneumonia; Comments: moderate impairment 10-25%; Test Date: 20210824; Test Name: desaturation; Result Unstructured Data: Test Result:85-90 %; Test Date: 20210824; Test Name: PCR COVID; Test Result: Positive ; Comments: Variant delta
CDC Split Type: FRPFIZER INC202101262833

Write-up: Vaccination failure; COVID-19 pneumonitis; 3 doses of covid vaccine (COMIRNATY); 3 doses of covid vaccine (COMIRNATY); This is a spontaneous report from a contactable other healthcare professional via Regulatory Authority, downloaded from the regulatory authority (FR-AFSSAPS-NY20214398). A 75-year-old male patient received bnt162b2 (COMIRNATY), dose 3 intramuscular on 09Jun2021 (Lot Number: FD0785) as single dose, dose 2 via an unspecified route of administration on 08Apr2021 (Lot Number: EW2239) as single dose and dose 1 via an unspecified route of administration on 11Mar2021 (Lot Number: EP9605) as single dose for COVID-19 immunisation; rituximab (TRUXIMA), intramuscular from 2006 (Batch/Lot Number: Unknown) to 17Jun2021, at 1000 mg, 6x/month for rheumatoid arthritis. Medical history included insulin-reducing type II diabetes, seropositive and erosive rheumatoid arthritis, arterial hypertension, dyslipidemia, AFiB, COPD, severe hypokinetic dilated heart disease of ischemic origin, triple bypass surgery, upper right lobectomy on non-metastatic pulmonary adenocarcinoma, appendectomy, cardiopulmonary arrest on acute thrombosis of the left common trunk with angioplasty, and fitting of a defibrillator. Smoking cessation. Concomitant medications included fluindione (PREVISCAN) 20 mg, scored tablet (fluindione, alginic (acid), wheat starch, potato starch, lactose monohydrate, stearic (acid), talc): oral, daily dose not reported (According INR; lot/batch not provided) from an unknown date for complete arrhythmia due to atrial fibrillation; clopidogrel (PLAVIX) 75 mg, film-coated tablet (clopidogrel (hydrogenosulfate), microcrystalline cellulose, carnauba wax, clopidogrel base, titanium dioxide, red iron (oxide), hydroxypropylcellulose l (low substituted), hypromellose, lactose, macrogol 6000, mannitol, castor oil ) hydrogenee, triacetin): oral, 75 milligram 1 time(s) per day from an unknown date for ischemic heart disease; potassium chloride (DIFFU K), capsule (potassium (chloride), c.i. pigment yellow 42, ethylcellulose, gelatin ((mammal / beef)), magnesium (stearate), sodium (laurilsulfate), titanium (dioxide)): oral, 6 dosage form 1 time(s) per day from an unknown date for hypokalemia; bisoprolol (acid fumarate) (bisoprolol (acid fumarate)): oral, 7.5 milligram 1 time (s) per day from an unknown date for high blood pressure; furosemide (furosemide): oral, 160 milligram 1 time(s) per day from an unknown date for arterial hypertension; ramipril (ramipril): oral, 10 milligram 1 time(s) per day from an unknown date for arterial hypertension; eplerenone (eplerenone): oral, 25 milligram 1 time(s) per day from an unknown date for arterial hypertension; ferrous fumarate (FUMAFER) 66 mg, film-coated tablet (ferrous fumarate, corn starch, sodium carboxymethyl starch, sodium docusate, iron, hypromellose, macrogol 6000, polyvidone k90, magnesium stearate):oral, 66 milligram 1 time(s) per day from an unknown date for mineral supplementation; pantoprazole (pantoprazole): oral, 20 milligram 1 time(s) per day from an unknown date for gastroesophageal reflux prophylaxis; atorvastatin calcium (TAHOR) 80 mg, film-coated tablet (atorvastatin calcium trihydrate, sorbic acid, atorvastatin, calcium carbonate, microcrystalline cellulose, croscarmellose sodium, titanium dioxide, purified water, emulsifier, hydroxypropylcellulose, hypromellose, lactose monohydrate, macrogol 8000, polysorbone, magnesium magnesium stearate 80, talc): oral, 80 milligram 1 time (s) per day from an unknown date for dyslipidemia; insulin glargine (ABASAGLAR) 100 units / ml solution for injection in pre-filled pen (insulin glargine ((bacteria / escherichia coli))): subcutaneous, 60 international unit 1 time (s) per day from an unknown date for non-insulin-dependent diabetes mellitus; insulin lispro (HUMALOG HD KWIKPEN) 100 iu / ml kwikpen solution for injection (insulin lispro): subcutaneous, 48 international unit 1 time (s) per day from an unknown date for non-insulin-dependent diabetes mellitus; glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER) 85 micrograms / 43 micrograms inhalation powder, hard capsule (glycopyrronium, indacaterol): oral, 1 dosage form 1 time (s) per day from an unknown date for Chronic obstructive pulmonary disease; alfuzosin hydrochloride (XATRAL) lp 10 mg, prolonged-release tablet (alfuzosin hydrochloride, microcrystalline cellulose, ethylcellulose, iron (oxide) yellow, hypromellose, mannitol, povidone, hydrogenated castor (oil), hydrated colloidal silica, magnesium stearate): oral, 10 milligram 1 time (s) per day from an unknown date for benign prostatic hyperplasia; allopurinol (allopurinol): oral, 100 milligram 1 time (s) per day from an unknown date for hyperuricemia. Ongoing treatment with fluindione (PREVISCAN) according to INR, clopidogrel (PLAVIX) 75 mg 0-1-0, potassium (DIFFU K) 2-2-2, bisoprolol 7.5 mg 1-0-0, furosemide 40 mg 2- 2-0, ramipril 5 mg 2-0-0, eplerenone 25 mg 0-1-0, iron (FUMAFER) 66 mg 1-1-1, pantoprazole 20 mg 0-0-1, atorvastatin (TAHOR) 80 mg 0 -0-1, insulin (ABASAGLAR) 60 IU / d, insulin (HUMALOG) 100 IU / mL 16-16-16, indacaterol / glycopyrronium (ULTIBRO BREEZHALER) 85 ug / 43 ug 1-0-0, alfuzosin (XATRAL LP ) 10 mg 1-0-0, allopurinol 100 mg once a day, rituximab every 6 months since 2006 (23 courses). The patient experienced vaccination failure (death, hospitalization, medically significant) on 19Aug2021, COVID-19 pneumonitis (death, hospitalization, medically significant) on 19Aug2021 and 3 doses of covid vaccine (off label use and booster) (non-serious) on 09Jun2021 with outcome of unknown. The patient died due to COVID-19 pneumonitis on 16Sep2021. An autopsy was not performed. The patient experienced the following events: 1.On 19Aug2021, 162 day after beginning Comirnaty, concentrate for injection. mr covid-19 vaccine (modified nucleoside) in an unspecified time after beginning Truxima 500 mg concentrate for solution for infusion: (MedDRA PT: Pneumonie covid-19). The event was assessed as Serious (Death). For this event, it was unknown if the patient received a corrective treatment. 2.On 19Aug2021, 162 day after beginning Comirnaty, concentrate for injection. mr covid-19 vaccine (modified nucleoside) in an unspecified time after beginning Truxima 500 mg concentrate for solution for infusion: (MedDRA PT: Vaccination failure). The event was assessed as Serious (Death). For this event, it was unknown if the patient received a corrective treatment. The relevant laboratory test(s) included: 1. on 24Aug2021, PCR COVID : positive (comment: Variant delta). 2. on 24Aug2021, CT scan: sars-cov2 pneumonia, moderate impairment 10-25%. The causality assessment was provided as follow: 1.Comirnaty, concentrate for injection. mRNA vaccine covid-19 (modified nucleoside) and Pneumonia covid-19: not provided- Source not provided: not provided (Method: not provided). 2. Comirnaty concentrate for injection. mRNA covid-19 vaccine (modified nucleoside) and Vaccination failure: not provided- Source not provided: not provided (Method: not provided). 3.Truxima 500 mg, concentrate for solution for infusion and Pneumopathy covid-19: not provided- Source not provided: not provided (Method: not provided). 4.Truxima 500 mg, concentrate for solution for infusion and Vaccination failure: not provided- Source not provided: not provided (Method: not provided). 17Aug2021: occurrence of diarrhea. 19Aug2021 : onset of dyspnea, cough and fever. 21Aug2021 : worsening of symptoms. AMOXICILLINE introduced, increase of furosemide to 80 mg 2 / day. 24Aug2021: 85-90% desaturation, patient taken to emergency room. Oxygen therapy at 2 L / min. On CT scan, SARS-CoV2 pneumonia, moderate impairment 10-25%. Positive covid test, delta variant. The patient is hospitalized. Inclusion in the French cohort COVID. Introduction of dexamethasone 6 mg. 25Aug2021: inclusion in the protocol COVITREM-1. Oxygen therapy with glasses between 2 and 3 L / min. 28Aug2021: desaturation, polypnea, agitation, requiring the establishment of oxygen therapy with a mask at high concentration FiO2 100%. Transfer to intensive care. 16Sep2021: patient death. The action taken with rituximab was unknown. Conclusion: 76-year-old man with a long history, immunocompromised, who presented with SARS-CoV2 pneumonia despite 3 doses of covid vaccine (COMIRNATY) and during treatment with rituximab (TRUXIMA). Respiratory degradation requiring resuscitation transfer. Evolution towards death. Reporter''s comment: 76-year-old man with a long history of immunosuppression who developed SARS-CoV2 pneumonia despite 3 doses of covid vaccine (COMIRNATY) and rituximab (TRUXIMA) treatment. Respiratory deterioration requiring transfer to intensive care. Evolution towards death.; Reporter''s Comments: 76-year-old man with a long history of immunosuppression who developed SARS-CoV2 pneumonia despite 3 doses of covid vaccine (COMIRNATY) and rituximab (TRUXIMA) treatment. Respiratory deterioration requiring transfer to intensive care. Evolution towards death.; Reported Cause(s) of Death: Pneumopathie COVID-19


VAERS ID: 1766210 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-10
Onset:2021-07-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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: 2021-07-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC202101294554

Write-up: Pulmonary embolus; This is a spontaneous report from a contactable physician received from the regulatory authority report number GB-MHRA-TPP22299854C1627689YC1632234200553, Safety Report Unique Identifier GB-MHRA-ADR 26010421. A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jul2021 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient medical history included: No significant past medical history. Fit and well 40 year old. Concomitant medications were not reported. On 10Jul2021 (as reported), the patient experienced pulmonary embolus with fatal outcome. The patient died on 10Jul2021 (as reported). It was not reported if an autopsy was performed. The clinical course was reported as follows: Patient died 3 days after having Pfizer vaccine. Massive Pulmonary Embolus. Reporter''s comments This Patient died 3 days after receiving the Pfizer vaccine. Cause of death: Pulmonary Embolism. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained; Reporter''s Comments: This Patient died 3 days after receiving the Pfizer vaccine. Cause of death: Pulmonary Embolism.; Reported Cause(s) of Death: Pulmonary Embolism


VAERS ID: 1766599 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-04
Onset:2021-09-21
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FE8206 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Fall, Neurological examination, Subarachnoid haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral arterial aneurysm; Hypertension; Surgery (a surgery was performed 2 times at a hospital)
Allergies:
Diagnostic Lab Data: Test Date: 20210904; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210921; Test Name: level of consciousness; Result Unstructured Data: Test Result:300
CDC Split Type: JPPFIZER INC202101297978

Write-up: Subarachnoid haemorrhage; fallen in the station; This is a spontaneous report from a contactable physician received from the regulatory authority. The regulatory authority report number is v21128450. A 50-year-old female patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FE8206, expiration date: 31Oct2021), via an unspecified route of administration on 04Sep2021 at 09:00 (at the age of 50-years-old - as reported) at dose 1, single for COVID-19 immunisation. Body temperature before vaccination on 04Sep2021 was 36.7 degrees Centigrade. The patient''s family history was unknown. Medical history included hypertension and cerebral arterial aneurysm for which a surgery was performed 2 times at a hospital. The patient''s concomitant medications were not reported. On 21Sep2021 at approximately 19:00 (reported as 17 days after the vaccination), the patient experienced subarachnoid haemorrhage. On 21Sep2021 (reported as 17 days after the vaccination), the patient was admitted to a hospital. The course of the event was as follows: On 21Sep2021, the patient had fallen in the station. The level of consciousness was 300. The patient was admitted to a hospital. Four and a half hours later, the patient died. On 21Sep2021 (reported as 17 days after the vaccination), the outcome of the event subarachnoid haemorrhage was fatal. The outcome of the other event was unknown. The patient died on 21Sep2021. The cause of death was subarachnoid haemorrhage. It was unknown if an autopsy was performed. The reporting physician classified the event subarachnoid haemorrhage 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: Subarachnoid haemorrhage


VAERS ID: 1766600 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC202101302429

Write-up: Death; This is a spontaneous report from a contactable physician received via a sales representative. A 75-year-old male patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection), On 09Jul2021 (the day of vaccination) at the age of 75-year-old (Lot number unknown, Expiration date unknown) via an unspecified route of administration as single dose for COVID-19 immunization. The family history and medical history were not provided. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (COMIRNATY), On unknown date in 2021 (Lot# unknown, Expiration date unknown) as single dose for covid-19 immunisation. On unknown date in 2021 (unknown days/hours/minutes after the vaccination), the patient experienced death. The course of the event was as follows: On 09Jul2021 (the day of vaccination), the patient received the second dose of BNT162b2 vaccination. On unknown date in 2021 (unknown days after the vaccination), several days later, the patient died. When the patient was found dead, it was assumed that one month had passed since the patient died. The causality between the event and BNT162b2 was not provided. The outcome of the event was fatal on unknown date in 2021 (unknown days after the vaccination). Information on the lot/batch number has been requested.; Sender''s Comments: The information currently provided is too limited to make a meaningful medical assessment. However, per company causality assessment guidance, the event of death with unknown cause is assessed as related until the cause of death is clarified. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1766605 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-24
Onset:2021-09-22
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004229 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiovascular disorder, Headache, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-24
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Suspected cardiovascular disease; Headache; Pyrexia; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP096983) on 28-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This case, initially reported to Takeda by a physician, was received via Moderna''s adverse reaction reporting site (TASK0021923), and reported to the regulatory authority by a physician, was received via the regulatory authority (Ref, v21128079). On 24-Aug-2021, the patient received the 1st dose of this vaccine. On an unknown date, body temperature before the vaccination: 36.3 degrees Celsius. On 21-Sep-2021, at 19:35, the patient received the 2nd dose of this vaccine. On 22-Sep-2021, pyrexia developed. On 23-Sep-2021, at 07:30, pyrexia of 37.8 degrees Celsius developed. Headache developed. At 21:00, pyrexia of 38.9 degrees Celsius developed. The patient reported that the face was red, and pyrexia relapsed. On 24-Sep-2021, at 07:30, the family member contacted the patient, but there was no reply. The estimated time of death was around 11:00. At 15:40, the patient was found in a decubitus position at home. Police confirmed that there was no pulse. An ambulance was called. At 15:55, the ambulance arrived. The patient was not transported after checking the status. At night, dead body was sent to a hospital for examination. Cardiovascular disease was suspected from troponin T positive, etc. The outcome of pyrexia, headache, and suspected cardiovascular disease was reported as fatal. Follow-up investigation will be made. Company Comment: The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) and there is temporal relationship.; Sender''s Comments: This case concerns a 33-year-old, male patient with no relevant medical history, who experienced the unexpected event of Cardiovascular disorder and expected events of Pyrexia and Headache. The events occurred respectively 3 days, 1 day and 2 days after the second dose of Spikevax and had a fatal outcome. The rechallenge was not applicable, as the events had a fatal outcome. The events were considered related to the product per the reporter''s assessment. The events of Pyrexia and Headache are consistent with the current understanding of the mechanism of action of the study medication. The benefit-risk relationship of Moderna Covid is not affected by this report.; Reported Cause(s) of Death: Pyrexia; Headache; Disorder circulatory system


VAERS ID: 1766607 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002181 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Acute myocardial infarction, Depressed level of consciousness
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), 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: 2021-06-08
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPMODERNATX, INC.MOD20213

Write-up: Depressed level of consciousness; Acute myocardial infarction; This case was received via regulatory authority (Reference number: JP-TAKEDA-2021TJP098050) on 28-Sep-2021 and was forwarded to Moderna on 30-Sep-2021. This case, initially reported to the regulatory authority by a physician, was received via the agency (Ref, v21128058). Since late May-2021, the patient had been feeling unwell. On 08-Jun-2021, at 17:45, the patient received the 1st dose of this vaccine. Around 21:00, the patient went home, and the respirator alarm went off. Around 21:40, the patient had a depressed level of consciousness and called for ambulance. At 22:58, the patient was pronounced dead at the hospital where the patient was transported. The results of the pathological autopsy showed mixed old and new myocardial infarction foci, and the cause of death was diagnosed as acute myocardial infarction. The causal relationship with this vaccine is not clear. The outcome of depressed level of consciousness and acute myocardial infarction was reported as fatal. Follow-up investigation will be made. Company Comment: The events "depressed level of consciousness" that developed after the administration of the COVID-19 vaccine mRNA (mRNA 1273) may also be affected by a complication disease, etc. Although the event "acute myocardial infarction" developed after the administration of the COVID-19 vaccine mRNA (mRNA 1273), factors such as concurrent conditions may have also had an influence.; Reporter''s Comments: The events "depressed level of consciousness" that developed after the administration of the COVID-19 vaccine mRNA (mRNA 1273) may also be affected by a complication disease, etc. Although the event "acute myocardial infarction" developed after the administration of the COVID-19 vaccine mRNA (mRNA 1273), factors such as concurrent conditions may have also had an influence.; Sender''s Comments: This case concerns an 82-year-old male who presented Malaise from 1 month prior to the administration of the product, Myasthenia gravis and antiphospholipid antibody syndrome. Report of "respirator alarm went off" may suggests other underlying conditions not described in this report. The patient experienced the unexpected fatal events of Depressed level of consciousness and Acute myocardial infarction. The events occurred the same day of the administration of COVID 19 Vaccine Moderna and had a fatal outcome the same day. The cause of death was reported as Depressed level of consciousness and Acute myocardial infarction. The autopsy result is described in narrative as follows: "mixed old and new myocardial infarction foci". The rechallenge is not applicable, as the events happened immediately after the first dose. Myasthenia gravis, Antiphospholipid syndrome are confounders/co-suspects for the events. Although sender�s causality assessment for the events is possible, it clearly states the presence of confounding mentioned factors. The benefit risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: Depressed level of consciousness; Acute myocardial infarction


VAERS ID: 1766620 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-17
Onset:2021-09-27
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-27
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRMODERNATX, INC.MOD20213

Write-up: seizure; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizure) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Sep-2021 at 6:34 AM, the patient experienced SEIZURE (seizure) (seriousness criteria death and medically significant). The patient died on 27-Sep-2021. The reported cause of death was Seizure. It is unknown if an autopsy was performed. Treatment information not provided. The patient in his 20s after having seizure at around 5:40 am 27-Sep-2021, the patient was transferred to the hospital emergency room but eventually died at around 6:34 AM the same day. Concomitant medications were not provided. Company Comment: This case concerns a male patient in his 20''s age with no relevant medical history, who experienced the unexpected event of Seizure . The event occurred approximately 10 days after the first dose of Spikevax and had a fatal outcome on the same day. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender''s Comments: This case concerns a male patient in his 20''s age with no relevant medical history, who experienced the unexpected event of Seizure . The event occurred approximately 10 days after the first dose of Spikevax and had a fatal outcome on the same day. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Seizure


VAERS ID: 1766784 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-09-02
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Discomfort, Fall, Fatigue, Myocarditis
SMQs:, Accidents and injuries (narrow), Cardiomyopathy (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: 2021-09-16
   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: TWPFIZER INC202101289374

Write-up: Uncomfortable; General tiredness; Fall on stairs; the patient might experience myocarditis after vaccination and cause the death; This is a spontaneous report from a non-contactable physician via Pfizer medical colleague. An adult male patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Sep2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that: the patient felt uncomfortable, general tiredness, and had been fall on stairs. The patient was expired on sofa at the morning of 16Sep2021. The reporter suspected all those events might related to the BNT162b2 Vaccine. He guessed the patient might experience myocarditis after vaccination and cause the death. The patient outcome of myocarditis was fatal and unknown for the other events. An autopsy was not performed. The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender''s Comments: Based on the information available and a close temporal association a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event Myocarditis. 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: Myocarditis


VAERS ID: 1767633 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-08-11
   Days after vaccination:132
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3001531 / 1 - / OT

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

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-13
   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: Cardiac hypertrophy (Left ventricular hypertrophy)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATMODERNATX, INC.MOD20213

Write-up: This case was received via regulatory authority (Reference number: AT-BASGAGES-2021-048936) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SUBARACHNOID HAEMORRHAGE in a 72-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 3002188 and 3001531) for COVID-19 vaccination. Concurrent medical conditions included Cardiac hypertrophy (Left ventricular hypertrophy). On 01-Apr-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 11-Aug-2021 at 12:30 PM, after starting mRNA-1273 (Spikevax), the patient experienced SUBARACHNOID HAEMORRHAGE (seriousness criteria death, hospitalization, medically significant and life threatening). The patient died on 13-Aug-2021. The reported cause of death was Subarachnoid haemorrhage. An autopsy was performed, but no results were provided. Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter. Patient was death by Sudden massive cerebral hemorrhage there was no signs of thrombosis or aneurysm. Patient passes away on 13-AUG-2021 at 11:10. This case concerns a 72-year-old, female patient with a medical history of Left ventricular hypertrophy, who experienced the unexpected event of SUBARACHNOID HAEMORRHAGE. The event occurred approximately 3 months after the second dose of Spikevax and had a fatal outcome, with death occurring two days later. The rechallenge was not applicable as no additional dose is going to be administered. The medical history of Left ventricular hypertrophy could be a confounder. The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translated document received on 1-OCT-2021 that contains updated batch/ lot number of 1st dose of suspect product. Current condition comment and narrative updated.; Sender''s Comments: This case concerns a 72-year-old, female patient with a medical history of Left ventricular hypertrophy, who experienced the unexpected event of SUBARACHNOID HAEMORRHAGE. The event occurred approximately 3 months after the second dose of Spikevax and had a fatal outcome, with death occurring two days later. The rechallenge was not applicable as no additional dose is going to be administered. The medical history of Left ventricular hypertrophy could be a confounder. The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Subarachnoid haemorrhage


VAERS ID: 1767694 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-27
Onset:2021-08-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004224 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein, Cardiac arrest, Computerised tomogram head, Death, Echocardiogram
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: 2021-08-28
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: DUPHALAC [LACTULOSE]; ZOPICLONE ACTAVIS; DIVISUN; AERIUS [DESLORATADINE]; DERMOVAT [CLOBETASOL PROPIONATE]; NOVORAPID; EURAX; OXYNORM; KALIUMKLORID ORIFARM; VENTOLINE [SALBUTAMOL]; LEVAXIN; FLUANXOL [FLUPENTIXOL DIHYDROCHLORIDE]; FOLSYRE OR
Current Illness: Aortic stenosis (Moderate-high degree.); Constipation; COPD; Dyspnoea; Hyperlipidaemia; Hypothyreosis; Smoker; Type 2 diabetes mellitus
Preexisting Conditions: Medical History/Concurrent Conditions: B-cell lymphoma ((2012)Treated with cytostatic therapy, no recurrent disease.); Bruise of head (Back of head, due to fall from chair.); Cardiac failure (Ejection fraction 30% on echocardiogram in Aug/2020.); Colon cancer ((1997) Surgically cured.); Fall (From chair); Fall; Fracture of humerus; Frailty; Infection (No certain infection focus.); Living in care (Short-term stay, due to increased need for care.); Multimorbidity; Non STEMI; Overweight; Pain; Schizoaffective disorder (Severe, mixed manic-depressive type.)
Allergies:
Diagnostic Lab Data: Test Date: 20210826; Test Name: Computerised tomogram head; Result Unstructured Data: Check-up after fall from chair. No pathologic findings.; Test Name: C-reactive protein; Result Unstructured Data: increased; Test Date: 20210712; Test Name: Echocardiogram; Result Unstructured Data: Dilated left ventricle with pronounced systolic (EF approx 20%) failure and pronounce diastolic failure.
CDC Split Type: NOMODERNATX, INC.MOD20213

Write-up: Cardiac arrest; This case was received via regulatory authority (Reference number: 00048373) on 24-Sep-2021 and was forwarded to Moderna on 24-Sep-2021. This regulatory authority case was reported by a physician and describes the occurrence of CARDIAC ARREST (Cardiac arrest) and DEATH in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 3004224) for Vaccination. The patient''s past medical history included Fall (From chair) on 26-Aug-2021, Fracture of humerus on 13-Apr-2021, Fall on 13-Apr-2021, B-cell lymphoma ((2012)Treated with cytostatic therapy, no recurrent disease.), Overweight, Infection (No certain infection focus.) from 09-Jul-2021 to 26-Jul-2021, Cardiac failure (Ejection fraction 30% on echocardiogram in Aug/2020.), Colon cancer ((1997) Surgically cured.), Pain, Frailty, Living in care (Short-term stay, due to increased need for care.) on 26-Jul-2021, Schizoaffective disorder (Severe, mixed manic-depressive type.), Non STEMI in August 2020, Multimorbidity and Bruise of head (Back of head, due to fall from chair.) on 26-Aug-2021. Concurrent medical conditions included Hypothyreosis, Hyperlipidaemia, Type 2 diabetes mellitus, Smoker, Aortic stenosis (Moderate-high degree.), COPD, Constipation and Dyspnoea. Concomitant products included LACTULOSE (DUPHALAC [LACTULOSE]) for Constipation, SALBUTAMOL (VENTOLINE [SALBUTAMOL]) and IPRATROPIUM BROMIDE (ATROVENT) for Dyspnoea, ZOPICLONE (ZOPICLONE ACTAVIS), COLECALCIFEROL (DIVISUN), DESLORATADINE (AERIUS [DESLORATADINE]), CLOBETASOL PROPIONATE (DERMOVAT [CLOBETASOL PROPIONATE]), INSULIN ASPART (NOVORAPID), CROTAMITON (EURAX), OXYCODONE HYDROCHLORIDE (OXYNORM), POTASSIUM CHLORIDE (KALIUMKLORID ORIFARM), LEVOTHYROXINE SODIUM (LEVAXIN), FLUPENTIXOL DIHYDROCHLORIDE (FLUANXOL [FLUPENTIXOL DIHYDROCHLORIDE]), FOLIC ACID (FOLSYRE ORIFARM), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOL ACTAVIS), OXAZEPAM (SOBRIL), BETAMETHASONE VALERATE, CLIOQUINOL (BETNOVAT MED CHINOFORM), PARACETAMOL (PARACET [PARACETAMOL]), EMPAGLIFLOZIN (JARDIANCE), BUMETANIDE (BURINEX) and METOCLOPRAMIDE HYDROCHLORIDE (AFIPRAN) for an unknown indication. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criterion death) and DEATH (seriousness criteria death and medically significant). The patient died on 28-Aug-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jul-2021, Echocardiogram: abnormal (abnormal) Dilated left ventricle with pronounced systolic (EF approx 20%) failure and pronounce diastolic failure.. On 26-Aug-2021, Computerised tomogram head: normal (normal) Check-up after fall from chair. No pathologic findings.. On an unknown date, C-reactive protein: increased (High) increased. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered CARDIAC ARREST (Cardiac arrest) and DEATH to be unlikely related. No treatment medication was reported. The patient had multimorbidity, and cardiac arrest due to cardiovascular disease was considered the cause of death. The reporter stated that there was absolutely no suspected connection with vaccination, but is issuing a report due to the short interval between vaccination and death. Company comment -This case concerns a 63 year old female with medical history of pronounced cardiac failure, COPD, frailty, aortic stenosis, diabetes, hyperlipidemia and a myriad of other co-morbidities who experienced the serious event of Cardiac arrest resulting in Death two days after the first dose of Spikevax. Re-challenge is not applicable as this was dose 1. Reported causality is Not related. The list of serious cardiac and respiratory conditions and other serious comorbidities are confounders as all could contribute to death by cardiac arrest. he benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Translation document received on 30 Sep 2021. Updated narrative with event details. Added concomitant details missed to capture initially.; Sender''s Comments: This case concerns a 63 year old female with medical history of pronounced cardiac failure, COPD, frailty, aortic stenosis, diabetes, hyperlipidemia and a myriad of other co-morbidities who experienced the serious event of Cardiac arrest resulting in Death two days after the first dose of Spikevax. Re-challenge is not applicable as this was dose 1. Reported causality is Not related. The list of serious cardiac and respiratory conditions and other serious comorbidities are confounders as all could contribute to death by cardiac arrest. he benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Cardiac arrest


VAERS ID: 1767788 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-04-27
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Sars-CoV-2 PCR test; Test Result: Positive; Comments: Variant PCR-based: B.1.1.7 Variant sequenced : N/A n501y-positive: yes
CDC Split Type: ATPFIZER INC202101272111

Write-up: Vaccination failure; SARS-CoV-2 infection; This is a spontaneous report from a contactable physician from the Regulatory Authority. The regulatory authority number AT-BASGAGES-2021-044533. A 95-years-old female patient received second dose of bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: EK9788)) via intramuscular on 04Feb2021 as single dose, the patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, (Batch/Lot Number: EJ6797)) via an unspecified route of administration on 14Jan2021 as, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 27Apr2021, The patient experienced vaccination failure, sars-cov-2 infection. The patient underwent lab tests and procedures which included sars-cov-2 test was positive on Variant PCR-based B.1.1.7 Variant sequenced n501y. The patient died on unknown date. It was not reported if an autopsy was performed. The outcome of the event was fatal. No follow-up attempts possible. No further information expected. Reported Cause(s) of Death: unknown cause of death.


VAERS ID: 1767866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-03-16
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET1831 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-16
   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: ATPFIZER INC202101272235

Write-up: Died in the sauna that night; towards the evening of 16Mar2021: shivering; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the regulatory authority number AT-BASGAGES-2021-049054. A 81-years-old male patient received bnt162b2 (COMIRNATY, formulation: solution for injection, lot number: ET1831, expiry date: not reported), via an unspecified route of administration on 12Mar2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient lived in his own household without support, was mentally and physically fit (= healthy) and did physical work on the ladder / scaffolding on his house construction site until the last day. On 16 Mar2021, the patient died in the sauna that night, towards the evening of 16mar2021: shivering. The patient died on 16Mar2021. It was not reported if an autopsy was performed. Clinical outcome of the events was reported as fatal for death and unknown for chills. Relatedness of drug to reaction(s)/event(s): Death: Source of assessment: Primary Source Reporter /Result of Assessment: Conditional/ Unclassified Chills: Source of assessment: Primary Source Reporter /Result of Assessment: Conditional/ Unclassified No follow-up attempts are possible. No further information is expected.


VAERS ID: 1767867 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-02-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6790 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Cerebral haemorrhage, Cerebrovascular accident, Death, Headache, Movement disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-24
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202101272344

Write-up: could no longer stand up; Strokes right Hemisphere; Cerebral haemorrhage; could no longer speak; Death; massive Headache; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number AT-BASGAGES-2021-19795. An 80-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 18Feb2021 (Batch/Lot Number: EJ6790), at the age of 80 years old, as dose 2, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received COMIRNATY on 28Jan2021 (lot no: EJ-6134) as dose 1, single for COVID-19 immunization. The patient experienced massive headache on 18Feb2021; could no longer stand up, strokes right hemisphere, cerebral haemorrhage, could no longer speak all on 19Feb2021; and death on 24Feb2021. Clinical course was reported as follows. After the 2nd vaccination on 18Feb2021, the patient complained of massive headaches in the evening and was found his spouse the following night, sitting in the dining room. Since he could no longer get up and speak, he was flown to the hospital by ambulance helicopter, where he died on 24Feb2021. On 19Feb2021, he experienced cerebral haemorrhage and strokes in right half of the brain, operating theater, intensive care unit. It was not reported if an autopsy was performed. The patient had not recovered from headache, could no longer stand up, strokes right hemisphere, cerebral haemorrhage, and could no longer speak, while outcome of death was fatal. Sender Comment: BASGAGES-comment: Follow-up information has been requested. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1767923 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-08-12
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, COVID-19, Computerised tomogram, Gait disturbance, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; GLIBENCLAMIDE; RANITIDINE
Current Illness: Diabetes
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210812; Test Name: COVID-19 virus test positive; Result Unstructured Data: positive; Test Date: 20210813; Test Name: Computerised tomography; Result Unstructured Data: 80% of the lungs affected
CDC Split Type: BRJNJFOC20211003593

Write-up: SUSPECTED COVID 19; SUSPECTED CLINICAL VACCINATION FAILURE; PAIN IN THE BONES; DIFFICULTY TO WALK; This spontaneous report received from a consumer concerned a 54-year-old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included: diabetes. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported. Batch number: unknown, expiry: unknown) frequency One total, dose was not reported, administered on 06-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included glibenclamide for diabetes. Metformin for diabetes, and ranitidine for diabetes. On 12-Aug-2021, the patient was tested positive for Covid-19 with 80% of the lungs affected, which was confirmed as suspected Covid 19 and suspected clinical vaccination failure. On the same date patient experienced pain in the bones and difficulty to walk, patient had the symptoms difficulty to breath . The patient was hospitalized on the same date. The number of days hospitalization and discharge information was not reported. Laboratory data included: COVID-19 virus test positive (NR: not provided) positive. On 13-AUG-2021, Laboratory data included: Computerized tomography (NR: not provided) 80% of the lungs affected. On an unspecified date the patient died from suspected covid-19. It was unspecified if an autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from suspected Covid 19 on an unspecified date, had not recovered from pain in the bones, and difficulty to walk, and the outcome of suspected clinical vaccination failure was not reported.. This report was serious (Death, and Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211003768. The report is associated with product quality complaints.; Sender''s Comments: V0: 20211003593-covid-19 vaccine ad26.cov2.s - suspected covid 19, pain in the bones, and difficulty to walk. 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). 20211003593-Covid-19 vaccine ad26.cov2. s- suspected clinical vaccination failure. 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: SPECIAL SITUATIONS; Reported Cause(s) of Death: SUSPECTED COVID-19


VAERS ID: 1767929 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-12
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD7209 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Cerebrovascular accident, Dizziness, Haemorrhagic stroke, Headache, Nausea, Pain in extremity, Retching
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-28
   Days after onset: 27
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC202101294858

Write-up: my wife left home and suffered her first stroke; another stroke was diagnosed, hemorrhagic; headache; nausea; retching; leg pain; dizziness; large abdominal swelling; This is a spontaneous report from a contactable consumer (patient''s husband). A female patient of an unspecified age received bnt162b2 (COMIRNATY), via an unspecified route of administration on 12Aug2021 (Batch/Lot Number: FD7209; Expiration Date: 05Dec2021) as dose 1, single for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter notified the death of his wife (patient), which happened after taking the vaccine. On 12Aug2021, the patient was vaccinated, as shown in the vaccination card with lot. After the sting, she was unwell for 6 consecutive days with symptoms of headache on the day she was vaccinated and then, on the following days in Aug2021, nausea, retching, large abdominal swelling, leg pain and dizziness. On 18Aug2021, after 6 days of reactions, the patient left home and suffered her first stroke, which was diagnosed in the first hospital and she was sent to another city in a reference hospital for stroke. In the second hospital, another stroke was diagnosed, hemorrhagic in Aug2021, and she needed a brain surgery urgently. The patient was transferred to the third hospital, she underwent the surgery and stayed for 9 days in the Intensive Care and died on 28Aug2021. Cause of death was reported as "stroke was diagnosed, hemorrhagic". It was unknown if an autopsy was performed. Outcome of other events was unknown.; Reported Cause(s) of Death: another stroke was diagnosed, hemorrhagic


VAERS ID: 1767939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-09-01
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-01
   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: CAPFIZER INC202101275355

Write-up: past away; sick; This is a spontaneous report from a contactable consumer (patient''s wife friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for covid-19 immunsation. The patient''s medical history and concomitant medications were not reported. The reporter complained that how there was no informing "a lot of people died from the Pfizer Covid Vaccine. They were not getting the materials safety data sheet. It''s a lie. A lot of people have died. They died, millions of them died from the Covid vaccine. It will cause infertility, cancer and ultimately death. It''s not saving lives, it''s making people sick. In line with this, the reporter''s friend just called and told the reporter that the friend''s husband past away 2 weeks ago (Sep2021). The patient got sick from his 2nd dose of Pfizer COVID-19 Vaccine, and he died. The patient got the vaccine 2 or 3 months ago. The patient died in Sep2021. Cause of death was unknown. The outcome of sick was unknown; outcome of past away 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: past away 2 weeks ago


VAERS ID: 1769109 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-07-15
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Ascites, Condition aggravated, Hepatic neoplasm
SMQs:, Liver related investigations, signs and symptoms (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Acute pancreatitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Liver tumours of unspecified malignancy (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Non-haematological tumours of unspecified malignancy (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: Liver tumour
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101291836

Write-up: liver tumour; Condition worsened; Ascites; This is a spontaneous report from a non-contactable physician downloaded from the regulatory authority case identification number: DE-DCGMA-21192052, Safety Report Unique Identifier DE-PEI-202100192193. An 81-year-old male patient received bnt162b2 (COMIRNATY), first dose, via an unspecified route of administration on 05May2021 at the age of 81 years old, as single dose for covid-19 immunisation. Medical history included previously inconspicuous liver tumour. There were no concomitant medications. The patient experienced liver tumour on 15Jul2021, condition worsened on 15Jul2021, ascites on 15Jul2021. The patient died on an unspecified date. It was not reported if an autopsy was performed. This report is serious - death, life threatening. Source of assessment: PEI. Result of Assessment was unclassifiable. Reporter''s comments: ADR: Comirnaty first vaccination, followed by development of fulminant course of a previously inconspicuous liver tumour with ascites, rapid physical deterioration until death. No follow-up attempts are possible. No further information is expected. Information on batch/lot number cannot be obtained.; Reporter''s Comments: ADR: Comirnaty first vaccination, followed by development of fulminant course of a previously inconspicuous liver tumour with ascites, rapid physical deterioration until death.; Reported Cause(s) of Death: Ascites; Condition aggravated; Hepatic neoplasm


VAERS ID: 1769140 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-05
Onset:2021-08-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1F036A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Aortic aneurysm rupture, Deep vein thrombosis, Dizziness
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? Yes
   Date died: 2021-08-07
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272431

Write-up: Abdominal aneurysm, ruptured; Abdominal cramps; Light headedness; Deep vein thrombosis leg; This is a spontaneous report from a non-contactable physician, downloaded from the Regulatory Authority-WEB number DE-PEI-202100195815. A 66-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration on 05Aug2021 (Batch/Lot Number: 1F036A) dose number unknown, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. On 06Aug2021, the patient experienced abdominal aneurysm, ruptured, abdominal cramps, light headedness, and deep vein thrombosis leg. The events were reported as life-threatening and required hospitalization. The patient''s outcome was fatal for light headedness, abdominal cramps, abdominal aneurysm, ruptured, and deep vein thrombosis leg. The patient died on 07Aug2021. It was not reported if an autopsy was performed. Event assessment: Comirnaty/all events/PEI/Result of Assessment: D. Unclassifiable. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Abdominal aneurysm, ruptured; Abdominal cramps; Light headedness; Deep vein thrombosis leg


VAERS ID: 1769141 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-23
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1440 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pulmonary embolism, Tumour marker increased, Tumour marker test
SMQs:, Embolic and thrombotic events, venous (narrow), Tumour markers (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-31
   Days after onset: 39
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: Asthma bronchial; Cardiac failure; Diabetes mellitus; Gallbladder adenocarcinoma; Goiter nodular; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210723; Test Name: tumor marker; Result Unstructured Data: Test Result:increased
CDC Split Type: DEPFIZER INC202101272436

Write-up: Tumor marker increased; Lung embolism; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number is DE-PEI-202100195826. A 74-year-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: FC1440) (also reported as mRNA TOZINAMERAN), via an unspecified route of administration on 08Jul2021 (at the age of 74 years old) as dose number unknown, 0.3 mL single for COVID-19 immunisation. Medical history included goiter nodular, diabetes mellitus, hypertension, asthma bronchial, cardiac failure, and gallbladder adenocarcinoma. The patient''s concomitant medications were not reported. On 23Jul2021, the patient experienced tumor marker increased. On an unspecified date in 2021, the patient also experienced lung embolism. The patient died on 31Aug2021. It was unknown if an autopsy was performed. The patient died due to tumor marker increased and lung embolism. The reporter assessed the relatedness of the drug to the events as unclassifiable (D) via PEI. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Tumor marker increased; Lung embolism


VAERS ID: 1769145 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1436 / 3 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Pyrexia, Somnolence
SMQs:, 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: 2021-09-20
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272567

Write-up: Unknown cause of death; Sleepiness; Pyrexia; This is a spontaneous report from a non-contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority report number DE-PEI-202100195916. An 89-year-old female patient received bnt162b2 (COMIRNATY; strength 0.3 ml), via an unspecified route of administration on 15Sep2021 (Lot Number: FC1436, unknown expiration) as dose 3 (booster), 0.3 ml single at the age of 89 years old for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received first dose of COMIRNATY on 18Feb2021 and second dose of COMIRNATY on 11Mar2021, both as 0.3 ml at the age of 88 years old for COVID-19 vaccination. On 15Sep2021, the patient experienced pyrexia and sleepiness. On 20Sep2021, the patient experienced unknown cause of death (as reported). However, stop date of sleepiness and pyrexia provided as 20Sep2021 with fatal outcome. Outcome of the events was fatal. The events were assessed as serious (death). It was unknown if autopsy was performed. The relatedness of COMIRNATY to events are assessed by PEI as "D. Unclassifiable". No follow-up attempts are possible; information about batch number was already obtained.; Reported Cause(s) of Death: Unknown cause of death; Pyrexia; Sleepiness


VAERS ID: 1769166 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-07
Onset:2021-03-01
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2659 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute respiratory failure, Pneumonia, Renal failure
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Anaphylactic reaction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Eosinophilic pneumonia (broad), Chronic kidney disease (narrow), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-25
   Days after onset: 23
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101276420

Write-up: Pneumonia; Acute respiratory failure; kidney failure; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB [DE-PEI-CADR2021058358], Sender''s (Case) Safety Report Unique Identifier is DE-PEI-202100049877. A 90-year-old male patient received the second dose of BNT162B2 (COMIRNATY, Strength: 0.3 ml, Batch/Lot Number: ER2659) at single dose on 07Mar2021 for covid-19 immunisation. Medical history included dementia. Concomitant medications were not reported. The patient experienced pneumonia on 11Mar2021 (as reported), acute respiratory failure on 08Mar2021, kidney failure in Mar2021. The patient died on 25Mar2021. It was not reported if an autopsy was performed. The outcome of events was fatal. Sender''s comments: Information on risk factors or underlying conditions. Dementia/Acute respiratory insufficiency and pneumonia starting 1 day post vaccination. Patient died on 25Mar2021, cause of death kidney failure related to pre-existing disease Event stop date for pneumonia: 18Mar2021 (as reported) The PEI assessment for Acute respiratory failure and Pneumonia with the suspect product Comirnaty is D. ; Reported Cause(s) of Death: kidney failure related to pre-existing disease; Acute respiratory failure; Pneumonia


VAERS ID: 1769178 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-09
Onset:2021-08-01
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3004500 / 1 - / OT

Administered by: Unknown       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: 2021-08-20
   Days after onset: 19
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: Obesity
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20213

Write-up: Herzinfarkt; This case was received via regulatory authority (Reference number: 202100190807) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Herzinfarkt) in a 45-year-old male patient who received mRNA-1273 (Spikevax) (batch nos. 3004500 and UNK) for Prophylactic vaccination. Concurrent medical conditions included Obesity. On 09-Aug-2021, the patient received third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced MYOCARDIAL INFARCTION (Herzinfarkt) (seriousness criteria death and medically significant). The patient died on 20-Aug-2021. The reported cause of death was Infarct myocardial. It is unknown if an autopsy was performed. No concomitant medications were provided. The patient experienced heart attack. There were no known pre-existing conditions but a risk factor was perhaps obesity. The patient exercised on day 11 after the second vaccination. This case concerns a 45 year-old male with the concurrent medical condition of obesity, who experienced the unexpected event of Myocardial infraction(medically significant, death). This event occurred approximately the same month as the third dose of Spikevax, with the patient dying on 20-Aug-2021. The reported cause of death was Infarct myocardial. The concurrent medical condition of obesity remains a cofounder.The benefit-risk relationship of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Translation document was received on 02-Oct-2021, contains no new information. On 04-Oct-2021: Follow-up received on 4-Oct-2021. patient death date updated.; Reporter''s Comments: This case concerns a 45 year-old male with the concurrent medical condition of obesity, who experienced the unexpected event of Myocardial infraction(medically significant, death). This event occurred approximately the same month as the third dose of Spikevax, with the patient dying on 20-Aug-2021. The reported cause of death was Infarct myocardial. The concurrent medical condition of obesity remains a cofounder.The benefit-risk relationship of Spikevax is not affected by this report.; Reported Cause(s) of Death: Infarct myocardial


VAERS ID: 1769182 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 1D014A / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Apathy, Death, Diarrhoea, Disorientation, Fatigue, Hypersomnia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-06
   Days after onset: 69
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: Arthrosis; Hepatic cirrhosis
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to insect sting (Wasp sting); Jaundice
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272630

Write-up: Diarrhea, vomiting; Diarrhea, vomiting; vomiting; Diarrhea; Diarrhea, vomiting; she slept more and more during the day; apathetic; This is a spontaneous report from a non-contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021181065. Safety Report Unique Identifier DE-PEI-202100193166. A 77-year-old female patient received bnt162b2 (COMIRNATY), via an unspecified route of administration on 26May2021 (Batch/Lot Number: 1D014A) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hepatic cirrhosis from 2013 and ongoing , ongoing arthrosis, allergy to wasp sting from an unknown date and unknown if ongoing and jaundice from 1968 to an unknown date. The patient''s concomitant medications were not reported. On 29May2021 the patient experienced fatigue, vomiting, diarrhea, disorientated, slept more and more during the day and apathetic. On 06Aug2021 the patient experienced unknown cause of death. The events have caused hospitalization. The outcome of the events fatigue, vomiting, diarrhea and disorientated was not recovered, unknown for the rest of the events. The patient died on 06Aug2021. An autopsy was not performed. Sender Comment: Do you or the person concerned have any known allergies? If yes, which ones? Wasp sting Details of risk factors or previous illnesses Liver cirrhosis, first diagnosed in 2013. Osteoporosis Jaundice 1968 infectious hepatitis / A few days after the second vaccination the first symptoms appeared, such as diarrhoea and vomiting as well as extreme fatigue. From week to week her health deteriorated visibly and she slept more and more during the day. At times she appeared disoriented and apathetic. On 26 July, she was taken to hospital because she was acutely apathetic and no longer responded. At first, she was still responsive and went to the toilet on her own. After four days, she was already no longer able to articulate or sit or turn on her own. She died on 06Aug2021. Batch/ lot number: 1D014A. Relatedness of drug to reaction(s)/event(s) for all events : D. Unclassifiable No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1769184 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-09-07
Onset:2021-09-12
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-09-12
   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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202101272495

Write-up: died 5 days after vaccination; This is a spontaneous report from a non-contactable consumer downloaded from the regulatory authority-WEB DE-PEI-CADR2021181933 with Safety Report Unique Identifier DE-PEI-202100194656. An 88-year-old female patient received BNT162B2 (COMIRNATY, 0.3mL solution for injection; Batch/Lot number and Expiration Date: not reported), via an unspecified route of administration on 07Sep2021 as dose number unknown, 0.3mL single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 12Sep2021, 5 days after vaccination, the patient was reported to have died. It was not reported if an autopsy was performed. The event was considered serious as death was reported. The causality assessment for the by regulatory authority was D. Unclassifiable. The patient''s outcome was fatal for unknown cause of death. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died 5 days after vaccination


VAERS ID: 1769185 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-02-19
Onset:2021-05-11
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-10-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Muscle spasms, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Dystonia (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-08-16
   Days after onset: 97
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 INC202101272643

Write-up: Unknown cause of death; Face, cramps; Myalgia; This is a spontaneous report from a non-contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number DE-PEI-CADR2021181994, Safety Report Unique Identifier DE-PEI-202100194549. A 92-year-old patient of an unspecified gender received BNT162B2 (COMIRNATY, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 19Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient''s relevant medical history and concomitant medications were not reported. The patient experienced "face, cramps" and myalgia both on 11May2021 and unknown cause of death on 16Aug2021. The events of "face, cramps" and myalgia were reported as non-serious while unknown cause of death was serious (death). No autopsy was done. The outcome of the event unknown cause of death was fatal while the outcome of the events face, cramps and myalgia was unknown. The causal relationship between all the events and the administration of CORMINATY was assessed as "Unclassifiable (D)" by the PEI. PEI Comment: Do you or the person concerned have any known allergies? If yes, which ones? No No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


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