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From the 10/15/2021 release of VAERS data:

Found 17,128 cases where Vaccine is COVID19 and Patient Died



Case Details

This is page 133 out of 172

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VAERS ID: 1441184 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-21
Onset:2021-03-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-23
   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: Arthritis rheumatoid; Hypertension arterial
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728619

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021051601. A 73-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: ER9470), intramuscular, administered in arm left on 21Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history included hypertension arterial and arthritis rheumatoid both from an unknown date. The patient''s concomitant medications were not reported. The patient experienced death on 23Mar2021. It was reported that night from 22Mar2021 to 23Mar2021, the patient was found dead at home. Special police report and autopsy carried out on 25Mar2021 without precision despite telephone and email reminders from the declaring doctor. The outcome of the event was fatal. The patient died on 23Mar2021. Cause of death was unknown. An autopsy was performed that revealed no information available. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1441188 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Death, Fatigue, SARS-CoV-2 test, Vital signs measurement
SMQs:, Guillain-Barre syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-07
   Days after onset: 31
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: AFib; Asthenia (morning); Chronic venous insufficiency; CVA (Disabling stroke with left half plegia); Diverticulosis; Gastrooesophageal reflux; Hypertrophic cardiomyopathy; Hypotension (morning); Malaise (morning); Obesity
Allergies:
Diagnostic Lab Data: Test Date: 20210429; Test Name: Test PCR; Test Result: Negative ; Test Date: 20210506; Test Name: vital signs; Result Unstructured Data: Test Result:normalized; Comments: vitals were taken after the vaccination
CDC Split Type: FRPFIZER INC2021728592

Write-up: Death unexplained/found dead in his bed; Asthenia; fatigued patient; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021051785. A 94-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscularly administered in the right arm on 06May2021 16:00 (Lot Number: ET6956) as dose 2, single for covid-19 immunisation. Medical history included atrial fibrillation, diverticulum, cerebrovascular accident (CVA) which was disabling stroke with left half plegia, chronic venous insufficiency, gastrooesophageal reflux, hypertrophic cardiomyopathy and obesity, all from 28Mar2021 to an unknown date; and patient was asthenic and had a malaise with hypotension on 06May2021 morning. Oral instructions from the doctor not to vaccinate the patient. The patient''s concomitant medications were not reported. patient experienced death unexplained on 07May2021 11:30; and fatigued and asthenia, both on 07May2021. It was mentioned that a note that this is a patient who is in a precarious state following a stroke at the end of Mar2021. The patient had negative PCR test on 29Apr2021. At 16:00, the nurse vaccinated the patient. The vitals were taken after the vaccination which were normalized. On 07May2021 morning, the patient was tired, the caregivers stayed more than an hour to wash him, they left the room around 10:30. At 11:30, the patient was found dead in his bed (Death unexplained). The The outcome of the events fatigue and asthenia were not recovered while the outcome of the other event was fatal. The patient died on 07Jun2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1441190 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute coronary syndrome, Angiocardiogram, Chest pain, Troponin
SMQs:, Myocardial infarction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bladder neoplasm NOS (Prostate / bladder tumor); Coronary artery occlusion; Epilepsy (Epilepsy under Tegretol); Heart failure; Myocardial infarction (with chronic right coronary artery occlusion / anterior interventricular stent); Prostatic neoplasm NOS (Prostate / bladder tumor); Stent placement
Allergies:
Diagnostic Lab Data: Test Date: 20210430; Test Name: Coronary angiography; Result Unstructured Data: Test Result:unknown; Test Date: 20210429; Test Name: Troponin; Result Unstructured Data: Test Result:Troponin +
CDC Split Type: FRPFIZER INC2021728817

Write-up: This is a spontaneous report from a contactable physician. The regulatory authority report number is [FR-AFSSAPS-2021052242]. A 94-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 20Apr2021 (Lot Number: EW4815) as dose 2, single for COVID-19 immunisation. Medical history included prostate and bladder tumor an unknown date, Heart failure an unknown date, myocardial infarction in 2008 with chronic right coronary artery occlusion/anterior interventricular stent, epilepsy (under Tegretol) on an unknown date. The patient''s concomitant medications were not reported. The patient previously took tegretol for epilepsy. The patient experienced chest pain on 23Apr2021 and non-ST segment elevation acute coronary syndrome on 29Apr2021. The events were assessed a serious-fatal. Background/history of the disease: The declarant reports "Chest pain from approximately 23Apr. Diagnosis of acute coronary syndrome ST- Troponin + on 29Apr - Coronary angiography on 30Apr - Death on 05May". The patient underwent lab tests and procedures which included Coronary angiography: unknown on 30Apr2021 and troponin: troponin + on 29Apr2021.The patient died on 05May2021. It was not reported if an autopsy was performed. The pharmacovigilant notes: Accountability score established without prejudice to the elements of investigation that could be carried out as part of legal or amicable compensation procedures. Reaction(s)/Event(s) Assessed for the event Chest Pain: Time Interval between Beginning of Drug Administration and Start of Reaction/Event (number): 4 days Time Interval between Last Dose of Drug and Start of Reaction / Event (number): 4 days Did reaction recur on readministration? 3 (YES -- UNK (rechallenge was done, outcome unknown)) Reaction(s)/Event(s) Assessed for the event Acute coronary syndrome: Time Interval between Beginning of Drug Administration and Start of Reaction / Event (number): 10 days Time Interval between Last Dose of Drug and Start of Reaction / Event (number) : 10 days Did reaction recur on readministration? 3 (YES -- UNK (rechallenge was done, outcome unknown)) No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Chest pain; Non ST segment elevation acute coronary syndrome


VAERS ID: 1441191 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-25
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiocardiogram, Blood pressure measurement, Electrocardiogram, Hepatic cytolysis, Multiple organ dysfunction syndrome, Myocardial infarction, Renal failure, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatitis, non-infectious (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Myocardial infarction (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, arterial (narrow), Chronic kidney disease (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-28
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LEVOTHYROX; PERINDOPRIL; AMLODIPINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Thyroidectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210425; Test Name: coronography; Result Unstructured Data: Test Result:attests to a very severe and very advanced tritron; Comments: tritronascular involvement with an acute occlusion of the proximal left anterior descending artery of thrombotic appearance followed by stenosis of its downstream bed, a long chronic sub-occlusion of the right coronary artery, staged lesions. on the marginal circumflex network indicating that the coronary disease is old.; Test Date: 20210425; Test Name: arterial pressure; Result Unstructured Data: Test Result:70 / 50 mmHg; Test Date: 20210425; Test Name: ECG; Result Unstructured Data: Test Result:extensive anterior infarction; Test Date: 20210425; Test Name: ultrasound; Result Unstructured Data: Test Result:severe myocardial involvement with 25% left ventri; Comments: ventricular ejection fraction collapse and associated right ventricular systolic dysfunction.; Test Date: 20210426; Test Name: ultrasound; Result Unstructured Data: Test Result:Persistence of the collapse (20%) of Left ventricu; Comments: ventricular ejection fraction on the follow-up ultrasound, despite dobutamine and Noradrenaline.
CDC Split Type: FRPFIZER INC2021728593

Write-up: Infarct myocardial; multiorgan failure (hepatic cytolysis, renal failure ...); multiorgan failure (hepatic cytolysis, renal failure ...); multiorgan failure (hepatic cytolysis, renal failure ...); This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021052293. A 78-year-old male patient received bnt162b2 (COMIRNATY), intramuscular administered in left arm on 22Apr2021 (Batch/Lot Number: EW4815) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. Medical history included arterial hypertension and thyroidectomy. Concomitant medications included levothyroxine sodium (LEVOTHYROX); perindopril; and amlodipine. In the early evening of 25Apr2021, the patient experienced infarct myocardial. Patient was hospitalized urgently, after urgent medical aid service intervention. The patient was hospitalized for infarct myocardial from 25Apr2021 to an unknown date. His condition deteriorated rapidly. On patient''s hospitalization report, it was reported that patient had presented 3 days before his hospitalization, during gardening, chest pains similar to the pains from 25Apr2021 evoking recent-onset angina. On 25Apr2021, from the beginning of the admission, patient develops ventricular fibrillation which was reduced by external electric shock. It was in insufficient overall congestive heart rate at low flow with arterial pressure = 70 / 50mmHg. The electrocardiogram (ECG) showed an extensive anterior infarction. Ultrasound showed severe myocardial involvement with 25% left ventricular ejection fraction collapse and associated right ventricular systolic dysfunction. The coronography attests to a very severe and very advanced tritronascular involvement with an acute occlusion of the proximal left anterior descending artery of thrombotic appearance followed by stenosis of its downstream bed, a long chronic sub-occlusion of the right coronary artery, staged lesions. On the marginal circumflex network indicating that the coronary disease was old. Placement of 3 active stents treatment of heart failure by diuretics and ventilation. On 26Apr2021, the patient had persistence of the collapse (20%) of left ventricular ejection fraction on the follow-up ultrasound, despite dobutamine and noradrenaline. On 27Apr2021, onset of ventricular hyperexcitability leading to external electric shocks and initiation of intravenous (IV amiodarone. On 28Apr2021, the patient had multiorgan failure (hepatic cytolysis, renal failure ...). Therapeutic measures were taken as a result of infarct myocardial. The events resulted in fatal outcome. The patient died on 28Apr2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: multiorgan failure (hepatic cytolysis, renal failure ...); multiorgan failure (hepatic cytolysis, renal failure ...); multiorgan failure (hepatic cytolysis, renal failure ...); Infarct myocardial


VAERS ID: 1441193 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-03
Onset:2021-04-15
   Days after vaccination:71
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, COVID-19, Hyperthermia, Oxygen saturation decreased, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Accidents and injuries (broad), Respiratory failure (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: 2021-04-29
   Days after onset: 14
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Behavior disorder (subarachnoid hemorrhage and left hemispherical subdural blade in 2013 leading to behavioral disorder); Dyslipidemia; Hypertension (HTN); Subarachnoid hemorrhage (Polytrauma with subarachnoid hemorrhage and left hemispherical subdural blade in 2013)
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: RT-PCR; Test Result: Positive ; Comments: variant
CDC Split Type: FRPFIZER INC2021728830

Write-up: SARS-CoV-2 test positive; Vaccination failure; congestion with desaturation; hyperthermia; asthenia; This is a spontaneous report from Other Health Professional downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-2021052593. A 90-year-old female patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: EJ6788), intramuscularly on 03Feb2021 as single dose and first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection Batch/Lot Number: EM0477), via an unspecified route of administration on 13Jan2021 as single dose for covid-19 immunisation. Medical history included HTN (Hypertension), dyslipidemia, subarachnoid hemorrhage started in 2013 (Polytrauma with subarachnoid hemorrhage and left hemispherical subdural blade in 2013) and behavioral disorders in 20213. The patient had no history of covid-19. The patient had no PCR test history. Allergic history was unknown. The patient''s concomitant medications were not reported. On 15Apr2021 (onset 71 days after 2nd injection of SARS-COV-2 infection), the patient experienced sars-cov-2 test positive, vaccine failure and congestion with desaturation, hyperthermia, asthenia on an unspecified date. The patient underwent lab tests and procedures which included RT-PCR (sars-cov-2 test): positive on 15Apr2021. The patient died on 29Apr2021. An autopsy was not performed. The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6788. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. For this lot Adverse Event Safety Request For Investigation and/or Lack of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the referenced PR ID resulted in the following conclusion: Reference PR ID 5595397 (see File attachment in this investigation record) The complaint for adverse event/LOE of PFIZER-BIONTECH COVID-19 VACCINE was investigated. 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. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Regulatory Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The investigative process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause. Outcome of event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: infection covid-19


VAERS ID: 1441204 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-02
Onset:2021-05-11
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   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: Tobacco user (1/2 pack per day)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728608

Write-up: Several episodes of cough; Sudden death unexplained; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021054556. A 70-year-old male patient received BNT162B2 (COMIRNATY), intramuscular, administered in left arm on 02May2021 (Batch/Lot Number: EX6537) as dose 2, single for COVID-19 immunisation. Medical history included tobacco user (tobacco consumption of 1/2 pack per day). No cardiac or coronary history. No long-term treatment. The patient''s concomitant medications were not reported. On 11May2021 06:00 (10 Day after the beginning of drug administration, as reported), the patient experienced sudden death unexplained. On 02May2021 second injection of the COMIRNATY vaccine. Several episodes of cough in the previous days (unknown date). No fever, no dyspnea, no alarming symptoms. On 10May2021 in the evening, the patient scrabble with his wife then television, his wife has gone to bed. Around 6AM, patient found dead in front of the television. Call for emergency services, cardiac massage. Conclusion was unexplained sudden death, at home, a 70-year-old patient, with no particular medical history, 10 days after a second injection of the COMIRNATY vaccine (batch EX6537). Outcome of event several episodes of cough was unknown. The patient died on 11May2021. 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: Sudden death unexplained


VAERS ID: 1441218 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-04-20
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK9788 / 2 LA / 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: Medical History/Concurrent Conditions: Dementia; Hypertension; Parkinson''s disease
Allergies:
Diagnostic Lab Data: Test Date: 20210420; Test Name: SARS-CoV-2 test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728904

Write-up: Vaccination failure; Onset of a severe form of Covid requiring antibiotics, anticoagulants, oxygen; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021057652. A 90-year-old male patient received first dose of bnt162b2 (COMIRNATY; Batch/Lot Number: EM0477) intramuscularly administered into left arm on 14Jan2021 as dose 1, single and the second dose intramuscularly administered into left arm on 04Feb2021 (Batch/Lot Number: EK9788) as dose 2, single for COVID-19 immunisation. Medical history included dementia, hypertension and parkinson''s disease. The patient''s concomitant medications were not reported. On 20Apr2021 the patient experienced vaccination failure and had an onset of a severe form of COVID requiring antibiotics, anticoagulants and oxygen. Patient underwent lab test and procedures which included SARS-CoV-2 test: positive on 20Apr2021. Patient died as a result of the severe form of COVID on an unspecified date on 2021. It was not reported if an autopsy was performed. Product quality complaint concluded on 21Jun2021 that the investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EM0477 and EK9788. 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. Health Authority concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The process determined that a regulatory notification was required. The reported defect could not be confirmed. No root cause were identified as the complaint was not confirmed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Vaccination failure; Onset of a severe form of Covid requiring antibiotics, anticoagulants, oxygen


VAERS ID: 1441223 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-01
Onset:2021-05-05
   Days after vaccination:34
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2246 / UNK LA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, Sudden death
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: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEBIVOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Accident at work; Agitation; Embolism pulmonary; Hypertension arterial; Paranoid state; Thrombosis venous deep
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728799

Write-up: Sudden death unexplained; doctor immediately noticed asystole; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-2021059136. A 60-year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Left on 16Apr2021 (Lot Number: EW2246) as dose 1, single for COVID-19 immunisation; risperidone, oral from Apr2021 (Batch/Lot Number: Unknown) to 03May2021, at 2mg morning and 4mg evening for paranoid state; tiapride hydrochloride (TIAPRIDAL), oral from Apr2021 (Batch/Lot Number: Unknown) to an unspecified date, at 100 mg morning and evening for paranoid state; diazepam (VALIUM), oral from 04Apr2021 (Batch/Lot Number: Unknown) to an unspecified date, at 30 drop, daily for agitation. Medical history included Hypertension arterial (HTA), agitation and paranoid state, all from an unknown date and unknown if ongoing. In 2016, occupational accident, deep vein thrombosis (during functional rehabilitation), complicated by pulmonary embolism. Concomitant medications included nebivolol taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden death unexplained on 05May2021. The clinical course was reported as follows: Patient admitted to a psychiatric establishment on 03Apr2021, for behavioral disorders, agitation and paranoid state. On 05May2021, the patient collapsed in the hallway, an on-site doctor immediately noticed asystole, and began cardiac massage. The rescue team, which arrived a few minutes later, confirmed the death. The action taken in response to the event for risperidone, for tiapride hydrochloride and for diazepam was not applicable. Therapeutic measures were taken as a result of sudden death unexplained. The patient died on 05May2021. An autopsy was not performed. Time Interval between Drug Administration - Risperidone and Start of Even - Death: 3 days Time Interval between Drug Administration - Comirnaty and Start of Even - Death: 20 days Time Interval between Drug Administration - Valium and Start of Even - Death: 32 days No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Sudden death unexplained


VAERS ID: 1441236 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Investigation
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: METOPROLOL FUMARATE; AMIODARONE; COAPROVEL; XARELTO; MACROGOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Arterial hypertension; Arthritis; Atrial fibrillation; Extrasystoles (for many years); Hysterectomy; Leg fracture; Non-smoker; Oophorectomy; Osteosynthesis
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: biology; Result Unstructured Data: Test Result:nothing to report
CDC Split Type: FRPFIZER INC2021728764

Write-up: unexplained death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-2021061845. A 78-year-old female patient received her first dose of BNT162B2 (COMIRNATY; lot number: ET6956), intramuscular on 26Apr2021 (at an unspecified age) at dose 1, single in the left arm for COVID-19 immunisation. Medical history included extrasystoles for many years, arterial hypertension, complete arrhythmia due to atrial fibrillation, oophorectomy in 1991, hysterectomy in 1991, left tibia-fibula fracture with osteosynthesis in 2003, right tibiotarsal arthritis, and non-smoker. The patient lived at home alone and had no child. The patient was not considered at risk of developing a severe form of the disease COVID-19, she did not have COVID-19 and was not tested. The patient''s father died of stroke at 87-years-old, and the patient''s mother suddenly died at the age of 81-years-old as a result of her diabetes. Concomitant medications included metoprolol fumarate, amiodarone, hydrochlorothiazide, irbesartan (COAPROVEL), rivaroxaban (XARELTO) 20 mg coated tablet for complete arrhythmia due to atrial fibrillation with often spontaneous hematomas, and macrogol. It was reported that the patient had an unexplained death during the night of 30Apr2021 to 01May2021 (pending clarification). The patient had no complaint before the onset of death. The patient had her neighbors on the phone on 30Apr2021 at around 22:00 and there was nothing to report. In the morning, seeing the shutters closed, the neighbors called for help. Death was noted by the emergency doctor who concluded asphyxia on cardiac arrest. The patient was found lying on the bed in a sleeping position. No autopsy was conducted. The reporting physician did not see the patient, but the patient''s brother reported that he saw signs of bleeding from the orifices (nasal) post-mortem. The patient was on rivaroxaban (XARELTO) 20 mg coated tablet for complete arrhythmia due to atrial fibrillation with often spontaneous hematomas and her cardiologist suggested that she switch to ELIQUIS at the start of 2021 but the patient did not dare to change her treatment too much. There was no modification of treatment. The patient''s latest biology was last Feb2021 and there was nothing to report. Consultation with the cardiologist in Mar2021 had nothing to reported. In total, it was reported that the patient was found dead on her bed at home six days after the first dose of BNT162B2 (COMIRNATY) (pending clarification). No obvious cause of death (cardiac arrest according to emergency doctor). Causality with the vaccine was very uncertain for the reporting physician. Outcome of the event was fatal. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: unexplained death


VAERS ID: 1441241 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4598 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Altered state of consciousness, Blood glucose, Blood pressure measurement, Blood pressure systolic, Coma scale, Computerised tomogram, Dysstasia, Facial paralysis, Haemorrhagic stroke, Headache, Heart rate, Hypertension, Motor dysfunction, Oxygen saturation, Oxygen saturation decreased, Respiratory rate, Vomiting
SMQs:, Acute pancreatitis (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hearing impairment (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 1
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: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm (stented); Atrial fibrillation; Cardiac failure; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210524; Test Name: hemoglucotest; Result Unstructured Data: Test Result:10.6 mmol/L; Test Date: 20210524; Test Name: Blood pressure; Result Unstructured Data: Test Result:173/83 mmHg; Test Date: 20210524; Test Name: systolic blood pressure; Result Unstructured Data: Test Result:180 mmHg; Test Date: 20210524; Test Name: glasgow scale; Result Unstructured Data: Test Result:14; Test Date: 20210524; Test Name: glasgow scale; Result Unstructured Data: Test Result:5 (Y1M3V1); Test Date: 20210524; Test Name: CT scan; Result Unstructured Data: Test Result:stroke; Comments: without injection: stroke + intracranial hematoma and involvement; Test Date: 20210524; Test Name: heart rate; Result Unstructured Data: Test Result:85; Comments: bpm; Test Date: 20210524; Test Name: oxygen saturation; Test Result: 90 %; Test Date: 20210524; Test Name: respiratory rate; Result Unstructured Data: Test Result:30; Comments: mvt/min
CDC Split Type: FRPFIZER INC2021728665

Write-up: Haemorrhagic stroke/ stroke with intracranial hematoma and involvement; probable blood pressure surge/Systolic blood pressure (BP) 180 mmHg/Blood pressure (BP): 173/83 mmHg/hypertensive episode; progressive consciousness disorders/altered state of consciousness; brutal headache; vomiting; motor deficit/motor dysfunction; no longer standing up; Oxygen Saturation (SaO2): 90%, oxygen saturation decreased; left facial paralysis; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021062561. A 90-year-old male patient received bnt162b2 (COMIRNATY, lot number: FA4598, expiry date unknown), intramuscular, administered in the left arm on 20May2021, dose 2, single for COVID-19 immunization. Medical history included atrial fibrillation, abdominal aortic aneurysm (stented), cardiac failure and hypertension arterial all from an unknown date and unknown if ongoing. Concomitant medications included apixaban (ELIQUIS) taken for atrial fibrillation, start and stop date were not reported. On 23May2021 there was an appearance of a left facial paralysis. On 24May2021, in the morning, the patient had a brutal headache with vomiting and progressive consciousness disorders/altered state of consciousness. Glasgow 14 at the beginning. The patient had Global motor deficit/motor dysfunction, difficulty in putting on clothes, did not get up anymore, no longer standing up. No fall, no head trauma. On arrival at the ER: Blood pressure (BP): 173/83 mmHg, pulse 85 beats/min, Oxygen Saturation (SaO2): 90%, oxygen saturation decreased, spontaneous ventilation room air, blood glucose (hemoglucotest): 10.6 mmol/l, respiratory rate: 30 movements/min. Glasgow 5 (Y1M3V1), isocore pupils areoreactive, not spastic, bilateral BBK. Respiration loaded, bilateral ronchi. CT scan without injection showed stroke with intracranial hematoma and involvement. As per the neurosurgeon''s opinion; no surgical management was needed. Comfort care was suggested. The patient died on 24May2021. The patient had a hemorrhagic stroke on Monday, 24May2021 leading to death with probable blood pressure surge/hypertensive episode according to the children and systolic blood pressure (BP) 180 mmHg. The outcome of the other events was not recovered. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Haemorrhagic stroke/ stroke with intracranial hematoma and involvement


VAERS ID: 1441260 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-16
Onset:2021-05-30
   Days after vaccination:103
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6789 / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dementia, Fall, Gait disturbance, General physical health deterioration
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   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: AFib; Angioplasty; Arrhythmia; Benign prostatic hyperplasia; Chronic renal failure; Dementia; Disease coronary artery; Hypertension arterial; Hyperuricaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728781

Write-up: aggravation of dementia; Repeated falls; difficulty in walking; Reduced general condition; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021065250. A 93-years-old male patient received second dose of bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 16Feb2021 (Batch/Lot Number: EJ6789) as 0.3 ML single dose for COVID-19 immunisation. Medical history included Benign prostatic hyperplasia, Angioplasty, Chronic renal failure, Hyperuricaemia, Hypertension arterial, AFib, Arrhythmia, Dementia, Disease coronary artery. The patient''s concomitant medications were not reported. It was reported that the patient was considered at risk of developing a severe form of Covid-19, he had not had it and had not been tested. The patient had repeated falls, severe deterioration in general condition with difficulty in walking, aggravation of dementia. No falls between 01Jan2021 and 16Feb2021. Six falls have occurred since the second injection. The patient died on 30May2021. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: AEG


VAERS ID: 1441262 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-19
Onset:2021-05-25
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / 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: 2021-05-29
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ankylosing spondylitis; Atrial fibrillation; Breast cancer ((neoplasm breast)); Cardiac failure ((heart failure)); Colonic diverticulosis ((bowel diverticulosis, diverticulosis of the intestine)); Congestive (dilated) cardiomyopathy; Hypertension arterial ((hta, high blood pressure)); Insufficiency renal ((kidney failure)); Sleep apnea; Stroke ((history of multiple strokes))
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Covid-19 infection (PCR); Test Result: Positive
CDC Split Type: FRPFIZER INC2021728766

Write-up: Vaccination failure/ Covid-19 infection (PCR positive on 25May2021); Vaccination failure/ Covid-19 infection (PCR positive on 25May2021); This is a spontaneous report from a contactable other healthcare professional (HCP), downloaded from the Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-2021065718. The case was originating from a professional health report via the agency portal number 20210527130252537. A 79-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), intramuscularly (IM), administered in the left arm on 05Feb2021 (Batch/Lot Number: EJ6788, Expiration date: unknown) as dose 1, single and IM, administered in the left arm on 19Mar2021 (Batch/Lot Number: ER9470, Expiration date: unknown) as dose 2, single, for COVID-19 immunization. Relevant medical history included atrial fibrillation, cardiac failure (heart failure), sleep apnea, ankylosing spondylitis, congestive (dilated) cardiomyopathy, breast cancer (neoplasm breast), stroke (history of multiple strokes), insufficiency renal (kidney failure), hypertension arterial (hta, high blood pressure), and colonic diverticulosis (bowel diverticulosis, diverticulosis of the intestine). The patient had no history of allergy or long-term treatment informed. The patient''s concomitant medications were not reported. The patient experienced vaccination failure, further reported as Covid-19 infection with polymerase chain reaction (PCR) positive on 25May2021. It was further reported that the patient had COVID-19 vaccination for D1 + D2; confirmed vaccination failure. The patient tested positive for COVID-19 on 25May2021. On 26May2021, the patient presented with a Covid-19 infection (PCR positive on 25May2021) with respiratory decompensation and tachycardia. On 27May2021, she was hospitalized urgently. The patient died on 29May2021. An autopsy was not performed. On 21Jun2021, investigation result was received from Product Quality Complaints Group. The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6788. 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. The company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable.The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. A sample was not sent to the QC-lab to determine the amount of active ingredient since the complaint was received within six months after the release date of the involved batch. All analytical results were checked and were within registered limits. The investigation of the Reference PR ID 5832496 resulted in the following conclusion: The complaint for PFIZER-BIONTECH COVID-19 VACCINE was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot ER9470. 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. The company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Vaccination failure/ Covid-19 infection (PCR positive on 25May2021); Vaccination failure/ Covid-19 infection (PCR positive on 25May2021)


VAERS ID: 1441263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-05-03
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Death, Full blood count, Glomerular filtration rate, Pyrexia, SARS-CoV-2 test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FOLIC ACID ARROW; PREDNISONE ARROW; METHOTREXATE; COLECALCIFEROL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Rheumatoid arthritis
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: creatinine; Result Unstructured Data: Test Result:57 umol/l; Test Date: 202102; Test Name: hemogram; Result Unstructured Data: Test Result:normal; Test Date: 202102; Test Name: CKD EPI; Result Unstructured Data: Test Result:81; Comments: ml/min/1.73m2; Test Date: 20210118; Test Name: SARS-CoV-2 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021728827

Write-up: Death NOS; fever; This is a spontaneous report from a contactable consumer downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021065769. An 85-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 22Apr2021 (Batch/Lot Number: Unknown) as DOSE 1, single for COVID-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications included folic acid (FOLIC ACID ARROW), prednisone (PREDNISONE ARROW), methotrexate (METHOTREXATE) and colecalciferol (COLECALCIFEROL) all taken for unspecified indications and therapy dates. The patient previously took escitalopram and hydrochlorothiazide arrow + ramipril for unknown indications in Feb2021. The patient had negative COVID-19 test on 18Jan2021. It was also reported that hemogram was normal, creatinine: 57 umol/l, and CKD EPI 81ml/min/1.73m2 in Feb2021. She also had no history of COVID-19. In 2021, the patient had an onset of fever. Then, the patient died on 03May2021 (unknown cause of death). It was unknown if autopsy was performed. Outcome of fever was unknown. No follow-up attempts are possible. Information on batch/lot number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1441271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-03
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD0785 / 1 LA / 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: 2021-06-03
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728594

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB (Regulatory Authority Number: FR-AFSSAPS-2021067609). A 67-years-old female patient received BNT162B2 (COMIRNATY; solution for injection), intramuscularly administered in the left arm on 01Jun2021 (lot number: FD0785) as dose 1, 0.3 ml, single for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced sudden death on 03Jun2021 (2 days after vaccination). 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: Sudden death


VAERS ID: 1441281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC1526 / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Auscultation, Body temperature, Cardiac arrest, Heart rate
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), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Tobacco user (15-20 cigarettes per day)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: Body temperature; Result Unstructured Data: Test Result:37 Centigrade; Test Date: 20210606; Test Name: Pulse; Result Unstructured Data: Test Result:120 bpm; Test Date: 20210606; Test Name: Cardiopulmonary auscultation; Result Unstructured Data: Test Result:normal
CDC Split Type: FRPFIZER INC2021728635

Write-up: Hypoxic arrest; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-2021070544. A 49-year-old male patient received BNT162B2 (COMIRNATY), dose 1 intramuscular, administered in Arm Right on 05Jun2021 (Batch/Lot Number: FC1526) as dose 1, single for COVID-19 immunization. Medical history included ongoing smoking 15-20 cigarettes per day. No long-term treatment. The patient''s concomitant medications were not reported. The next afternoon (06Jun2021) the patient complained of difficulty in swallowing. He saw a retired doctor living in the same region who examined him and found no apparent edema. The temperature was 37 centigrades (taken under the arm). Pulse at 120 bpm but the patient being known to be emotional the doctor was not worried about this value. Cardiopulmonary auscultation is otherwise normal. The patient took 1 tablet of Lysopaine, 1 g of Paracetamol and would have taken 1/4 tablet of Lexomil on the advice of this doctor when he suspected an anxious reaction. At around 9:30 p.m. the Emergency medical services intervenes at his home when a sudden cardiac arrest has occurred. The emergency doctor specifies that the patient was in cardiac arrest on their arrival with a rapid intervention of the firefighters for 20 minutes performing a cardiac massage. The Emergency medical services attempted resuscitation for 1 hour with cardiac massage and administration of adrenaline without recovery of a cardiac rhythm. The doctor specifies that it was noted a reorganization level of the larynx with edema but without identified presence of foreign body, nor aspect suggestive of an edema of Quick. No rash. So no suspected allergic origin. Relatives reported that the patient could no longer breathe and had gone outside to get some air. The hypothesis of a hypoxic cardiac arrest on sudden suffocation was strongly suspected by the emergency physician. No sign suggestive of myocardial infarction, no pneumothorax, no sign suggestive of massive pulmonary embolism, no sign of pulmonary oedema. No signs of bleeding were observed. A forensic obstacle was posed for autopsy. Call forensic medicine service: autopsy done, but legal proceedings in progress so the information cannot be communicated. The patient died on 06Jun2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Hypoxic arrest


VAERS ID: 1441289 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-11
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Coma, Communication disorder, Drug ineffective, Nervous system disorder, Respiratory disorder, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Respiratory failure (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 12
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alcoholism; Cardiac failure; Chronic renal failure; Dementia; Depression; Hypertension arterial; Obesity; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210511; Test Name: PCR test positive for SARS-CoV-2 variant alpha; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728794

Write-up: COVID-19 aggravated; drug ineffective; Neurological impairment; comatose; poor communication; respiratory impairment; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021072167. A 89-years-old male patient received first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EX0893; Expiration Date: unknown) intramuscular, administered in Arm Left on 21Apr2021 as 0.3 mL single dose for COVID-19 immunization. Medical history included chronic kidney disease, depression, hypertension, type 2 diabetes mellitus, cardiac failure, dementia and obesity from an unknown date and unknown if ongoing and also included ethylism from an unknown date to unknown date. The patient''s concomitant medications were not reported. During the course of the injection, no manifestation of adverse effects and patient was clinically stable. On 11May2021 the patient experienced COVID-19 aggravated, drug ineffective, neurological impairment, comatos, poor communication and respiratory impairment. The patient underwent lab tests and procedures which included SARS-COV-2 test which positive on 11May2021. The outcome of events neurological impairment, comatos, poor communication and respiratory impairment was unknown. The patient died on 23May2021 due to COVID-19 infection. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: COVID-19 infection


VAERS ID: 1441297 (history)  
Form: Version 2.0  
Age: 87.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-09
Onset:2021-02-19
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6795 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood gases, Blood glucose, Blood pressure measurement, Body temperature, Brain natriuretic peptide, C-reactive protein, Coma, Coma scale, Computerised tomogram head, General physical health deterioration, Hypoxia, Investigation, Neutrophilia, Oxygen saturation, PCO2, PO2, SARS-CoV-2 test, Troponin, White blood cell count
SMQs:, Asthma/bronchospasm (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Respiratory failure (broad), 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: 2021-02-23
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: PRADAXA
Current Illness: Atrial fibrillation paroxysmal; Cognitive disturbance; Falling (Repetitive falls); Hypertension arterial; Hypotension orthostatic; Ischemic heart disease; Macular hole; Urinary retention
Preexisting Conditions: Medical History/Concurrent Conditions: Acute retention of urine; Confusional state; COVID-19; Hospitalization (In Dec2020: patient hospitalized in After Care and Rehab for confusional syndrome on acute retention of urine.); Stroke (with moderate left deficit)
Allergies:
Diagnostic Lab Data: Test Date: 20210222; Test Name: Blood gas; Result Unstructured Data: Test Result:7.19; Comments: pH; Test Date: 20210219; Test Name: glucose; Result Unstructured Data: Test Result:1.04 g/l; Test Date: 20210219; Test Name: blood pressure; Result Unstructured Data: Test Result:112 / 98 mmHg; Test Date: 20210219; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Test Date: 20210221; Test Name: bnt; Test Result: Negative ; Test Date: 20210221; Test Name: Glasgow score; Result Unstructured Data: Test Result:Diagnosis of coma with Glasgow score of 8-10 in a; Comments: Diagnosis of coma with Glasgow score of 8-10 in a GIR1 patient with indwelling catheter; Test Date: 20210222; Test Name: Glasgow score; Result Unstructured Data: Test Result:6-7, neurological worsening; Test Date: 20210221; Test Name: Brain CT; Result Unstructured Data: Test Result:does not find intracranial bleeding; Test Date: 20210222; Test Name: Brain CT; Result Unstructured Data: Test Result:No hemorrhagic stroke; Test Date: 20210221; Test Name: c-reactive protein; Result Unstructured Data: Test Result:10; Test Date: 20210221; Test Name: investigation; Result Unstructured Data: Test Result:IRS pupils; Comments: In the emergency room, the initial clinical examination found IRS pupils, the patient moved all 4 limbs, "stertor" snoring. + / + Vesicular murmur without sino-atrial block, abdomen without radiating pain, no globe, no fecaloma.; Test Date: 20210221; Test Name: neutrophilia; Result Unstructured Data: Test Result:13 g/l; Test Date: 20210219; Test Name: oxygen saturation; Test Result: 94 %; Test Date: 20210222; Test Name: Blood gas; Result Unstructured Data: Test Result:64 mmHg; Test Date: 20210222; Test Name: Blood gas; Result Unstructured Data: Test Result:67 mmHg; Test Date: 20210209; Test Name: PCR Covid-19; Test Result: Negative ; Test Date: 20210221; Test Name: Troponin; Test Result: Negative ; Test Date: 20210221; Test Name: hyperleukocytosis; Result Unstructured Data: Test Result:17 g/l
CDC Split Type: FRPFIZER INC2021770507

Write-up: Coma; Hypoxia/desaturation; General physical health deterioration; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-2021075785. An 87-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 09Feb2021 (Batch/Lot Number: EJ6795) as dose 1, 0.3 ml single at the age of 87-year-old for covid-19 immunisation. Medical history included ongoing urinary retention, ongoing stented ischemic heart disease, ongoing cognitive disturbance, stroke from 2013 to an unknown date (with moderate left deficit), ongoing hypertension arterial, ongoing atrial fibrillation paroxysmal, SARS-COV2 pneumonia from Mar2020 to an unknown date, ongoing macular hole, ongoing hypotension orthostatic, ongoing falling (Repetitive falls), and in Dec2020, patient hospitalized in after care and rehabilitation for confusional syndrome on acute retention of urine. Concomitant medications included dabigatran etexilate mesilate (PRADAXA) taken for an unspecified indication, start and stop date were not reported, and quadruple therapy for hypertension. On 09Feb2021: Transfer to a retirement home. PCR Covid-19 negative. First injection of the vaccine against Covid-19 bnt162b2, batch no. EJ6795, 0.3 mL intramuscularly in the left arm. The patient experienced coma, hypoxia, general physical health deterioration on 19Feb2021. Event reported as: On 19Feb2021: Patient with little answering machine. Seen by the doctor at the retirement home: blood pressure at 112 / 98mmHg, O2 desaturation at 94%, temperature at 36.7 C, HGT at 1.04g / L. 21Feb2021: Patient not communicating, referred to the emergency room for suspected stroke, with mental confusion and disturbed vigilance. In the emergency room, the initial clinical examination found IRS pupils, the patient moved all 4 limbs, "stertor" snoring. + / + Vesicular murmur without sino-atrial block, abdomen without radiating pain, no globe, no fecaloma. Biological inflammatory syndrome discovered on the blood test with hyperleukocytosis at 17G / L including neutrophilia at 13G / L and CRP at 10, ECBU leuco + blood + germ +. Troponin negative, BNP negative. Brain CT scan does not find intracranial bleeding. Diagnosis of coma with Glasgow score of 8-10 in a GIR1 patient with indwelling catheter; possible male urinary tract infection hence the introduction of cefotaxime sodium (CLAFORAN) 1g, 3 times a day. Prescription of morphine IVSE, midazolam IVSE in total, diagnosis of patient with deterioration of general condition and desaturation, kept for reassessment the next day. Evolution: 22Feb2021: Glasgow at 6-7, neurological worsening. No spontaneous opening of the eyes, movement of avoidance to noxious stimuli. No words but moans. Paradoxical breathing, irregular heart sounds, no clear signs of heart failure. Compression points on the lower limbs, especially on the right. No hemorrhagic stroke on the CT scan. Blood gas measurement finding a pH of 7.19, a pO2 at 67mmHg and pCO2 at 64mmHg. Transferred the same day to the After Care for end of life ("life-threatening prognosis without immediate resuscitation"): patient not stimulable, congested in the lungs. 23Feb2021: deceased patient. Total: coma, deterioration of general condition and desaturation 12 days after the 1st injection of the bnt162b2 vaccine against Covid-19 in an 87-year-old patient with a long history. The patient died on 23Feb2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Coma; Hypoxia; General physical health deterioration


VAERS ID: 1441298 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-06-07
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA8016 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (in childhood); Depression; Family history of cardiovascular disorder; Rhinitis allergic
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021770576

Write-up: Infarct myocardial; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB [FR-AFSSAPS-2021076995]. A 45-year-old male patient received the first dose of BNT162B2 (COMIRNATY, Batch/Lot#: FA8016) via intramuscular at single dose in left arm on 25May2021 for COVID-19 immunisation. Medical history included asthma in childhood; depression; rhinitis allergy. Patient was with no known personal risk factors but presence of familial cardiovascular risk factors. Concomitant medication was not reported. Patient experienced infarct myocardial that resulted in death. On 07Jun2021, onset of brief chest pain without the need to consult. Appearance on 11Jun2021 of discomfort in the evening requiring the intervention of the firefighters. Death of the patient following a myocardial infarction. It was unknown if an autopsy was performed or not. The outcome of event was fatal. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: myocardial infarction


VAERS ID: 1441302 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-22
Onset:2021-04-23
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ALDACTONE [SPIRONOLACTONE]; FUROSEMIDE; STAGID; METFORMIN HYDROCHLORIDE; CARDENSIEL; ATORVASTATIN; DIFFU K; BISOCE; ELIQUIS; SERESTA; TOUJEO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure (ischemic and rhythmic); Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210423; Test Name: fever; Result Unstructured Data: Test Result:39; Comments: a fever of 39
CDC Split Type: FRPFIZER INC2021728842

Write-up: cardiopulmonary arrest; chest tightness; fever of 39; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB FR-AFSSAPS-AM20211312, Safety Report Unique Identifier FR-AFSSAPS-2021051331 A 85-year-old male patient received bnt162b2 (COMIRNATY, lot number : EW4815, expiry date unknown), intramuscular, administered in the left deltoid on 22Apr2021, dose 2, single for COVID-19 immunization. Medical history included ischemic and rhythmic cardiac failure and type 2 diabetes mellitus on an unknown date and unknown if ongoing. Concomitant medications included spironolactone (ALDACTONE); furosemide (manufacturer unknown); metformin embonate (STAGID); metformin hydrochloride (manufacturer unknown); bisoprolol fumarate (CARDENSIEL); atorvastatin (manufacturer unknown); potassium chloride (DIFFU K); bisoprolol fumarate (BISOCE); apixaban (ELIQUIS); oxazepam (SERESTA) and insulin glargine (TOUJEO), all taken for an unspecified indication, start and stop date were not reported. On 23Apr2021, the next day after the vaccination, the patient complained of chest tightness and a fever of 39, the patient took Doliprane. There was no gylcemic value (concept of hypoglycemia). On 24Apr2021, the patient experienced cardiopulmonary arrest. Resuscitation attempt at home ambulance included cardiac massage, ventilation and administration of adrenaline. The patient died on 24Apr2021 due to cardiopulmonary arrest. The outcome of the other events was unknown. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: cardiopulmonary arrest


VAERS ID: 1441406 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-04-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cardiac arrest, Dehydration, Pain, Salivary hypersecretion, Somnolence
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Respiratory failure (broad), Hypoglycaemia (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-25
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Low weight (history of thinness (35kgs)); Swallowing disorder
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728654

Write-up: Arrest cardiac; dehydration; hypersalivation; Somnolence/ drowsiness; Asthenia; Pain upon movement; This is a spontaneous report received from a contactable consumer (patient''s daughter) downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-CF20210924. An 88-year-old female patient received BNT162B2 (COMIRNATY), intramuscular, administered in Arm Left on 20Apr2021 (Lot Number: EW4815) as dose 1, single for COVID-19 immunisation. Medical history included swallowing disorders and history of thinness (35kgs). The patient''s concomitant medications were not reported. From 21Apr2021, the patient presented with asthenia without clinical warning signs (absence of edema, urticaria, respiratory and cardiocirculatory failure), the patient also experienced somnolence/drowsiness and pain upon movement on 21Apr2021. On 22Apr2021, the patient experienced dehydration and hypersalivation involving a home medical intervention with continuous glucose infusion. On 25Apr2021, this patient, during the installation of an infusion, presented a heart problem, arrest cardiac requiring cardiopulmonary resuscitation for 45 minutes. On arrival at the emergency medical services, death was declared at 7:40 AM. The outcome of the event "arrest cardiac" was fatal, for the event somnolence and pain upon movement was recovered on 21Apr2021, for the event asthenia was not recovered and for all other events was unknown. The patient died on 25Apr2021 due to cardiac arrest. An autopsy was not performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: CARDIAC ARREST


VAERS ID: 1441411 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-15
Onset:2021-03-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Arrhythmia, Atrial fibrillation, Blood creatinine, Blood potassium, Blood sodium, C-reactive protein, C-reactive protein increased, Cerebral arteriosclerosis, Cerebral atrophy, Cerebrovascular accident, Chest X-ray, Computerised tomogram, Dehydration, Discomfort, Electrocardiogram, Electrolyte imbalance, Emergency care examination, General physical health deterioration, Heart rate, Hypertension, Hyponatraemia, Inflammation, Laboratory test, Left ventricular hypertrophy, Magnetic resonance imaging, Polymerase chain reaction, Respiratory disorder, White blood cell count, White blood cell count increased
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (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), Acute central respiratory depression (broad), Hyponatraemia/SIADH (narrow), Hypertension (narrow), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-31
   Days after onset: 15
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: TOUJEO; STAGID; LOXEN [NICARDIPINE HYDROCHLORIDE]; ESIDREX; ATENOLOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arterial hypertension; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210323; Test Name: angioTDM; Result Unstructured Data: Test Result:appearance of a gap in the left corona radiata; Comments: appearance of a gap in the left corona radiata, moderate atheromatous P1P2 stenosis on the left.; Test Name: creatinine; Result Unstructured Data: Test Result:84 umol/l; Test Name: serum potassium; Result Unstructured Data: Test Result:4.3 mmol/L; Test Name: sodium; Result Unstructured Data: Test Result:131 mmol/L; Comments: hyponatremia; Test Name: chest x-ray; Result Unstructured Data: Test Result:finding an alveolointerstitial syndrome with doubt; Comments: finding an alveolointerstitial syndrome with doubt about the focus of the upper right lobe.; Test Date: 20210317; Test Name: non-injected CT scan; Result Unstructured Data: Test Result:no recent ischemia, lacunar condition with diffuse; Comments: no recent ischemia, lacunar condition with diffuse cortico-subcortical atrophy; Test Name: CRP; Result Unstructured Data: Test Result:8 mg/l; Test Name: ECG; Result Unstructured Data: Test Result:found a regular sinus rhythm with a left axis and; Comments: found a regular sinus rhythm with a left axis and an appearance of left ventricular hypertrophy.; Test Date: 20210324; Test Name: ECG; Result Unstructured Data: Test Result:showed a complete arrhythmia; Comments: showed a complete arrhythmia due to atrial fibrillation, retained as the etiology of the stroke.; Test Date: 20210317; Test Name: emergency room consultation; Result Unstructured Data: Test Result:right facial palsy, HR 69 / min, TA 174 / 67mmHg.; Comments: right facial palsy, HR 69 / min, Arterial pressure 174 / 67mmHg. Performing a non-injected CT scan (no recent ischemia, lacunar condition with diffuse cortico-subcortical atrophy). Return home without argument for a stroke.; Test Date: 20210317; Test Name: heart rate; Result Unstructured Data: Test Result:69; Comments: 69/min; Test Date: 20210317; Test Name: Arterial pressure; Result Unstructured Data: Test Result:174/67 mmHg; Test Name: laboratory test; Result Unstructured Data: Test Result:revealed a hydroelectrolyte disorder; Comments: revealed a hydroelectrolyte disorder with hyponatremia at 131 mmol/L, serum potassium at 4.3 mmol/L, no renal failure, creatinine at 84 ?mol/L, biological inflammatory syndrome with increase in leukocytes at 12.75 giga/L and PNN (Polynuclear neutrophils) at 9.54 giga/L, CRP (C-reactive protein) at 8 mg/l.; Test Date: 20210323; Test Name: cMRI; Result Unstructured Data: Test Result:highlights a recent deep left sylvian infarction; Test Name: PCR; Test Result: Negative ; Test Name: increase in leukocytes; Result Unstructured Data: Test Result:12.75; Comments: 12.75 giga/L; Test Name: PNN; Result Unstructured Data: Test Result:9.54; Comments: 9.54 giga/L
CDC Split Type: FRPFIZER INC2021728780

Write-up: CEREBRAL VASCULAR ACCIDENT/Stroke; left ventricular hypertrophy; hydroelectrolyte disorder; hyponatremia at 131 mmol/L; biological inflammatory syndrome; increase in leukocytes at 12.75 giga/L and PNN (Polynuclear neutrophils) at 9.54 giga/L; CRP (C-reactive protein) at 8 mg/l; biological dehydration; Sudden clinical degradation, particularly on the respiratory level; less comfortable; complete arrhythmia due to atrial fibrillation; complete arrhythmia due to atrial fibrillation; moderate atheromatous P1P2 stenosis; Arterial pressure 174 / 67mmHg; lacunar condition with diffuse cortico-subcortical atrophy; clinical degradation/deterioration of general condition; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-CN20211014 with Safety Report Unique Identifier FR-AFSSAPS-2021007793. A 94-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, administered in the arm, on 15Mar2021 (Batch/Lot number unknown), as dose 2, single, for COVID-19 vaccination. Medical history included Arterial hypertension/high blood pressure, Type 2 diabetes, history of stroke all from unknown dates, not reported if ongoing or not. Concomitant medications included insulin glargine (TOUJEO); metformin embonate (STAGID strength: 700 mg); nicardipine hydrochloride (LOXEN strength: 50 mg); hydrochlorothiazide (ESIDREX strength: 25 mg); and atenolol strength: 50 mg, all taken for unspecified indications, start and stop dates were not reported. On 16Mar2021, the day after the injection, the patient experienced cerebral vascular accident/stroke which required emergency room visit and hospitalization. It was reported that the day after the injection, there was clinical degradation, conscious but aphasic patient, who answers only with yes, persistence of right facial paralysis with fall of the right labial commissure, and erasure of the nasolabial fold. On 17Mar2021, upon emergency room consultation, the patient presented with right facial palsy, heart rate (HR) was 69/min, arterial pressure was 174/67mmHg. Performed a non-injected CT scan (no recent ischemia, lacunar condition with diffuse cortico-subcortical atrophy). The patient returned home without argument for a stroke. On 19Mar2021, the patient was again referred to emergency for deterioration of general condition with difficult home maintenance. On an unspecified date, a chest x-ray was performed finding an alveolointerstitial syndrome with doubt about the focus of the upper right lobe. The ECG (Electrocardiogram) found a regular sinus rhythm with a left axis and an aspect of left ventricular hypertrophy. The laboratory tests revealed a hydroelectrolyte disorder with hyponatremia at 131 mmol/L, serum potassium at 4.3 mmol/L, no renal failure, creatinine at 84 umol/L, biological inflammatory syndrome with increase in leukocytes at 12.75 giga/L and PNN (Polynuclear neutrophils) at 9.54 giga/L and CRP (C-reactive protein) at 8 mg/l. The diagnosis retained was that of a sudden deterioration in general condition, associated with clinical and biological dehydration, and the discovery of a biological inflammatory syndrome. Hydration was therefore introduced. On 23Mar2021, the result of angio TDM (Therapeutic drug monitoring) of ASDs showed appearance of a gap in the left corona radiata, moderate atheromatous P1P2 stenosis on the left. On 23Mar2021, cMRI (Cardiac Magnetic Resonance Imaging) highlighted a recent deep left sylvian infarction. On 24Mar2021, following the transthoracic echocardiography request for cardiological assessment, re-reading of the ECG (Electrocardiogram) showed a complete arrhythmia due to atrial fibrillation, retained as the etiology of the stroke. On 26Mar2021, there was sudden clinical degradation, particularly on the respiratory level. The patient became less comfortable, which required the placement of midazolam at 0.5 mg per hour then of MORPHINE at 1 mg/h on 30Mar2021 with bolus during the toilet. The patient died on 31Mar2021 (also reported as 30Mar2021). The cause of death was reported as cerebral vascular accident/stroke. The outcome of cerebral vascular accident/stroke was fatal. The outcome of the remaining events was unknown. Information about the batch/lot number has been requested.; Reported Cause(s) of Death: CEREBRAL VASCULAR ACCIDENT/Stroke


VAERS ID: 1441419 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-12
Onset:2021-04-18
   Days after vaccination:37
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 pneumonia, Computerised tomogram thorax, Drug ineffective, Peripheral ischaemia, SARS-CoV-2 test, Salmonella sepsis
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-19
   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: SOLUPRED [METHYLPREDNISOLONE]; MABTHERA; IMUREL [AZATHIOPRINE SODIUM]; ZELITREX; SPECIAFOLDINE; ORACILLINE [PHENOXYMETHYLPENICILLIN]; OMEPRAZOLE; ATORVASTATIN; ASPIRINE PROTECT; AMIODARONE; RAMIPRIL HCTZ; RAMIPRIL; CALCIFORTE [CALCIUM CARBO
Current Illness: AFib; Hypertension arterial; Hypogammaglobulinaemia
Preexisting Conditions: Medical History/Concurrent Conditions: Achilles tendon repair (left); Anemia hemolytic autoimmune (NOS); Appendectomy; Femoral neck fracture; Hip prosthesis insertion (total right hip replacement); Meniscus operation (right); Transient ischaemic attack; Tuberculosis genitourinary NOS (urinary tuberculosis)
Allergies:
Diagnostic Lab Data: Test Date: 20210409; Test Name: chest CT scan; Result Unstructured Data: Test Result:lesions suggestive of COVID-19; Comments: with involvement of approximately 25% of the lung parenchyma; Test Date: 20210409; Test Name: SARS-Cov2 PCR test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728640

Write-up: Drug ineffective/ SARS-Cov2 test positive/ pneumopathie COVID; Drug ineffective/ SARS-Cov2 test positive/COVID-19 pneumonia; Acute ischemia of the left lower limb; septicemia with salmonella; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority report number is FR-AFSSAPS-DJ20211320 and the safety report unique identifier is FR-AFSSAPS-2021057709 received via regulatory authority. An 86-year-old male patient received BNT162B2 (COMIRNATY, lot number and expiration date were unknown), intramuscular on Feb2021 at dose 1, single and intramuscular on 12Mar2021 at dose 2, single for COVID-19 immunisation. Medical history included tuberculosis genitourinary NOS (urinary tuberculosis), meniscus operation (right), ongoing hypertension arterial, transient ischaemic attack from 2018, anemia hemolytic autoimmune (NOS) from 2017, ongoing hypogammaglobulinaemia, achilles tendon repair (left), appendectomy, hip prosthesis insertion (total right hip replacement), femoral neck fracture, and ongoing AFib from 2017. Concomitant medications included methylprednisolone (SOLUPRED) effervescent tablet from 2017 for anemia hemolytic autoimmune (NOS), rituximab (MABTHERA) from Jan2018 to Feb2018, then from Nov2020 to 02Mar2021 for anemia hemolytic autoimmune (NOS), azathioprine sodium (IMUREL) tablet from Oct2020 to 08Jan2021, then from 02Mar2021 for anemia hemolytic autoimmune (NOS), valaciclovir hydrochloride (ZELITREX) tablet, folic acid (SPECIAFOLDINE) tablet, phenoxymethylpenicillin (ORACILLINE) tablet, omeprazole, atorvastatin, acetylsalicylic acid (ASPIRINE PROTECT), amiodarone, hydrochlorothiazide, ramipril (RAMIPRIL HCTZ), ramipril, calcium carbonate (CALCIFORTE), cholecalciferol, paracetamol, and rituximab from Nov2020. The patient was hospitalized on 09Apr2021 in the context of deterioration in general condition associated with diarrhea and fever, which occurred on an unspecified date in 2021 and lasted for several days. On 09Apr2021, the SARS-Cov2 PCR test was positive and the chest CT scan revealed lesions suggestive of COVID-19 with involvement of approximately 25% of the lung parenchyma. COVID-19 pneumonia was reported. At the same time, there was a septicemia with salmonella starting from the digestive system from an unspecified date in 2021, treated with cefotaxime from the onset. On the pulmonary level, the oxygen frequency quickly increased until oxygen therapy was required at the flow rate. Corticosteroid therapy with dexamethasone was introduced. Evolution towards gradual degradation. Acute ischemia of the left lower limb was unobstructed on 18Apr2021. On 19Apr2021, marked discomfort, mottling, and signs of respiratory struggle were observed. Small doses of opioids were introduced to relieve it. The patient will died quickly during the day. It should be noted that the patient was monitored for an autoimmune hemolytic anemia diagnosed in 2017 and treated by corticosteroid therapy initially with a progressive recovery, then treated by increasing corticosteroid therapy and carrying out four courses of MABTHERA in Jan-Feb2018. IMUREL was introduced in Oct2020 at 25 mg times 3x/day. Rituximab was resumed in Nov2020 with 5 grade and last course carried out on 02Mar2021. IMUREL had been stopped on 08Jan2021 due to neutropenia and had been resumed at 25 mg, 2x/day on 02Mar2021. In total, the declaration of a death from COVID-19 pneumonia in an immunocompromised patient who received 2 injections of COMIRNATY. The outcome of the events "septicemia with salmonella" and "acute ischemia of the left lower limb" was unknown. The patient died on 19Apr2021. The cause of death was "drug ineffective/ SARS-Cov2 test positive/COVID-19 pneumonia." 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: Drug ineffective/ SARS-Cov2 test positive/COVID-19 pneumonia; Drug ineffective/ SARS-Cov2 test positive/COVID-19 pneumonia.


VAERS ID: 1441429 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Agonal respiration, Haemorrhagic stroke, Hyperventilation, Loss of consciousness, Pulse absent, Scan brain
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-10
   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: KARDEGIC; BISOPROLOL; PANTOPRAZOLE; ATORVASTATIN; XATRAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adenocarcinoma of prostate; Bariatric surgery; COPD; Diabetic retinopathy; Dyslipidaemia; Hypertension arterial; Metastatic bronchial carcinoma; Obstructive sleep apnea syndrome; Thyroid nodule; Type II diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: brain scan; Result Unstructured Data: Test Result:a massive hemorrhagic left temporo-occipital strok; Comments: a massive hemorrhagic left temporo-occipital stroke with meningeal hemorrhage, ventricular flooding, and subfalcoral involvement.
CDC Split Type: FRPFIZER INC2021728636

Write-up: he was found unconscious with noisy breathing.; he was found unconscious with noisy breathing/heavy breathing; On arrival of the rescue team: agonal breathing, no pulse; On arrival of the rescue team: agonal breathing, no pulse; Haemorrhagic stroke; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-GR20211766. Safety Report Unique Identifier FR-AFSSAPS-2021058435. A 67-year-old male patient received bnt162b2 (COMIRNATY), intramuscular on 05May2021 (Batch/Lot number was not reported) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included bariatric surgery, diabetic retinopathy, type II diabetes mellitus, adenocarcinoma of prostate, COPD (Chronic obstructive pulmonary disease), obstructive sleep apnea syndrome, dyslipidaemia, metastatic bronchial carcinoma, hypertension arterial and thyroid nodule. Concomitant medications included acetylsalicylate lysine (KARDEGIC), bisoprolol, pantoprazole, atorvastatin and alfuzosin hydrochloride (XATRAL). On 10May2021, the patient was found unconscious with heavy breathing. On arrival of the emergency services: agonal breathing, no pulse, beginning of cardiopulmonary resuscitation. After 2 minutes, the patient regained effective circulation but remained unconscious. Intubation and hospitalization. Brain scan shows massive hemorrhagic left temporo-occipital stroke, with meningeal hemorrhage, ventricular flooding and subfalcoral involvement. Differential diagnosis: Prostate cancer and bronchial cancer undergoing treatment, metastatic to the brain for the second. The patient died on 10May2021 at 11:30. The events were assessed as serious (caused hospitalization and death). An autopsy was not performed. No follow-up attempts are possible, information about the batch number cannot be obtained.; Reported Cause(s) of Death: Haemorrhagic stroke; he was found unconscious with noisy breathing; he was found unconscious with noisy breathing/heavy breathing; On arrival of the rescue team: agonal breathing, no pulse; On arrival of the rescue team: agonal breathing, no pulse


VAERS ID: 1441444 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-04
Onset:2021-02-21
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-22
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes (under diet); Living in nursing home
Allergies:
Diagnostic Lab Data: Test Date: 20210221; Test Name: scanner; Result Unstructured Data: Test Result:stroke confirmed
CDC Split Type: FRPFIZER INC2021728623

Write-up: CVA; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-LY20212642. An 84-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 04Feb2021 (Batch/Lot Number: EJ6788) as dose 1, single for COVID-19 immunisation. Medical history included diabetes (under diet) and living in residential institution. The patient''s concomitant medications were not reported. On 21Feb2021, the patient experienced cerebrovascular accident (CVA). An "absence" was noted by the nursing staff of the nursing home where the female patient lives (as reported). Stroke was suspected. The female patient was then taken to the emergency room for an assessment. A stroke was confirmed on the scanner. On 21Feb2021, patient had worsening of the condition in the aftermath. Treatment administered to patient (as reported). The patient underwent lab tests and procedures which included scanner: stroke confirmed on 21Feb2021. The patient died on 22Feb2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: CVA


VAERS ID: 1441479 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-09
Onset:2021-05-13
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood creatinine, Blood glucose, Blood lactic acid, Diarrhoea, Fall, Glomerular filtration rate, Hypoglycaemia, Multiple organ dysfunction syndrome, Oxygen saturation, PCO2, PO2, Sepsis, Troponin, Whole body scan, pH body fluid
SMQs:, Hyperglycaemia/new onset diabetes mellitus (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), Pseudomembranous colitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (narrow), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-17
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LASILIX [FUROSEMIDE]; ELIQUIS; TEMERIT; BIPRETERAX [INDAPAMIDE;PERINDOPRIL ARGININE]; TAHOR; EUPANTOL; FUMAFER; TRAMADOL; ZYLORIC; SPIRIVA; MACROGOL; LOXEN [NICARDIPINE HYDROCHLORIDE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arrhythmia; Atrial fibrillation; Dyslipidemia; Gout; Hip replacement; Hypertension; Inguinal hernia; Obesity; Sleep apnea syndrome
Allergies:
Diagnostic Lab Data: Test Date: 20210517; Test Name: serum creatinine; Result Unstructured Data: Test Result:500 ?M; Test Date: 20210517; Test Name: hypoglycemia; Result Unstructured Data: Test Result:0.47 g/l; Test Date: 20210517; Test Name: lactates; Result Unstructured Data: Test Result:9.5 mM; Test Date: 20210517; Test Name: GFR; Result Unstructured Data: Test Result:9 ml/min; Test Date: 20210517; Test Name: oxygen saturation; Test Result: 98 %; Comments: under 3 L of O2; Test Date: 20210517; Test Name: PCO2; Result Unstructured Data: Test Result:28 mmHg; Test Date: 20210517; Test Name: pH; Result Unstructured Data: Test Result:7.15; Test Date: 20210517; Test Name: PO2; Result Unstructured Data: Test Result:127 mmHg; Test Date: 20210517; Test Name: troponin; Result Unstructured Data: Test Result:35.2 ug/L; Test Date: 20210517; Test Name: Thoraco-abdomino-pelvic scanner; Result Unstructured Data: Test Result:absence of visible mediastinal; Comments: absence of visible mediastinal or hilar lymphadenopathy. Cardiomegaly. No pleural or pericardial effusion. Absence of significant parenchymal abnormality, in particular alveolar condensation syndrome. Normal appearance of the bronchi. Homogeneous dysmorphic hepatomegaly, apart from a probable biliary cyst in segment IV of the right liver. No dilation of the intrahepatic bile ducts. Moderate global atrophy of the pancreas. No splenomegaly. Presence of bilateral renal cysts measuring at most approximately 75 mm at the level of the upper left pole with exorenal development. No dilation of the pyelocaliciel cavities. Calcified aortic atheromatosis without aneurysm. No visible lumbar-aortic or pelvic lymphadenopathy. Respect of pelvic fatty spaces. Numerous metallic artefacts at the pelvic level related to hip prostheses. No peritoneal effusion. Left inguinal hernia without sign of pain.
CDC Split Type: FRPFIZER INC2021728669

Write-up: Sepsis; fall due to sepsis; Multi organ failure; Hypoglycaemia; diarrhea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20211988. An 83-year-old male patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 09May2021 (Batch/Lot Number: EX6537) as dose 1, single for COVID-19 immunisation. Medical history included complete arrhythmia by atrial fibrillation, hypertension, dyslipidemia, paired sleep apnea syndrome, bilateral total hip prosthesis, obesity, inguinal hernia, and gout. Concomitant medications included furosemide (LASILIX), apixaban (ELIQUIS), nebivolol hydrochloride (TEMERIT), indapamide, perindopril arginine (BIPRETERAX), atorvastatin calcium (TAHOR), pantoprazole sodium sesquihydrate (EUPANTOL), ferrous fumarate (FUMAFER), tramadol, allopurinol (ZYLORIC), tiotropium bromide (SPIRIVA), macrogol, and nicardipine hydrochloride (LOXEN); all taken for unspecified indications, start and stop dates were not reported. The patient experienced diarrhea, sepsis and fall on 13May2021, and experienced multi organ failure and hypoglycaemia on 17May2021. The events were reported as follows: On 13May2021, there was occurrence of diarrhea. On 15May2021, there was hospitalization for management of a fall due to sepsis. On 16May2021, there was worsening of the patient''s general condition. Patient recused from intensive care due to his medical history. On 17May2021, hypoglycemia occurred in the morning at 0.47 g / L, not rising despite the injection of 14 ampoules of G30. The lab tests included: pH 7.15, PCO2 28 mmHg, P02 127 mmHg, Sat O2 98% under 3 L of O2, lactates 9.5 mM, troponin 35.2 ug / l; Thoraco-abdomino-pelvic scanner: absence of visible mediastinal or hilar lymphadenopathy. Cardiomegaly. No pleural or pericardial effusion. Absence of significant parenchymal abnormality, in particular alveolar condensation syndrome. Normal appearance of the bronchi. Homogeneous dysmorphic hepatomegaly, apart from a probable biliary cyst in segment IV of the right liver. No dilation of the intrahepatic bile ducts. Moderate global atrophy of the pancreas. No splenomegaly. Presence of bilateral renal cysts measuring at most approximately 75 mm at the level of the upper left pole with exorenal development. No dilation of the pyelocaliciel cavities. Calcified aortic atheromatosis without aneurysm. No visible lumbar-aortic or pelvic lymphadenopathy. Respect of pelvic fatty spaces. Numerous metallic artefacts at the pelvic level related to hip prostheses. No peritoneal effusion. Left inguinal hernia without sign of pain. Multiple organ failure with acute non-obstructive renal failure with GFR 9 mL / min (serum creatinine 500 uM) and rhabdomyolysis leading to death at 3:30 p.m. An autopsy was planned (as reported). Conclusion: 83-year-old patient who presented with sepsis with multi-organ failure and severe hypoglycemia with fatal outcome following vaccination with COMIRNATY (COVID-19 vaccine). The patient died on 17May2021. The outcome of fall and diarrhea was unknown. An autopsy was performed, and results were not provided. The possible imputability, established according to the usual method (Official Bulletin of the health agency) is obviously without prejudice to the elements investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. No further information is expected; Reported Cause(s) of Death: Multi organ failure; Hypoglycaemia; Sepsis


VAERS ID: 1441480 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-05-09
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Coma scale, Computerised tomogram head, Haemorrhagic stroke, Platelet count, Prothrombin level
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fractured vertebra (compression); Hepatitis C (cured HCV infection); Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210509; Test Name: activated partial thromboplastin time; Result Unstructured Data: Test Result:0.83; Test Date: 20210509; Test Name: glasgow; Result Unstructured Data: Test Result:3; Test Date: 20210509; Test Name: brain ct scan; Result Unstructured Data: Test Result:Right frontal lobe hematoma; Comments: Right frontal lobe hematoma with sub-falcor involvement. Acute subdural hematoma of the right convexity. Subarachnoid hemorrhage with tetraventricular flooding.; Test Date: 20210509; Test Name: platelets; Result Unstructured Data: Test Result:237 g/l; Test Date: 20210509; Test Name: prothrombin leve; Test Result: 88 %
CDC Split Type: FRPFIZER INC2021728659

Write-up: Haemorrhagic stroke; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NC20212054. A 78-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 24Apr2021 (Batch/Lot Number: Unknown) as dose 1, single for covid-19 immunisation. Medical history included hypertension, cured HCV infection, and vertebral compression. On 09May2021, the patient experienced haemorrhagic stroke. Clinical course was reported as follows. On 09May2021, onset at the beginning of the afternoon of discomfort with headache, neck pain and hypertension. Emergency hospitalization due to the occurrence of neurological deterioration. When admitted, the patient was Glasgow 3. Brain CT scan: Right frontal lobe hematoma with sub-falcor involvement. Acute subdural hematoma of the right convexity. Subarachnoid hemorrhage with tetraventricular flooding. Prothrombin level: 88%, activated partial thromboplastin time: 0.83, platelets: 237 G / L. Death of the patient on 09May2021 at 9:25 p.m. Evolution: death due to the effect. It was not reported if an autopsy was performed. Conclusion: 78-year-old patient who presented with a fatal haemorrhagic stroke 2 weeks after vaccination with COMIRNATY (COVID-19 vaccine). The possible imputability, established according to the usual method is obviously without prejudice to the elements investigations which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts possible. No further information expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: Haemorrhagic stroke


VAERS ID: 1441481 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-05-06
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET7205 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Hypertension; Knee arthroplasty; Overweight; Sleep apnea
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728655

Write-up: Death unexplained/dead; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NC20212057, Safety Report Unique Identifier FR-AFSSAPS-2021060103. An 81-year-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 06Apr2021 (Batch/Lot Number: ET7205) as dose 2 single for covid-19 immunisation. Medical history included overweight, diabetes from 1999, hypertension from 2005, sleep apnoea from 2018 and right total knee arthroplasty in 2019. The patient''s concomitant medications were not reported. The patient previously received dose 1 of Comirnaty on 09Mar2021, administered in the right arm (lot number: EP9605) for Covid-19 immunization and experienced Bullous pemphigoid. On 06May2021, the patient was declared dead/death unexplained however was found dead on 07May2021 next to his bed with his blanket. The patient died on 06May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1441500 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-01
Onset:2021-06-06
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MOPRAL [OMEPRAZOLE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diverticulitis; Foot surgery (with revision surgery and infection (staphylococcal sepsis)); Staphylococcal septicaemia
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728703

Write-up: Heart arrest; This is a spontaneous report from a contactable pharmacist downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-NT20212040, Safety Report Unique Identifier FR-AFSSAPS-2021071274. A 60-year-old male patient received the second dose of BNT162B2 (COMIRNATY, solution for injection), intramuscular on 01Jun2021 (Lot number was not reported) as dose 2, single for COVID-19 immunisation. Medical history included Foot surgery in 2010 with revision surgery and infection (staphylococcal sepsis); and diverticulitis from an unknown date and unknown if ongoing. It was not reported if patient had prior COVID nor did he get tested. Concomitant medication included omeprazole (MOPRAL) occasionally taken for an unspecified indication, start and stop date were not reported. Patient who was a restaurateur received the second injection of COMIRNATY on 01Jun2021. Cardiac arrest was observed at home on 06Jun2021, followed by the death of the patient after 1 hour of resuscitation (rescue intervention, adrenaline). The patient had no cardiac history, was not taking any chronic treatment. After questioning his wife, no evocative signs the previous days. The patient was athletic and had received a first injection of COMIRNATY in early May2021, he then felt very tired. The patient died on 06Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: Heart arrest


VAERS ID: 1441512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-25
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Body mass index, Death, Nausea, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthralgia; Insomnia; Tabaquism
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:25.7
CDC Split Type: FRPFIZER INC2021728681

Write-up: Death unexplained; Epigastralgia; Pain in arm; Emesis; Nausea; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-NY20211311. A 57-year-old female patient received bnt162b2 (COMIRNATY, lot EX7389), intramuscular on 06May2021 as dose 2, single for Covid-19 immunisation. Medical history included smoking (tabaquism), insomnia and arthralgia. She had her first dose of bnt162b2 on 07Apr2021 (lot number: EW2239) intramuscularly. The patient''s concomitant medications were not reported. On 25May2021 she had emesis/vomiting, nausea and pain in left arm; had epigastralgia on 26May2021 (all medically significant). The patient died from unexplained death on 26May2021. She was found dead leaning in couch. Her husband had tried to call her about 11:00 AM and had no response. When she was found, she was dead since a few hours. The family finally refused autopsia (was not performed). The outcome of nausea, emesis, epigastralgia and pain in arm was not recovered. Reporter comments: No recent ECG. No toxicological assessment. Autopsy under discussion. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unexplained death


VAERS ID: 1441573 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-19
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW2239 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute chest syndrome, Anti-platelet antibody, Bacterial test, Blood bilirubin, Blood gases, Body temperature, C-reactive protein, Cardiac arrest, Coma, Condition aggravated, Emergency care examination, Haemoglobin, Oxygen saturation, PCO2, PO2, Platelet count, Respiratory failure, Respiratory rate, Sickle cell anaemia with crisis, Tachycardia, Thrombocytopenia, Troponin, White blood cell count, X-ray, pH body fluid
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haematopoietic thrombocytopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-24
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness: Hospitalization
Preexisting Conditions: Medical History/Concurrent Conditions: Drepanocytosis (heterozygous sickle cell anemia S/B+); Hospitalization (Last hospitalization for CVO (crise vaso-occlusive) in Nov2011); Pain; Sickle cell anemia; Thalassaemia; Vaso-occlusive crisis (monitored for several crise vaso-occlusive (2 to 3 / years)); Vaso-occlusive crisis
Allergies:
Diagnostic Lab Data: Test Date: 20210523; Test Name: anti PF4 A; Test Result: Negative ; Test Name: antigenemia tests; Test Result: Negative ; Comments: Pneumococcus and Legionella; Test Date: 20210521; Test Name: bilirubin; Result Unstructured Data: Test Result:63 umol/l; Test Date: 20210521; Test Name: GDS; Result Unstructured Data: Test Result:5; Comments: under 5 l/min; Test Date: 20210521; Test Name: body temperature; Result Unstructured Data: Test Result:38.3 Centigrade; Test Date: 20210521; Test Name: CRP; Result Unstructured Data: Test Result:275 mg/l; Test Date: 20210520; Test Name: On arrival at the emergency room; Result Unstructured Data: Test Result:the patient is afebrile without any notion of shiv; Comments: the patient is afebrile without any notion of shivering or contagion at home; Test Name: hemoglobin; Result Unstructured Data: Test Result:10-10.5 g/dl; Comments: a baseline hemoglobin level; Test Date: 20210521; Test Name: hemoglobin; Result Unstructured Data: Test Result:8.6 g/dl; Test Date: 20210520; Test Name: saturation in ambient air; Test Result: 100 %; Test Date: 20210521; Test Name: pCO2; Result Unstructured Data: Test Result:38 mmHg; Test Date: 20210521; Test Name: ph; Result Unstructured Data: Test Result:7.43; Test Date: 20210520; Test Name: platelets; Result Unstructured Data: Test Result:237 g/l; Test Date: 20210521; Test Name: platelets; Result Unstructured Data: Test Result:102 g/l; Test Date: 20210522; Test Name: platelets; Result Unstructured Data: Test Result:64 g/l; Test Date: 20210523; Test Name: platelets; Result Unstructured Data: Test Result:55 g/l; Test Date: 20210521; Test Name: pO2; Result Unstructured Data: Test Result:100 mmHg; Test Date: 20210520; Test Name: respiratory rate; Result Unstructured Data: Test Result:14; Comments: mvt/min; Test Date: 20210521; Test Name: respiratory rate; Result Unstructured Data: Test Result:6; Comments: l/min; Test Date: 20210524; Test Name: respiratory rate; Result Unstructured Data: Test Result:4; Comments: l/min; Test Date: 20210520; Test Name: tachycardia; Result Unstructured Data: Test Result:100; Comments: bpm; Test Date: 20210521; Test Name: Troponin; Result Unstructured Data: Test Result:71.9 ng/L; Test Date: 20210521; Test Name: leukocytes; Result Unstructured Data: Test Result:14600; Test Date: 20210524; Test Name: pulmonary x-ray; Result Unstructured Data: Test Result:bilateral infiltrates
CDC Split Type: FRPFIZER INC2021728714

Write-up: Acute chest syndrome; Thrombocytopenia; Vaso-occlusive crisis; Condition aggravated; Arrest cardiac; Coma; Respiration failure; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-PB20213309. A 43-year-old male patient received bnt162b2 (COMIRNATY, Lot Number: EW2239), intramuscular on 11May2021 as dose 1, single for COVID-19 vaccination. The patient medical history included drepanocytosis, thalassaemia, heterozygous sickle cell anemia S/B+ with multiple complications was monitored for several CVOs (crise vaso-occlusive) (2 to 3 / years) with a baseline hemoglobin level of 10-10.5 g / dL and who was included in a bleeding protocol. Last hospitalization for CVO (crise vaso-occlusive) in Nov2011. CVO (crise vaso-occlusive) pain in the left foot and in the right shoulder since 07May2021 with analgesia taken at home: Tramadol with Acupan but persistent pain despite repeated analgesics. Consult 09May2021 for increased pain. In addition, no clear triggering factor for CVO (Central crise vaso-occlusive) identified: no sport, no infectious argument (no cough, no pain, normal transit and urination), no change in hydration or introduction of new drugs. Hospitalization from 09May2021 to 12May2021, return home on paracetamol, Acupan and tramadol. The patient''s concomitant medications were not reported. The vaccination happened during hospitalization by Comirnaty (Dose 1, lot: EW2239) on 11May2021. On 19May2021, the patient experienced vaso-occlusive crisis/condition aggravated. On 20May2021, the patient experienced acute chest syndrome and thrombocytopenia. On 21May2021, the patient experienced respiratory failure. On 23May2021, the patient experienced coma. On 24May2021 the patient experienced arrest cardiac. Clinical course details: The patient was hospitalized again on 20May2021 for pelvic pain, and bilateral basal chest pain that appeared overnight, with a feeling of dyspnea, no cough, little sputum. The patient took tramadol at home to try to relieve the pain. On arrival at the emergency room: the patient was afebrile without any notion of shivering or contagion at home, tachycardia at 100 bpm, eupneic in ambient air with a respiratory rate of 14 mvt / min, and 100% saturation in ambient air. During hospitalization: on the cardiovascular level: no syncope, no palpitation, no signs of heart failure, auscultation without any abnormalities found, no signs of TVP (thrombose veineuse profonde), no signs of venous insufficiency, palpable and symmetrical pulse, no signs of peripheral hypoperfusion, free ganglionic areas; on the respiratory: bilateral chest pain at the bases, no cough, little sputum, no signs of respiratory distress, hypoxia or hypercapnia, auscultation without any abnormalities found. Clinical degradation on the night of 21May2021 with appearance of desaturation with polypnea and fever at 38.3 C, well tolerated from a haemodynamic point of view. GDS (Blood gas (arterial)) under 5L / min: pH 7.43, pCO2 38mmHg, pO2 100mmHg. Increase in biological inflammatory syndrome with 14,600 leukocytes and CRP 275mg / L, Troponin 71.9ng / L, Hb 8.6g / dL with bilirubin 63?mol / L. Introduction of probabilistic antibiotic therapy with TAZOCILLIN ROVAMYCINE, realization of antigenemia tests which were negative (Pneumococcus and Legionella) and transfer to intensive care. Eupneic under 6L / min, dyspnea at the slightest effort. No sign of respiratory distress, no sign of hypercapnia. No cough, no sputum, no hemoptysis. Bilateral and symmetrical vesicular murmur with crackling of the 2 bases. In the Cardiovascular level: No chest pain, no palpitations. No sign of peripheral hypoperfusion. Regular tachycardic heart sounds with no added noise, no signs of heart failure, no TJ (jugular turgor), no RHJ (hepato-jugular reflux). Soft and painless calves, non-edematous. In the Neurological level: Glasgow 15, conscious and oriented patient. No headache. No sensitivo-motor deficit of the 4 limbs. No abnormality of the cranial pairs. In conclusion: Acute hypoxemic chest syndrome possibly on D17 of a COVID vaccination. Lack of formal arguments for a current superinfection, continuation of probabilistic antibiotic therapy with TAZOCILLINE. On 24May2021, clinical improvement in pain during the day according to the patient, less dyspnea under 4L O2 / min, apyrexia. On pulmonary x-ray, bilateral infiltrates. In the evening, there was a call because the patient seemed to be in pain, taking vital signs without particularities. New call was made, disturbances of consciousness then coma. There was a call of the resuscitator due to clinical deterioration, then cardiac arrest, massage 30 minutes. Death certificate at 11:59 PM. Search for anti-PF4 carried out on a sample of 23May2021 negative because platelets fall (237 G / L on 20May2021 then 102 on 21May2021 then 64 on 22May2021 then 55 on 23May2021). Therapeutic measures were taken as a result of vaso-occlusive crisis/condition aggravated, acute chest syndrome, thrombocytopenia, respiratory failure and coma. The events vaso-occlusive crisis/condition aggravated, acute chest syndrome, thrombocytopenia resulted in emergency room visit. The patient was hospitalized from 20May2021 due to vaso-occlusive crisis/condition aggravated, acute chest syndrome, thrombocytopenia, and prolonged hospitalization due to respiratory failure and coma. The outcome of arrest cardiac was fatal; while not recovered from the other events. The patient died on 24May2021. Cause of death was arrest cardiac. It was unknown if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1441592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-04
Onset:2021-05-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac arrest, 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), Cardiomyopathy (broad), Respiratory failure (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ESOMEPRAZOLE; VERATRAN; EPINITRIL; ZYMAD; KARDEGIC; TIAPRIDE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Alzheimer''s disease; Asymptomatic COVID-19; Cardiac failure congestive; Chronic obstructive airways disease; Disease coronary artery; Osteoporosis; Skull trauma
Allergies:
Diagnostic Lab Data: Test Date: 20201110; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728804

Write-up: dies suddenly without prior clinical manifestations/cardiovascular origin/arrest cardiac; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-RE20211438. Safety Report Unique Identifier: FR-AFSSAPS-2021053838. A 92-year-old male patient received bnt162b2 (COMIRNATY, lot number: ET6956), intramuscular, administered in the left arm on 04May2021, dose 2, single for COVID-19 immunization. Medical history included Disease coronary artery, Cardiac failure congestive, Chronic obstructive airways disease, skull trauma, osteoporosis, Alzheimer''s disease all from an unknown date and unknown if ongoing and contracted COVID-19 (asymptomatic) with a positive COVID-19 virus test on 10Nov2020. The patient was considered to be at risk of developing a severe form of the COVID-19 disease. Concomitant medications included esomeprazole (manufacturer unknown); clotiazepam (VERATRAN); glyceryl trinitrate (EPINITRIL); colecalciferol (ZYMAD); acetylsalicylate lysine (KARDEGIC) and tiapride (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of bnt162b2 on an unknown date for COVID-19 immunization. On 05May2021, the patient dies suddenly without prior clinical manifestations at 10:45 a.m. He had no symptoms that could be related to vaccination in the first 23 hours after vaccination. The death certificate evokes a cardiovascular origin/arrest cardiac in view of the patient''s cardiovascular history. The patient died on 05May2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Arrest cardiac


VAERS ID: 1441596 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-03-28
   Days after onset: 9
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: JANUVIA [SITAGLIPTIN PHOSPHATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hepatitis C positive; Hernia hiatal; Tetanus; Type 2 diabetes mellitus (treated with Januvia)
Allergies:
Diagnostic Lab Data: Test Date: 20210319; Test Name: blood test; Result Unstructured Data: Test Result:normal; Comments: except for a slight disturbance of the hepatic test due to hepatitis C; Test Date: 20210319; Test Name: hepatic assessment; Result Unstructured Data: Test Result:slight disturbance of the hepatic test due to hepa; Comments: slight disturbance of the hepatic test due to hepatitis C
CDC Split Type: FRPFIZER INC2021728588

Write-up: Death; notion of malaise with loss of consciousness; notion of malaise with loss of consciousness; intense asthenia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-RN20211009. A 97-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in left arm on 18Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included hernia hiatal, tetanus, hepatitis c positive, diabetes type 2 (treated with januvia). The patient had no history of covid-19 and was not tested for covid-19. Concomitant medication included sitagliptin phosphate (JANUVIA) taken for type 2 diabetes and use of antipyretics. On 19Mar2021, the day after the injection, the patient experienced intense asthenia, no flu syndrome, notion of malaise with loss of consciousness without further details. This led to blood test on 19Mar2021 which was normal except for a slight disturbance of the hepatic assessment due to his hepatitis C. The patient was an autonomous patient in daily life. On 28Mar2021, the patient experienced death. Outcome of events notion of malaise with loss of consciousness and intense asthenia was unknown. The patient died on 28Mar2021. An autopsy was not performed. There was no autopsy or additional investigations planned. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: DEATH


VAERS ID: 1441603 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-29
Onset:2021-04-30
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EJ6788 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaemia postoperative, COVID-19 pneumonia, Cervical vertebral fracture, Computerised tomogram, Delirium, Discomfort, Faecaloma, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Accidents and injuries (narrow), Osteoporosis/osteopenia (broad), Infective pneumonia (narrow), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-06
   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: Benign prostatic hyperplasia; Fall; Hernia hiatal; Major neurocognitive disorder; Osteoporosis; Starvation
Preexisting Conditions: Medical History/Concurrent Conditions: Fecal impaction; Hip replacement; Malnutrition; Pulmonary tuberculosis; Subdural hematoma (bilateral dural operated)
Allergies:
Diagnostic Lab Data: Test Date: 20210503; Test Name: CT; Result Unstructured Data: Test Result:20% COVID-19 disease and aspiration pneumonia; Test Date: 20210423; Test Name: sars-cov-2 test pcr; Test Result: Negative ; Test Date: 20210426; Test Name: sars-cov-2 test pcr; Test Result: Negative ; Test Date: 20210430; Test Name: sars-cov-2 test pcr; Test Result: Positive ; Comments: weakly Positive; Test Date: 20210501; Test Name: sars-cov-2 test pcr; Test Result: Positive
CDC Split Type: FRPFIZER INC2021728649

Write-up: fracture of the femoral neck; hyperactive delirium; discomfort; Large fecaloma; Post-operative anemia; Vaccination failure; SARS-CoV-2 test positive/SARS-CoV-2 pneumonia; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB. The regulatory authority number is FR-AFSSAPS-RN20211493 with Safety Report Unique Identifier FR-AFSSAPS-2021058633. A 93-year-old male patient received BNT162B2 (COMIRNATY Solution for injection), intramuscular, on 29Jan2021 (Batch/Lot Number: EJ6788), as dose 2, single; and intramuscular, on 08Jan2021 (Batch/Lot Number: EM0477), as dose 1, single, for COVID-19 immunisation. Medical history included major neurocognitive disorder, starvation, hernia hiatal, benign prostatic hyperplasia/benign prostatic hypertrophy, osteoporosis, and repetitive falls, all from unknown dates and ongoing; sub-hematoma (bilateral dural operated, as reported), hip replacement, malnutrition, fecal impaction, pulmonary tuberculosis in 2008, not reported if ongoing or not. The patient''s concomitant medications were not reported. On 25Apr2021, the patient was operated on for a fracture of the femoral neck (placement of an intermediate prosthesis). The patient experienced post-operative anemia and large fecaloma of favorable evolution (onset dates not reported). On 30Apr2021, the patient experienced vaccination failure and was SARS-CoV-2 test positive. On 02May2021, the patient developed COVID-19 infection with involvement of the lung parenchyma. On 03May2021, CT showed 20% COVID-19 disease and aspiration pneumonia. SARS-CoV-2 pneumonia was reported. There was difficulty in oxygen therapy in the face of agitation related to hyperactive delirium (onset date not reported). Increase in analgesics and addition of sedative were done for discomfort and dyspnea. The patient underwent SARS-CoV-2 test PCR which was negative on 23Apr2021, negative on 26Apr2021, weakly positive on 30Apr2021 and positive on 01May2021. The patient was recovering from large fecaloma (reported as favorable evolution). The outcome of the events vaccination failure and SARS-CoV-2 test positive/SARS-CoV-2 pneumonia was fatal. The outcome of the remaining events was unknown. The patient died on 06May2021. It was not reported if an autopsy was performed. Note: Subject to other elements of investigations which could be carried out within the framework of legal or amicable compensation procedures. Official bulletin of the Ministry in charge of health. On 21Jun2021, investigation result for lot number EJ6788 was received. The result was reported as follows: The complaint for adverse event/LOE of "PFIZER-BIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation and an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot EJ6788. 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. Company concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No follow up attempts needed. No further information is expected.; Reported Cause(s) of Death: Vaccination failure; SARS-CoV-2 test positive/SARS-CoV-2 pneumonia


VAERS ID: 1441607 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-02-18
Onset:2021-05-01
   Days after vaccination:72
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 2 RA / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Cardiac arrest, Death
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: 2021-05-01
   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: TEGLUTIK; ALPRAZOLAM; BISOPROLOL; LANSOPRAZOLE; SCOPODERM [HYOSCINE]; TIORFAN; SMECTA [DIOSMECTITE]
Current Illness: Diarrhea
Preexisting Conditions: Medical History/Concurrent Conditions: Amyotrophic lateral sclerosis; Frontotemporal dementia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 20210129; Test Name: Potassium; Result Unstructured Data: Test Result:4.3 mmol/L; Test Date: 20210313; Test Name: Potassium; Result Unstructured Data: Test Result:4.2 mmol/L; Test Date: 20210413; Test Name: Potassium; Result Unstructured Data: Test Result:3.9 mmol/L; Test Date: 20210423; Test Name: Potassium; Result Unstructured Data: Test Result:3.6 mmol/L
CDC Split Type: FRPFIZER INC2021728638

Write-up: Death unexplained; cardiac arrest; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority. Regulatory Authority Report Number: FR-AFSSAPS-SE20210992. Safety Report Unique Identifier: FR-AFSSAPS-2021050515. A 66-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in Arm Right on 29Apr2021 (Lot Number: ET6956) as DOSE 2, SINGLE for COVID-19 immunisation; domperidone (DOMPERIDONE ARROW), via an unspecified route of administration from 25Feb2021 (Batch/Lot Number: Unknown) to an unspecified date, at 30 mg, 1x/day for an unspecified indication; escitalopram oxalate (ESCITALOPRAM ARROW), via an unspecified route of administration from an unspecified date (Batch/Lot Number: Unknown) to an unspecified date, at 10 mg, 1x/day, long-term treatment for an unspecified indication; cyamemazine tartrate (TERCIAN), via an unspecified route of administration from 18Feb2021 (Batch/Lot Number: Unknown) to an unspecified date, at 5 mg, 1x/day, via an unspecified route of administration from 02Mar2021 (Batch/Lot number was not reported) to an unspecified date, at 10 mg, 1x/day for an unspecified indication. Medical history included ongoing diarrhea from 21Apr2021; amyotrophic lateral sclerosis, frontotemporal dementia, hypertension from an unknown date. Concomitant medications included riluzole (TEGLUTIK) taken for an unspecified indication, start and stop date were not reported; alprazolam taken for an unspecified indication, start and stop date were not reported; bisoprolol taken for an unspecified indication, start and stop date were not reported; lansoprazole taken for an unspecified indication, start and stop date were not reported; hyoscine (SCOPODERM) taken for an unspecified indication, start and stop date were not reported; racecadotril (TIORFAN) taken for an unspecified indication, start and stop date were not reported; diosmectite (SMECTA) taken for an unspecified indication from 22Apr2021 to an unspecified stop date. The patient haven''t had COVID-19 or been tested for COVID-19. On 01May2021, the patient had death unexplained within 48 hours of the dose 2 of vaccination of COMINARTY, without precursor sign or deterioration of the state of health except for diarrhea since 21Apr2021. Probable sudden cardiac arrest without prodrome in 2021. In palliative care of an ALS (amyotrophic lateral sclerosis) with neurological degradation over the last weeks, totally dependent, under enteral nutrition by gastrostomy. It was concluded: death occurred 48 hours after dose 2 of COMIRNATY in a patient under palliative management of ALS. Note the introduction in February 2021 of treatment with TERCIAN and DOMPERIDONE in a patient who was already on long-term ESCITALOPRAM (with risk of cardiac disorders). The patient underwent laboratory tests which included biology: potassium 4.3 mmol / l on 29Jan2021, potassium 4.2 mmol / l on 13Mar2021, potassium 3.9 mmol / l on 13Apr2021 and potassium 3.6 mmol / l on 23Apr21. The patient died on 01May2021. It was not reported if an autopsy was performed. The outcome of cardiac arrest was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death unexplained


VAERS ID: 1441608 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-30
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET6956 / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood triglycerides, Cardiac arrest, Chest discomfort, Death, Dyspnoea, Haemoptysis, High density lipoprotein, Low density lipoprotein
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-30
   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: NEBIVOLOL; AMLODIPINE; ROSUVASTATINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker (30 packages / year in 2006); Hypercholesterolaemia; Hypertension arterial
Allergies:
Diagnostic Lab Data: Test Date: 2018; Test Name: Triglycerides; Result Unstructured Data: Test Result:0.98 g/l; Test Date: 2018; Test Name: HDL cholesterol; Result Unstructured Data: Test Result:0.85 g/l; Test Date: 2018; Test Name: LDL cholesterol; Result Unstructured Data: Test Result:2.31 g/l
CDC Split Type: FRPFIZER INC2021728628

Write-up: unexplained death; probable cardiac arrest; "tightness" in the chest; difficulty in breathing; hemoptysis; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is [FR-AFSSAPS-SE20210994] and Safety Report Unique Identifier [FR-AFSSAPS-2021050579]. A 71-year-old female patient received bnt162b2 (COMIRNATY), intramuscular on 21Apr2021 (Lot Number: ET6956) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included hypertension arterial, hypercholesterolaemia; both from unknown date; and tobacco cessation (30 packages / year in 2006) from unknown date to unknown date. Concomitant medications included nebivolol, amlodipine and rosuvastatine; all taken for an unspecified indication, start and stop date were not reported. It was not reported if the patient had COVID-19 or if patient has been tested. On 30Apr2021, the patient will present in the early evening "tightness" in the chest with difficulty in breathing. She will then present with hemoptysis, then had unexplained death at 21:00 p.m. from a probable cardiac arrest. The patient had underwent laboratory tests which included biology in 2018: LDL cholesterol 2.31 g / l, HDL cholesterol 0.85 g / l and triglycerides: 0.98 g / l. The patient died on 30Apr2021. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unexplained death


VAERS ID: 1441610 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC6997 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Aortic thrombosis, Blood cholesterol, Blood triglycerides, Body mass index, High density lipoprotein, Investigation, Low density lipoprotein, Sudden death
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-29
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CYMBALTA; LAROXYL
Current Illness: Depression; Small fibre neuropathy (front of neuropathic pain of the lower limbs evolving since the end of 2010 undetermined etiology)
Preexisting Conditions: Medical History/Concurrent Conditions: Appendectomy; Overweight (BMI of 25.7)
Allergies:
Diagnostic Lab Data: Test Date: 20161228; Test Name: total cholesterol; Test Result: 6.91 mmol; Comments: VN<6,21; Test Date: 20161228; Test Name: triglycerides; Test Result: 2.72 mmol; Comments: VN<1,70; Test Name: BMI; Result Unstructured Data: Test Result:25.7; Test Date: 20161228; Test Name: HDL; Test Result: 1.37 mmol; Comments: VN$g1,45; Test Date: 2014; Test Name: neuropathy assessment; Result Unstructured Data: Test Result:no hypertension, no diabetes; Test Date: 20161228; Test Name: LDL; Test Result: 4.3 mmol
CDC Split Type: FRPFIZER INC2021728806

Write-up: Aortic thrombosis; Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB FR-AFSSAPS-SE20211321, Safety Report Unique Identifier FR-AFSSAPS-2021066303 A 48-year-old male patient received the first dose of bnt162b2 (COMIRNATY, solution for injection), intramuscular, administered in Arm Left on 26May2021 (Lot Number: FC6997) as dose 1, single for COVID-19 immunisation. Medical history included depression from 2017 and ongoing, small fibre neuropathy in front of neuropathic pain of the lower limbs evolving since the end of 2010, of undetermined etiology from 2012 and ongoing, appendicectomy and slight overweight BMI of 25.7. Patient has no known allergies and no concept of smoking or alcoholism. Patient had no prior COVID. It is unknown if patient has been tested. Patient not a person at risk of developing a severe form of COVID-19. Concomitant medications included duloxetine hydrochloride (CYMBALTA) and amitriptyline hydrochloride (LAROXYL) taken for an unspecified indication, start and stop date were not reported. Both concomitant medications were reported to be taken by the patient long term. On 29May2021, getting up at 9 am (3 days after vaccination), the patient presented ''severe headaches and pain in one leg. He went back to bed. His wife and daughter went shopping; on their return, he slept in the bed. A moment later, they hear him ''breathing loudly'' (gasps most certainly). They called for help. Cardiopulmonary resuscitation is carried out as well as 2 uses of a semi-automatic defibrillator, no effect. The SMUR doctor pronounced the death at 11:45 am with medico-legal obstacle. An autopsy was performed on 02Jun2021: ''the forensic pathologist noted the presence of a 7.5 cm blood clot in the aorta. She could not confirm it, but this clot could be the result of the vaccination.'' Site of aortic thrombosis unknown; no access at this stage to the preliminary autopsy report. An anatomopathological analysis of the thrombus with dating was requested (usual time for reporting results: 3 months). Patient''s risk factors for arterial thrombosis: no notion of atheromatous inheritance, slight overweight (BMI at 25.7), no known smoking, no hypertension, no diabetes found in 2014 as part of the neuropathy assessment, no recent lipid assessment but the assessment of 28Dec2016 disturbed (total cholesterol at 6.91 mmol / l (VN <6.21); HDL at 1.37 mmol / l (VN$g 1.45); LDL at 4.30 mmol / l and triglycerides at 2.72 mmol / l (VN <1.70)). CONCLUSION: sudden death of a 48-year-old patient with no known cardiovascular history occurring 3 days after a 1st dose of COMIRNATY vaccine with evidence of a 7.5 cm aortic thrombosis at autopsy (preliminary report, awaiting dating of the thrombus). Therapeutic measures were taken as a result of aortic thrombosis (aortic thrombosis). The patient died on 29May2021. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: sudden death; aortic thrombosis


VAERS ID: 1441622 (history)  
Form: Version 2.0  
Age: 94.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-24
Onset:2021-04-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4815 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardio-respiratory arrest, SARS-CoV-2 test, Sudden death
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), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-04-24
   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: TEMERIT DUO; LEVOTHYROX
Current Illness: Hypertension arterial; Hypothyroidism
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: antigen covid-19 test; Test Result: Negative
CDC Split Type: FRPFIZER INC2021728642

Write-up: Sudden death; cardio-respiratory arrest (asystole, pupils in mydriasis); This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number FR-AFSSAPS-TS20211587, Safety Report Unique Identifier FR-AFSSAPS-2021050379. A 94-year-old female patient received bnt162b2 (COMIRNATY, Lot Number: EW4815), intramuscular on 24Apr2021 11:30 as dose number unknown, single for COVID-19 immunization. Medical history included ongoing arterial hypertension and ongoing hypothyroidism. Patient in good general condition. Concomitant medications included hydrochlorothiazide, nebivolol hydrochloride (TEMERIT DUO) taken for arterial hypertension and levothyroxine sodium (LEVOTHYROX) taken for hypothyroidism, both start and stop date were not reported. On 24Apr2021 17:00 (around 5 pm) at home after 15 minutes of absence from the entourage, found in cardio-respiratory arrest (in asystole, pupils in mydriasis), sitting on her sofa, mouth open. Patient was treated with external cardiac massage, intubation, adrenaline but no effective cardiac recovery. End of resuscitation at 6:10 p.m. and death certificate: sudden death without a prodrome, in 6 hours after vaccination. The patient died on 24Apr2021. An autopsy was not performed. Patient had antigen COVID-19 test on Apr2021 and was negative. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: cardio-respiratory arrest; sudden death


VAERS ID: 1441623 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-04-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX0893 / 1 - / 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: 2021-04-24
   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: Erysipelas; Pressure ulcer; Venous insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2021728647

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB with regulatory authority number FR-AFSSAPS-TS20211588 and Safety Report Unique Identifier is FR-AFSSAPS-2021050407. A 73-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular on 21Apr2021 (Lot Number: EX0893) as dose 1, single for covid-19 immunisation. Medical history included venous insufficiency, transient episodes of erysipelas and pressure ulcers (venous insufficiency and transient episodes of erysipelas, currently passing state registered nurse at home every day for treatment of pressure ulcers). The patient had no cardiovascular history. The patient''s concomitant medications were not reported. It was reported that a declaration via the reporting portal for a simple declaration of death. The patient was seen on 23Apr2021 by his son where everything was normal. On 24Apr2021, the patient was found dead in his bed by a doctor (sudden death). No sign on the body that could suggest a pulmonary embolism. Scientific autopsy desired by the doctor (but ultimately not performed). In total, unexplained death, 48 hours after the first dose of Comirnaty, in a patient with no particular history, living at home, and having normal activities, continued until the day before death. The outcome of the event was fatal. The patient died on 24Apr2021. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Sudden death


VAERS ID: 1441653 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-01-05
Onset:2021-01-06
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021132514

Write-up: Face presentation/ RH side of face dropped; Death; This is a spontaneous report from a contactable consumer received from the Regulatory Authority. The regulatory authority report number is GB-MHRA-WEBCOVID-202102042211546580, Safety Report Unique Identifier GB-MHRA-ADR 24705490. A 96-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 05Jan2021 as dose 2, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 15Dec2020 as dose 1, single for COVID-19 immunisation. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient has not tested positive for COVID-19 since having the vaccine. The patient experienced face presentation on 06Jan2021. It was reported that noticeable RH side of face dropped but not associated with any other reaction or pain or discomfort. Unfortunately (name) was now deceased. Reporter find it very surprising that as the Health Services certified his death that you are attempting to contact him. The event death was considered as serious (fatal) by the consumer. The outcome of the event face presentation was resolved on 10Jan2021 and fatal for the other event. The patient died on an unspecified date in 2021. An autopsy was not performed. No follow-up attempts are possible, information about batch number cannot be obtained.; Reported Cause(s) of Death: Death


VAERS ID: 1441717 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-02-05
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-02-05
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021737827

Write-up: Heart attack; 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-202106182144537980-GDIRG Safety Report Unique Identifier GB-MHRA-ADR 25502714. A 82-year-old male patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation.The patient medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. On 05Feb2021, patient had heart attack, collapsed & died suddenly outside his own flat. Ambulance & police attended. No attempt to resusitate was made. No doctor attended to confirm death. Relatives requested autopsy. Patient has not tested positive for COVID-19 since having the vaccine. It was not reported if an autopsy was performed. No follow-up attempts are possible, Information about batch number cannot be obtained.; Reported Cause(s) of Death: Heart attack


VAERS ID: 1441718 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-27
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Death, Dyspnoea, Haemoptysis, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Infective pneumonia (broad), COVID-19 (broad)

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Patient has not had symptoms associated with COVID-19 Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021773591

Write-up: Death; Shortness of breath; Coughing blood; Chest pain; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106182203135760-KIZAH and Safety Report Unique Identifier is GB-MHRA-ADR 25503136 . A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 13May2021 (Lot number was not reported) as first dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 27May2021, the patient experienced shortness of breath, coughing blood and chest pain with outcome of not recovered. On 27May2021, the patient experienced death unexplained. The patient underwent lab tests and procedures which included covid-19 virus test: No - Negative COVID-19 test on unspecified date. Patient has not tested positive for COVID-19 since having the vaccine. The patient died on 27May2021. It was unknown whether an autopsy was performed or not. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1441726 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-26
Onset:2021-05-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-26
   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: FOLIC ACID
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Pregnancy (Patient no longer pregnant at the time of reporting.); Vitamin supplementation
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test; Test Name: scan; Result Unstructured Data: Test Result:nothing wrong with her placenta or the baby; Comments: 12 week scan
CDC Split Type: GBPFIZER INC2021772466

Write-up: Maternal exposure during pregnancy; Miscarriage of pregnancy; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106211836307990-I0TYG, Safety Report Unique Identifier GB-MHRA-ADR 25513969. A 41-year-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 26May2021 as dose1, single for COVID-19 immunisation. Medical history included suppressed lactation and pregnancy, patient no longer pregnant at the time of reporting, vitamin supplementation. Concomitant medication included folic acid taken for vitamin supplementation. The patient experienced maternal exposure during pregnancy, first-trimester (12 weeks) on 26May2021 and miscarriage of pregnancy on 26May2021. In detail, the patient stated that the heartbeat of her perfectly formed and perfectly healthy baby stopped the same time she had the vaccine. Pregnancy ended the day of vaccine. 12 week scans say there was nothing wrong with her placenta or the baby. Patient has not tested positive for COVID-19 since. The patient underwent lab tests and procedures which included SARS-COV-2 test: no-negative covid-19 test on an unknown date. As per health authority outcome of miscarriage was fatal. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1441731 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Contusion, Epistaxis, Hallucination, Migraine, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (narrow), Termination of pregnancy and risk of abortion (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? Yes
   Date died: 2021-03-05
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021776658

Write-up: Miscarriage; Nosebleed; Bruise; Migraine; Hallucination; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202106230919115640-1PBPG, Safety Report Unique Identifier GB-MHRA-ADR 25523828. A female patient of unspecified age received Unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. On an unspecified date, the patient experienced nosebleed, bruise, migraine and hallucination. The above mentioned events were reported as serious with seriousness criteria as Disabling/Incapacitating, life threatening, and Other medically important condition. On an unspecified date, the patient experienced miscarriage with seriousness criteria as Results in death, congenital anomaly/birth defect, Disabling/Incapacitating, life threatening, and Other medically important condition. The patient underwent lab tests and procedures which included COVID-19 virus test on an unspecified date: negative (No - Negative COVID-19 test). The outcome of event nosebleed was not recovered, for events Bruise and hallucination was recovering, for event migraine was recovered on an unspecified date, and for event miscarriage was fatal. The patient died on 05Mar2021. It was not reported if an autopsy was performed. Patient has not tested positive for COVID-19 since having the vaccine. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Miscarriage


VAERS ID: 1441755 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-05-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-12
   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: Abdominal aortic aneurysm; Acute bronchitis (The patient received antibiotic treatment for acute bronchitis but a few days later fever and coughing occurred due to bronchopneumonia.); Chronic pancreatitis; Dementia; Hemiparesis (The patient was hospitalized from 22Apr/2021 after suffering a stroke with left-sided hemiparesis); Hypertension; Ischemic heart disease; Parkinsonism; Stroke (The patient was hospitalized from 22Apr2021 after suffering a stroke with left-sided hemiparesis.)
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: sars-cov-2 pcr test; Test Result: Negative ; Test Date: 20210510; Test Name: sars-cov-2 pcr test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021770880

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-455721. A 80-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 11May2021 (Batch/Lot Number: FA5829) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ischemic heart disease, hypertension, Parkinsonism, hemiparesis, dementia, chronic pancreatitis and abdominal aortic aneurism, stroke and Acute bronchitis. The patient''s concomitant medications were not reported. The patient was hospitalized from 22Apr2021 after suffering a stroke with left-sided hemiparesis. His general condition deteriorated after the brain infarction and developed a feverish state. The patient received antibiotic treatment for acute bronchitis but a few days later fever and coughing occurred due to bronchopneumonia. PCR tests done on 05May2021 and 10May2021 were both negative. On 12May2021 at 20:00 the patient passed away. The cause of death was cardiac insufficiency. Sender Comment: Based on the discharge summary, the adverse event is related to the patient''s primary cardiovascular diseases. The patient also had a stroke which contributed to his deteriorating state, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Sender''s Comments: The company does not attribute the patient''s death to BNT162b2 (COMIRNATY). The recent stroke and subsequent bronchopneumonia provide reasonable explanation for this elderly patient''s demise. Comorbidities ischemic heart disease, hypertension, and Parkinsonism might have played contributory role towards the deterioration of the general condition.; Reported Cause(s) of Death: cardiac insufficiency


VAERS ID: 1441756 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-05-12
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6537 / 2 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-14
   Days after onset: 2
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KALIUM-R; NEBILET; ULTIBRO BREEZHALER; XARELTO; COVEREX AS; CALCIVID; NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; MEGACE; MEFORAL [METFORMIN HYDROCHLORIDE]; APRANAX [NAPROXEN]; VENTOLIN [SALBUTAMOL]; MILURIT; RALGEN; XETER
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Bone metastases; COPD; Hypertension; Lung adenocarcinoma metastatic
Allergies:
Diagnostic Lab Data: Test Date: 202012; Test Name: Lab test; Result Unstructured Data: Test Result:acute kidney failure
CDC Split Type: HUPFIZER INC2021770881

Write-up: dyspnea; Death; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB HU-OGYI-455821. A 76-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular on 01May2021 07:07 (Batch/Lot Number: EX6537) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. Medical history included hypertension, COPD and atrial fibrillation, lung adenocarcinoma and bone metastases. Patient previously received the first dose of bnt162b2 (COMIRNATY) batch number: ET3620 on 27Mar2021 for covid-19 immunisation. Concomitant medication(s) included potassium chloride (KALIUM-R) taken for an unspecified indication, start and stop date were not reported; nebivolol hydrochloride (NEBILET) taken for an unspecified indication, start and stop date were not reported; glycopyrronium bromide, indacaterol maleate (ULTIBRO BREEZHALER) taken for an unspecified indication, start and stop date were not reported; rivaroxaban (XARELTO) taken for an unspecified indication, start and stop date were not reported; perindopril arginine (COVEREX AS) taken for an unspecified indication, start and stop date were not reported; calcium carbonate, colecalciferol (CALCIVID) taken for an unspecified indication, start and stop date were not reported; pantoprazole sodium sesquihydrate (NOACID [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) taken for an unspecified indication, start and stop date were not reported; megestrol acetate (MEGACE) taken for an unspecified indication, start and stop date were not reported; metformin hydrochloride taken for an unspecified indication, start and stop date were not reported; naproxen (APRANAX [NAPROXEN]) taken for an unspecified indication, start and stop date were not reported; salbutamol (VENTOLIN [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported; allopurinol (MILURIT) taken for an unspecified indication, start and stop date were not reported; tramadol hydrochloride (RALGEN) taken for an unspecified indication, start and stop date were not reported; rosuvastatin calcium (XETER) taken for an unspecified indication, start and stop date were not reported. The patient was hospitalized on 13May2021 after experiencing dyspnea for 2 days. In Aug2020 the patient was diagnosed with lung adenocarcinoma and bone metastases which was determined as inoperable. Between 21Dec2020-23Dec2021 the patient was treated in the Covid-19 Pulmonology Department. Laboratory result showed acute kidney failure. The patient received therapy, but his condition progressed and passed away on 14May2021 at 08:35 due to his lung metastases and cardiac decompensation. Sender Comment: Based on the discharge summary, the adverse event is related to the patient''s lung adenocarcinoma with metastases, therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information currently available, the pre-existing lung cancer disease progression might have contributed to the clinical course leading to the patient''s demise. However, unless further information regarding specific cause of death provided, at present, the reported event death, cause unknown, is assessed as possibly related to suspect drug, as a cautionary measure and for reporting purposes. Event dyspnea is due to the lung cancer and unrelated to suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identifies as part of this review, as well as any appropriate action in response, will be promptly notifies to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: cardiac decompensation; Lung adenocarcinoma metastatic


VAERS ID: 1441757 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-22
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW9127 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Disease recurrence, General physical health deterioration, Ileus paralytic, Neoplasm progression, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Malignancy related conditions (narrow), Gastrointestinal obstruction (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-03
   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: Medical History/Concurrent Conditions: Cachexia; Colon cancer; Hypertension; Ileus paralytic (emergency surgery in 2015); Prostate cancer (he received oncotherapy)
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: COVID-19 antigen test; Test Result: Negative ; Test Date: 20210428; Test Name: COVID-19 PCR test; Test Result: Negative
CDC Split Type: HUPFIZER INC2021770883

Write-up: continuously deteriorating general condition caused by cancer; continuously deteriorating general condition caused by cancer/lung and liver metastases; paralytic ileus; paralytic ileus; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB HU-OGYI-455921. A 77-year-old male patient received second dose bnt162b2 (COMIRNATY, Batch/Lot Number: EW9127), intramuscular administered in arm left on 09Apr2021 11: 30 at 0.3 mL single dose for covid-19 immunisation. Medical history included colon cancer from 2015 (not ongoing), cachexia, ileus paralytic (emergency surgery in 2015), hypertension, prostate cancer (for which he received oncotherapy). The patient had an emergency surgery in 2015 because of ileus where colon cancer was identified. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (COMIRNATY, batch number: EP2163) on 05Mar2021 for COVID-19 immunisation. The patient was hospitalized on 28Apr2021 because of paralytic ileus (on 22Apr2021) for which he received surgery. During surgery, lung and liver metastases were identified but were assessed as inoperable on 28Apr2021. The patient passed away on 03May2021 at 22:17 due to his continuously deteriorating general condition caused by cancer. The patient underwent lab tests included COVID-19 antigen test: negative on 28Apr2021, COVID-19 PCR test: negative on 28Apr2021. The outcome of events was fatal. The patient died on 03May2021. It was not reported if an autopsy was performed. Sender Comment: Based on the discharge summary, the adverse event is related to the patient''s primary disease (cancer with metastases), therefore the causal relationship is unlikely between the suspected drug and the adverse event. The case is considered serious because the outcome was fatal. Further information is not expected. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: paralytic ileus; paralytic ileus; continuously deteriorating general condition caused by cancer; continuously deteriorating general condition caused by cancer/lung and liver metastases


VAERS ID: 1441758 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5833 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-12
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ZIMOVANE; MIRTAZAPIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic insomnia; Depression; Polysubstance abuse (Known polysubstance misuse ongoing for years.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEPFIZER INC2021770520

Write-up: Sounds like a cardiorespiratory arrest. Post mortem pending; This is a spontaneous report from a contactable Physician downloaded from the Agency Regulatory Authority-WEB. Regulatory authority report number IE-HPRA-CVARR2021061510872 with Safety Report Unique Identifier IE-HPRA-2021-076528. A 45-year-old male patient received second dose of BNT162B2 (COMIRNATY, Batch/Lot Number: FA5833), via an unspecified route of administration at the age of 45-year-old on 12Jun2021 at 0.3 ml single dose for COVID-19 immunisation. Medical history included chronic insomnia, polysubstance misuse (Known polysubstance misuse ongoing for years) and depression. The patient previously received first dose of bnt162b2 (COMIRNATY, Batch/Lot number: EW6126) on 10May2021 at 0.3ml single dose for COVID-19 immunisation and no adverse reaction. Concomitant medications included zopiclone (ZIMOVANE) taken for chronic insomnia from 08Oct2004 to 12Jun2021; mirtazapine (MIRTAZAPIN) taken for depression from 22Aug2005 to 12Jun2021. The patient experienced sounds like a cardiorespiratory arrest, post mortem pending on 12Jun2021. The patient''s relative performed CPR until emergency services arrived. The duration of reaction was approximately one hour prior to death. The reporter outlined that the event sounds like a cardiorespiratory arrest and port-mortem was pending. The reporter also outlined that their clinical judgement was likely to be an underlying undiagnosed cardiovascular condition, and not sure if an inflammatory response to the vaccine was a precipitating event. The outcome of event was fatal. The patient died on 12Jun2021. 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: Sounds like a cardiorespiratory arrest. Post mortem pending


VAERS ID: 1441761 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EK4242 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood potassium, Cardiac failure, Chest X-ray, Electrocardiogram, Heart rate, Inflammatory marker test, Multiple organ dysfunction syndrome, Pneumonia, Renal failure, Respiratory failure, Septic shock
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac 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 (narrow), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), 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), Hypokalaemia (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; Dyslipidemia; Hypertension; Myocardial infarction
Allergies:
Diagnostic Lab Data: Test Name: difficulty balancing potassium; Result Unstructured Data: Test Result:difficulty balancing potassium; Test Name: chest x-ray; Result Unstructured Data: Test Result:impression of atypical pulmonary infection; Test Name: ECG; Result Unstructured Data: Test Result:death was determined; Test Name: pulse; Result Unstructured Data: Test Result:no pulse; Test Name: inflammatory indices; Result Unstructured Data: Test Result:increased
CDC Split Type: ILPFIZER INC2021785937

Write-up: heart failure; pneumonia; respiratory failure due to pneumonia; septic shock with multi-system damage, renal failure; septic shock with multi-system damage, renal failure; septic shock with multi-system damage, renal failure; This is a spontaneous report received from a contactable other HCP via MOH Epidemiology department. An 85-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Lot Number: EK4242) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypertension, dyslipidemia, diabetes, MI (Myocardial infarction). The patient''s concomitant medications were not reported. The patient was admitted due to shortness of breath and increased inflammatory indices, on chest X-ray impression of atypical pulmonary infection. Antibiotic treatment with tazocin and azenyl was started, followed by a deterioration in his condition, he was anesthetized and ventilated. The patient had a very severe septic shock with multi-system damage, renal failure, started dialysis treatment. Increased doses of noradrenalin were needed, difficulty balancing potassium despite dialysis. The patient continued with increased inflammatory indices, respiratory failure due to pneumonia. He had no pulse and no breathing, an ECG was performed and his death was determined. The cause of death was pneumonia and heart failure. The other events were not recovered. 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.; Sender''s Comments: The event pneumonia was considered as an intercurrent condition and unrelated to the use of bnt162b2. The events respiratory failure, septic shock with multi-system damage and renal failure were considered as secondary to pneumonia and therefore unrelated to bnt162b2. The patient''s advanced age and underlying co-morbidities also contributed to the occurrence of reported events. 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: heart failure; pneumonia


VAERS ID: 1441762 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-25
Onset:2021-05-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET2838 / 2 - / -

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

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis; Hyperlipidemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021785952

Write-up: She was found deceased; This is a spontaneous report received from a contactable other HCP via MOH Epidemiology department. An 89-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 25May2021 13:22 (Lot Number: ET2838) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Hyperlipidemia, gastritis, hypertension. The patient''s concomitant medications were not reported. The complex chronic nursing patient treated in the HOME CARE unit. She was vaccinated with the second Pfizer vaccine, arrived to the vaccination by ambulance. The next morning (26May2021) the nurse tried to wake her. She was found deceased. The patient died on 26May2021. It was not reported if an autopsy was performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Death with unknown cause is considered related to BNT162B2 for reporting purpose. Case will be reassessed once receiving additional information, including cause of death. 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: She was found deceased


VAERS ID: 1441775 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-31
Onset:2021-04-07
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER9470 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Acute kidney injury, Anuria, Arthralgia, Blood pressure measurement, Bradycardia, Cardiac arrest, Heart rate, Hepatic failure, Hyperhidrosis, Hypotension, Laboratory test, Nephrological examination
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Hepatic failure, fibrosis and cirrhosis and other liver damage-related conditions (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Arthritis (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-09
   Days after onset: 32
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NEBIVOLOL; LASIX [FUROSEMIDE]; TRIATEC [LOSARTAN POTASSIUM]; DEBRIDAT [TRIMEBUTINE]; CARDIOASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Decompensation cardiac; Femur fracture; Hypertension; Mastectomy
Allergies:
Diagnostic Lab Data: Test Date: 20210407; Test Name: blood pressure; Result Unstructured Data: Test Result:70 / 30; Test Date: 20210407; Test Name: heart rate; Result Unstructured Data: Test Result:30; Comments: 30 bpm; Test Name: blood chemistry; Result Unstructured Data: Test Result:unknown result; Test Name: nephrological reports; Result Unstructured Data: Test Result:unknown result
CDC Split Type: ITPFIZER INC2021728712

Write-up: diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; diffuse joint pain 02May2021: abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest.; This is a spontaneous report from a contactable physician downloaded from the Agency Regulatory Authority-WEB, regulatory authority number IT-MINISAL02-742143. A 96-year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administered in left arm on 31Mar2021 15:34 (Batch/Lot Number: ER9470; Expiration Date: 31Jul2021) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included femur fracture from 01Jan2018, mastectomy from 01Jan1983, hypertension, decompensation cardiac from 01Jan2020; all unknown if ongoing. Concomitant medications included nebivolol; furosemide (LASIX); losartan potassium (TRIATEC) taken for hypertension; trimebutine (DEBRIDAT) taken for gastrointestinal hypomotility; acetylsalicylic acid (CARDIOASPIRIN). The patient previously took bnt162b2 (lot number: ET1831, expiry date: 30Jun2021) in the left shoulder on 10Mar2021 16:54 for COVID-19 immunisation and ceftriaxone (ROCEPHIN) and experienced drug allergy. The patient experienced diffuse joint pain on 02May2021 and abdominal pain, hypotension (blood pressure 70 / 30), bradycardia (30 bpm), sweating, acute renal failure with anuria, liver failure, cardiac arrest on 07Apr2021. The patient underwent other lab tests and procedures which included nephrological reports and blood chemistry with unknown result on an unspecified date. The patient died on 09May2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: abdominal pain; sweating; diffuse joint pain; Hypotension; Acute kidney failure; Bradycardia; Anuria; Arrest cardiac; Failure liver


VAERS ID: 1441781 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-04-18
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITPFIZER INC2021728686

Write-up: After 11 days from Comirnaty vaccination, the patient experienced a hemorrhagic stroke which resulted in death after one week in a coma state at a hospital facility.; This is a spontaneous report received from a contactable consumer downloaded from the Regulatory Authority-WEB. The regulatory authority report number is IT-MINISAL02-742496. An 89-year-old female patient received bnt162b2 (COMIRNATY, Batch/Lot number was not reported), intramuscular, administered in arm left (also reported as left shoulder) on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. After 11 days from COMIRNATY vaccination (18Apr2021), the patient experienced a hemorrhagic stroke which resulted in death after one week in a coma state at a hospital facility. Measures taken (Timely transfer to Emergency Room). The outcome of the event was fatal. The patient died on an unspecified date. It was unknown if an autopsy was performed. No follow-up attempts are possible. No further information is expected. Information on lot and batch numbers cannot be obtained.; Reported Cause(s) of Death: hemorrhagic stroke


VAERS ID: 1442040 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-17
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021727582

Write-up: Cardiac failure; This is a spontaneous report from a non-contactable physician via COVID-19 Adverse Event Self-Reporting Solution. A 73-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), intramuscular in the left arm on 09Jun2021 at 14:00 at a single dose for covid-19 immunisation. Medical history included hypertensive cardiac failure. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medical history included hypertensive cardiac failure. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient''s concomitant medications were not reported. On 17Jun2021, the patient experienced cardiac failure, which was serious for hospitalization from 17Jun2021 to 17Jun2021 and death. The clinical course was as follows: on 09Jun2021 at 14:00 (the day of vaccination), the patient received the first single dose of BNT162b2. On 17Jun2021 (8 days after the vaccination), the patient experienced cardiac failure. On 17Jun2021 (8 days after the vaccination), the patient admitted to the hospital, and died on the same date. The adverse event resulted in emergency room/department or urgent care, hospitalization, and death. The outcome of the event was fatal with treatment in the intensive care unit (ICU) for the adverse event. Cause of the death was reported as cardiac failure. No autopsy was performed. The reporting physician assessed the event as serious (death and hospitalization). The causality of the event was not reported. Therapeutic measures were taken as a result of cardiac failure. The clinical outcome of the event, cardiac failure, was fatal. The patient died on 17Jun2021 due to cardiac failure. An autopsy was not performed. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of cardiac failure with fatal outcome. The reported event likely represent intercurrent medical condition in this elderly patent with history of hypertensive cardiac failure. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1442041 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-05-31
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-31
   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 failure
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021727642

Write-up: Renal failure; This is a spontaneous report from a contactable physician received via the Agency. An 88-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FA7338, expiration date: 30Sep2021), intramuscular in left arm on 29May2021 at 15:00 (at the age of 88-years-old) at dose 1, single for COVID-19 immunization. Medical history included renal failure. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had allergies to medications, food, or other products. The patient''s concomitant medications were not reported. On 29May2021 at 15:00 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FA7338, expiration date: 30Sep2021), intramuscular in the left arm for COVID-19 immunization. On 31May2021 (reported as 2 days after the vaccination), the patient experienced renal failure. The patient died on 31May2021. The cause of death was renal failure. It was unknown if the patient received a treatment for the event. It was unknown if an autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. The causality assessment was not provided.; Sender''s Comments: Based on the information currently available, a causal association between the reported event and BNT162B2 cannot be fully excluded. Case will be reassessed when additional 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 RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Renal failure


VAERS ID: 1442050 (history)  
Form: Version 2.0  
Age: 86.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-24
Onset:2021-05-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Biopsy bone marrow, Body temperature, Oxygen saturation, Platelet count, Platelet count decreased, Respiratory failure, Respiratory rate
SMQs:, Anaphylactic reaction (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (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), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-30
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bruising of face; Contusion of breast; Fall; Fractured zygoma (diagnosed on 26May2021)
Allergies:
Diagnostic Lab Data: Test Date: 20210528; Test Name: Bone marrow examination; Result Unstructured Data: Test Result:decrease in platelets; Comments: slight increase in megakaryocytes and decrease in platelet production and platelet release, for which diagnosis of decrease in platelets mediated by immunization reaction was made; Test Date: 20210524; Test Name: Body temperature; Result Unstructured Data: Test Result:37.2 Centigrade; Comments: before vaccination; Test Date: 20210527; Test Name: SpO2; Test Result: 88 %; Test Date: 20210527; Test Name: PLT; Result Unstructured Data: Test Result:32000 /mm3; Test Date: 20210527; Test Name: Respiratory rate; Result Unstructured Data: Test Result:22 breaths/minute; Test Date: 20210528; Test Name: Platelet count; Result Unstructured Data: Test Result:decrease
CDC Split Type: JPPFIZER INC2021727871

Write-up: Marked decrease in platelets; Respiratory failure; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number is v21114746. An 86-year-old female patient received the first dose of the bnt162b2 (COMIRNATY; Lot Number: FA5829; Expiration Date: 31Aug2021), via an unspecified route of administration on 24May2021 at 14:27 at a single dose for covid-19 immunisation. Medical history included fall on 24May2021, bruised left side of the face and chest on 24May2021, and fracture of zygoma and zygomatic arch on 24May2021 (diagnosed on 26May2021). The patient had no family history. The patient''s concomitant medications were not reported. Points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status) were not reported. On 27May2021, the patient experienced marked decrease in platelets and respiratory failure, which required hospitalization and serious for death. The clinical course was as follows: on 24May2021 at 14:27 (the day of vaccination), the patient received the first dose of BNT162b2. On 27May2021 (3 days after the vaccination), the patient experienced marked decrease in platelets and respiratory failure. On 30May2021 (6 days after the vaccination), the outcome of the events was fatal. The course of the event was as follows: on 24May2021, the patient visited the reporting hospital to receive the vaccine. At the entrance of the hospital, the patient fell and bruised left side of the face and chest. The patient was seen at orthopedics department of the reporting hospital and was assessed as not urgent; thus, on the same day, the patient was vaccinated and returned home. On the same day on 24May2021, the patient visited another general hospital. On 26May2021, the patient visited dental and oral surgery department of a hospital and was diagnosed with fracture of zygoma and zygomatic arch. The patient received conservative treatment and was referred to the reporting hospital for follow-up. On 27May2021, when visiting the reporting hospital, marked decrease in platelets was noted (platelets 32000/mm3). At that time, respiratory failure (SpO2 88%, respiratory rate 22 breaths/minute) was already noted. On 28May2021, bone marrow examination was conducted for decrease in platelets, which suggested decrease in platelets due to trauma, medication, and/or immunization reaction. Treatment with prednisolone acetate (PREDONINE) was initiated; however, the condition did not improve and the patient died and was discharged from the hospital. Therapeutic measures were taken as a result of marked decrease in platelets (platelet count decreased). The clinical outcome of the events, marked decrease in platelets and respiratory failure, was fatal. The patient died on 30May2021 due to marked decrease in platelets and respiratory failure. It was not reported if an autopsy was performed. The reporting physician classified the events as serious (death) and assessed that the causality between the events and BNT162b2 was unassessable. Other possible cause of the event such as any other diseases was not provided. The reporting physician commented as follows: Since platelet counts from before the vaccination to 27May2021 were unknown, onset timing of decrease in platelets was unknown. Bone marrow findings included slight increase in megakaryocytes and decrease in platelet production and platelet release, for which diagnosis of decrease in platelets mediated by immunization reaction was made. As its cause, the vaccine could not be ruled out.; Reported Cause(s) of Death: Marked decrease in platelets; Respiratory failure


VAERS ID: 1442051 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5715 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardio-respiratory arrest, Cerebrovascular accident, Heart rate, Oxygen saturation
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Acute central respiratory depression (broad), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-10
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral haemorrhage; Epilepsy
Allergies:
Diagnostic Lab Data: Test Date: 20210609; Test Name: Blood pressure; Result Unstructured Data: Test Result:126/62 mmHg; Comments: 14:35; Test Date: 20210609; Test Name: Blood pressure; Result Unstructured Data: Test Result:133/72 mmHg; Comments: 16:00; Test Date: 20210609; Test Name: Blood pressure; Result Unstructured Data: Test Result:121/64 mmHg; Comments: 20:00; Test Date: 20210610; Test Name: Blood pressure; Result Unstructured Data: Test Result:101/53 mmHg; Comments: 06:00; Test Date: 20210610; Test Name: Blood pressure; Result Unstructured Data: Test Result:128/78 mmHg; Comments: 14:00; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: Before vaccination; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:36.9 Centigrade; Comments: 14:35; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: 16:00; Test Date: 20210609; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: 20:00; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: 06:00; Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: 14:00; Test Date: 20210609; Test Name: pulse rate; Result Unstructured Data: Test Result:66; Comments: Unit:/min 14:35; Test Date: 20210609; Test Name: pulse rate; Result Unstructured Data: Test Result:78; Comments: Unit:/min 16:00; Test Date: 20210609; Test Name: pulse rate; Result Unstructured Data: Test Result:60; Comments: Unit:/min 20:00; Test Date: 20210610; Test Name: pulse rate; Result Unstructured Data: Test Result:73; Comments: Unit:/min 06:00; Test Date: 20210610; Test Name: pulse rate; Result Unstructured Data: Test Result:61; Comments: Unit:/min 14:00; Test Date: 20210610; Test Name: pulse rate; Result Unstructured Data: Test Result:radial artery was not palpable; Comments: 18:55 no heart beat; Test Date: 20210609; Test Name: SpO2; Test Result: 98 %; Comments: 14:35; Test Date: 20210609; Test Name: SpO2; Test Result: 98 %; Comments: 16:00; Test Date: 20210609; Test Name: SpO2; Test Result: 98 %; Comments: 20:00; Test Date: 20210610; Test Name: SpO2; Test Result: 97 %; Comments: 06:00; Test Date: 20210610; Test Name: SpO2; Test Result: 99 %; Comments: 14:00; Test Date: 20210610; Test Name: SpO2; Result Unstructured Data: Test Result:could not be measured %; Comments: 18:55
CDC Split Type: JPPFIZER INC2021727894

Write-up: Cardio-respiratory arrest; stroke; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21114747. The patient was a 79-year and 3-month-old male. Body temperature before vaccination was 36.9 degrees Centigrade. Medical history included epilepsy and late effects of cerebral haemorrhage. Concomitant medications were not provided. The patient had no relevant family history. On 09Jun2021 at 14:20 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5715, Expiration date 31Aug2021) intramuscularly in the left upper arm, as dose 1, single, at the age of 79-years-old, for COVID-19 immunization. On 10Jun2021 at 18:55 (1 day after the vaccination), the patient experienced cardio-respiratory arrest. On 10Jun2021 at 20:17, the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: On 09Jun2021 at 14:20, BNT162b2 was intramuscularly injected into the left upper arm. At 14:35, his vital signs were as follows: BP (blood pressure) was 126/62 mmHg, body temperature was 36.9 degrees Centigrade, pulse rate was 66/min, and SpO2 (oxygen saturation percutaneous) was 98%. Thereafter at 16:00, his vital signs were as follows: BP was 133/72 mmHg, body temperature was 36.8 degrees Centigrade, pulse rate was 78/min, and SpO2 was 98%. At 20:00, BP was 121/64 mmHg, body temperature was 36.6 degrees Centigrade, pulse rate was 60/min, and SpO2 was 98%. On 10Jun2021 at 06:00, BP was 101/53 mmHg, body temperature was 36.4 degrees Centigrade, pulse rate was 73/min, and SpO2 was 97%. He made reactions when spoken to. Decreased consciousness level was not noted. At 14:00, BP was 128/78 mmHg, body temperature was 36.7 degrees Centigrade, pulse rate was 61/min, and SpO2 was 99%. The patient developed tendency toward somnolence then. At 17:00, tube feeding was finished and when a facility member went to get a bottle of tube feeding, no marked change was noted in his condition. However, at 18:55, when visiting his room, a facility member found that the patient had facial pallor. Since radial artery was not palpable and spontaneous respiration ceased, oxygen administration was started and a monitoring device was set up, but there was no heartbeat and SpO2 could not be measured. Vomiting was not seen and only frothy white sputum was suctioned. A staff member called his family and when they arrived, the patient''s death was confirmed at 20:17. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the event and BNT162b2 as unassessable. The physician commented as: stroke was considered as a possible cause of the event.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1442053 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-13
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure acute, Magnetic resonance imaging head
SMQs:, Cardiac failure (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: Medical History/Concurrent Conditions: Brain tumour; Brain tumour operation; Dizziness; Glioma; Hyperlipidaemia; Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: head MRI; Result Unstructured Data: Test Result:no abnormalities
CDC Split Type: JPPFIZER INC2021728162

Write-up: Acute cardiac failure; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 79-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received prescribed medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Other medical history included glioma, dizziness, hyperlipidaemia, hypertension, brain tumour operation, and brain tumour. The patient was receiving the treatment with anticancer drugs after the operation. On 13Jun2021 at 11:00 (the day of vaccination), at the age of 79-years-old, the patient received the first single dose of BNT162B2 (COMIRNATY, solution for injection, lot number FC3661, expiration date 30Sep2021) intramuscular at dose 1, single in the left arm for COVID-19 immunization at a clinic. In Jun2021, the patient experienced acute cardiac failure. The patient did not receive any treatment for the event. On 16Jun2021, the patient died. The event resulted in death. An autopsy was performed, and the cause of death was acute cardiac failure. The course of the events was as follows: On 15Jun2021, the patient was visiting a hospital where she had booked an appointment as an outpatient for a follow up of brain tumour operation. She was explained that the results of head MRI on 2021 showed no abnormalities. On 16Jun2021 at around 15:30, the patient''s acquaintance visited her, she was found dead in the room. An autopsy was performed because of abnormal death, and based on the result of the autopsy, the cause of death was acute cardiac failure. Judicial autopsy was not performed. Since the vaccination, the patient has not been tested for COVID-19. The causality assessment was not provided. Outcome of the event was fatal.; Sender''s Comments: Based on a plausible temporal relationship, a possible causal relationship between events acute cardiac failure and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: acute cardiac failure; Autopsy-determined Cause(s) of Death: acute cardiac failure


VAERS ID: 1442062 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Pneumonia aspiration
SMQs:, Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021729050

Write-up: Swallowing difficult; Pneumonia aspiration; This is a spontaneous report from a contactable physician via a Pfizer sales representative. The patient was an elderly of unknown gender. The patient''s medical history and concomitant medications were not reported. On an unspecified date and time (the day of vaccination), the patient received BNT162B2 (COMIRNATY Solution for injection; Lot Number and Expiration Date were not reported), via an unspecified route of administration, as dose number unknown, single, for COVID-19 immunization. On an unspecified date and time (1 week after the vaccination), the patient experienced swallowing difficult and pneumonia aspiration. The course of the events was as follows. Historical findings of swallowing difficult were absent. On an unspecified date (a week after receiving BNT162b2), the patient started to have swallowing difficult and developed pneumonia aspiration. The patient died later. The reporter thought the causal relationship was unrelated as there was a one-week gap from the administration of BNT162B2. Swallowing was normal before vaccination. On an unspecified date, the outcome of the events was fatal. The patient died on an unspecified date. It was unknown whether autopsy was done. The seriousness of the events was not reported. The reporting physician assessed that the events was unrelated to BNT162B2. No follow-up attempts are possible; information about lot or batch number cannot be obtained.; Sender''s Comments: Based on the available limited information, a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events swallowing difficulty and pneumonia aspiration with a fatal outcome can be excluded. The case will be reassessed if additional information becomes available regarding patient''s autopsy details, relevant medical history and any concomitant conditions. 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: Swallowing difficult; Pneumonia aspiration


VAERS ID: 1442063 (history)  
Form: Version 2.0  
Age: 80.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 16
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Emphysema; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021729561

Write-up: Death; Cold; This is a spontaneous report from a contactable physician received from the Agency Regulatory Authority. Regulatory authority report number is v21114856. An 80-year-old male patient received the first dose of BNT162B2 (COMIRNATY, solution for injection, Lot number EY0779 with Expiration Date 31Aug2021), via an unknown route, on 04Jun2021 11:00 (at the age of 80-year-old) at 0.3 mL single dose for COVID-19 immunisation. Relevant medical history included hypertension and emphysema. No relevant concomitant medications were provided. After vaccination, in Jun2021, the patient had symptom of common cold, and an antitussive was administered. On 17Jun2021, at around 12:00 (13 days and one hour after vaccination), the patient was found dead at his home. The cause of death was not provided. The outcome of the event ''cold'' at the time of death was unknown. It was unknown if an autopsy was performed. The reporting physician assessed that the causality between the event ''death'' and BNT162B2 as unassessable. Other possible cause of the event such as any other diseases was emphysema. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Death


VAERS ID: 1442066 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-13
Onset:2021-05-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW4811 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, Cardiac failure, Cerebral infarction, Oxygen saturation
SMQs:, Cardiac failure (narrow), Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 24
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes mellitus; Parkinson''s disease
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210513; Test Name: blood pressure; Result Unstructured Data: Test Result:140/68; Test Date: 20210513; Test Name: body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210513; Test Name: SpO2; Test Result: 83 %
CDC Split Type: JPPFIZER INC2021730311

Write-up: Severe Cardiac failure; Cerebral infarction; This is a spontaneous report from a contactable physician received from the Regulatory Authority. The regulatory authority report number is v21114954. A 77-year and 3-month-old male patient received the first dose of BNT162B2 (COMIRNATY; Lot Number: EW4811; Expiration Date: 31Jul2021), via an unspecified route of administration, on 13May2021 at 09:20 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing diabetes mellitus and ongoing Parkinson''s disease. The patient had no particular family history and no allergic history. No particular abnormalities were observed at the time of medical interview. The patient''s concomitant medications were not reported. The patient experienced cerebral infarction on 03Jun2021, which required hospitalization from 03Jun2021 (20 days after the vaccination) to 06Jun2021 and was reported as fatal. The patient also experienced severe cardiac failure on 13May2021 at 12:00 (2 hours/40 minutes after the vaccination), which required hospitalization from an unspecified date to an unspecified date. The clinical course was reported as follows: The body temperature before vaccination was 36.4 degrees Centigrade on 13May2021. On 13May2021, at around 12:00 (2 hours and 40 minutes after vaccination), the patient experienced dyspnoea and wheezing. The blood pressure was 140/68 and the oxygen saturation (SpO2) was 83% on 13May2021. The patient was emergently transferred to the general hospital. Since the patient was diagnosed with severe cardiac failure, he was transferred to other hospital. The symptoms improved, and cardiac rehabilitation was initiated. On 03Jun2021 (20 days, 14 hours, and 40 minutes after vaccination), the patient experienced cerebral infarction (suspected cardiogenic). He was transferred to other hospital. On 06Jun2021 (23 days, 14 hours, and 40 minutes after vaccination), the patient died. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of cerebral infarction was fatal and of severe cardiac failure was unknown. The patient died on 06Jun2021 (reported as: 23 days, 14 hours, and 40 minutes after vaccination). The cause of death was reported as cerebral infarction. It was not reported if an autopsy was performed. The reporting physician assessed that the causality between the event and BNT162B2 as unassessable. Other possible cause of the event, such as any other diseases, was unknown. The reporting physician commented as follows: The causality between cardiac failure and BNT162b2 vaccination was unknown. The physicians at the hospital, where the patient was referred to, agreed with this opinion.; Reported Cause(s) of Death: Cerebral infarction


VAERS ID: 1442070 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-15
Onset:2021-06-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC5295 / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: XARELTO
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cerebral infarction
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021735157

Write-up: Death; This is a spontaneous report from a contactable pharmacist received via COVID-19 Adverse Event Self-Reporting Solution. This 85-year-old (non-pregnant) female patient received the second dose of BNT162B2 (COMIRNATY; solution for injection, Lot number FC5295 with Expiration Date 30Sep2021), via an unknown route, on 15Jun2021 at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (COMIRNATY; solution for injection, Lot number FC5295 with Expiration Date 30Sep2021) on 25May2021 at single dose for COVID-19 immunisation. Relevant medical history included cerebral infarction. Relevant concomitant medications included rivaroxaban (XARELTO). On 16Jun2021, (1 day after the vaccination), the patient experienced death. The cause of death was not provided. On 18Jun2021, (3 day after the vaccination), the death of the patient was reported to a clinic, the vaccination facility. Since the vaccination, the patient has not been tested for COVID-19. Autopsy was not performed.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event death and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: death


VAERS ID: 1442071 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021738448

Write-up: the patient was found dead; This is a spontaneous report from a contactable physician from a Pfizer company representative. The patient of unknown gender was 79 years old. Patient information other than age was unknown. Medical history and concomitant medications were not reported. On an unspecified date (the day of vaccination), the patient received a dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown), at the age of 79 years old, via an unspecified route of administration as dose number unknown, single for COVID-19 immunization. On an unknown date (9 days after the vaccination), the patient was found dead. It was reported that judicial autopsy would be performed for the mysterious death, and the police was also informed about the vaccination. The seriousness and causality of the event were not reported. It was unknown if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: The limited information provided in this report does not allow a full assessment of the case. The event "death" with unknown cause is assessed as related to the suspect drug per company guidance. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history and concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: the patient was found dead


VAERS ID: 1442084 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY0779 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation, Body temperature, C-reactive protein, Cardiac failure chronic, Computerised tomogram thorax, N-terminal prohormone brain natriuretic peptide, Oxygen saturation, PO2, Pneumonia, Urinary tract infection, Urine output
SMQs:, Cardiac failure (narrow), Supraventricular tachyarrhythmias (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 18
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation paroxysmal; Cardiac failure chronic; Dementia
Allergies:
Diagnostic Lab Data: Test Date: 20210610; Test Name: Body temperature; Result Unstructured Data: Test Result:36.8 Centigrade; Comments: Before vaccination; Test Date: 20210611; Test Name: chest CT; Result Unstructured Data: Test Result:bilateral pleural effusion; Test Date: 20210611; Test Name: CRP; Result Unstructured Data: Test Result:7.07; Test Date: 20210614; Test Name: CRP; Result Unstructured Data: Test Result:3.06; Comments: improvement; Test Date: 20210611; Test Name: NT-proBNP; Result Unstructured Data: Test Result:5799; Test Date: 20210610; Test Name: SpO2; Result Unstructured Data: Test Result:decreased; Comments: After the vaccination; Test Date: 20210611; Test Name: Partial pressure O2; Result Unstructured Data: Test Result:69.0; Test Date: 202106; Test Name: urine output; Result Unstructured Data: Test Result:500-700 mL; Comments: Unit: mL/day low
CDC Split Type: JPPFIZER INC2021766901

Write-up: Cardiac failure chronic aggravated; Urinary tract infection; Pneumonia; atrial fibrillation paroxysmal; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115783. The patient was a 90-year-old female. Body temperature before vaccination was 36.8 degrees Centigrade. Medical history included heart diseases (cardiac failure chronic, atrial fibrillation paroxysmal) and dementia. Regarding ADL (activities of daily living), the patient required total assistance. Concomitant medications were not provided. The patient had no relevant family history. On 10Jun2021 at 14:00 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY0779, Expiration date 31Aug2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 11Jun2021 (1 day after the vaccination), the patient experienced cardiac failure chronic aggravated. On 16Ju2021, the patient was hospitalized. On 19Jun2021 (8 days after the vaccination), the patient died of cardiac failure chronic aggravated. It was not reported if an autopsy was performed. The course of the events was as follows: On 10Jun2021 (the day of the vaccination), decreased intake for lunch was noted. Considering that since from before it had been noted that her food intake was sometimes lower, no pyrexia was noted on that day and her general condition was not bad, the reporting physician determined that it was possible for her to receive the vaccination. After the vaccination, oedema of bilateral lower limbs worsened, and SpO2 (oxygen saturation percutaneous) decreased. Therefore, on 11Jun2021 (1 day after the vaccination), the patient visited the reporter''s hospital as an outpatient. Blood gases showed pO2 69.0, chest CT showed bilateral pleural effusion and NT-proBNP was 5799. Based on the results of the tests, a diagnosis of cardiac failure chronic aggravated was made. Also, CRP (C-reactive protein) was 7.07 and pyuria was noted, and so it was considered that urinary tract infection triggered the cardiac failure to worsen. The patient was prescribed oral antibacterial drugs and oral diuretics and then returned home. Afterwards, urine output was low (500-700 mL/day) and the oedema did not improve. On 14Jun2021, the patient visited the hospital again where CRP showed 3.06 indicating that the infection showed improvement. The patient was prescribed diuretic with an increased dose and she returned home. Thereafter, the patient could not consume meals. On 16Jun2021, the patient was admitted to the reporter''s hospital. On admission, although pleural infusion remained, as dehydration in the blood was noted, diuretic was discontinued, and her progress was monitored while fluid infusion was being administered. After admission, atrial fibrillation paroxysmal was present. Beta-blockers at low dosage were started to be administered. On 19Jun2021 at 05:48, a monitor showed bradycardia. At 05:56, asystole developed. At 06:05, resuscitation was performed, but it did not succeed. At 06:52, resuscitation was discontinued. Autopsy imaging (from the head to the pelvis) showed just increased pleural effusion compared to that on admission. It was determined that the patient died due to cardiac failure. The reporting physician classified the event as serious (fatal outcome 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 urinary tract infection and pneumonia. The reporting physician commented as follows: A diagnosis of cardiac failure chronic aggravated was definite but the causal relationship with BNT162b2 was uncertain. The outcome of event Urinary tract infection was recovering and other events was unknown.; Reported Cause(s) of Death: Cardiac failure chronic aggravated


VAERS ID: 1442085 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-19
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Pneumonia, Respiratory failure
SMQs:, Anaphylactic reaction (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ELIQUIS
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disease, unspecified; Lung disease
Allergies:
Diagnostic Lab Data: Test Date: 20210619; Test Name: CT scan; Result Unstructured Data: Test Result:pneumonia
CDC Split Type: JPPFIZER INC2021767095

Write-up: Respiratory failure due to pneumonia; Respiratory failure due to pneumonia; This is a spontaneous report from a contactable physician received via the Agency. The patient was an 82-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received apixaban (ELIQUIS) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included lung disease and heart disease (details unknown). On 12Jun2021 at 14:00 (the day of vaccination) (82-year-old at vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscular in the left arm for COVID-19 immunization at a clinic/emergency room. On 19Jun2021 (7 days after the vaccination), the patient experienced respiratory failure due to pneumonia. The patient did not receive treatment for the event. The event resulted in death. It was unknown if an autopsy was performed. The course of the events was as follows: On 19Jun2021, the patient''s family who entered the room found the patient dead at his house. The patient was transferred to a nearby hospital where the patient''s death was confirmed. CT scan showed pneumonia and the physician noted in the medical certificate that the patient died of respiratory failure due to pneumonia. Since the vaccination, the patient had not been tested for COVID-19. The assessment of causality between the event and BNT162B2 was not provided. The seriousness of the event was reported as serious (death). The outcome of events respiratory failure and pneumonia was fatal.; Sender''s Comments: There is no reasonable possibility that the fatal events, respiratory failure and pneumonia, were related to COMIRNATY use. This is more likely associated with the underlying lung disease and heart disease. Advanced age may have been contributory as well.; Reported Cause(s) of Death: pneumonia; Respiratory failure


VAERS ID: 1442086 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 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: End stage cancer (probably renal cancer under treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021767525

Write-up: Cardiac failure; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient in his 70s received the first dose of BNT162B2 (COMIRNATY; batch/lot number was not reported), via an unspecified route of administration, on an unspecified date (in his 70s at vaccination) as a single dose for COVID-19 immunisation. The patient was receiving the treatment with anticancer drugs for end stage cancer (probably renal cancer). Two weeks after the vaccination, the patient died due to cardiac failure. The date of death was unknown. The outcome of event was fatal. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (fatal outcome) and assessed that the event was possibly related to BNT162B2. Information on the lot/batch number has been requested.; Sender''s Comments: Based on the temporal relationship, the association between the fatal event cardiac failure with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1442087 (history)  
Form: Version 2.0  
Age: 92.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-02
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: 2021-06-10
   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: JPPFIZER INC2021767699

Write-up: death; This is a spontaneous report from a contactable other health professional received via a Pfizer sales representative. A 92-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection) unknown number dose at the age of 92-year-old via an unspecified route of administration on 08Jun2021 (lot number, and expiration date were not reported) as single dose for COVID-19 immunisation. Medical history included unspecified underlying disease(s). Concomitant medications were not reported. On 08Jun2021, the patient was vaccinated at the reporting clinic. Two days later, the patient died. Seriousness criteria and causality assessment were not provided. It was not reported if Autopsy Done. The outcome of the event was fatal.; Sender''s Comments: The reported event of death is considered as related due to lack of information. The company processes "death cause unknown" cases as possibly related and documents them as related in the global safety database unless information is provided that allows the Company to exclude that there is a reasonable possibility of relatedness to the suspect product. This case will be re-evaluated upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1442092 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-05-16
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3617 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure chronic, Ejection fraction, Mobility decreased, Myalgia, Oxygen saturation, Respiratory distress
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (narrow), Anaphylactic reaction (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-13
   Days after onset: 28
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac failure chronic; Dialysis (3 times a week); Left ventricular ejection fraction decreased
Allergies:
Diagnostic Lab Data: Test Name: EF; Result Unstructured Data: Test Result:around 20%; Test Date: 20210517; Test Name: SpO2; Result Unstructured Data: Test Result:The SpO2 would decrease down to 92% on body motion %; Comments: The SpO2 would decrease down to 92% on body motion but would recover to 98-99% at rest in lying position
CDC Split Type: JPPFIZER INC2021770058

Write-up: cardiac failure chronic/ aggravation of general condition; Respiratory discomfort when moving; Difficulty in body movement; Generalised muscle aches; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115787. An 83-year-old male patient received first dose of bnt162b2 (COMIRNATY, Batch/Lot Number: EX3617; Expiration Date: 31Aug2021), via an unspecified route of administration on 15May2021 at age of 83-year-old as single dose for covid-19 immunisation. Medical history included cardiac failure chronic with ejection fraction (EF) around 20% on echocardiography and maintenance dialysis 3 times a week from 17Aug2018. It was not reported whether there were points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). Body temperature before vaccination, family history, and concomitant medications were not reported. On 15May2021 (the day of vaccination), the patient received a coronavirus vaccine at the local hospital. On 16May2021 in the morning (1 day after the vaccination), the patient experienced generalised muscle aches. On 17May2021 (2 days after the vaccination), the patient experienced respiratory discomfort when moving. He had usually entered the room on foot independently, but because of respiratory discomfort, he went inside by using a wheelchair and underwent dialysis. Hereinafter, the patient was picked up and dropped off while on a wheelchair. The SpO2 would decrease down to 92% on body motion but would recover to 98-99% at rest in lying position. In early Jun2021, the condition was improving but on 11Jun2021 (27 days after the vaccination), the patient had aggravated respiratory discomfort and was transported by ambulance to another hospital. It was reported that the patient had died later on 13Jun2021 (29 days after the vaccination). The outcome of event generalised muscle aches was not recovered, of events difficulty in body movement and respiratory discomfort when moving was fatal. It was not reported whether autopsy was done. The reporting physician classified the events difficulty in body movement and respiratory discomfort when moving as serious (hospitalization) and assessed the causality between the event difficulty in body movement and respiratory discomfort when moving and BNT162b2 as unassessable. The seriousness and causality of the event generalised muscle aches were not reported. Other possible causes of the events difficulty in body movement and respiratory discomfort when moving such as any other diseases was cardiac failure chronic. The reporting physician commented as follows: We made this report because the patient who had cardiac failure chronic with ejection fraction (EF) around 20% on echocardiography experienced aggravation of general condition after the vaccination with death outcome. The causal relationship was unassessable. The course of the events was as follows: The patient started to undergo maintenance dialysis 3 times a week at the reporting clinic from 17Aug2018. On 15May2021 (the day of vaccination), the patient received a coronavirus vaccine at the local hospital. On 16May2021 in the morning (1 day after the vaccination), the patient experienced generalised muscle aches. On 17May2021 (2 days after the vaccination), the patient experienced respiratory discomfort when moving. He had usually entered the room on foot independently, but because of respiratory discomfort, he went inside by using a wheelchair and underwent dialysis. Hereinafter, the patient was picked up and dropped off while on a wheelchair. The SpO2 would decrease down to 92% on body motion but would recover to 98-99% at rest in lying position. In early Jun2021, the condition was improving but on 11Jun2021 (27 days after the vaccination), the patient had aggravated respiratory discomfort and was transported by ambulance to another hospital. It was reported that the patient had died later on 13Jun2021 (29 days after the vaccination). The reporting physician classified the events difficulty in body movement and respiratory discomfort when moving as serious (hospitalization) and assessed the causality between the event difficulty in body movement and respiratory discomfort when moving and BNT162b2 as unassessable. The seriousness and causality of the event generalised muscle aches were not reported. Other possible cause(s) of the events difficulty in body movement and respiratory discomfort when moving such as any other diseases was cardiac failure chronic. The reporting physician commented as follows: We made this report because the patient who had cardiac failure chronic with ejection fraction (EF) around 20% on echocardiography experienced aggravation of general condition after the vaccination with death outcome. The causal relationship was unassessable.; Reported Cause(s) of Death: cardiac failure chronic; Respiratory discomfort when moving; Difficulty in body movement


VAERS ID: 1442093 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-22
Onset:2021-06-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Fall, Oxygen saturation, Respiratory arrest
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Hypersensitivity (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-22
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INSULIN
Current Illness: Dementia; Diabetes mellitus; Insulin therapy; Pancreatic carcinoma
Preexisting Conditions: Medical History/Concurrent Conditions: Hypertension
Allergies:
Diagnostic Lab Data: Test Date: 20210622; Test Name: BP measurement; Result Unstructured Data: Test Result:not possible; Test Date: 20210622; Test Name: BP measurement; Result Unstructured Data: Test Result:68 systolic; Comments: after vaccination; Test Date: 20210601; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before the first vaccination; Test Date: 20210622; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: before the second vaccination; Test Date: 20210622; Test Name: SpO2; Test Result: 93 %; Comments: first measurement after vaccination; Test Date: 20210622; Test Name: SpO2; Result Unstructured Data: Test Result:75-85 %; Comments: second measurement after vaccination
CDC Split Type: JPPFIZER INC2021770100

Write-up: Respiratory arrest; fallen from the bed; no energy; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115858. The report is also from another physician via the Agency. The patient was a non-pregnant 91-year-old female. Body temperature before the first vaccination was 36.4 and before the second vaccination was 36.4 degrees centigrade. Medical history included ongoing pancreatic carcinoma, ongoing diabetes mellitus, ongoing insulin therapy, hypertension and ongoing dementia. Family history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no known allergies. Within 2 weeks of vaccination, the patient received ongoing insulin therapy and other ongoing oral medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Jun2021 at 10:30, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot number EY5420, Expiration date 31Aug2021) at 0.3 ml intramuscularly in her left arm. On 22Jun2021 at 10:50 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021) at 0.3 ml intramuscularly in her left arm as a single dose for COVID-19 immunisation. On 22Jun2021 at 18:15 (7 hours and 25 minutes after the vaccination), the patient respiratory arrest. On 22Jun2021 at 18:59 (8 hours and 9 minutes after the vaccination), the patient died. On 22Jun2021 (the day of vaccination), the outcome of the event was fatal. No autopsy was done. The course of the events was as follows: On 22Jun2021 at 10:50 (the day of vaccination), the patient received the second vaccination at nursing home/senior living facility. She had no energy. Recently, the patient had difficulty in maintaining a standing posture and oral ingestion and had been nutritionally depleted. After the vaccination, there was no change in vital signs, but at 16:45 (5 hours and 55 minutes after the vaccination), she was found fallen from the bed at visit to her room. Blood pressure (BP) measurement was not possible. The SpO2 was 93%. The BP was measured again and was 68 systolic. The patient was conscious and responsive. Thereafter, frequent room visits were made. At 18:10 (7 hours and 20 minutes after the vaccination), upward rotation of both eyes and jaw breathing were present, BP measurement was not possible, and the SpO2 was in 75-85%. At 18:15 (7 hours and 25 minutes after the vaccination), respiratory arrest developed. At 18:59 (8 hours and 9 minutes after the vaccination), the attending physician confirmed the patient''s death. The course of the events from another physician was as follows: The patient, a resident of the nursing home, was on a follow-up care for end-stage pancreatic carcinoma and was being debilitated gradually with decreased oral intake volume. She continued receiving insulin therapy for diabetes mellitus and taking oral medications. Although debilitation was progressing day by day, on 22Jun2021 in the morning, the second dose of the vaccine was given by the physician performing mobile vaccination. On the same day just after 18:10, the consciousness level decreased, and the respiratory state was aggravated. She started jaw breathing at 18:30 and was confirmed dead at 18:59. The death cause was pancreatic carcinoma. Autopsy was not performed. Treatment was not given for the adverse events. Caring records: Date: 21Jun2021, Time: 19:05, Type: message, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: The patient strongly refused to have dinner. Approached to her again at the time indicated on the left. She woke up with a craving for a melon. She went to the dining room after urination at the toilet. She had two bites of the melon, two bites of jelly, and ENSURE 10 cc. There was a slight choke with fluid intake. Soon after that she went to the bed after oral cleaning as she wished to. Date: 22Jun2021, Time: 07:30, Type: message, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: [Request of conference] It is getting harder and harder for the patient to keep standing and she has been unable to eat at all. Also, for a bath, it is desirable that she takes a bath with bathing aids. We would like to have a conference about that too. Sometimes she can eat a little bit of food but that makes it hard for her to take the ENSURE. It is considered that the ENSURE is more nutritious. Leading her to the dining room every time might be hard and pain for her too. She can go to the restroom and urinate now but with her physical condition, maybe it is a good idea to consider changing on the bed. If today''s not possible, in a few days, please have a conference. Thank you, room team. Date: 22Jun2021, Time: 16:45, Type: accident report, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: [Fall from the bed] When the staff visited her room for an individual care, the staff found her lying on the side of the bed on the floor with her left side down and looked like her head was under the bed. One of her socks was off. Talked the day shift workers, and after to the night shift nurse (NS), and the day shift NS, and asked for their help. Did not see much pain, just redness around her left lumbar region. SpO2 93%. BP gets an error in automated blood pressure machine. The NS side had her blood pressure taken again, and the top number was 68, but was not able to take her bottom number. Date: 22Jun2021, Time: 17:00, Type: message, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: The staff found her on the floor. No redness or swelling of the head although her head was caught in between the bed frame. She repeatedly said, "No pain, I am ok." Due to the low value of ''JBP'' 68/, had her lower limbs lifted. Date: 22Jun2021, Time: 17:42, Type: message, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: After the fall, as this was also typed in the accident prevention measures, a fall prevention mat was installed, and the bed was set to a low floor. Date: 22Jun2021, Time: 17:45, Type: message, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: The staff visited her room and asked for dinner and she said, "I will get up", so the staff helped her to take her out of the bed. After that, the staff asked her if she wanted to use the restroom, and she said "yes", the staff led her to the restroom. She sat on the toilet but no urination, and she said she was going to finish. After that she tried to stand up, but she seemed a little unsteady, so we let her sit on the toilet again, and she was transferred to a wheelchair with two people assisting her. Date: 22Jun2021, Time: 18:00, Type: nursing, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: [Contact to the family] Contacted her sister by a phone, told her that we were unable to take her BP and her breath was about to stop. Asked if she can come right away but not able to, so decided to contact her again if the condition changes. Date: 22Jun2021, Time: 18:00, Type: nursing, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: 22Jun2021 at 18:00: Contacted to Clinic but has not come back from a (PRIVACY) visit. Told the office member about the situation and told them to come to the nursing department as soon as he is back. Date: 22Jun2021, Time: 18:00, Type: message, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: [Sudden change response] She came to the dining room in a wheelchair, and as we tried to prepare her insulin eye drops, her both eyes rolled upward to the left, and observed abnormal breathing and hypopnea, so returned to the room. Three people helped her putting her back on the bed, unable to take her blood pressure. SpO2 was going up and down in between 75 to 85. Respiration irregularity was confirmed while her eyes closed and jaw breathing. Reported to NS and (PRIVACY). Reported to family too. Explained the situation as (PRIVACY) visited the room. Date: 22Jun2021, Time: 18:15, Type: nursing, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: [Respiratory arrest] Confirmed respiratory arrest and contacted to the family (sister) by a phone. At 18:59, (PRIVACY) was confirmed dead. Date: 23Jun2021, Time: 09:50, Type: message, Target: user, Test items: others, Diary sharing: off, Home-visit care: off: Insurance card and medication record are stored in the upper part of the cabinet facing the window. The outcome of respiratory arrest was fatal, and outcome of other events was unknown. The reporting physician classified the event respiratory arrest as non-serious and assessed that the events was unrelated to BNT162b2. Other possible cause(s) of the events such as any other diseases was pancreatic carcinoma. The reporting physician commented as follows: The vaccination was given when pancreatic carcinoma was in end stage. We considered that the death was not due the vaccination.; Sender''s Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported respiratory arrest. 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: Pancreatic carcinoma; Respiratory arrest


VAERS ID: 1442094 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-19
Onset:2021-06-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic dissection, 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: 2021-06-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Hypertension
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: Test Result:no intracranial lesion; Comments: Other apparently lethal findings were not observed; Test Date: 20210619; Test Name: CT; Result Unstructured Data: Test Result:thoracic aortic dissection (Stanford A)
CDC Split Type: JPPFIZER INC2021770106

Write-up: Cardio-respiratory arrest; Thoracic aortic dissection (Stanford A); This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115826. The patient was a 91-year and 6-month-old female. Body temperature before vaccination was not reported. Family history was not reported. Medical history included hypertension, and angina pectoris and others. Concomitant medications were not reported. On 19Jun2021 at 09:16 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On 19Jun2021 estimated at around 11:00 (estimated around 1hour and 44minutes after the vaccination), the patient experienced cardio-respiratory arrest. On 19Jun2021 (on the same day of the vaccination), the outcome of the event was fatal. It was unknown if an autopsy was performed. The course of the event was as follows: The patient''s neighbor found the patient lying on the gravel next to the entrance within the premise of the patient''s home. Initial waveform showed asystole. No bystander cardiopulmonary resuscitation (CPR) was conducted. No early postmortem phenomenon was observed. The "doctor car" arrived and a physician conducted full course of advanced cardiac life support (ACLS) for approximately 1 hour; however, the condition did not improve from asystole and the patient was transferred to a hospital. CT revealed thoracic aortic dissection (Stanford A) and it was assessed that resuscitation was difficult. At 13:14, death was confirmed. CT revealed no intracranial lesion, and other apparently lethal findings were not observed (Interpreted by the reporting physician). The reporting physician classified the event cardio-respiratory arrest 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 not provided. The reporting physician commented as follows: The case was reported although causality between the event cardio-respiratory arrest and the vaccination was considered as low. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1442095 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-08
Onset:2021-06-19
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5423 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Body temperature, Myocardial infarction, Myocarditis
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (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: 2021-06-19
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BAYASPIRIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: Autopsy; Result Unstructured Data: Test Result:positive for troponin in the blood; Test Date: 20210608; Test Name: Body temperature; Result Unstructured Data: Test Result:36.6 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021770113

Write-up: positive for troponin in the blood / possibility of myocardial infarction or myocarditis; positive for troponin in the blood / possibility of myocardial infarction or myocarditis; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115827. The patient was an 85-year-old male. Body temperature before vaccination was 36.6 degrees centigrade on 08Jun2021. Family history was not reported. Medical history included heart disorder. Concomitant medication included acetylsalicylic acid (BAYASPIRIN) taken orally for an unspecified indication, start date was not reported and ongoing. On 08Jun2021 at 13:30 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY5423, Expiration date 31Aug2021), at an unspecified age, via an unspecified route of administration as a single dose for COVID-19 immunization. On 19Jun2021 estimated at 13:00 (around 10 days 23 hours 30 minutes after the vaccination), the patient experienced possibility of myocardial infarction or myocarditis. On 19Jun2021 (11 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 08Jun2021, the patient received the first vaccination individually at the reporting hospital. The patient''s primary care physician was at another hospital. On 19Jun2021, the patient died at home (estimated time of death was 13:00). Autopsy was conducted in Jun2021, which was positive for troponin in the blood. There was a possibility of myocardial infarction or myocarditis. Causality between the event and the vaccination was unknown. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause of the event such as any other diseases was myocardial infarction.; Reported Cause(s) of Death: positive for troponin in the blood / possibility of myocardial infarction or myocarditis; positive for troponin in the blood / possibility of myocardial infarction or myocarditis


VAERS ID: 1442097 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-16
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Gastrointestinal disorder, Illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
   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: REZALTAS; FEBURIC; FORXIGA; EQUMET; MAGMITT
Current Illness: Hypertension; Type 2 diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021771415

Write-up: it was assumed that the patient had already had gastrointestinal symptoms; endogenous disease; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a 77-year-old male. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received azelnidipine/olmesartan medoxomil (REZALTAS), febuxostat (FEBURIC), dapagliflozin propanediol monohydrate (FORXIGA), metformin hydrochloride/ vildagliptin (EQUMET HD), and magnesium oxide (MAGMITT) within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had allergies to medications, food, or other products. Other medical history included ongoing hypertension and ongoing type 2 diabetes mellitus. On 29May2021 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date were not provided) via an unspecified route of administration for COVID-19 immunization at a different hospital from the reporter''s. On 16Jun2021 (18 days after the vaccination), the patient died of endogenous disease (assumption). (The event resulted in death.) The patient did not receive treatment for the event. An autopsy was not performed. The course of the events was as follows: On 29May2021, the patient received the first dose of the vaccination. No obvious problems were noted. On 16Jun2021 at around 18:30, when his wife got back from work, she found the patient dead in the bathroom, and she called an ambulance. As postmortem changes were noted, a postmortem examination was performed. From the circumstances, it was assumed that the patient had already had gastrointestinal symptoms but any further information beyond this was uncertain. It was determined that the patient died of some endogenous diseases. Until the day he died, there had been some changes in his physical condition, but on the previous day of the vaccination, his primary doctor did not point out any problems. Since the vaccination, the patient has not been tested for COVID-19. The patient died on 16Jun2021. An autopsy was not performed. The assessment of causality between the event and BNT162b2 was not provided.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event illness (fatal) and the suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. ; Reported Cause(s) of Death: endogenous disease


VAERS ID: 1442101 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-21
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute abdomen, Chest discomfort, Decreased appetite, Dyspnoea, Haematochezia, Mesenteric arterial occlusion, Pain in extremity, Pulmonary embolism, Stool analysis, Thrombosis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal haemorrhage (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-24
   Days after onset: 3
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchial asthma
Allergies:
Diagnostic Lab Data: Test Date: 20210620; Test Name: stool; Result Unstructured Data: Test Result:normal
CDC Split Type: JPPFIZER INC2021777043

Write-up: thrombosis; pulmonary embolism; a large amount of bloody stool; vomited; foot pain; a small amount of a meal/unable to take meals; Acute abdomen; Superior Mesenteric arterial occlusion suspected; chest distress; rough breathing; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115998. The patient was an 85-year and 6-month-old female. Body temperature before vaccination was not provided. The family history was not provided. The patient had medical history of bronchial asthma. On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 17Jun2021 at 11:15 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021) via an unspecified route of administration at the age of 85-year-old as a single dose for COVID-19 immunization. On 21Jun2021 at 00:00 (3 days/12 hours/45 minutes after the vaccination), the patient experienced acute abdomen and Superior Mesenteric arterial occlusion suspected. On 24Jun2021 (7 days after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 17Jun2021 (the day of vaccination), at 11:15, the patient received the second dose of BNT162b2 vaccination. Thereafter, no particular changes were observed. On 19Jun2021 (2 day after vaccination), the patient was able to go to the day care facility without problems, and she had good appetite. From 21Jun2021 (4 days after vaccination) to 22Jun2021 (5 days after vaccination), the patient had abdominal pain, chest distress, and rough breathing. On 22Jun2021 (5 days after vaccination), the patient had a small amount of a meal. On 23Jun2021 (6 days after vaccination), the patient was absent from the day care, and she was unable to take meals and vomited. The patient could take only fluid. On the same day, the patient repeatedly had the symptoms such as rough breathing, foot pain, and abdominal pain. The last time when the patient orally took was on 24Jun2021, at 03:00 (6 days, 15 hours, and 45 minutes after vaccination), and she drank a small amount of water. At 05:00 (6 days, 17 hours, and 45 minutes after vaccination), the patient''s son found the patient not breathing. At that time, the patient had a large amount of bloody stool. Based on the medical histories, the cause of death caused by thrombosis (Superior Mesenteric arterial occlusion or pulmonary embolism) was considerable. Based on the clinical course, the causality between the event and BNT162b2 vaccination was suggested. The last time when the patient had defecation was on 20Jun2021 (3 days after vaccination), and it was normal stool. The outcome of event Acute abdomen, Superior Mesenteric arterial occlusion suspected, abdominal pain, thrombosis, pulmonary embolism was fatal, of event chest distress was recovered on 22Jun2021 and other events was unknown. The reporting physician classified the event as serious (death) and assessed that the event was related to BNT162b2. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: After the patient received the second dose of BNT162b2 vaccination, on Day 3, the patient had abdominal pain, and the outcome of the event was death on Day 7. The patient was receiving home care: however, recently, the disease condition was stable, and the causality between the event and BNT162b2 vaccination was suspected. Since the patient had abdominal pain, melena, and respiratory discomfort, it was considered that thrombosis was possibly involved in the event.; Reporter''s Comments: After the patient received the second dose of BNT162b2 vaccination, on Day 3, the patient had abdominal pain, and the outcome of the event was death on Day 7. The patient was receiving home care: however, recently, the disease condition was stable, and the causality between the event and BNT162b2 vaccination was suspected. Since the patient had abdominal pain, melena, and respiratory discomfort, it was considered that thrombosis was possibly involved in the event.; Reported Cause(s) of Death: Acute abdomen; Superior Mesenteric arterial occlusion suspected; thrombosis; pulmonary embolism


VAERS ID: 1442102 (history)  
Form: Version 2.0  
Age: 89.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-17
Onset:2021-06-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-17
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Debility; General malaise; Inappetence
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021777088

Write-up: Geromarasmus; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116019. The patient was an 89-year-old male. Body temperature before vaccination was not provided. The family history was not provided. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). On unknown date in 2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown). On 17Jun2021 (the day of vaccination), the patient received the second dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number unknown, Expiration date unknown) via an unspecified route of administration as a single dose for COVID-19 immunization. On 17Jun2021 at 18:00 (18 hours after the vaccination), the patient experienced geromarasmus. On 17Jun2021 (on the day of the vaccination), the patient was admitted to the hospital. On 17Jun2021 (on the day of the vaccination), the outcome of the event was fatal. The course of the event was as follows: On unknown date in May2021, the patient had inappetence and general malaise, the debility gradually progressed. On 17Jun2021 (the day of vaccination), although the patient had general malaise, he received the second dose of BNT162b2 vaccination, and he went home in the morning. Thereafter, at around 18:00 (18 hours after vaccination), the patient''s wife found that the patient had no reactions, and he was emergently transferred. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: The causality between the event and BNT162b2 vaccination was unknown. However, the cause of death was suspected to be geromarasmus according to the clinical course. No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: Geromarasmus


VAERS ID: 1442103 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-16
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7338 / 1 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Cardiac valvulopathy; Prostate cancer
Allergies:
Diagnostic Lab Data: Test Date: 20210616; Test Name: Body temperature; Result Unstructured Data: Test Result:36.0 Centigrade; Comments: before vaccination
CDC Split Type: JPPFIZER INC2021777094

Write-up: Cardio-respiratory arrest; Apnoea; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21115909. The patient was a 71-year and 4-month-old male. Body temperature before vaccination was 36.0 degrees centigrade. Family history was unknown. Medical history included cardiac valvulopathy and prostate cancer. On 16Jun2021 at 13:45 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA7338, Expiration date 30Sep2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unspecified date in Jun2021, the patient experienced cardio-respiratory arrest and apnoea. On 19Jun2021 (on the same day after the vaccination), the outcome of the event was fatal. The course of the event was as follows: On 16Jun2021 at 13:45, the patient received the vaccine at home. On 17Jun2021, a pharmacist delivered drugs to a patient face-to-face. On 21Jun2021, the police contacted the reporting clinic that the patient experienced cardio-respiratory arrest at home. On 22Jun2021, death certificate was made by the police. It was unknown if autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible causes of the event such as any other diseases were cardiac valvulopathy and prostate cancer.; Reported Cause(s) of Death: Cardio-respiratory arrest; Apnoea


VAERS ID: 1442104 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5829 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aortic aneurysm rupture, Body temperature, Haemoptysis, Pulmonary embolism, X-ray
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, venous (narrow), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-02
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ASVERIN [TIPEPIDINE HIBENZATE]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bronchiectasis; Rhinitis allergic
Allergies:
Diagnostic Lab Data: Test Date: 20210527; Test Name: Body temperature; Result Unstructured Data: Test Result:36 Centigrade; Comments: Before vaccination; Test Date: 2020; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown result; Test Date: 202105; Test Name: X-ray; Result Unstructured Data: Test Result:no change in the pulmonary condition from the prev
CDC Split Type: JPPFIZER INC2021777179

Write-up: suspected pulmonary thromboembolism; suspected aortic aneurysm rupture; Haemoptysis; This is a spontaneous report from a contactable physician received from the Regulatory Authority, report numbers are v21115952 and v21116180. An 88-year and 11-month-old female patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# FA5829, Expiration date 31Aug2021) an unspecified route of administration on 27May2021 at 10:30, at patient age of 88-year-old, as a single dose for COVID-19 immunization. Medical history included rhinitis allergic. The patient thought that she was diagnosed with bronchiectasis 30 years ago, but her attending physician had never mentioned about that as a diagnosis. The patient was receiving tipepidine hibenzate (ASVERIN) for cough due to rhinitis allergic (she took enough medicine to suppress a cough which appeared with change of season). The patient had no relevant family history. On 27May2021, body temperature before vaccination was 36 degrees Centigrade. On 27May2021 at 10:30 (the day of vaccination), the patient received the vaccine (at the mass vaccination site). On 28May2021 at around 03:00 in the morning (1 day after the vaccination), haemoptysis occurred. On 30May2021 at around 03:00 in the morning (3 days after the vaccination), haemoptysis occurred. On 31May2021 at around 17:00 (4 days after the vaccination), haemoptysis occurred. On 01Jun2021, an appointment was made at hospital A (to be examined at 15:00 on 02Jun2021). On 02Jun2021 at around 0:00 (6 days after the vaccination, assumed time of death on the medical certificate), the patient died of haemoptysis (death due to haemoptysis). On 02Jun2021 at around 06:15, the patient''s eldest daughter found her dead in cardio-respiratory arrest. She was sitting on the toilet seat leaning to the left. There was a large amount of blood in the bathroom sink, on the sides of the sink and toilet, and on the floor as well as on her nose, mouth and hands (partially in clots). The blood in the bathroom sink partially solidified in dark clots, creating large slimy chunks. It stopped before the drain and did not go down by itself. While cleaning, it did not go down with water and had to be broken in pieces with the back of a brush to wash away. The patient lived alone and was assisted by her eldest daughter at every meal. She had never vomited blood before the vaccination and was able to consume normal amount of food for a healthy adult. She had no problem in conversing with others in everyday life. However, there was a sudden change of condition after receiving the vaccine on 27May2021 and passed away. The patient had cough from seasonal allergic rhinitis, for which tipepidine hibenzate had been prescribed. Bronchiectasis stated on the Vaccine Screening Questionnaire had been diagnosed 30 years earlier and she was convinced that she was affected by it although she usually had no sputum, bloody sputum or haemoptysis. Plus, she had never been mentioned of bronchiectasis by her attending physician at hospital A as a diagnosis (she was always accompanied by her eldest daughter at visits). Based on the recent X-ray taken in May2021, she was told by her attending physician that there was no change in the pulmonary condition from the previous year and that oxygen was properly absorbed. She took prescribed oral medications only when she needed to suppress cough at change of season and most of medicines were left unused (still available at home). Therefore, bronchiectasis described on the Vaccine Screening Questionnaire was a diagnosis made 30 years ago and was not a recent diagnosis and she took enough medicine to suppress a cough which appeared with change of season. An appointment for the vaccination was made since her attending physician told that there would be no problem. After receiving the vaccine at 10:30 on 27May2021, haemoptysis persisted for a few days from 03:00 of 28May2021. As the episodes continuously occurred three times, they (maybe the patient''s family, not sure if they includes the reporter) became anxious and telephoned the vaccination appointment center on 01Jun2021. They were told that it was an adverse reaction due to the vaccination. When they asked what to do, they were put on hold for a while and then told to contact a hospital as the center could not make any medical judgement. So, they telephoned the appointment center (a woman answered) of hospital A. When they said that the patient vomited blood after receiving the vaccine, she replied that it was an adverse reaction due to the vaccination and told them to contact the call center for vaccination. So, they said that they had already done, and they were told to contact a hospital, then they were put on hold again. After a while, they were able to make an appointment for 15:00 on 02Jun2021. The hospital (a woman) called them back right after and asked if it was haemoptysis and what kind of blood it was. So, they answered that there were sputum-tinged blood and blood itself. She said that if it was not a pulmonary condition they might be asked to come back to a hospital again on another day for gastrointestinal examination and she became silent. So, they asked what to do, then she told them to just understand that if no diagnosis was made at the department of pulmonary medicine on the day, they might be referred to the department of gastrointestinal medicine. So, they replied that they understood, and ended the conversation. However, the patient passed away that night (sometime in the night of 01Jun2021 or around 0:00 on 02Jun2021 according to the estimation of the physician who performed postmortem examination). The patient was found dead by her eldest daughter in the morning. Her eldest daughter found the body and her grandchild called for an emergency assistance around 06:20. They were instructed over the phone to give resuscitation as there may be a chance of saving her. The patient was in a sitting position but they were instructed to pull her off the toilet and lay her down on the floor. The grandchild was in a confused state screaming and was encouraged by the operator over the phone to perform the resuscitation but he or she did not know how, and so asked where to place hands, how many centimeters apart, during which an emergency service team arrived. Several emergency service team staff arrived and were astonished by the scene. The emergency center ended the call as they acknowledged the arrival. One of them said that he would explain to the family and told the eldest daughter, her husband and the grandchild that they had a list to follow but resuscitation was unlikely to succeed. The emergency team told the family that they should decide whether to bring her to the hospital and force resuscitation on her (showing movements for cardiac massage) or not to do so, and that but the emergency team were not doctors, so they should call a physician at a university hospital and explain the situation before reaching a conclusion. So, the patient''s family asked for the physician''s confirmation over the phone. After confirmation by telephone, the emergency team said that the abdomen was warm maybe due to her posture but rigor mortis was in progress and there was no pupillary reflex and that even if they brought her to the hospital and performed resuscitation, the chance would be very low. So, the family decided not to transport her. (the leader of the emergency team). Then, the police station personnel (criminal affairs division: approx. 4 persons including detectives) arrived. They took pictures of the rooms and personal belongings, and several detectives asked questions on the course, to which answer was given one by one. A detective said that when a possibility of foul play was high an autopsy would be conducted but it damaged the body. So, they responded that they did not desire an autopsy because it would hurt to see her body cut by a scalpel. The detective said that they were not doctors and so they could not determine the cause of death and that they had a forensic doctor to do it. (There are 3 forensic doctors around the area.) They also said that they did not know when a forensic doctor could come, but the body would be placed in a funeral house. They asked the family which funeral house they would prefer. So, the family selected the funeral house that they knew by name. The detective also said that it might take a while to receive results if possibility of foul play was low and depending on the availability of a forensic physician and it could be sometime after tomorrow. Another police office said that he or she would check if there were any stabbing wounds, and closed the doors to the rooms. Quite long time passed and it was unknown what they checked over the body. It seemed they worked in the bedroom. Funeral house arrived. The detective instructed (somebody) to transport the body to the police station at first. Right before the body was taken out of the house (on the stretcher), the detective gave permission to them to enter the bedroom and they were able to see her face. Blood was cleaned but still remained around the nose and mouth. They witnessed the detective shoved two sheets of bed cover into the closet with his leg. At 11:15, the body was taken out of the house along with the funeral house staff and the police officers. The detective said that the family would hear from them around noon at the earliest. Around noon, the detective called the family and said that as a result of diagnosis, there was no possibility of foul play and their involvement ended. The grandchild asked the name of the forensic physician and was told to check with the funeral house and the conversation ended. Immediately after this, (unspecified) called the family and said that examination was performed by (unspecified) of hospital B. On 02Jun2021, they received a death certificate (results of postmortem examination) and read the findings for the first time. However, they had doubts about the death certificate. The patient led a normal life with healthy appetite before vaccination (rather, she possibly consumed more food than her grandchild in his/her 30s or the eldest daughter in her 60s) and had, of course, no haemoptysis. As the bereaved family, they could not help but to think that haemoptysis was obviously an abnormal change of physical condition following vaccination. The last massive haemoptysis discovered by the bereaved family was terrifying. The police officers also took numerous pictures of the body and the rooms; the emergency team and police officers also saw the bathroom sink. -When the body was settled, the family went to see her. They were given the towels received from the police but no explanation was given as to what the towel and bath towel were used for. Other reference source 1. Police Station/ criminal affairs division After receiving a request for autopsy from the bereaved family to clarify the cause of death due to the questionable cause of death described on the postmortem certificate, although they initially did not exhibit their clear desire for autopsy to the police, (unspecified) contacted the family around 15:40 on 04Jun2021. The detective responded that although he or she asked the police HQ, the request was declined since this case was closed and no change could be made. The detective reported that the decision was explained to the family. The bereaved family received the explanation from the detective that there was no possibility of foul play, the case was closed, they were no longer responsible and that the autopsy could not be arranged from that time. (Unspecified) contacted the detective by telephone around 14:25 on 17Jun2021. Regarding the document the police created for the case on 02Jun2021 (including pictures taken in the house), the bereaved family should contact the resident consultation section of the police station if they request disclosure of information on behalf of the deceased person. The circumstances of death were verbally informed to the doctor who performed postmortem examination but pictures were not shown to the physician. 2. (Unspecified) of hospital B Since there was no physician who made a diagnosis of haemoptysis and oversaw the course from onset to death, reporting from the town office using the report on the symptoms occurring following vaccination (for guardian) was considered. As the physician was advised by the prefectural government to submit the Report on suspected adverse reaction following vaccination, the physician met with (unspecified) around 14:30 on 08Jun2021. The clinical course provided by the bereaved family was explained. However, the physician was unaware of haemoptysis. (unspecified) was wondering if there was trace of blood on the body, so asked) the place of postmortem examination. The physician answered a morgue of the police station; it seems there was no trace of blood. The physician insisted that the primary responsibility was determination of foul play and that causality to the vaccine could not be judged and that the Report on suspected adverse reaction following vaccination could not be submitted. Despite the advice from the prefectural government, the municipal government was also capable of reporting and early reporting was considered important, (the reporter) did not strongly request the physician to submit the report. 3. President of Hospital C Since the physician examined the patient for vaccination, a meeting was arranged around 18:30 on 09Jun2021 between (unspecified) and (unspecified). On the day of vaccination, no abnormality was detected and no follow-up examination was performed afterwards, and thus the physician had no knowledge of condition at the time of death. The submission of the Report on suspected adverse reaction following vaccination was considered more difficult than the physician of hospital B and the physician was told that his/her name would be given on the Report on the symptoms occurring following vaccination (for guardian) as a vaccinating physician. 4. The emergency team member of the fire department Since the emergency team witnessed the death scene, and upon request from the bereaved family, (unspecified) inquired about the circumstances. (around 18:00 on 15Jun2021). According to (the emergency team member), the operation center received an emergency call at 06:22 on 02Jun2021 and the emergency team arrived at the scene at 06:30. The reporter/family member was applying pressure on the sternum until the emergency team arrived as per instruction of the operation center. Upon arrival, the injured person was lying on the floor between the toilet and bathroom sink (seemed to have been moved from the toilet to apply pressure on the sternum as per instruction of the operation center) and there were blood stains on the bathroom sink, floor and the clothes of the injured. Cardiac and respiratory arrests were confirmed by the crew and rigor mortis was noted on the jaw and legs. However, the abdomen was warm, the crew requested a physician (emergency center of a university hospital) for advice regarding the decision not to transport the body to the hospital. The abdominal warmth was considered attributable to the heated seat in the house and the advice was not to transport the body. At 07:21, the emergency team left the scene for the police to take over. The emergency team were not to make judgement on the cause of death, but as they were informed by the family that it was after receiving the coronavirus vaccine, it was communicated to the police. The emergency team explained the family that this case would be reported to the applicable organization, which was meant to be the healthcare center, as reported by the operation center. When the operation center received a case suspected of adverse reactions, the name/gender/address/vaccination date/vaccination place of the injured as well as the number of doses are reported to the healthcare center. This is the information obtained by (unspecified). The healthcare center has received reports to collect information but does not report them to different government organizations. Association between direct cause of death and the vaccine: According to the postmortem investigation conducted by the town office personnel, who was believed to have completed the postmortem certificate was surprised, saying that there was no trace of haemoptysis at the time of examination and he was not informed of haemoptysis by the police officer who provided the information. Although the authenticity of this statement and the details of postmortem examination were unknown, the postmortem examination/cause of death without the consideration of haemoptysis, an important piece of information, must be generally considered as low quality and credibility. In the present case, the patient with no known underlying diseases newly developed episodes of haemoptysis after receiving the vaccine and eventually sustained sudden death from massive haemoptysis 6 days after the vaccination. The possibility of foul play was denied. Differentiation from lung cancer and pulmonary infections usually precede, among others. However, the patient underwent a regular health checkup, during which chest X-ray revealed no apparent lung cancer. There were no pyrexia or expectoration, either. Vascular lesions, such as pulmonary thromboembolism, aortic dissection or aortic aneurysm rupture, would be considered next. The patient in this case kept vomiting bright red blood and so it was different from haematemesis, however, gastrointestinal diseases would be differentiated next. As for gastrointestinal disease, the patient had no gastrointestinal symptoms including haematemesis and blood in stool prior to vaccination and no signs suggestive of progressive gastrointestinal malignancy or hepatic diseases were observed. Therefore, the cause of death in this case was considered to be suspected pulmonary thromboembolism or suspected aortic aneurysm rupture based on the clinical course of sudden death from massive haemoptysis or circumstances at the time of death. In the report of the research officer of the infectious disease surveillance center, it was pointed out that although very few, there had been reports of thromboembolism by Pfizer vaccine and in addition, there was a report of death from arteriosclerosis as an adverse reaction to Pfizer vaccine. It should be extremely rare for a patient with no underlying conditions to die from such massive haemoptysis in a short time span as shown above. There has been reports of similar adverse reactions. The timeline with sequence of vaccination, following which haemoptysis occurred, leading to death from massive haemoptysis in a short period of time, all these indicated that there was a direct causal relationship between the vaccination and the symptoms/death, and thus considered related. Furthermore, there were no other possible causes as the patient had no past medical history. There were no findings to deny it was a vaccination-associated event, either. The reporting physician classified the events as serious (fatal outcome) and assessed that the events were related to BNT162b2. There was no other possible cause of the event such as any other diseases.The reporting physician commented as follows: The cause of death in this case was considered to be suspected pulmonary thromboembolism or aortic aneurysm rupture. There was a direct causal relationship between the symptoms/death and BNT162b2, and it was considered as related and there were no other causes.; Reported Cause(s) of Death: suspected pulmonary thromboembolism or aortic aneurysm rupture; suspected pulmonary thromboembolism or aortic aneurysm rupture; Haemoptysis


VAERS ID: 1442105 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-11
Onset:2021-06-18
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-18
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210611; Test Name: body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021777732

Write-up: Cardiac failure suspected; This is a spontaneous report from a contactable physician received via the Agency and from the Regulatory Authority. Regulatory authority report number is v21116230. The patient was a 81-year-old male. The body temperature before vaccination (36.3 degrees Celsius). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history on the medical interview. On 11Jun2021 10:06 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FC3661, Expiration date 30Sep2021) at 81 years old via intramuscular route of administration in the arm left for COVID-19 immunisation. Until 18Jun2021 (7 days after vaccination), the course was observed without problems. On 21Jun2021 (10 days after vaccination), the patient was found dead. The cause of death was cardiac failure suspected; however, the details were unknown. Since the patient was found dead approximately 3 days after the death, the patient was assumed to have had some kinds of adverse events on 18Jun2021 (7 days after vaccination). Since the vaccination, the patient has not been tested for COVID-19. The patient died on 18Jun2021. It was not reported if an autopsy was performed. The reporting physician classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. There was no other possible cause of the event such as any other diseases. The reporting physician commented as follows: Since there was only a report after the death by the family, the details were unknown. Thus, the causality between the death and BNT162b2 vaccination was also unknown.; Reported Cause(s) of Death: Cardiac failure suspected


VAERS ID: 1442106 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-24
Onset:2021-06-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3661 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Agonal respiration, Body temperature, Cardio-respiratory arrest, Dyspnoea, Heart rate decreased, Myocardial ischaemia, Pallor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Cardiomyopathy (broad), Other ischaemic heart disease (narrow), Hypotonic-hyporesponsive episode (broad), Respiratory failure (narrow)

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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Aortic dissection (under treatment); Marrow dysplasia (under treatment)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210624; Test Name: Body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: Before vaccination
CDC Split Type: JPPFIZER INC2021785469

Write-up: Pallor facial; breathing difficulty; cardio-respiratory arrest at the time of visit to a hospital; suspected ischaemic heart disease; agonal respiration; no effective heartbeat was noted; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number is v21116343. The patient was an 84-year and 8-month-old female. Body temperature before vaccination was 36.7 degrees Centigrade. Medical history (current diseases) included abdominal aortic aneurysm dissection and marrow dysplasia (under treatment). Concomitant medications and family history were not provided. On 24Jun2021 at 18:00 (the day of vaccination), the patient received the first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot# FC3661, Expiration date: 30Sep2021) an unspecified route of administration as a single dose for COVID-19 immunization. On 24Jun2021 at 20:00 (2 hours after the vaccination), the patient experienced pallor facial, breathing difficulty and cardio-respiratory arrest at the time of visit to a hospital. On 24Jun2021 at 22:14 (4 hours and 14 minutes after the vaccination), the patient died. It was not reported if an autopsy was performed. The course of the events was as follows: The patient was regularly visiting the hematology department of a medical facility. On 24Jun2021 from 09:00 to 16:00, she went to a facility for daycare service. When she got home, she looked exhausted. Afterwards, she received the vaccination at a hospital (different from the reporter''s), and then she returned home. At around 20:00, when she left the bathroom, she developed pallor facial and breathing difficulty, and so an emergency service was requested. When the emergency team treated the patient, agonal respiration appeared. Therefore, CPK (as reported) was performed. Drip infusion and administration of noradrenaline were also performed, then return of spontaneous circulation was seen. However, after arriving at the hospital, no effective heartbeat was noted. The intention for DNAR (do-not-attempt-resuscitation) was confirmed. At around 22:00, her heartbeat was lost. At 22:14, the patient''s death was confirmed. The reporting physician classified the event as serious (fatal outcome) and assessed the causality between the events and bnt162b2 as unassessable. There was no other possible cause of the events such as any other diseases. The reporting physician commented as follows: CT performed at the time of visit to the hospital showed changes in her lung, and no distinction between changes due to the resuscitation and those caused by pulmonary edema/pneumonia could be made. It was difficult to identify the cause of death, but it was considered to be suspected ischaemic heart disease. The causal relationship with bnt162b2 was unknown. The outcome of event cardio-respiratory arrest at the time of visit to a hospital and suspected ischaemic heart disease was fatal. The outcome of other event was unknown. The patient died on 24Jun2021. It was not reported if an autopsy was performed.; Reported Cause(s) of Death: cardio-respiratory arrest at the time of visit to a hospital; suspected ischaemic heart disease


VAERS ID: 1442107 (history)  
Form: Version 2.0  
Age: 79.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   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: TRICHLORMETHIAZIDE; EZETIMIBE; BELSOMRA; CETIRIZINE; DEPAS [ETIZOLAM]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Angina pectoris; Chest pain; Dementia; Hip surgery; Hypercholesterolaemia (on outpatient treatment since Oct2016); Hypertension (on outpatient treatment since Oct2016); Insomnia (on outpatient treatment since Oct2016); Knee operation; Osteoporosis; Rehabilitation therapy; Thyroiditis chronic (on outpatient treatment since Oct2016)
Allergies:
Diagnostic Lab Data: Test Date: 20210623; Test Name: Body temperature; Result Unstructured Data: Test Result:36.3 Centigrade; Comments: before vaccination; Test Date: 201801; Test Name: coronary computerised tomography (CT) test; Result Unstructured Data: Test Result:no abnormality was revealed; Test Name: magnetic resonance imaging (MRI) test; Result Unstructured Data: Test Result:unknown; Comments: she only received a follow-up care with magnetic resonance imaging (MRI) test and did not take medications
CDC Split Type: JPPFIZER INC2021785477

Write-up: Cardio-respiratory arrest; This is a spontaneous report from a contactable physician received from the Regulatory Authority. Regulatory authority report number are v21116439 and v21116461. This is a report received via the Agency. A 79-year and 9-month-old female patient received the second dose of BNT162B2 (COMIRNATY, solution for injection, lot number: FA5765, expiration date: 30Sep2021), at the age of 79 years old, intramuscularly in left arm on 23Jun2021 at 16:00 at single dose for COVID-19 immunisation. Body temperature before vaccination was 36.3 degrees centigrade. Medical history included angina pectoris and osteoporosis. The patient was on outpatient treatment for hypercholesterolaemia, hypertension, thyroiditis chronic, and insomnia since Oct2016. In the same year, the patient had surgery for coxarthrosis and knee arthrosis and was undergoing outpatient rehabilitation and others. In addition, the patient had mild dementia and was visiting the neurology department, but she only received a follow-up care with magnetic resonance imaging (MRI) test and did not take medications. In Dec2017, she had an attack of chest pain. In Jan2018, she was referred to a medical university and underwent examinations such as coronary computerised tomography (CT) test, but no abnormality was revealed. There was no allergic history including anaphylaxis. The patient was not pregnant at time of vaccination. Family history was unremarkable. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID Vaccine. The patient received trichlormethiazide (strength: 1 mg), ezetimibe (strength: 10 mg), suvorexant (BELSOMRA, strength: 15 mg), cetirizine (strength: 10 mg), and etizolam (DEPAS, strength: 0.5 mg) within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (lot number: EY0779, expiration date: 31Aug2021), at the age of 79 years old, intramuscularly in left arm on 02Jun2021 at 11:00 at single dose for COVID-19 immunisation. On 02Jun2021 at 11:00, the patient previously received the first dose of BNT162B2. On 23Jun2021 at 16:00 (the day of vaccination), the patient received the second dose of BNT162B2. On 25Jun2015 around 17:00 (2 days 1 hour after the vaccination), the police stepped into the house and found the patient in cardio-respiratory arrest, and the patient died. On 25Jun2021 (2 days after the vaccination), the outcome of the event was fatal. No autopsy was performed. The course of the events was as follows: On 23Jun2021, the patient received the second vaccination and was observed for 20 minutes. The patient had no problem and went home. However, 2 days later, the patient was found dead at home. On 25Jun2021 in the afternoon, the family telephoned the patient, but she did not answer, and they called the police. The family called the reporting hospital, found the patient in cardio-respiratory arrest, and knew about the death. The death cause was cardio-respiratory arrest. No autopsy was performed. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the adverse event. The reporting physician classified the events as serious (death) and assessed the causality between the events and BNT162B2 as unassessable. Other possible cause of the events such as any other diseases: This time, the family contacted the patient but failed, so they called the police. The family knew about the death when the police informed that they stepped into the house and found the patient in cardio-respiratory arrest. There was a past history of attack suggestive of angina pectoris, and the possibility of sudden death due to acute cardiac failure could not be denied as well. The reporting physician commented as follows: The causal relationship with the vaccine was unknown. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Cardio-respiratory arrest


VAERS ID: 1442108 (history)  
Form: Version 2.0  
Age: 97.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-23
Onset:2021-06-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA5765 / 1 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-25
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021785522

Write-up: Cardiac failure; This is a spontaneous report from a contactable physician via the Agency. The patient was a non-pregnant 97-year-old female. The most recent COVID-19 vaccine was administered at the doctor''s office/urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Jun2021 at 13:00 (the day of vaccination), the patient received the first single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number FA5765, Expiration date 30Sep2021) intramuscularly at the age of 97-year-old in the left arm for COVID-19 immunization. On 25Jun2021 at unknown time (2 days after the vaccination), the patient experienced cardiac failure. The reporter stated that the adverse event resulted in death on 25Jun2021. The death cause was cardiac failure. Autopsy was not performed. Treatment for the adverse event was not given. The reporting physician assessed the event as serious (death). The causality of the event was not reported. The outcome of event was fatal.; Sender''s Comments: Limited information can not support a complete medical assessment. A possible contributory role of BNT162B2 vaccine can not be excluded for the reported event of cardiac failure due to temporal relationship. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Cardiac failure


VAERS ID: 1442109 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-23
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY2173 / 2 LA / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-23
   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: Hypertension
Preexisting Conditions: Medical History/Concurrent Conditions: Fracture; Gallstones; Gastric cancer; Uterine myoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021786195

Write-up: Cardiac failure acute suspected; This is a spontaneous report from a contactable physician received via the Agency. The patient was a non-pregnant 90-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received unknown medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Other medical history included hypertension, gastric cancer, uterine myoma, gallstones, and fracture. There was no relevant past drug history. On 21May2021, the patient previously received the first dose of BNT162b2 (COMIRNATY, Lot# unknown, Expiration date unknown) for COVID-19 immunization at the age of 90-year-old. On 12Jun2021 at 12:00 (the day of vaccination), the patient received the second single dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number EY2173, Expiration date 31Aug2021) intramuscularly in the arm left for COVID-19 immunization. On 23Jun2021 (11 days after the vaccination), the patient experienced cardiac failure acute suspected. The patient died on 23Jun2021, and no autopsy was performed. The outcome of the event was fatal with treatment including cardiopulmonary resuscitation. The reporting physician assessed the event as serious (death). Since the vaccination, the patient has not been tested for COVID-19. The reporter commented that although the causality between the event and BNT162b2 vaccination was unknown, the patient died on 23Jun2021.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.; Reported Cause(s) of Death: Cardiac failure acute suspected


VAERS ID: 1442111 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-18
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Dementia; Diabetes mellitus; Hepatitis alcoholic; Hypercholesterolaemia; Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021787771

Write-up: Death; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A male patient in his 70s received bnt162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 18Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included dementia, hypertension, diabetes mellitus, hypercholesterolaemia and hepatitis alcoholic. The patient was regularly visiting the reporter''s clinic for about 5 years, and had no history of hospitalization. The patient''s concomitant medications were not reported. On an unspecified date, the patient previously received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration as a single dose for COVID-19 immunization. On an unspecified date (several days after the second dose of the vaccination), the patient found dead at home. The cause of death was not reported. It was unknown if an autopsy was performed. The reporting physician commented as follows: The causal relationship with BNT162b2 was unknown but when the patient visited the physician''s clinic on 15Jun2021, no particular symptoms were noted, and he received the second dose of BNT162b2 on 18Jun2021. Information on the lot/batch number has been requested.; Sender''s Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. This case will be reassessed when additional information, particularly the clinical course before death, complete medical history, concomitant medication and autopsy report, becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: Death


VAERS ID: 1442112 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia
SMQs:, Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021787777

Write-up: Pneumonia; This is a spontaneous report from a contactable physician received via a Pfizer sales representative. A 93-year-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Dose number, lot number, and expiration date were not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient Date of birth, height, weight, medical history and concomitant medications were unknown. On an unspecified date (4 days after the vaccination), the patient experienced pneumonia. The patient visited the hospital for malaise and pyrexia. Common cold was suspected and cold remedy was prescribed; however, it turned out at a later date that the patient had pneumonia. On an unspecified date, the patient was referred to another hospital and hospitalized for a few days. On an unspecified date, the patient was discharged from the hospital and subsequently died. It was not reported whether an autopsy was performed. The reporting physician assessed that the causality between the event and BNT162b2 was unknown. ; Reported Cause(s) of Death: Pneumonia


VAERS ID: 1442127 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FD1921 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Altered state of consciousness, Blood bicarbonate, Blood creatinine, Blood glucose, Blood potassium, Blood urea, C-reactive protein, COVID-19, Cardiac failure congestive, Chest X-ray, Chronic obstructive pulmonary disease, Computerised tomogram, Dyspnoea, Eosinophil count, Fibrin D dimer, Glomerular filtration rate, Granulocyte count, Haematocrit, Haemoglobin, Hypercapnia, Hypertension, Hypoxia, Investigation, Lymphocyte count, Mean cell haemoglobin, Mean cell haemoglobin concentration, Mean platelet volume, Monocyte count, Neutrophil count, Oxygen saturation, Oxygen saturation decreased, PCO2, PO2, Platelet count, Red cell distribution width, Respiratory failure, Respiratory rate increased, SARS-CoV-2 test, Tachypnoea, Vaccination failure, White blood cell count, pH body fluid
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Hypokalaemia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-16
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: BUMETANIDE; OMEPRAZOLE; SALMETEROL; BUDESONIDE; UMECLIDINIUM; SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Benign prostatic hypertrophy; COPD; COVID-19 (admitted to hospital and discharged on the 6th February); Heart failure with preserved ejection fraction (Grade 1 Diastolic Dysfunction); Hypertension
Allergies:
Diagnostic Lab Data: Test Name: HCO3; Result Unstructured Data: Test Result:35.5; Test Name: creatinine; Result Unstructured Data: Test Result:71 umol/l; Test Name: creatinine; Result Unstructured Data: Test Result:135 umol/l; Test Name: creatinine; Result Unstructured Data: Test Result:107 umol/l; Test Date: 20210613; Test Name: Creatinine; Result Unstructured Data: Test Result:135 umol/l; Comments: high; Test Date: 20210613; Test Name: glucose; Result Unstructured Data: Test Result:9.16 mmol/L; Test Date: 20210613; Test Name: potassium; Result Unstructured Data: Test Result:5.72 mmol/L; Test Date: 20210613; Test Name: urea serum; Result Unstructured Data: Test Result:18 mmol/L; Test Date: 20210613; Test Name: chest X-ray; Result Unstructured Data: Test Result:Bilateral pleural effusions and overlying air spac; Comments: Bilateral pleural effusions and overlying air space shadowing; Test Date: 20210613; Test Name: CT30; Result Unstructured Data: Test Result:30; Test Date: 20210613; Test Name: CRP; Result Unstructured Data: Test Result:26.9 mg/l; Comments: High; Test Date: 20210613; Test Name: eosinophils; Result Unstructured Data: Test Result:0.04 x10 9/l; Test Date: 20210614; Test Name: eosinophils; Result Unstructured Data: Test Result:0 x10 9/l; Test Date: 20210614; Test Name: D-Dimer; Result Unstructured Data: Test Result:1039 ng/ml; Comments: High; Test Date: 20210613; Test Name: GFR; Result Unstructured Data: Test Result:47; Comments: low; Test Date: 20210613; Test Name: Immature granulocytes; Result Unstructured Data: Test Result:0.30 x10 9/l; Test Date: 20210614; Test Name: Immature granulocytes; Result Unstructured Data: Test Result:0.24 x10 9/l; Test Date: 20210614; Test Name: haematocrit; Test Result: 40.1 %; Test Date: 20210613; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.5 g/dl; Comments: low; Test Date: 20210614; Test Name: Haemoglobin; Result Unstructured Data: Test Result:11.5 g/dl; Test Date: 20210614; Test Name: MSU for C/S; Result Unstructured Data: Test Result:No bacteria cultivated; Test Date: 20210613; Test Name: osmolality calculated; Result Unstructured Data: Test Result:307 mOsm/kg; Test Date: 20210613; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.74 x10 9/l; Comments: low; Test Date: 20210614; Test Name: lymphocytes; Result Unstructured Data: Test Result:0.75 x10 9/l; Test Date: 20210613; Test Name: mean cell haemoglobin; Test Result: 23 pg; Test Date: 20210614; Test Name: mean cell haemoglobin; Test Result: 23 pg; Test Date: 20210613; Test Name: mean cell haemoglobin conc; Result Unstructured Data: Test Result:28.4 g/dl; Test Date: 20210614; Test Name: mean cell haemoglobin conc; Result Unstructured Data: Test Result:28.7 g/dl; Test Date: 20210613; Test Name: mean platelet volume; Result Unstructured Data: Test Result:9 fL; Test Date: 20210613; Test Name: monocytes; Result Unstructured Data: Test Result:2.02 x10 9/l; Test Date: 20210614; Test Name: monocytes; Result Unstructured Data: Test Result:2.15 x10 9/l; Test Date: 20210613; Test Name: Neutrophils; Result Unstructured Data: Test Result:21.82 x10 9/l; Comments: high; Test Date: 20210614; Test Name: Neutrophils; Result Unstructured Data: Test Result:20.09 x10 9/l; Test Name: SpO2; Result Unstructured Data: Test Result:65.9; Test Name: pCO2; Result Unstructured Data: Test Result:113.5 mmHg; Test Date: 20210613; Test Name: pCO2; Result Unstructured Data: Test Result:99.7 mmHg; Test Name: pH; Result Unstructured Data: Test Result:7.1; Test Date: 20210613; Test Name: pH; Result Unstructured Data: Test Result:7.15; Test Date: 20210613; Test Name: platelets; Result Unstructured Data: Test Result:269; Comments: normal; Test Name: pO2; Result Unstructured Data: Test Result:114.4 mmHg; Test Date: 20210613; Test Name: pO2; Result Unstructured Data: Test Result:54.6 mmHg; Test Date: 20210613; Test Name: red cell distribution width; Test Result: 15.4 %; Test Date: 20210614; Test Name: red cell distribution width; Test Result: 15.5 %; Test Date: 20210131; Test Name: Sars-Cov-2 PCR test; Result Unstructured Data: Test Result:positive; Test Date: 20210213; Test Name: Sars-Cov-2 PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210430; Test Name: Sars-Cov-2 PCR test; Result Unstructured Data: Test Result:negative; Test Date: 20210613; Test Name: Sars-Cov-2 PCR test; Result Unstructured Data: Test Result:positive, CT 30; Test Date: 20210613; Test Name: WBC; Result Unstructured Data: Test Result:24.96 x10 9/l; Comments: high
CDC Split Type: MTPFIZER INC2021733858

Write-up: Chronic obstructive pulmonary disease exacerbation; Congestive Heart Failure; Hypertension; high respiratory rate; oxygen saturation low (less than 93%); Dyspnea; Tachypnea; Hypoxemia; type 2 Respiratory failure; Acute kidney injury; Altered consciousness; hypercapnia; Covid-19; Covid-19; This is a spontaneous report from a contactable physician. This is second of 2 reports. This report is about the second dose. An 82-years-old male patient received BNT162B2 (COMIRNATY, solution for injection), dose 2 intramuscular on 14May2021 (at the age of 82 years old) (Batch/Lot Number: FD1921) as, single, dose 1 intramuscular on 23Apr2021 (at the age of 82 years old) (Batch/Lot number: ET6956) as single dose for COVID-19 immunisation. Relevant medical history included hypertension, Heart failure with preserved ejection fraction (Grade 1 Diastolic Dysfunction), chronic obstructive pulmonary disease, benign prostatic hypertrophy, COVID-19 positive on 31Jan2021. Concomitant medications included bumetanide, at 1mg tablet: 1 - 0.5 -0; omeprazole at 20 mg daily, salmeterol at 25mcg Inhaler - 2 puffs BD, budesonide at 100mcg Inhaler - 2 puffs BD, umeclidinium at 1 puff daily; salbutamol at 100mcg - 2 puffs tds/prn. On 30Apr2021 the patient had a COPD exacerbation, was admitted to hospital and found to be COVID negative on admission. Discharged on 06May2021. On an unspecified date, the patient experienced Covid-19, chronic obstructive pulmonary disease exacerbation, congestive heart failure, hypertension, high respiratory rate, oxygen saturation low (less than 93%), dyspnea, tachypnea, hypoxemia, type 2 respiratory failure, acute kidney injury, altered consciousness, hypercapnia. The patient display clinical signs at rest indicative of severe systemic illness: Patient had concomitant severe COPD (chronic obstructive pulmonary disease) and had a high RR (more than 30 breaths/min) and SPO2 less than 93%. Patient had out of hospital respiratory arrest - reason for admission. ABGs on NRM: pH7.1, pCO2 113.5, pO2 114.4, SpO2 65.9, HCO3 35.5. Patient started on NIV PINSP 15, PEEP 6, FIO2 40%. Over course of admission there was minimal improvement with deterioration despite maximal NIV settings. The patient received hydrocortisone 100mg tds IV given for COPD from 13Jun2021 to 16Jun2021. Also, he started on regular nebulized salbutamol 2.5mg QDS plus Ipratropium Bromide 0.5mg QDS. In between the first and second vaccine shots, the patient experienced COPD exacerbation, was admitted to hospital (30Apr2021 to 06May2021) and required oral prednisolone. The patient died on 16Jun2021 at the Hospital. It was not reported if an autopsy was performed. Patient admitted on the 13Jun2021 and died in hospital on the 16Jun2021 (4 days). Patient was not admitted to the ICU. Primary cause of death was Chronic obstructive pulmonary disease exacerbation due to COVID-19 and other significant contributory causes were Congestive Heart Failure and Hypertension. This case died 4 days after found positive. Was previously positive for COVID on 31Jan2021 (Case 18207). Patient suffered from COPD and had Respiratory Type 2 failure. His symptomatology for the first COVID infection was cough and shortness of breath (SOB). His symptomatology for this second infection was SOB. In fact, he was admitted after suffering respiratory arrest. On 13Jun2021 patient suffered SOB and respiratory arrest, was admitted to hospital and found to be Covid positive. The patient underwent laboratory examinations that included Sars-cov-2 PCR test: positive on 31Jan2021, negative on 13Feb2021, negative on 30Apr2021, Computerized tomogram: positive CT30 on 13Jun2021, Chest X-Ray: Bilateral pleural effusions and overlying air space shadowing on 13Jun2021, WBC 24.96 [4.30 - 11.40 x 10^9/L], neutrophils 21.82 [2.10 - 7.20 x 10^9/L], immature granulocytes 0.30 [0.00-0.09x10^9/L], lymphocytes 0.74 [1.30 - 3.60x10^9/L], Monocytes 2.02 [0.4-1.10x10^9/L], eosinophils 0.04 [0.10 - 0.70x10^9/L] haemoglobin 11.5 [14.1 - 17.2 g/dl], mean cell Hb 23 [27-32 pg], mean cell Hb conc 28.4 [33 - 36 g/dl], red cell distribution width 15.4 [11.9 - 14.6%], mean platelet volume 9 [9.2 - 12.6 fL], urea serum 18 [1.7 - 8.3 mmol/l], creatinine serum 135 [59- 104 umol/l], potassium serum 5.72 [3.5 - 5.1 mmol/l], c-reactive protein 26.9 [0-5 mg/l], glucose 9.16 [3.9 - 9 mmol/l], osmolality calculated 307 [275-299 mOsm/kg]. WBC 23.27 [4.30 - 11.40 x 10^9/L], neutrophils 20.09 [2.10 - 7.20 x 10^9/L], immature granulocytes 0.24 [0.00-0.09x10^9/L], lymphocytes 0.75 [1.30 - 3.60x10^9/L], Monocytes 2.15 [0.4-1.10x10^9/L], eosinophils 0.00 [0.10 - 0.70x10^9/L], haemoglobin 11.5 [14.1 - 17.2 g/dl], haematocrit 40.1 [40.4 - 50.4%], mean cell Hb 23 [27-32 pg], mean cell Hb conc 28.7 [33 - 36 g/dl], red cell distribution width 15.5 [11.9 - 14.6%] on 14Jun2021. Therapeutic measures were taken as a result of COPD. The outcome of events Covid-19, chronic obstructive pulmonary disease exacerbation, congestive heart failure, hypertension was fatal, and outcome of all other events was unknown. No further information expected. Complete report.; Sender''s Comments: The Company cannot completely exclude the possible causality between the COVID 19 ,Vaccination failure , Chronic obstructive pulmonary disease exacerbation, Congestive Heart Failure, Hypertension, high Respiratory rate , Respiratory failure, Acute kidney injury reported and death , and the administration of the COVID 19 vaccine, BNT162B2, based on the reasonable temporal association. Additional information is needed to better assess the case, including complete medical history, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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) : MT-PFIZER INC-2021734386 same patient/drug, different dose/events; Reported Cause(s) of Death: Chronic obstructive pulmonary disease exacerbation; Congestive Heart Failure; Hypertension


VAERS ID: 1442134 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021775698

Write-up: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.; the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer . Received from Medical Information Team. This is the first of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 unknown on an unspecified date (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced for the particular case of the pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was not reported if an autopsy was performed.Verbatim: Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.Applicant agrees to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021783516 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783505 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783513 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783520 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783522 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783511 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783526 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783508 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783507 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783510 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783521 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783528 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783517 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783527 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783524 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783518 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783509 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783512 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783514 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783515 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783523 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783506 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783525 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783531 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783530 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783519 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783532 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783533 Master case, different patient, same AE, same product;MX-PFIZER INC-2021783529 Master case, different patient, same AE, same product; Reported Cause(s) of Death: unknown cause of death


VAERS ID: 1442135 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: MXPFIZER INC2021783506

Write-up: died; This is a spontaneous report from a contactable consumer from Medical Information Team. This consumer reported similar events for thirty patients. This is the third of thirty reports. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on an unspecified date for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient died after the first dose. It was unknown if an autopsy was performed or not. The outcome of event was fatal. Journalist required information as they were conducting an investigation of vaccines against COVID-19 including that of Pfizer. Reporter commented that several patients had died after the application of the complete scheme or the first dose, they suspected that it may be due to the fact that according to the information collected they were taking up to 7.5 doses from the vials and according to what they understand there were a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 the same reporter, product and similar adverse event in different patients; Reported Cause(s) of Death: died


VAERS ID: 1442136 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783507

Write-up: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.; This is a spontaneous report from a contactable consumer. Received from Medical Information Team. This consumer reported similar events for thirty patients. This is the fourth of thirty reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot/batch number not provided), via unknown route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was unknown if an autopsy was performed. information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.


VAERS ID: 1442137 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783508

Write-up: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.; This is a spontaneous report from a contactable consumer. Received from Medical Information Team. This consumer reported similar events for thirty patients. This is the fifth of thirty reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot/batch number not provided), via unknown route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was unknown if an autopsy was performed. information on the lot/batch number has been requested. ; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.


VAERS ID: 1442138 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783509

Write-up: 6 people died with the complete scheme and 24 with the first dose; the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer received from Medical Information Team. The reporter reported same events for 30 patients, this is the 6th of 30 reports. A patient of unspecified age and gender received bnt162b2 (Batch/Lot Number: Unknown), first dose via an unspecified route on an unspecified date as dose 1, single for covid-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient died with the complete scheme and 24 with the first dose on an unspecified date. The patient died on an unspecified date. It was not reported if an autopsy was performed. Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Applicant agrees to be contacted to delve into the issue and refer directly to the people directly affected. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: 6 people died with the complete scheme and 24 with the first dose


VAERS ID: 1442139 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783510

Write-up: 6 people died with the complete scheme and 24 with the first dose; it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer. This is the 7th of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 unknown on an unspecified date (Batch/Lot Number: Unknown) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the event Death was fatal. The information on the batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose


VAERS ID: 1442140 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783511

Write-up: died; taking up to 7.5 doses from the vials and according to what they understand there were a maximum of 5 doses; This is a spontaneous report from a contactable consumer, received from medical information team. This consumer reported same events for 30 patients. This is the 8th of 30 reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 unknown on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died on an unspecified date with the first dose. Journalist required information as they were conducting an investigation of vaccines against COVID-19 including that of Pfizer. He commented that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they were taking up to 7.5 doses from the vials and according to what they understand there were a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on unknown date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 different patient, same AE, same product; Reported Cause(s) of Death: died


VAERS ID: 1442141 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783512

Write-up: died with the first dose; taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer or other non-healthcare professional, received from medical information team. This is the 9th of 30 reports made by same report, same drug, same event, different patient. A patient of unspecified age and gender received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), dose 1 unknown on an unspecified date (Batch/Lot Number: unknown) as 1st dose, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. It was not reported if an autopsy was performed. It was commented that several patients had died after the application of the complete scheme or the first dose, they suspect that it might be due to the fact that according to the information collected they were taking up to 7.5 doses from the vials and according to what they understand there were a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: died with the first dose


VAERS ID: 1442142 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

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: MXPFIZER INC2021783517

Write-up: died; This is a spontaneous report from a contactable consumer received from Medical Information Team. This consumer reported same event for 30 patients. This is the 14th of 30 reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), via an unknown route of administration on an unspecified date (at an unspecified age) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient died with the first dose on an unspecified date. The outcome of the event was fatal. It was not reported if an autopsy was performed. Information on the batch/lot number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same event, same product; Reported Cause(s) of Death: died


VAERS ID: 1442143 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783519

Write-up: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.; This is a spontaneous report from a contactable consumer. Received from Medical Information Team. This consumer reported similar events for thirty patients. This is the sixteenth of thirty reports. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot/batch number not provided), via unknown route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Journalist requires information as they are conducting an investigation of vaccines against COVID-19 including that of Pfizer. He comments that several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was unknown if an autopsy was performed. information on the lot/batch number has been requested. Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 Master case, different patient, same AE, same product; Reported Cause(s) of Death: For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose.


VAERS ID: 1442144 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Death, Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: MXPFIZER INC2021783531

Write-up: 6 people died with the complete scheme and 24 with the first dose.; are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses; This is a spontaneous report from a contactable consumer or other non hcp. This reporter reported similar events for 30 patients, this is the 28th report. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 unknown on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first dose of bnt162b2 for covid-19 immunisation. Several patients have died after the application of the complete scheme or the first dose, they suspect that it may be due to the fact that according to the information collected they are taking up to 7.5 doses from the vials and according to what they understand there are a maximum of 5 doses. For the particular case of the Pfizer vaccine, 6 people died with the complete scheme and 24 with the first dose. The patient died on an unspecified date. It was not reported if an autopsy was performed. information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : MX-PFIZER INC-2021775698 same reporter, different patient, same AE, same product; Reported Cause(s) of Death: 6 people died with the complete scheme and 24 with the first dose.


VAERS ID: 1442186 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-05
Onset:2021-05-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX7389 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Cholecystitis, Decreased appetite, Drug ineffective, Dyspnoea, Hyperhidrosis, Malaise, Nausea, Pneumonia, SARS-CoV-2 test, Suspected COVID-19
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Infectious biliary disorders (narrow), Gallbladder related disorders (narrow), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-11
   Days after onset: 6
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: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20201003; Test Name: corona, confirmed by test; Test Result: Positive
CDC Split Type: NLPFIZER INC2021728822

Write-up: possibly COVID 19; Sweating; abdominal pain, gall bladder inflammation; Nausea; Not feeling well; no appetite; Drug ineffective; possible bilateral pneumonia; Shortness of breath; abdominal pain, gall bladder inflammation; This is a spontaneous report from a contactable consumer or other non hcp downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00565553. A 68-years-old male patient received BNT162B2 (COMIRNATY, unspecified solution for injection), via an unspecified route of administration on 05May2021 (Batch/Lot Number: EX7389) as UNKNOWN, 0.3ML SINGLE for covid-19 immunization. The patient past Medical history included covid-19 from 03Oct2020 to an unknown date. The patient''s concomitant medications were not reported. it was reported the patient felt unwell on the day itself he experienced nauseous, stomach problems, no appetite on 05May2021. the patient was seen by the GP (General Practitioner). Here the diagnosis "gall bladder inflammation" was made on 07May2021. The patient underwent immediate surgery on Saturday 08Aug2021. The gall bladder was removed. The operation was successful. Immediately after the operation. The patient also had with dyspnoea (3 days after start), nausea (within 1 day), malaise (within 1 day), decreased appetite (within 1 day), gallbladder inflammation (within 1 day), pneumonia (within 1 day), hyperhidrosis (3 days after start) following administration of covid-19 vaccine. The patient reported very short of breath and sweating heavily. On 11May2021 the diagnosis of possible COVID suspect was made (this without test) with complaints possibly bilateral pneumonia. The patient was died due to bilateral pneumonia on 11May2021. The autopsy was Unknown. The event outcome is Unknown for Drug ineffective, not feeling well, abdominal pain, gall bladder inflammation, no appetite, Nausea and Sweating and Fatal for rest of the events. Diagnostic procedures: According to the doctor hospital, the complaints could not be side effects of the vaccine! No, there was no proper further investigation.; Reporter''s Comments: Summary of reporter''s comments text: ---------- Do not know---------------------- Past drug therapy Do not know: no ---------- Chest tightness ---------------------- Additional information ADR (adverse drug reaction): My father felt unwell on the day itself. He had no appetite. He felt nauseous. He had stomach problems. On 07Jul2021 he was seen by the GP (General Practitioner) post. Here the diagnosis "gall bladder inflammation" was made.; Sender''s Comments: A causal association between BNT162B2 and the reported events suspected covid-19, pneumonia, dyspnea, cholecystitis, drug ineffective, decreased appetite, abdominal pain, abdominal pain, hyperhidrosis, nausea and malaise cannot be completely excluded based on information provided. Elderly age could also be contributor to causality. 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: suspected bilateral pneumonia


VAERS ID: 1442203 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-12
Onset:2021-06-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-14
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ex-smoker (smoked cigars); Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type: NLPFIZER INC2021770645

Write-up: Malaise/did not feel well; Cardiac arrest; Chest pain; This is a spontaneous report from a contactable consumer downloaded from the Regulatory Authority-WEB, regulatory authority number NL-LRB-00586576. A 67-year-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on 12Jun2021 as dose 2, single for covid-19 immunisation. Medical history included ex-smoker, there is a lot of high blood pressure in the family of 9 brothers and sisters. He does not know whether there was also high cholesterol in the family. The patient was not a smoker, but has smoked cigars in the past and likes to drink a glass, without immediately calling him an alcoholic. He wasn''t noticeably fat. The patient''s concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 Immunization. The patient experienced malaise, cardiac arrest, chest pain on 14Jun2021 (2 days after start). The patient was vaccinated for the second time with Pfizer on Saturday 12Jun2021 and did not feel well on 14Jun2021 in the evening. The patient has a girlfriend, he had eaten there, after dinner on the couch he didn''t feel so well, had some chest pain. The girlfriend insisted to call the doctor, but he didn''t want to hear about it, it would pass. The consumer says that this is a bit of the culture in the family: don''t complain, it will pass. Girlfriend insisted uncle stay with her, but he left for his own house anyway. Girlfriend didn''t trust it, called him, got no answer, went there and found him in the bathroom. 911 called, tried to resuscitate, but to no avail. The patient is in himself a healthy, active man. Reporter does not know whether he used medication. The consumer does say that there is a lot of high blood pressure in the family of 9 brothers and sisters. He does not know whether there was also high cholesterol in the family. The patient was not a smoker, but has smoked cigars in the past and likes to drink a glass, without immediately calling him an alcoholic. He wasn''t noticeably fat. The patient died on 14Jun2021. It was not reported if an autopsy was performed. No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Reporter''s Comments: summary of reporter comment: information about patient, adverse event description, patient''s and family medical history; Reported Cause(s) of Death: Chest pain; malaise; cardiac arrest


VAERS ID: 1442210 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-27
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: COVID-19 immunisation, Computerised tomogram, Deep vein thrombosis, Endobronchial ultrasound, Lung neoplasm malignant, Pain in extremity, Peripheral swelling, Sudden death, Wrong product administered
SMQs:, Torsade de pointes/QT prolongation (broad), Cardiac failure (broad), Angioedema (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Non-haematological malignant tumours (narrow), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-15
   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:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Computerized tomography; Result Unstructured Data: Test Result:tumor right lower lobe; Comments: CT-thorax detected tumor right lower lobe and possible malignant lymph nodes, suspicion of lung cancer.; Test Date: 20210610; Test Name: Endobronchial ultrasound; Result Unstructured Data: Test Result:uncomplicated procedure; Comments: including samples of lymph nodes in the mediastinum, uncomplicated procedure, no bleeding.
CDC Split Type: NOPFIZER INC2021770815

Write-up: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; wrong vaccine administered; pain and swollen left leg approximately 5 days after vaccination; pain and swollen left leg approximately 5 days after vaccination; SUDDEN DEATH UNEXPLAINED; CT-thorax 05Jun2021 detected tumor right lower lobe and possible malignant lymph nodes, suspicion of lung cancer; DVT; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-U8e5q5.A 59-years-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in Arm Left on 20May2021 (Batch/Lot Number: FA7812) as DOSE 1, SINGLE for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at DOSE 1, SINGLE for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient was diagnosed with DVT 7 days after vaccination with Comirnaty, second dose. Symptoms starting with pain and swollen left leg approximately 5 days after vaccination. CT-thorax 05Jun2021 detected tumor right lower lobe and possible malignant lymph nodes, suspicion of lung cancer. The patient is observed in well-being after endobronchial ultrasound 10Jun2021. The lab results included samples of lymph nodes in the mediastinum, uncomplicated procedure, no bleeding.Does not show up for an appointment at the hospital 14Jun2021 and 15Jun he is found dead at home. The cause of death is currently unknown.Therapeutic measures were taken as a result of dvt.DVT treated with apixaban (Eliquis).Apixaban paused during endobronchial ultrasound, resumed after the procedure.Reporter''s comment:Report unexpected death as a possible side effect / connection to vaccine since it is less than 4 weeks since vaccination. Not sure if there is any connection. Autopsy will be performed.Relatedness of drug to reaction(s)/event(s): Revaccination with different COVID-19 vaccine, DVT.Source of assessment: Regulatory Authority Result of Assessment: Possible No follow-up attempts possible. No further information expected.; Reporter comments : Symptoms starting with pain and swollen left leg approximately 5 days after vaccination. The patient is observed in well-being after endobronchial ultrasound 10Jun2021. Does not show up for an appointment at the hospital 14Jun2021 15Jun he is found dead at home. The cause of death is currently unknown. DVT treated with apixaban (Eliquis). Apixaban paused during endobronchial ultrasound, resumed after the procedure. Report unexpected death as a possible side effect / connection to vaccine since it is less than 4 weeks since vaccination. Not sure if there is any connection. Autopsy will be performed.; Reported Cause(s) of Death: DVT; SUDDEN DEATH UNEXPLAINED


VAERS ID: 1442211 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX6564 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase, Angiogram, Aphasia, Blood alkaline phosphatase, Blood bilirubin, Blood cholesterol, Blood creatinine, Blood electrolytes, Blood glucose, Blood pressure measurement, C-reactive protein, Carcinoembryonic antigen, Cerebral haemorrhage, Chest pain, Coma scale, Computerised tomogram head, Exercise electrocardiogram, Gamma-glutamyltransferase, Haemoglobin, Headache, Heart rate, Hemiparesis, Low density lipoprotein, NIH stroke scale, Neurological examination, Oxygen saturation, Pain in extremity, Platelet count, Prostatic specific antigen, Pyrexia, Ultrasound liver, White blood cell count
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Tendinopathies and ligament disorders (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: ATORVASTATIN; ALBYL-E
Current Illness: Hypertension (Quit antihypertensive drugs two years ago.)
Preexisting Conditions: Medical History/Concurrent Conditions: Abdominal aortic aneurysm (Elective graft surgery for abdominal aortic aneurysm in 2017); Aortic valve insufficiency (Examination in 2019 showed a small aortic valve insufficiency.); Cholecystolithiasis; Cigarette smoker (Quit in 1980.); Family history of cancer (One sister and one brother died of pancreatic cancer.); Family history of cardiovascular disorder (One sister with cerebral hemorrhage Mother died of aortic aneurysm.); Feeling unwell (He has experienced some tiredness and loss of weight over time, and not felt well (1-2 years).); Heart pounding; Tiredness (He has experienced some tiredness and loss of weight over time, and not felt well (1-2 years).); Umbilical hernia (Surgery for umbilical hernia in 1980s.); Weight loss (He has experienced some tiredness and loss of weight over time, and not felt well (1-2 years).)
Allergies:
Diagnostic Lab Data: Test Date: 20210525; Test Name: Alanine aminotransferase; Result Unstructured Data: Test Result:Normal; Test Date: 20210525; Test Name: CT angiography; Result Unstructured Data: Test Result:No aneurysm or other apparent vessel pathology; Comments: No aneurysm or other apparent vessel pathology as cause of cerebral hemorrhage. Small contrast extravasation centrally in the bleeding.; Test Date: 20210525; Test Name: Alkaline phosphatase; Result Unstructured Data: Test Result:140; Comments: Units:U/L; Test Date: 20210525; Test Name: Bilirubin; Result Unstructured Data: Test Result:40 mmol/L; Test Date: 20210525; Test Name: Cholesterol; Result Unstructured Data: Test Result:5.4 mmol/L; Test Date: 20210525; Test Name: Creatinine; Result Unstructured Data: Test Result:66 mmol/L; Test Date: 20210525; Test Name: Blood electrolytes; Result Unstructured Data: Test Result:Normal; Test Date: 20210525; Test Name: Glucose; Result Unstructured Data: Test Result:6 mmol/L; Test Date: 20210525; Test Name: Blood pressure; Result Unstructured Data: Test Result:148 per 93 mmHg; Test Date: 20210525; Test Name: Carcinoembryonic antigen; Test Result: Negative ; Test Date: 20210525; Test Name: Glasgow coma scale; Result Unstructured Data: Test Result:14-15; Test Date: 20210525; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:Parenchymal bleeding has increased; Comments: CT control: Parenchymal bleeding has increased in basal ganglia left side with substantial mass effect. Blood breaks through to ventricular system. Beginning ballooning of side ventricles; Test Date: 20210525; Test Name: Computerised tomogram head; Result Unstructured Data: Test Result:Parenchymal bleeding; Comments: Parenchymal bleeding in area of nucleus lentiformis and putamen left side. Size: 38 x 17 x x 28 mm. Probably related to hypertension. String of fresh blood along capsula interna laterally for nucleus caudatus left side. Edema with slight compression of front horn of side ventricle on the left side. Centerline minimal offset to the right (2 mm). Small amount of blood in left sulcus silvii. Open basal cistern space. Preserved differentiation between grey and white matter. Pneumatized mastoid cells. Calvarium normal.; Test Date: 20210525; Test Name: C-reactive protein; Result Unstructured Data: Test Result:5 mg/l; Test Date: 2020; Test Name: Exercise electrocardiogram; Result Unstructured Data: Test Result:Normal; Test Date: 20210525; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:200; Comments: Units:U/L; Test Date: 20210525; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: Test Result:11; Comments: Units:U/L; Test Date: 20210525; Test Name: Hemoglobin; Result Unstructured Data: Test Result:14.8 g/dl; Test Date: 20210525; Test Name: Pulse rate; Result Unstructured Data: Test Result:77; Comments: bpm; Test Date: 20210525; Test Name: Low density lipoprotein cholesterol; Result Unstructured Data: Test Result:1.9 mmol/L; Test Date: 20210525; Test Name: Neurological examination; Result Unstructured Data: Test Result:Moderate dysarthria; Comments: Moderate dysarthria, possible compontent expressive aphasia. Right sided hemianopsia or visual neglect. Hanging mouth and facial paralysis of lower part of face right side. No uvular deviation.; Test Date: 20210525; Test Name: NIH stroke scale; Result Unstructured Data: Test Result:10; Test Date: 20210525; Test Name: Oxygen saturation; Test Result: 91 %; Test Date: 20210525; Test Name: Thrombocyte count; Result Unstructured Data: Test Result:113 g/dl; Test Date: 20210525; Test Name: Prostatic specific antigen; Test Result: Negative ; Test Date: 2019; Test Name: Ultrasound liver; Result Unstructured Data: Test Result:Shows cholecystolithiasis.; Test Date: 20210525; Test Name: Leukocyte count; Result Unstructured Data: Test Result:4.9 x10 9/l
CDC Split Type: NOPFIZER INC2021770750

Write-up: HEMIPARESIS; STRONG HEADACHE; APHASIA; CHEST PAIN; CEREBRAL HEMORRHAGE; PAIN IN ARM; FEVER; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB, regulatory authority number NO-NOMAADVRE-FHI-2021-Umw444. A 73-year-old male patient received bnt162b2 (COMIRNATY, lot number: EX6564), dose 2 intramuscular, administered in Arm Left on 21May2021 09:00 (Batch/) as DOSE 2, SINGLE for covid-19 immunisation. The medical history included ongoing hypertension (Quit antihypertensive drugs two years ago), abdomial aortic aneurysm (elective graft surgery for abdominal aortic aneurysm in 2017), umbilical hernia (surgery for umbilical hernia in 1980s), aortic valve insufficiency (examination in 2019 showed a small aortic valve insufficiency), cholecystolithiasis (in 2019) and heart pounding (in 2020). He was a previous cigarette smoker (Quit in 1980) and has a moderate alcohol consumtion. He has a family history of cardiovascular disorder ad cancer (two siblings died of pancreatic cancer). The patient was treated in the past with antihypertensive drugs. He has experienced some tiredness and loss of weight over time, and not felt well (1-2 years). Concomitant medications included atorvastatin; acetylsalicylic acid, magnesium oxide (ALBYL-E). Relevant laboratory findings and investigations included in the report: Ultrasound liver in 2019, exercise electrocardiogram in 2020. The following laboratory findings and investigations were from 25May2021: Blood pressure, pulse rate, oxygen saturation, C-reactive protein, hemoglobin, leukocyte count, thrombocyte count (113 g/dL), blood electrolytes, creatinine, gamma-glutamyltransferase, alkaline phosphatase, alanine aminotransferase, bilirubin ( 40 mmol/L), glucose, cholesterol, low density lipoprotein cholesterol, prostatic specific antigen, carcinoembryonic antigen, CT head, CT angiography, NIH stroke scale, Glasgow coma scale and neurological examination. On 22May2021 the patient experienced pain in his arm, chest pain and strong headache and fever. On the 25May2021 the patient woke up at 10.30 with speech problems and right sided hemiparesis. He was admitted to hospital with cerebral hemorrhage. He had a GCS of 14-15, moderate dysarthria and a small component aphasia, but could make himself understood. Oriented of time, place and situation. No headache or other subjective symptoms other than despair over problems with speaking. At examination at 12.10 he has no general edema, cyanosis or icterus. NHISS 10. CT shows parenchymal bleeding in basal ganglia with largest diameter of 35 mm. Quick progression with breakthrough bleeding to ventricles. Not available for intervention. His prognosis was considered very bad. He was given fluids the first couple of days until no improvement was seen. He got palliative treatment, and died peacefully. High thombocyte count and liver tests were noted. It is possible that a cancer diagnosis has been overlooked, and could have contributed to the hemorrhage. Sore arm (Pain in arm), from 22May chest pain, severe headache and fever. Admitted 25May with hemiparesis and aphasia, detected cerebral haemorrhage. Time Interval between Beginning of Drug Administration and Start of Reaction / Events ALL: 2 days. Relatedness of drug to reaction(s)/event(s): ALL. Result of Assessment: Possible. The case was considered to be serious. This case was received from a physician. The patient died on an unspecified date. It was not reported if an autopsy was performed. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: HEMIPARESIS; STRONG HEADACHE; APHASIA; CHEST PAIN; CEREBRAL HEMORRHAGE; PAIN IN ARM; FEVER


VAERS ID: 1442220 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diplopia, Dizziness, Dysphagia, Dyspnoea, Headache, Malaise
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Ocular motility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PHPFIZER INC2021767847

Write-up: Headache; Difficulty of Breathing; Body Malaise; Dizziness Rotatory in Character; Dyspnea; Dysphagia; Diplopia; This is a spontaneous report from a contactable other hcp. This is a report received from the Regulatory authority, report number PH-PHFDA-300085809. A 49-years-old male patient received bnt162b2 (COMIRNATY), intramuscular at age of 49-years-old on 20May2021 (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 experienced headache, difficulty of breathing, body malaise, dizziness rotatory in character, dyspnea, dysphagia, diplopia, all on 20May2021 10:00. The outcome of the events reported as fatal. The patient died on an unspecified date in 2021. It was not reported if an autopsy was performed. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Headache; Difficulty of Breathing; Body Malaise; Dizziness Rotatory in Character; Dyspnea; Dysphagia; Diplopia


VAERS ID: 1442224 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-27
Onset:2021-05-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7842 / 2 LA / OT

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

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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021770773

Write-up: Death; This is a spontaneous report from a contactable physician downloaded from the WEB, regulatory authority number PL-URPL-DML-MLP.4401.3.738.2021.A 62-years-old male patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 27May2021 12:31 (Batch/Lot Number: FA7842; Expiration Date: 30Sep2021) as DOSE 2, 0.3ml SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced death on 27May2021. The patient died on 27May2021. It was not reported if an autopsy was performed. Outcome of event was fatal. Sender''s comments: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides) The reporting person classified them as severe. Due to the assessment of the reporting person and the patient''s death, classified the report as "severe". Due to the lack of additional information (potential other chronic diseases, medications used, allergies, etc.) to establish a causal relationship, an unclassified relationship between vaccination and death has been established. In addition, the report included information on the occurrence of adverse reactions on the day of vaccination at 08:00, which is a mistake (the vaccine was given at 12:31). Asked the appropriate sanitary and epidemiological station by e-mail for additional information and explanations. Relatedness of drug to reaction(s)/event(s): Source of assessment:The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Method of assessment : WHO (World Health Organization), Result of Assessment: unclassified No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: Unknown


VAERS ID: 1442225 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-06
Onset:2021-05-21
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-07-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY7015 / 2 LA / 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: 2021-05-21
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: GERD; Hypertension; Spinal osteoarthritis
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLPFIZER INC2021770776

Write-up: Sudden death; This is a spontaneous report from a contactable physician downloaded from the Regulatory Authority-WEB PL-URPL-DML-MLP.4401.3.739.2021. A 68-years-old female patient received bnt162b2 (COMIRNATY), dose 2 intramuscular, administered in Arm Left on 06May2021 12:05 (Batch/Lot Number: EY7015) as DOSE 2, 0.3 ML SINGLE for covid-19 immunisation. Medical history included GERD, Hypertension, Spinal osteoarthritis. The patient''s concomitant medications were not reported. The patient experienced sudden death on 21May2021 05:50 and no hospitalization.The patient died on 21May2021. It was not reported if an autopsy was performed.A letter was sent to the Registry Office regarding the information on the causes of death on the basis of the death certificate. The reporting person classified them as severe. Due to the assessment of the reporting person and the patient''s death, URPL classified the application as severe. Health result: death (date: 21May2021, at 5:50 a.m., cause: unknown) The data contained in the electronic report are all available to the URPL - in the case of obtaining additional information (for which the appropriate sanitary and epidemiological station was asked by e-mail), the next version will be sent .The casual relationship of Comirnaty and event assessed as unclassified by the URPL. Sender Comment: Comirnaty is an mRNA vaccine against COVID-19 (with modified nucleosides) The reporting person classified them as severe. Due to the assessment of the reporting person and the patient''s death, URPL classified the application as severe. Due to the lack of additional information (medications used, allergies, etc.) and the circumstances that could have contributed to / caused the patient''s death, URPL gave an unclassifiable cause-effect relationship between vaccination and death. URPL asked the appropriate sanitary and epidemiological station by e-mail if it already had information on the cause of death entered in the death certificate. No follow-up attempts possible. No further information expected.; Reported Cause(s) of Death: unknown


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